Vimovo uk summary of product characteristics

Vimovo uk summary of product characteristics

30.05.2013, admin
Vimovo uk summary of product characteristics

And AstraZeneca is a fixed-dose combination of enteric-coated naproxen a pain-relieving non-steroidal anti-inflammatory drug NSAID and immediate-release esomeprazole a proton pump inhibitor PPI.The FDA approval was supported by data from a clinical development program including results from the pivotal PN-and PN-studies which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared to patients receiving enteric-coated naproxen.affected by osteoarthritis which is the most common form of arthritis.While many patients with osteoarthritis treat their symptoms with NSAIDs of chronic NSAID users are at risk of gastrointestinal ulcers."In a single pill VIMOVO provides a vimovo uk summary of product characteristics vimovo smart moves proven pain reliever with a built-in PPI for arthritis patients at-risk for NSAID-associated gastric ulcers " said Howard Hutchinson M.D Chief Medical Officer AstraZeneca."The approval also demonstrates the commitment of AstraZeneca and POZEN to provide a new pain relief option that addresses the unmet medical needs of these patients." In the PN-and studies the primary end point was the cumulative incidence of gastric ulcers through six months.In each of the trials patients received either VIMOVO or enteric-coated naproxen mg twice daily over a six-month treatment period.Endoscopies were performed at baseline and at one vimovo uk summary of product characteristics three and six months.Data from study PN-showed a incidence of gastric ulcers in patients taking VIMOVO compared to among patients taking enteric-coated naproxen p..Study PN-showed a incidence of gastric ulcers among patients taking VIMOVO compared to with enteric-coated naproxen p..The most commonly observed adverse events in the clinical trials experienced by of patients in the VIMOVO group were erosive gastritis dyspepsia gastritis diarrhea gastric ulcer upper abdominal pain and nausea.Important Safety Information about VIMOVO Cardiovascular Risk Naproxen a component of VIMOVO may cause an increased risk of serious cardiovascular thrombotic events myocardial infarction and stroke vimovo uk summary of product characteristics which can be fatal.This risk may increase with duration of use.Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft CABG surgery.Gastrointestinal Risk NSAIDs including naproxen a component of VIMOVO cause an increased risk of serious gastrointestinal adverse events including bleeding ulceration and perforation of the stomach or intestines which can be fatal.These events can occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious vimovo uk summary of product characteristics gastrointestinal GI events.VIMOVO is contraindicated in patients with known hypersensitivity to any component of VIMOVO or substituted benzimidazolesin patients with a history of asthma urticaria or other allergic-type reactions after taking aspirin or other NSAIDsin patients during the peri-operative period in the setting of coronary artery bypass graft CABG surgeryor in patients in the late stages of pregnancy.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.Treatment should be withdrawn when active and clinically significant bleeding from any source occurs.As with all NSAIDs VIMOVO can lead to the onset vimovo uk summary of product characteristics of new hypertension or worsening of pre-existing hypertension either of which may contribute to the increased incidence of CV events.Blood pressure should be monitored closely.Fluid retention and edema have been observed in some patients taking NSAIDs including VIMOVO.NSAIDs should be used with caution in patients with fluid retention or heart failure.NSAIDs including VIMOVO may diminish the antihypertensive effect of angiotensin converting enzyme ACE inhibitors and angiotensin II antagonists beta-blockers and in some patients can reduce the natriuretic effect of furosemide and thiazides.VIMOVO can be administered with low-dose aspirin less than or equal to mg vimovo uk summary of product characteristics day therapy.The concurrent use of aspirin and VIMOVO may increase the risk of serious adverse events.VIMOVO is not recommended in patients with moderate or severe renal insufficiency.In addition NSAIDs may cause renal toxicity.VIMOVO is not recommended in patients with severe hepatic insufficiency.Consider dose reduction in mild moderate hepatic insufficiency.If abnormal liver enzymes persist or worsen discontinue use immediately.Serious skin adverse reactions such as exfoliative dermatitis Stevens-Johnson syndrome and toxic epidermal necrolysis which can vimovo uk summary of product characteristics be fatal and can occur without warning.Discontinue VIMOVO at first appearance of skin rash or any other sign vimovo uk summary of product characteristics of hypersensitivity.Symptomatic response to esomeprazole a component of VIMOVO does not preclude the presence of gastric malignancy.Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole of which VIMOVO contains an enantiomer.Several studies and literature reports indicate that long-term proton pump inhibitor PPI therapy is associated with an increased risk for osteoporosis-related fractures of the hip wrist or spine.Esomeprazole a component of VIMOVO inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability eg ketoconazole iron salts and vimovo uk summary of product characteristics digoxin.Concomitant use of VIMOVO and warfarin may result in increased risk of bleeding complications.Monitor for increases in INR and prothrombin time.The most commonly observed adverse events in clinical trials experienced by patients in the VIMOVO group were erosive gastritis dyspepsia gastritis diarrhea gastric ulcer upper abdominal pain and nausea. Not upwards of three days until authorize our app vIMOVO clonazepam and tramadol may increase your dose.Audience ampEar Heart Infectious sickness Men's Health Mental hale condition University of clonazepam and tramadol southerly Florida.Tonic-clonic seizures are nice oras clonazepam and tramadol Cardiovascular Risk Non-Steroidal Anti-inflammatory vimovo uk summary of product characteristics Drugs NSAIDs a component of VIMOVO may cause an increased risk of serious cardiovascular thrombotic events myocardial infarction and stroke which can be fatal.This risk may increase with duration of use.Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk see Warnings and Precautions .VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft CABG surgery see Contraindications and Warnings and Precautions .Gastrointestinal Risk NSAIDs including naproxen a component of VIMOVO cause an increased risk of serious gastrointestinal adverse events including bleeding ulceration and vimovo uk summary of product characteristics perforation of the stomach or intestines which can be fatal.These events can occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious gastrointestinal events see Warnings and Precautions .VIMOVO is a combination product that contains naproxen and esomeprazole.It is indicated for the relief of signs and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed vimovo uk summary of product characteristics compared to absorption from other naproxen-containing products. Keep VIMOVO and all medicines vimovo is it good out of the reach of children.General information about VIMOVO Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide.Do not use VIMOVO for a condition for which it was not prescribed.Do not give VIMOVO to other people even if they have the same symptoms you have.It may harm them.This Medication Guide summarizes the most important information about VIMOVO.If you would like more information ask your healthcare provider.You can ask your healthcare provider or pharmacist for information vimovo uk summary of product characteristics that is written for healthcare professionals.For more information call -What are the ingredients in VIMOVO. If you are pregnant.NSAID medicines should not be used by pregnant women late in their pregnancy.if you are breastfeeding.Talk to your healthcare provider.What are the possible side effects of Non–Steroidal Anti–Inflammatory Drugs NSAIDs. Pharmacodynamic parameters were also measured and demonstrated that the change in inhibition of platelet aggregation was related to the change in the exposure to clopidogrel active metabolite.Special Populations Geriatric Patients There is no specific data on the pharmacokinetics of Vimovo in patients over age Studies vimovo uk summary of product characteristics indicate that although total plasma concentration of naproxen is unchanged the unbound plasma fraction of naproxen is increased in the elderly although the unbound fraction is of the total naproxen concentration.Unbound trough naproxen concentrations in elderly subjects have been reported to range from to of total naproxen concentration compared with to in younger subjects.The clinical significance of this finding is unclear although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients see Adverse Reactions and vimovo uk summary of product characteristics Use in Specific Populations .The AUC and Cmax values of esomeprazole were slightly higher and respectively in the elderly as compared to younger subjects at steady state.Dosage adjustment for the esomeprazole component based on age is not necessary.Race Pharmacokinetic differences due to race have not been studied for naproxen.Approximately of Caucasians and to of Asians lack a functional CYPC enzyme and are called poor metabolizers.In these individuals the metabolism of esomeprazole is probably mainly catalyzed by CYPA.After repeated once-daily administration of mg esomeprazole the mean area under the plasma concentration-time curve was approximately higher vimovo uk summary of product characteristics in poor metabolizers than in subjects having a functional CYPC enzyme extensive metabolizers.Hepatic Insufficiency The pharmacokinetics of Vimovo or naproxen have not been determined in subjects with hepatic impairment.In patients with severe hepatic impairment Vimovo should be avoided due to increase of risk of NSAID associated bleeding and or renal failure associated with naproxen.Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen but the plasma concentration of unbound naproxen is increased.The implication of this finding for the naproxen component of Vimovo dosing is unknown but it vimovo uk summary of product characteristics is prudent to use the lowest effective dose.The AUCs of esomeprazole in patients with severe hepatic insufficiency Child Pugh Class C have been shown to be times higher than in patients with normal liver function.For this reason it has been recommended that esomeprazole doses not exceed mg daily in patients with severe hepatic impairment.However there is no dose adjustment necessary for patients with Child Pugh Class A and B for the esomeprazole component of Vimovo.There is no Vimovo dosage form that contains less than mg esomeprazole for twice daily dosing see Dosage and Administration Warnings vimovo uk summary of product characteristics and Precautions and Use in Specific Populations .Renal Insufficiency The pharmacokinetics of Vimovo or naproxen have not been determined in subjects with renal impairment.Given that naproxen its metabolites and conjugates are primarily excreted by the kidney the potential exists for naproxen metabolites to accumulate in the presence of renal insufficiency.Elimination of naproxen is decreased in patients with severe renal impairment.Naproxen-containing products including Vimovo is not recommended for use in patients with moderate to severe and severe renal impairment creatinine clearance ml min see Dosage and Administration Warnings and Precautions and Use in Specific Populations .No studies vimovo uk summary of product characteristics have been performed with esomeprazole in patients with decreased renal function.Since the kidney is responsible for the excretion of the metabolites of esomeprazole but not for the elimination of the parent compound the metabolism of esomeprazole is not expected to be changed in patients with impaired renal function.Gender The AUC and Cmax values of esomeprazole were slightly higher in females than in males at steady state.Dosage adjustment for the esomeprazole component based on gender is not necessary.Nonclinical Toxicology Carcinogenesis Mutagenesis Impairment of Fertility Naproxen A -year study was performed in rats to evaluate the vimovo uk summary of product characteristics carcinogenic potential of naproxen at rat doses of and mg kg day and mg m.The maximum dose used was times the highest recommended human dose.No evidence of tumorigenicity was found.Esomeprazole The carcinogenic potential of esomeprazole was assessed using omeprazole studies.In two -month oral carcinogenicity studies in rats omeprazole at daily doses of and mg kg day about to times the human dose of mg day expressed on a body surface area basis produced gastric ECL cell carcinoids in a dose-related manner in both male and female ratsthe incidence of this effect was markedly higher in vimovo uk summary of product characteristics female rats which had higher blood levels of omeprazole.Gastric carcinoids seldom occur in the untreated rat.In addition ECL cell hyperplasia was present in all treated groups of both sexes.In one of these studies female rats were treated with mg omeprazole kg day about times the human dose on a body surface area basis for year then followed for an additional year without the drug.No carcinoids were seen in these rats.An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of year treated vs controls.By the second year the difference between vimovo uk summary of product characteristics treated and control rats was much smaller vs but still showed more hyperplasia in the treated group.Gastric adenocarcinoma was seen in one rat No similar tumor was seen in male or female rats treated for years.For this strain of rat no similar tumor has been noted historically but a finding involving only one tumor is difficult to interpret.A -week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence but the study was not conclusive.Esomeprazole was negative in the Ames mutation test in the in vivo rat bone marrow cell chromosome aberration test and the in vivo mouse micronucleus test.Esomeprazole however was positive in the in vitro human lymphocyte chromosome aberration test.Omeprazole was positive in the in vitro human lymphocyte chromosome aberration test the in vivo mouse bone marrow cell chromosome aberration test and the in vivo mouse micronucleus test.The potential effects of esomeprazole on fertility and reproductive performance were assessed using omeprazole studies.Omeprazole at oral doses up to mg kg day in rats about times the human dose on a body surface area basis was found to have no effect on reproductive performance of parental animals.Animal Toxicology and or Pharmacology Naproxen Reproductive studies have been performed in rats at mg kg day mg m day .times the maximum recommended human dose rabbits at mg kg day mg m day .times the maximum recommended human dose and mice at mg kg day mg m day .times the maximum recommended human dose with no evidence of impaired fertility or harm to the fetus due to the drug.However animal reproduction studies are not always predictive of human response.Esomeprazole Reproductive studies have been performed in rats at oral doses up to mg kg day about vimovo uk vimovo uk summary of product characteristics summary of product characteristics times the human dose on a body surface area basis and in rabbits at oral doses up to mg kg day about times the human dose on a body surface area basis and have revealed no evidence of impaired fertility or harm to the fetus due to esomeprazole.Reproductive studies conducted with omeprazole in rats at oral doses up to mg kg day about times the human dose on a body surface area basis and in rabbits at doses up to mg kg day about times the human dose on a body surface area basis vimovo uk summary of product characteristics did not disclose any evidence for a teratogenic potential of omeprazole.In rabbits omeprazole in a dose range of to mg kg day about to times the human dose on a body surface area basis produced dose-related increases in embryo-lethality fetal resorptions and pregnancy disruptions.In rats dose-related embryo fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at to mg kg day about to times the human doses on a body surface area basis.Clinical Studies Two randomized multi-center double-blind trials Study and Study compared the incidence of gastric ulcer formation vimovo uk summary of product characteristics in patients taking Vimovo and patients taking enteric-coated naproxen.Subjects were at least years of age with a medical condition expected to require daily NSAID therapy for at least months and if less than years old with a documented history of gastric or duodenal ulcer within the past years.The majority of patients were female white The majority of patients were -years of age Approximately one quarter were on low-dose aspirin.Studies and showed that Vimovo given as mg mg twice daily statistically significantly reduced the -month cumulative incidence of gastric ulcers compared to enteric-coated naproxen mg twice daily vimovo uk summary of product characteristics see Table Approximately a quarter of the patients in Studies and were taking concurrent low-dose aspirin ≤ mg daily.The results for this subgroup analysis in patients who used aspirin were consistent with the overall findings of the study.The results at one month three months and six months are presented in Table Table – Cumulative Observed Incidence of Gastric Ulcers at and Months Study Study Vimovo N number EC-naproxen N number trials patients receiving Vimovo had a mean duration of therapy of days compared to days in patients receiving enteric-coated naproxen alone.A higher proportion of patients vimovo uk summary of product characteristics taking EC-naproxen discontinued the study due to upper GI adverse events including duodenal ulcers compared to Vimovo in both trials see Adverse Reactions The efficacy of Vimovo in treating the signs and symptoms of osteoarthritis was established in two -week randomized double-blind placebo-controlled trials in patients with osteoarthritis OA of the knee.In these two trials patients were allowed to remain on low-dose aspirin for cardioprophylaxis.Vimovo was given as mg mg twice daily.In each trial patients receiving Vimovo had significantly better results compared to patients receiving placebo as measured by change from baseline of the WOMAC pain subscale and the WOMAC physical function subscale and a Patient Global Assessment Score.Based on studies with enteric-coated naproxen improvement in patients treated for rheumatoid arthritis was demonstrated by a reduction in joint swelling a reduction in duration of morning stiffness a reduction in disease activity as assessed by both the investigator and patient and by increased mobility as demonstrated by a reduction in walking time.In patients with osteoarthritis the therapeutic action of naproxen has been shown by a reduction in joint pain or tenderness an increase in range of motion in knee joints increased mobility as demonstrated vimovo uk summary of product characteristics by a reduction in walking time and improvement in capacity to perform activities of daily living impaired by the disease.In patients with ankylosing spondylitis naproxen has been shown to decrease night pain morning stiffness and pain at rest.How Supplied Storage and Handling Vimovo mg mg tablets are oval yellow film-coated tablets printed with in black ink supplied as NDC Bottles of tablets Vimovo mg mg tablets are oval yellow film-coated tablets printed with in black ink supplied as NDC Bottles of tablets NDC Unit Dose Blisters package of tablets Storage Store at °C °Fexcursions permitted to -°C vimovo uk summary of product characteristics -°F see USP Controlled Room Temperature.Store in the original container and keep the bottle tightly closed to protect from moisture.Dispense in a tight container if package is subdivided.Patient Counseling Information See FDA-Approved Medication Guide Patients should be informed of the what is vimovo pills following before initiating therapy with Vimovo and periodically during the course of ongoing therapy.Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. Was previously taking amiptry.Was in a car accident in feb hurt back and left knee.have done physical therapy epid.My name is Patrick vimovo uk summary of product characteristics and Im years old.I was recently diagnosed with syringomyelia a few. Vimovo which contains naproxen a nonsteroidal anti-inflammatory drug NSAID and esomeprazole magnesium may increase the chance of a heart attack or stroke that can lead to death.This chance increases with longer use of NSAID medicines in people who have heart disease NSAID-containing medicines such as Vimovo should never be used right before or after a heart surgery called a coronary artery bypass graft CABG.NSAID-containing medicines such as Vimovo can cause ulcers and bleeding in the stomach and intestines at any time during treatment.Ulcers and vimovo uk summary of product characteristics bleeding can happen without warning symptoms may cause death The chance of a person getting an ulcer or bleeding increases with taking medicines called steroid hormones corticosteroids and blood thinners anticoagulants longer use smoking drinking alcohol older age having poor health NSAID medicines should only be used exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs NSAIDs. Human bodies though are far much superior to machines as they tramadol medication can sense distress and send signals of discomfort to the brain.Many studies carried out over vimovo vimovo uk summary of product characteristics cash price the past years have demonstrated the benefits of these.To tramadol medication process several characters of knee pain is a usual goal to bump the provocative cycle.As you age your body starts to tramadol medication deteriorate slowly eventually leading to severe knee pain.With tramadol medication society getting more energetic today causes progressively high knee problems.The general anatomy of the knee integrated function is being to bend and correct.They affect people of all ages but are very common in the tramadol medication older generation.Back pain problems can be categorized according to many factors.vimovo uk summary of product characteristics When I needed to make a return due to improper size the service was great.The order was shipped very quickly once submitted online.The velcro wrap is great makes for a tight fit and really helps my tendinitis.Active WrapR provides my athletes and tramadol medication patients are incredible.My two baseball-playing boys needed something to use post-game on their throwing arms.An Ice Wrap is tramadol medication the easiest way to apply ice to several places.November I had surgery on my left hand again the Ice Wrap was such a huge help.I have a Herniated product uk characteristics of summary vimovo disc and tramadol medication have been using other products but none of them tramadol medication have worked better than my new wrap.The tramadol medication wrap part is great too but as both of my shoulders are affected its too painful for me to put on by myself.Our tramadol medication exclusive best selling formulas practically wipe your discomfort tramadol medication away. My fiance went to the doctor this afternoon after being overdue for a check up.What went from a simple check up turned into a doctor prescribing him the medication Vimovo.He told me when he vimovo uk summary of product characteristics got home that the side effects were mild but being the paranoid woman I am I Googled it.I didn't like what I found.I'm very worried.High blood pressure runs in his family he has Asthma and he has a heart murmor he monitors.This is what I found about it but then again it's the internet.I could just be paranoid."Side-effects of Vimovo are generally mild but the naproxen component can be offensive causing a number of serious side-effects that include-Symptoms of heart attack that include pain in chest difficulty in breathing or vimovo uk summary of product characteristics pain in arms and shoulders.Asthma getting worseHypertensionSymptoms of stroke that include inaudible speech and confusionSymptoms of digestive tract bleeding that include blood in vomiting and black or tarry stools.Liver damage signs like jaundice or increased liver enzymesSigns of hypomagnesemia like seizures arrhythmia or muscle spasms."Has anyone out there taken this drug yet. The risk of bleeding ulcer associated with Vimovo and other NSAIDs increases if you also take corticosteroids or blood thinners smoke drink alcohol are in poor health or are elderly.Are there drug interactions associated with Vimovo. Plachetka expressed a desire to have a vimovo uk summary of product characteristics partnership in place on PA before the end of the second quarter Pozen has been very good at signing commercialization partnerships.The company landed pharmaceutical giant GlaxoSmithKline GSK in June to help develop and commercialize the U.S. Vimovo contains medicines naproxen a non-steroidal anti-inflammatory drug NSAID and esomeprazole magnesium a proton pump inhibitor PPI.Vimovo is a prescription medicine used to relieve signs and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis decrease the risk of developing stomach gastric ulcers in people who are at risk of developing gastric ulcers with NSAIDs It is not known if Vimovo vimovo uk summary of product characteristics is safe or effective in children under the age of Who should not take Vimovo. Swallow whole do not split chew crush.Overdosage View Vimovo overdosage for action to be taken in the event of an overdose.Contraindications Hypersensitivity to substituted benzimidazoles.History of asthma urticaria or aspirin or other NSAID-induced allergic-type reactionssevere hepatic impairment. What will it do for me?This is a combination medication that contains esomeprazole and naproxen.Esomeprazole belongs to the class of medications called proton pump inhibitors and naproxen belongs to the class of medications called nonsteroidal anti-inflammatory drugs NSAIDs.This combination medication vimovo uk summary of product characteristics is used to treat signs and symptoms of osteoarthritis OA rheumatoid arthritis RA and ankylosing spondylitis long-term inflammation disease of the joints and to decrease the risk of developing stomach ulcers in people at risk for developing stomach ulcers due to NSAIDs.Esomeprazole works by reducing the amount of acid that stomach produces.Naproxen relieves pain and reduces swelling and inflammation by reducing a substance in the body that leads to inflammation and pain.If immediate relief of pain is desired esomeprazole naproxen should not be used as it releases medication over a longer period of time.Your doctor vimovo uk summary of product characteristics may have suggested this medication for conditions other than those listed in these drug information articles.As well some forms of this medication may not be used for all of the conditions discussed here.If you have not discussed this with your doctor or are not sure why you are taking this medication speak to your doctor.Do not stop taking this medication without consulting your doctor.Do not give this medication to anyone else even if they have the same symptoms as you do.It can be harmful for people to take this medication if their doctor has vimovo uk summary of product characteristics not prescribed it.How should I use Vimovo?The recommended daily dose of esomeprazole naproxen is one mg tablet twice daily or one mg tablet twice daily. And the icing on the cake is the increased risk of heart abnormalities associated with this pain reliever.Despite all of this some prescribers love to write for it.And what is worse the most typical form of the drug is sold under the brand name Darvocet-N which has too much acetaminophen coupled with the propoxyphene which severely limits the safe dosage.I challenge anyone to find a practicing pharmacist anywhere that vimovo uk summary of product characteristics actually considers this a good drug for pain relief.I am definitely one vote for taking this product off the market.It is that bad. Why isn't the person consuming the product able to access it without the help of a doctor and an insurance company. Nonmedicinal ingredients carnauba wax croscarmellose sodium glycerol monostearate hypromellose iron oxide black iron oxide yellow macrogols magnesium stearate methacrylic acid-ethyl acrylate copolymer dispersion methyl parahydroxybenzoate polydextrose polysorbate povidone propylene glycol propyl parahydroxybenzoate silica colloidal anhydrous titanium dioxide and triethyl citrate. Inhibition of platelet aggregation by clopidogrel is entirely due to an active vimovo uk summary of product characteristics metabolite.The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications such as esomeprazole that inhibit CYPC activity.Concomitant use of clopidogrel with mg esomeprazole reduces the pharmacological activity of clopidogrel.When using esomeprazole a component of VIMOVO consider alternative anti-platelet therapy see Drug Interactions and Pharmacokinetics Bone Fracture Several published observational studies suggest that proton pump inhibitor PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip wrist or spine.The risk of fracture was increased in patients who received high-dose defined as multiple daily doses vimovo uk summary of product characteristics and long-term PPI therapy a year or longer.Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines.see Dosage and Administration and Adverse Reactions .VIMOVO a combination PPI NSAID is approved for use twice a day and does not allow for administration of a lower daily dose of the PPI.see Dosage and Administration Masking of Inflammation and Fever The pharmacological activity of VIMOVO in reducing fever and inflammation may diminish the utility of these vimovo uk summary of product characteristics diagnostic signs in detecting complications of presumed noninfectious noninflammatory painful conditions.Laboratory Tests Because serious GI tract ulcerations and bleeding can occur without warning symptoms physicians should monitor for signs or symptoms of GI bleeding.Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically.If clinical signs and symptoms consistent with liver or renal disease develop systemic manifestations occur eg eosinophilia rash etc.or if abnormal liver tests persist or worsen VIMOVO should be discontinued.Patients with initial hemoglobin values of g or less who are to receive long-term therapy should have vimovo uk summary of product characteristics hemoglobin values determined periodically.Serum chromogranin A CgA levels increase secondary to drug-induced decreases in gastric acidity.The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.Providers should temporarily stop esomeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high.If serial tests are performed e.g.for monitoring the same commercial laboratory should be used for testing as reference ranges between tests may vary see Pharmacodynamics .Hypomagnesemia Hypomagnesemia symptomatic and asymptomatic has been reported rarely in patients treated with PPIs for at least three months vimovo uk summary of product characteristics in most cases after a year of therapy.Serious adverse events include tetany arrhythmias and seizures.In most patients treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia e.g diuretics health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.see Adverse Reactions .Concomitant use of St John's Wort or Rifampin with VIMOVO Drugs that induce CYPC or CYPA such as St John’s Wort or rifampin vimovo uk summary of product characteristics can substantially decrease esomeprazole concentrations.Avoid concomitant use of VIMOVO with St John’s Wort or rifampin see Drug Interactions Concomitant use of VIMOVO with Methotrexate Literature suggests that concomitant use of PPIs with methotrexate primarily at high dosesee methotrexate prescribing information may elevate and prolong serum levels of methotrexate and or its metabolite possibly leading to methotrexate toxicities.In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients.see Drug Interactions Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of vimovo uk summary of product characteristics a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The adverse reactions reported below are specific to the clinical trials with VIMOVO.See also the full prescribing information for naproxen and esomeprazole magnesium products. Your pharmacist can provide more information about esomeprazole and naproxen.Remember keep this and all other medicines out of the reach of children never share your medicines with others and use this medication only for the indication prescribed.Every effort has been made to ensure that the information provided by vimovo uk summary of product characteristics Cerner Multum Inc.'Multum' is accurate up-to-date and complete but no guarantee is made to that effect.Drug information contained herein may be time sensitive.Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate unless specifically indicated otherwise.Multum's drug information does not endorse drugs diagnose patients or recommend therapy.Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and or to serve consumers viewing this vimovo uk summary of product characteristics service as a supplement to and not a substitute for the expertise skill knowledge and judgment of healthcare practitioners.The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe effective or appropriate for any given patient.Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.The information contained herein is not intended to cover all possible uses directions precautions warnings drug interactions allergic reactions or adverse effects.If you have questions vimovo uk summary of product characteristics about the drugs you are taking check with your doctor nurse or pharmacist.Copyright -Cerner Multum Inc.Version .Revision date Your use of the content provided in this service indicates that you have read understood and agree to the End-User License Agreement which can be accessed by clicking on this link.Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Pozen's PA product combines mg aspirin and mg delayed-release omeprazole.Omeprazole is the active ingredient in AastraZeneca's Prilosec but is now available both vimovo uk summary of product characteristics as a generic and over-the-counter.The problem with Vimovo however is the pricing strategy.Vimovo costs around per pill per day without a prescription.Although cheaper than branded Celebrex at around per day Pfizer has spent years building brand awareness and formulary coverage for Celebrex and the drug is now widely covered at Tier For most people this may be a -co-pay for a one month prescription.

Take the missed dose as soon as you remember.Skip the missed dose if it is almost time for your next scheduled dose.Do not take extra medicine to make up the missed dose.Back to Top Show reviews of VIMOVO for Sort by AllRheumatoid Arthritis reviews Most RecentHighest Primary Outcome Measures Change in area under the plasma concentration-time curve AUC from time zero to infinity Time Frame Pre-dose to Day Designated as safety issue No Secondary Outcome Measures Number of subjects with Adverse Events as a measure of Safety and Tolerability Time Frame Day Designated as safety issue Yes Number of subjects with Adverse Events as a measure of Safety and Tolerability Time Frame Day Designated as safety issue Yes Number of subjects with Adverse Events as a measure of vimovo uk summary of product characteristics Safety and Tolerability Time Frame Day Designated as safety issue Yes Number of subjects with Adverse Events as a measure of Safety and Tolerability Time Frame Day Designated as safety issue Yes A Phase I Open-label Randomised -way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation Manufactured by Roche in Healthy Volunteers. General information about Vimovo Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide.Do not use vimovo uk summary of product characteristics Vimovo for a condition for which it was not prescribed.Do not give Vimovo to other people even if they have the same symptoms you have.It may harm them.This Medication Guide summarizes the most important information about Vimovo.If you would like more information ask your healthcare provider.You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.For more information call -or go to What are the ingredients in Vimovo. AstraZeneca lança anti-inflamatório com protetor gástrico Vimovo é o primeiro medicamento a combinar a ação anti-inflamatória com a proteção gástrica vimovo uk summary of product characteristics em um único comprimido e está indicado para o alívio dos sintomas da artrite reumatoide espondilite aquilosante e osteoartrite São Paulo novembro de – A AstraZeneca lança no mercado brasileiro o Vimovo naproxeno associado ao esomeprazol magnésio para o controle das dores decorrentes de processos inflamatórios em pacientes com artrite reumatoide espondilite aquilosante e osteoartrite.Vimovo é indicado para o alívio de sinais e sintomas das três doenças.Trata-se de uma associação de dose fixa de naproxeno com revestimento entérico um antiinflamatório não esteroidal para alívio da dor e esomeprazol de liberação imediata um inibidor da bomba de vimovo uk summary of product characteristics prótons vimovo erowid IBP.Esta configuração permite que o esomeprazol seja absorvido antes do que o naproxeno permitindo assim o início da proteção gástrica antes que se atinja a máxima concentração do naproxeno no sangue.Com mais esse lançamento a AstraZeneca reforça sua atuação na área de reumatologia dor e inflamação atrelando sua experiência no ramo das doenças gastrointestinais.O medicamento estará disponível no mercado a partir de º de outubro.Ficha técnica Produto Naproxeno + Esomeprazol magnésio Indicações Uso AdultoVia Oral.Indicado para alívio sintomático no tratamento da artrite reumatoide osteoartrite e espondilite anquilosante em pacientes com risco de desenvolver vimovo uk summary of product characteristics úlceras gástricas ou duodenais associadas ao uso de antiinflamatórios não esteroidais AINEs. Swallow whole do not split chew crush.Overdosage View Vimovo overdosage for action to be taken in the event of an overdose.Contraindications Hypersensitivity to substituted benzimidazoles.History of asthma urticaria or aspirin or other NSAID-induced allergic-type reactionssevere hepatic impairment. Please see Important Safety Information and Prescribing Information for VIMOVO including Boxed Warnings.NOTES TO EDITORS About VIMOVO VIMOVOis a fixed-dose combination of delayed-release enteric-coated naproxen a non-steroidal anti-inflammatory drug NSAID and immediate-release esomeprazole a stomach acid-reducing proton pump inhibitor PPI approved for the relief of signs vimovo uk summary of product characteristics and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.VIMOVO is not recommended for use in children younger than years of age.VIMOVO has been developed as a sequential-delivery tablet formulation combining an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core.As a result esomeprazole is released first in the stomach prior to the dissolution of naproxen in the small intestine.The enteric coating prevents naproxen release at pH levels below providing protection against possible local gastric toxicity of naproxen.vimovo uk summary of product characteristics AstraZeneca submitted a Marketing Authorization Application MAA to the European Medicines Association EMEA for VIMOVO on October .Upon the FDA's notification of approval of the New Drug Application for VIMOVO a million milestone payment from AstraZeneca will be payable to POZEN.About Osteoarthritis Osteoarthritis is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints.Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain affecting million individuals worldwide and million Americans.A combination of factors can contribute to osteoarthritis including being vimovo uk summary of product characteristics overweight aging joint injury or stress heredity and muscle weakness.Osteoarthritis commonly affects the hands spine or large weight-bearing joints such as the hips and knees.About Rheumatoid Arthritis Rheumatoid arthritis is a chronic disease mainly characterized by inflammation of the lining or synovium of the joints.It can lead to long-term joint damage resulting in chronic pain loss of function and disability.About Ankylosing Spondylitis Ankylosing spondylitis is a chronic inflammatory disease that primarily causes pain and inflammation of the joints between the vertebrae of the spine and the joints between the spine and pelvis sacroiliac joints.Ankylosing vimovo uk summary of product characteristics spondylitis may also cause inflammation and pain in other parts of the body as well.ABOUT POZEN POZEN Inc headquartered in Chapel Hill NC is a pharmaceutical company committed to transforming medicine that Ireland -May-HealthPRZone.com Irish Medical Information PRESS RELEASENew Product Introduction Vimovo® naproxen esomeprazole Tuesday rd May AstraZeneca is pleased to announce the introduction of a new product Vimovo.Vimovo is the first and only NSAID PPI combination tablet offering proven NSAID pain relief with abuilt-in PPI.Each modified-release Vimovo tablet contains mg enteric-coated gastro-resistant naproxen and mg film-coated esomeprazole as magnesium trihydrate.Vimovo is indicated for vimovo uk summary of product characteristics the symptomatic treatment of osteoarthritis rheumatoid arthritis and ankylosingspondylitis in patients who are at risk for developing non-steroidal anti-inflammatory drugNSAID-associated gastric and or duodenal ulcers and where treatment with lower doses of naproxen orof other NSAIDs is not considered sufficient.In clinical trials it has been shown that the incidence of endoscopic gastric and duodenal ulcerswas significantly lower with Vimovo treatment compared to enteric-coated naproxen mg twicedaily alone without esomeprazole or other PPI during a -month treatment period.Vimovo can be administered with low-dose aspirin therapy.In clinical trials patients taking Vimovo incombination with low-dose aspirin did not have vimovo uk summary of product characteristics an increased occurrence of endoscopic gastric ulcerscompared to patients taking Vimovo alone.Vimovo is not intended for the treatment of acute pain conditions such as dental pain or gout.However flares of osteoarthritis rheumatoid arthritis and ankylosing spondylitis may be treated with Vimovo.The dose in adults is tablet mg mg twice daily.Vimovo must be swallowed whole with water andnot split chewed or crushed.It is recommended that Vimovo is taken at least minutes prior to foodintake.It is supplied in a tablet bottle.We know cost can be a concern nowadays.The good news is that how vimovo uk summary of product characteristics do you take vimovo Vimovo at €.for a tablet bottleMIMS Ireland actually costs less than if you prescribed the least Vimovo AlcoholVimovo generic name esomeprazole and naproxen contains a combination of two drugs which is used to treat symptoms of of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and also helps reduce the risk of stomach ulcers in people who may be at risk.Naproxen to a family of drugs known as nonsteroidal anti-inflammatory drugs NSAID which work by reducing substances in the body which cause inflammation pain and fever.Esomeprazole is a proton pump inhibitor which decreases vimovo uk summary of product characteristics the amount of acid produced in the stomach.It is suggested moderate drinking only while using this drug as the drug’s effectiveness may be decreased and the side effects may be increased.At this time the medical community defines moderate consumption of alcohol as no more than two drinks per day and no more than drinks per week.If anything more than that it is considered an unhealthy dependency on alcohol that may have adverse social family and health consequences.If a person drinks only once or twice a week but drinks on the same days each week and vimovo uk summary of product characteristics more than two drinks this is considered as an alcohol dependency.If a person binge drinks at any time during the week this is also considered as alcoholism.Some consider alcoholism as a disease while others consider it an addiction which is the result of personal choice and character fault.This school of thought blames the alcoholism on life style choices.Personally I consider alcoholism a genetic tendency as I have seen families of alcoholics even when they live far apart.These unfortunate people are probably dependent on alcohol from the first drink.When alcohol interacts with prescription or vimovo uk summary of product characteristics over the counter drugs it usually results in negative health effects most especially liver damage as the main organ affected.Before using this drug advise your doctor if you are allergic to any other drug or substance if you are using dietary or herbal supplements are pregnant plan to be or are breastfeeding have a history of kidney or liver disease heart disease high blood pressure fluid retention history of stroke heart attack or congestive heart failure loe levels of magnesium in the blood bleeding or blood clot disorder hemphilia history of stomach ulcer stomach bleeding intestinal disorder such vimovo uk summary of product characteristics as Crohn’s disease or ulcerative colitis asthma allergy to aspirin or if you smoke.Side EffectsLess serious side effects are constipation diarrhea or mild stomach pain.If these occur call your physician for advice.Serious side effects are severe allergic reactions such as hives difficult breathing tight chest swelling of the mouth face lips or tongue black bloody stools changes in urination chest pain confusion dark urine depression fainting fast irregular heartbeat fever chills sore throat loss of appetite mental or mood changes numb arm or leg one side weakness pale stools red swollen blistered peeling skin ringing vimovo uk summary of product characteristics in ears seizures severe headache or dizziness severe persistent stomach pain or nausea severe vomiting short of breath weight gain swelling of hands legs or feet bruising or bleeding joint or muscle pain tired or weak vision or speech problems granular vomit or jaundice.If these occur get emergency medical help.This site serves as an information source only and does not dispense medical advice or any other kind of advice.If you are seeking medical advice you are advised to consult your own physician.Vimovo Alcohol Vimovo AlcoholDrugs and AlcoholReturn from Vimovo Alcohol to home page This is vimovo uk summary of product characteristics Google's cche of It is a snapshot of the page as it appeared on May GMT.The current page could have changed in the meantime.Learn moreTip To quickly find your search term on this Date Sunday May Recently Food and Drug Administration USA approved Vimovo containing naproxen and esomeprasol for treating patients with arthritis with increased risk if NSAID-associated gastric ulcers.Vimovo is used to relieve symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis as well as to reduce the risk of stomach ulcers in patients with high risk of developing NSAID-associated ulcers.The medication contains two vimovo uk summary of product characteristics active ingredients – naproxen.Naproxen is a painkiller that belongs to a group of medicines called NSAID’s.The second component of Vimovo is esomeprasole that is immediate release proton pump inhibitor.Esomeprasole works by inhibiting the production of gastric acid for the stomach.FDA decision is based on the results of the clinical trials showed a significant reduction in the incidence of gastric ulcers compared with naproxen in monotherapy vs.The most common Vimovo side effects include indigestion diarrhea abdominal pain and nausea.An analyst from a Swiss bank «UBS AG Gbola Amous Gbola Amusa predicts that sales of vimovo uk summary of product characteristics Vimovo will reach millions of US dollars in year.According to the terms of license agreement between Astra Zeneca and Prozen Astra Zeneca will pay nearly millions US dollars to Prozen after Vimovo approval by FDA.In addition Prozen will get royalties from sales of this product. Methotrexate used to treat rheumatoid arthritis psoriasis and cancer.Probenecid for gout.

Kombinasjonsbehandling med beskyttende midler bør vurderes for slike pasienter og også for pasienter som trenger samtidig behandling med lavdose ASA eller andre legemidler som øker risikoen for gastrointestinale komplikasjoner.Pasienter med tidligere gastrointestinal toksisitet spesielt eldre bør melde fra om vimovo uk summary of product characteristics ev.uvanlige magesymptomer spesielt gastrointestinal blødning særlig i begynnelsen av behandlingen.Forsiktighet bør utvises ved samtidig bruk av legemidler som kan øke risikoen for sår eller blødning f.eks.orale kortikosteroider antikoagulanter som warfarin SSRIer eller blodplatehemmere som ASA.NSAIDs skal gis med forsiktighet til pasienter med tidligere gastrointestinale sykdommer ulcerøs kolitt Crohns sykdom da disse sykdommene kan forverres.Ved ev.alarmsymptomer f.eks.signifikant uventet vekttap stadige brekninger oppkast dysfagi hematemese eller melena og hvis gastrisk sår mistenkes eller er påvist skal malignitet utelukkes da behandling med esomeprazol kan maskere symptomene og forsinke diagnosen.Dyspesi kan fortsatt vimovo uk summary of product characteristics forekomme til tross for innholdet av esomeprazol.Behandling med protonpumpehemmere kan føre til svak økning i risiko for gastrointestinale infeksjoner som Salmonella og Campylobacter.Aseptisk meningitt Det kan være økt risiko for aseptisk meningitt hos pasienter med systemisk lupus erythematosus SLE og blandet bindevevssykdom.Hos disse pasientene bør naproksen kun brukes etter nøye avveining av fordeler og risiko.Vitamin B Esomeprazol kan redusere absorpsjonen av vitamin B grunnet hypo-eller aklorhydri.Kardiovaskulære og cerebrovaskulære effekter Tilstrekkelig monitorering og rådgivning er påkrevd ved hypertensjon og eller mild til moderat kongestiv hjertesvikt i anamnesen da væskeretensjon og ødemer er rapportert i forbindelse vimovo uk summary of product characteristics med NSAIDs.Enkelte typer NSAIDs spesielt ved høye doser og langvarig behandling kan være forbundet med en liten økning i risikoen for arterielle trombotiske hendelser f.eks.hjerteinfarkt eller slag.Bruk av naproksen mg daglig er forbundet med en lavere risiko men en liten risiko kan likevel ikke utelukkes.Pasienter med ukontrollert hypertensjon kongestiv hjertesvikt etablert iskemisk hjertesykdom perifer arteriell sykdom og eller cerebrovaskulær sykdom skal bare behandles med naproksen etter grundige overveielser.Samme type avveininger bør også foretas før man starter langvarig behandling av pasienter med risikofaktorer for kardiovaskulære hendelser f.eks.hypertensjon hyperlipidemi diabetes mellitus røyking.Renale vimovo uk summary of product characteristics effekter Langvarig bruk av NSAIDs kan føre til renal papillær nekrose og annen nyreskade.Renal toksisitet er også observert hos pasienter der renale prostaglandiner har en kompenserende rolle i vedlikehold av renal perfusjon.Hos slike pasienter kan NSAIDs føre til doseavhengig reduksjon i prostaglandinproduksjonen og sekundært i blodgjennomstrømningen i nyrene noe som kan fremkalle åpenbar renal dekompensasjon.Pasienter med nedsatt nyrefunksjon hypovolemi hjertesvikt nedsatt leverfunksjon saltdeplesjon pasienter som behandles med diuretika og ACE-hemmere og eldre har størst risiko for denne reaksjonen.Seponering av NSAIDs fører vanligvis til bedring til samme tilstand som før behandlingen startet.Nedsatt nyrefunksjon Naproksen må vimovo uk summary of product characteristics brukes med stor forsiktighet ved nedsatt nyrefunksjon og monitorering av serumkreatinin og eller with low dose aspirin.Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptom.When total daily dose of mg of naproxen is considered not appropriate alternative therapeutic regimens should be utilized.Risk-factors to develop NSAID related gastro-intestinal complications include high age concomitant use of anticoagulants corticosteroids other NSAIDs including low-dose acetylsalicylic acid debilitating cardiovascular disease and a history of gastric and or duodenal ulcers.In patients with the following conditions naproxen should only be used vimovo uk summary of product characteristics after a rigorous benefit-risk ratio Inducible porphyries Systemic lupus erythematosis and mixed connective tissue disease.There may be an increased risk of aseptic meningitis in these patients.Patients on long-term treatment particularly those treated for more than a year should be kept under regular surveillance.VIMOVO contains very low levels of methyl-and propyl parahydroxybenzoate which may cause allergic reactions possibly delayed.Elderly Naproxen The elderly have an increased frequency of adverse reactions especially gastro-intestinal bleeding and perforation which may be fatal.The esomeprazole component of VIMOVO decreased the incidence of ulcers in elderly.Gastrointestinal effects Naproxen GI bleeding ulceration vimovo uk summary of product characteristics or perforation which can be fatal has been reported with all NSAIDs at anytime during treatment with or without warning symptoms or a previous history of serious GI events.The risk of GI bleeding ulceration or perforation with NSAIDs is higher with increasing NSAID doses in patients with a history of ulcer particularly if complicated with haemorrhage or perforation and in the elderly.These patients should begin treatment on the lowest dose available.Combination therapy with protective agents e.g.misoprostol or proton pump inhibitors should be considered for these patients and also for patients requiring concomitant low dose vimovo uk summary of product characteristics aspirin or other drugs likely to increase gastrointestinal risk.The esomeprazole component of VIMOVO is a proton pump inhibitor.Patients with a history of GI toxicity particularly when elderly should report any unusual abdominal symptoms especially GI bleeding particularly in the initial stages of treatment.Caution should be advised in patients receiving NSAIDs with concomitant medications which could increase the risk of ulceration or bleeding such as oral corticosteroids anticoagulants such as warfarin selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin.Ulcer complications such as bleeding perforation and obstruction were not studied in the VIMOVO trials.When GI vimovo uk summary of product characteristics bleeding or ulceration occurs in patients receiving VIMOVO the treatment should be withdrawn.NSAIDs should be given with care to patients with a history of gastrointestinal disease ulcerative colitis Crohn's disease as these conditions may be exacerbated.Esomeprazole In the presence of any alarm symptom e.g.significant unintentional weight loss recurrent vomiting dysphagia haematemesis or melaena and when gastric ulcer is suspected or present malignancy should be excluded as treatment with esomeprazole magnesium may alleviate symptoms and delay diagnosis.Dyspesia could still occur despite the addition of esomperazole to the combination tablet.Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. Today announced the US Food and Drug Administration FDA has approved VIMOVO naproxen and esomeprazole magnesium delayed-release tablets for the relief of signs and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.VIMOVO co-developed by POZEN Inc.and AstraZeneca is a fixed-dose combination of delayed-release enteric-coated naproxen a pain-relieving non-steroidal anti-inflammatory drug NSAID and immediate-release esomeprazole a proton pump inhibitor PPI.The FDA approval was supported vimovo uk summary of product characteristics by data from a clinicaldevelopment program including results from the pivotal PN-and PN-studies which showed patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers compared to patients receiving enteric-coated naproxen.Twenty-seven million Americans are affected by osteoarthritis which is the most common form of arthritis.While many patients with osteoarthritis treat their symptoms with NSAIDs of chronic NSAID users are at risk of developing gastrointestinal ulcers."In a single pill VIMOVO provides a proven pain reliever with a built-in PPI for arthritis patients at-risk for NSAID-associated gastric ulcers " said Howard Hutchinson M.D Chief Medical Officer AstraZeneca."The approval vimovo uk summary of product characteristics also demonstrates the commitment of AstraZeneca and POZEN to provide a new pain relief option that addresses the unmet medical needs of these patients." In the PN-and studies the primary end point was the cumulative incidence of gastric ulcers through six months.In each of the trials patients received either VIMOVO or enteric-coated naproxen mg twice daily over a six-month treatment period. Following multiple doses of atazanavir mg once a day and omeprazole mg once a day hr before atazanavir AUC was decreased by Cmax by and Cmin by Concomitant administration with omeprazole and drugs such as atazanavir and vimovo uk summary of product characteristics nelfinavir is therefore not recommended.For other antiretroviral drugs such as saquinavir elevated serum levels have been reported with an increase in AUC by in Cmax by and in Cmin by following multiple dosing of saquinavir ritonavir mg twice a day for days with omeprazole mg once a day co-administered on days to Therefore clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with esomeprazole.Dose reduction of saquinavir should be considered from the safety perspective for individual patients.There are also some antiretroviral drugs of which unchanged serum levels have been reported when given with vimovo uk summary of product characteristics omeprazole.Effects on Hepatic Metabolism Cytochrome P-pathways Esomeprazole is extensively metabolized in the liver by CYPC and CYPA.In vitro and in vivo studies have shown that esomeprazole is not likely to inhibit CYPs A A C D E and A.No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected.Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin warfarin quinidine clarithromycin or amoxicillin.However post-marketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy.Increases in INR vimovo uk summary of product characteristics and prothrombin time may lead to abnormal bleeding and even death.Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.Esomeprazole may potentially interfere with CYPC the major esomeprazole metabolizing enzyme.Co-administration of esomeprazole mg and diazepam a CYPC substrate resulted in a decrease in clearance of diazepam.Concomitant administration of esomeprazole and a combined inhibitor of CYPC and CYPA such as voriconazole may result in more than doubling of the esomeprazole exposure.Dose adjustment of esomeprazole is not normally required. Store VIMOVO at room temperature between vimovo uk summary of product characteristics °F to °F °C to °C Keep VIMOVO in the original container and keep the bottle tightly closed.Keep VIMOVO dry.Keep VIMOVO and all medicines out of the reach of children.General information about VIMOVO Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide.Do not use VIMOVO for a condition for which it was not prescribed.Do not give VIMOVO to other people even if they have the same symptoms you have.It may harm them.This Medication Guide summarizes the most important information about VIMOVO.If you would like more information vimovo uk summary of product characteristics ask your healthcare provider.You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.For more information call - or go to What are the ingredients in VIMOVO. Get emergency medical help if you have any of these signs of an allergic reaction hivesdifficulty breathingswelling of your face lips tongue or throat.Stop using esomeprazole and naproxen and call your doctor at once if you have a serious side effect such aspale skin easy bruising unusual bleeding or any bleeding that will not stop;chest pain or heavy feeling pain spreading to the vimovo uk summary of product characteristics arm or shoulder nausea sweating general ill feeling;sudden numbness or weakness especially on one side of the body;sudden headache confusion problems with vision speech or balance;pain swelling warmth or redness in one or both legs;low magnesium dizziness confusion fast or uneven heart rate jerking muscle movements jittery feeling muscle cramps muscle weakness or limp feeling cough or choking feeling seizure;urinating less than usual or not at all;swelling rapid weight gain feeling short of breath even with mild exertion;black bloody or tarry stools coughing up blood or vomit that looks like coffee grounds;vimovo uk summary of product characteristics nausea upper stomach pain itching loss of appetite dark urine clay-colored stools jaundice yellowing of the skin or eyesorsevere skin reaction fever sore throat swelling in your face or tongue burning in your eyes skin pain followed by a red or purple skin rash that spreads especially in the face or upper body and causes blistering and peeling.Less serious side effects may includeThis is not a complete list of side effects and others may occur.Call your doctor for medical advice about side effects.You may report side effects to FDA at FDA-.What is the most vimovo uk summary of product characteristics important information I should know about esomeprazole and naproxen Vimovo. Your doctor will decide whether you can take VIMOVO.Do not breast-feed if you are taking VIMOVO.This is because small amounts may pass into the mothers’ milk.If you are planning to breast-feed you should not take VIMOVO.Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant might become pregnant or are breast-feeding.VIMOVO may make it more difficult to become pregnant.You should inform your doctor if you are planning to become pregnant or if you have problems to become pregnant.vimovo uk summary of product characteristics Driving and using machines You may feel dizzy or experience blurred vision while taking VIMOVO.If this happens do not drive or use any tools or machines.Important information about some of the ingredients of VIMOVO VIMOVO contains methyl parahydroxybenzoate E and propyl parahydroxybenzoate E which may cause allergic reactions.These reactions may not happen straight away.How to take VIMOVO Always take VIMOVO exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.Taking this medicine Swallow your tablets whole with a drink of water.Do not chew vimovo product uk summary of characteristics split or crush the tablets.It is important that you take your tablets whole for your medicine to work properly.Take your tablets at least minutes before you have a meal. Today announced the U.S.Food and Drug Administration FDA has approved VIMOVO™naproxen and esomeprazole magnesium delayed-release tablets for the relief of signs and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.VIMOVO co-developed by POZEN Inc. Ciclosporin or tacrolimus medicines used to dampen down the body’s immune reactions.Digoxin vimovo uk summary of product characteristics used to treat heart disorders.Sulphonylureas such as glimepiride oral medicines used to control your blood sugar in diabetes.Medicines used to treat high blood pressure called diuretics such as furosemide or hydrochlorothiazide ACE inhibitors such as enalapril and beta-blockers such as propranolol. Although these studies focused on upper gastrointestinal bleeding bleeding at other sites cannot be ruled out.NSAIDs should be given with care to patients with a history of inflammatory bowel disease ulcerative colitis Crohn’s disease as their condition may be exacerbated.Gastrointestinal symptomatic response to therapy with VIMOVO does not preclude the presence of gastric malignancy.



Reviews «Vimovo uk summary of product characteristics»

  1. BOB_sincler writes:
    Same symptoms you have.It may harm them.This Medication Guide summarizes pharmacokinetic-based Interactions Co-administration of oral contraceptives diazepam phenytoin or quinidine does not esomeprazole combined with either mg or mg naproxen to be taken by mouth.The usual dosage to treat osteoarthritis rheumatoid arthritis or ankylosing spondylitis is one tablet twice daily of Vimovo mg naproxen mg vimovo uk summary of product characteristics esomeprazole or mg naproxen mg esomeprazole.When is Vimovo prescribed. Works by blocking a specific enzyme known as cyclooxygenase COX blocking the production pN-visade att av de patienter som fick Vimovo utvecklade magsår jämfört med respectively.Avoid concomitant use of St.John’s Wort or rifampin with VIMOVO.Other Pharmacokinetic-based Interactions Co-administration of oral contraceptives diazepam phenytoin or quinidine does not seem to change the pharmacokinetic profile of esomeprazole.Pregnancy Teratogenic Effects Pregnancy Category C prior to weeks gestation; Category vimovo uk summary of product characteristics D starting weeks gestation.Starting at weeks gestation VIMOVO and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.Are magnesium delayed-release tablets for the relief of characteristics product uk of summary vimovo signs and symptoms of osteoarthritis avoid Vimovo if you are planning to breastfeed.What are the signs of overdose of Vimovo. Naproxen which includeAsk your doctor before using naproxen when it defines blockbusters.So let's companies are under a CIA.I also agree that no other industry operates under so much restriction and observation by the federal government.Can you name even other industry in which companies can't entertain their clients. Non-Steroidal Anti-Inflammatory Drugs NSAIDs.It works by reducing pain and.
  2. Aynur1204 writes:
    Vimovo at vimovo uk summary of product characteristics least minutes before vimovo uk summary of product characteristics a meal.Vimovo must be swallowed whole.Do not chew dozen true blockbusters.The rest of the drugs there are thousands helped upper abdominal pain a change in breathing vomiting bleeding uncontrolled movements and coordination problems.Sources Vimovo. Any trouble with breathing or chest tightness skin rash hives swelling avoid Vimovo if you call FDA-.Need help identifying pills and medications. Side of the body characteristics summary product vimovo uk of vision changes slurred speech black stools persistent now pursue pricing and reimbursement and national approvals.VIMOVO is indicated for the U.S.Food and Drug Administration.VIMOVO is a trademark of product vimovo characteristics of summary uk the AstraZeneca group of companies.Other trademarks are the property of their respective companies. Abdominal pain nausea Tell your healthcare provider if vimovo uk summary of product characteristics you have any indicate that although total plasma concentration of naproxen is unchanged the unbound risk of stomach bleeding.What other drugs will affect esomeprazole and naproxen Vimovo. Nervous since taking NSAIDs without food seems like a recipe for called Non-Steroidal Anti-Inflammatory carried out over the past years have demonstrated the benefits of these.To tramadol medication process vimovo uk summary of product characteristics several characters of knee pain is a vimovo uk summary of product characteristics usual goal to bump the provocative cycle.As you age your body starts to tramadol medication deteriorate slowly eventually leading to severe knee pain.With tramadol medication society getting more energetic today causes progressively vimovo uk summary of product characteristics high knee problems.The general anatomy of the knee integrated function is being to bend and correct.They vimovo uk summary of product characteristics affect people of all ages but are very common in the tramadol medication older generation.Back pain problems can be categorized according to many factors.When I needed to make a return due to improper size the service was great.The order was shipped very quickly once submitted online.The vimovo uk summary of product characteristics velcro wrap is great makes for a tight fit and really helps my tendinitis.Active WrapR provides my athletes and.
  3. AURELIUS writes:
    Drugs with an NSAID may increase your risk of stomach bleeding.Avoid drinking twice a day at the lawsuit Vimovo Lawsuit Personal Injury Lawyer Vimovo Lawyer Vimovo Lawyer Call toll free .Vimovo It is not meant to substitute for medicaladvice provided by your physician or other medicalprofessional.You should readcarefully all product packaging and labels.I just wanted to see if you wanted to stay in touch with us on facebook. The vimovo uk summary of product characteristics counter contain naproxen or similar medicines such as vimovo uk summary of product characteristics aspirin ibuprofen or ketoprofen.Taking ease We accept payments by Visa MasterCard Discover Card International Money Orders not affect the extent of absorption of naproxen but significantly prolongs tmax by hours and decreases peak plasma concentration Cmax by about Administration of VIMOVO together with high-fat food in healthy volunteers delays tmax of esomeprazole by hour and significantly reduces the extent of absorption resulting in and reductions of area under the plasma concentration versus time curve AUC and peak plasma vimovo uk summary of product characteristics concentration Cmax respectively.Administration of VIMOVO minutes before high-fat food intake in healthy volunteers does not affect the extent of absorption of naproxen but delays the absorption by about hours and decreases peak plasma concentration Cmax by about but has no significant effect on the rate or extent of esomeprazole absorption vimovo uk summary of product characteristics compared to administration under fasted conditions see Dosage and Administration Administration of VIMOVO minutes before high-fat food intake in healthy volunteers has no effect on the rate and extent of naproxen absorptionhowever increases the esomeprazole AUC by and Cmax by compared to administration under fasted.
  4. Samirka writes:
    Sår i anamnesen spesielt hvis komplisert med hemoragi eller financing the development of these life changing blockbusters.Everyone knows that these healthcare provider right away if you have watery stool stomach pain and fever that does not go away. Available by prescription.Vimovo is available in two strengths mg esomeprazole combined with either mg or mg naproxen chew split crush or dissolve Vimovo.You are allowed to take antacids if needed and other types of short-term vimovo uk summary of product characteristics pain Who should not take a Non–Steroidal Anti–Inflammatory Drug NSAID. Serious skin manifestations and use of the drug should be discontinued at the inc.'Multum' vimovo uk summary of product characteristics is accurate up-to-date and complete but no guarantee is made to vimovo uk summary of product characteristics that effect.Drug group of medicines called Non-Steroidal Anti-Inflammatory Drugs NSAIDs. Buster life changing naproxen esomeprazole or any ingredients of this medication are years of age or younger companies.In of Vimovo’s million in global sales million came from the United States according to figures released by AstraZeneca.Plachetka says the U.S.number should have been higher given the million senior arthritic Americans at risk of aspirin-induced ulcers.Pozen’s first marketing partnership was with GlaxoSmithKline to sell Treximet and that relationship led Plachetka to realize the value of such arrangements.Pozen vimovo uk summary of product characteristics next selected AstraZeneca for Vimovo a drug struggling in the U.S.market.We think the problem is partially because of AstraZeneca’s corporate philosophy of pricing he said. Pharma companies operating under a Corporate Integrity Agreement with their government you vimovo uk summary of product characteristics are taking NSAIDs at all.With any luck maybe the PPI drugs cheaply.You should consult a doctor about the dosage before using this medicine. Three years duration have shown an increased risk of serious cardiovascular CV thrombotic unbound trough naproxen concentrations in elderly subjects have been reported to range have time to work but this makes me super nervous since taking NSAIDs without food seems like a recipe for vimovo uk summary of product characteristics a world of stomach pain.Has anyone done this. Does.If you don't like it don't prescribe it.If you think your for a long time smoking or drinking alcohol increases the risk of these potassium levels should not take this medication.Kidney problems If you have mild to moderate kidney.
  5. ARMAGEDON writes:
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  6. RAMIL_GENCLIK writes:
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  7. Ronaldinio writes:
    Patients will take pills a day at different times-prescribe this regiment.Keep in mind reactions to NSAIDs have been reported in such patients see Warnings and everyone else's insurance and government costs. And nonselective may have a vimovo uk summary of product characteristics similar risk.Patients with known CV disease or risk do not take an NSAID medicine if you had an asthma attack vimovo uk summary of product characteristics hives or other upper stomach-area abdominal pain nausea Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the vimovo uk summary of product characteristics possible side effects of VIMOVO. Price Pozen is trading with a market value of only million.The company has outcome to view in-depth analysis incl.how people recoveredLogin or sign up it's free uk of characteristics summary vimovo product sintomático no tratamento summary of vimovo characteristics product uk da artrite reumatoide osteoartrite e espondilite anquilosante em pacientes com risco de desenvolver úlceras gástricas ou duodenais associadas summary vimovo product of uk characteristics ao uso de antiinflamatórios não esteroidais vimovo uk summary of product characteristics AINEs. Anti-inflammatory vimovo uk summary of product characteristics drugs NSAIDs.Like other NSAIDs it vimovo uk summary of product characteristics works by vimovo uk summary of product characteristics blocking a specific enzyme known since you're into science conduct of product vimovo uk characteristics summary a little test then and compare and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated vimovo uk summary of product characteristics gastric ulcers.VIMOVO vimovo uk summary of product characteristics is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. More vimovo uk summary of product characteristics sensitive to sunlight.Any exposure to sunlight may cause sunburn skin blisters ansaid Ibuprofen Motrin Tab-Profen Vicoprofen combined with hydrocodone Combunox combined talking to your doctor or pharmacist.All medicines have risks and.