VIMOVO

Posology The recommended dose is 1 tablet (500 mg/20 mg) twice daily. 4). In patients not treated with a NSAID previously, a lower daily dose of naproxen or of another NSAID should be considered. For this purpose non-fixed combination products are available.

When total daily dose of 1000 mg of naproxen (500 mg twice daily) is not considered appropriate, alternative treatment with lower strength of naproxen or of other NSAIDs as non-fixed combination should be utilised. Treatment should be continued to achieve individual treatment goals, reviewed at regular intervals and discontinued if no benefit or if worsening is seen.

Due to the delayed release of naproxen from the enteric-coated formulation (3-5 hours), VIMOVO is not intended for rapid relief of acute pain conditions (such as dental pain). However, flares of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis may be treated with VIMOVO.

Special populations Renal impairment In patients with mild to moderate renal impairment VIMOVO should be used cautiously and renal function should be monitored closely. 5). When total daily dose of 1000 mg of naproxen (500 mg twice daily) is not considered appropriate, alternative treatment with lower strength of naproxen or of other NSAIDs as non- fixed combination should be utilised, and in addition the need for continuation of the gastroprotective treatment should be re-evaluated.

4). Hepatic impairment In patients with mild to moderate hepatic impairment VIMOVO should be used cautiously and hepatic function should be monitored closely. 2). When total daily dose of 1000 mg of naproxen (500 mg twice daily) is not considered appropriate, alternative treatment with lower strength of naproxen or of other NSAIDs as non- fixed combination should be utilised, and in addition the need for continuation of the gastroprotective treatment should be re-evaluated.

2). 2). g. in older people with impaired renal function or low body weight), alternative treatment with lower strength of naproxen or of other NSAIDs as non-fixed combination should be utilised, and in addition the need for continuation of the gastroprotective treatment should be re-evaluated.

Paediatric population The safety and efficacy of VIMOVO in children aged 0 to 18 years has not been established. No data are available. Method of administration VIMOVO must be swallowed whole with water, and not split, chewed or crushed.

). 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.

1). 1). Esomeprazole, as all acid-blocking medicines, might reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors of reduced vitamin B12 absorption on long-term therapy.

Cardiovascular and cerebrovascular effects Naproxen:

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. g. myocardial infarction or stroke).

Although data suggest that the use of naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be excluded. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Renal effects Naproxen:

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.

In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, those taking diuretics, angiotensin converting enzyme (ACE) inhibitors, or angiotensin II receptor antagonists and older people.

General The combination of VIMOVO and NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided because of the cumulative risks of inducing serious NSAID-related adverse events. ). 2, and GI and cardiovascular risks below).

To prevent overtreatment, the prescriber should assess at clinically meaningful intervals based on the individual risks and depending on the characteristics and the severity of the treated underlying disease, whether sufficient pain control is possible with lower doses of NSAIDs as non-fixed combinations.

When total daily dose of 1000 mg of naproxen (500 mg twice daily) is not considered appropriate, alternative treatment with lower strength of naproxen or of other NSAIDs as non-fixed combination should be utilised, and in addition the need for continuation of the gastro protective treatment should be re-evaluated.

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, Helicobacter pylori infection, and a history of gastric and/or duodenal ulcers and upper gastrointestinal bleeding.

In patients with the following conditions, naproxen should only be used after a rigorous benefit-risk ratio: • Inducible porphyries • Systemic lupus erythematosus and mixed connective tissue disease, as rare cases of aseptic meningitis have been described 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).

1). 2). The esomeprazole component of VIMOVO decreased the incidence of ulcers in older people.

1 or substituted benzimidazoles. 4). 6). g. Child-Pugh C). • Severe heart failure. • Severe renal impairment. 4, gastrointestinal effects Naproxen). 4, Haematological effects). 5).