Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NAPROXEN; ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
PHARMAFORTE (MALAYSIA) SDN. BHD.
NAPROXEN; ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
60Tablet Tablets; 60 Tablets
PATHEON PHARMACEUTICALS INC
_Consumer Medication Information_ _Leaflet (RiMUP)_ VIMOVO MODIFIED-RELEASE TABLETS _ _ Naproxen /esomeprazole (500mg/20mg) 1 WHAT IS IN THIS LEAFLET 1. What Vimovo is used for 2. How Vimovo works 3. Before you use Vimovo 4. How to use Vimovo 5. While you are using it 6. Side effects 7. Storage and Disposal of Vimovo 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT VIMOVO IS USED FOR Vimovo is used to treat the following inflammatory problems: • Osteoarthritis (degenerative joint disease). • Rheumatoid Arthritis (systemic inflammatory disorder that affects joints). • Ankylosing Spondylitis (chronic inflammatory disease of the skeleton). Vimovo helps to reduce pain, swelling, redness and heat (inflammation). You will be given this medicine if you need to be treated with an anti- inflammatory medicine and you are at risk of getting a stomach ulcer or an ulcer in your small intestine (gut). This medicine has been shown to reduce the risk of ulcers occurring when compared to taking naproxen on its own. HOW VIMOVO WORKS Vimovo contains two different medicines called naproxen and esomeprazole. Each of these medicines works in a different way. Naproxen belongs to a group of medicines called “Non-Steroidal Anti-Inflammatory Drugs” (NSAIDs). It works by reducing inflammation. Esomeprazole belongs to a group of medicines called “proton pump inhibitors”. It works by reducing the amount of acid your stomach produces. Esomeprazole helps to reduce the risk of ulcers and stomach problems developing in patients who need to take naproxen to reduce inflammation. BEFORE YOU USE VIMOVO - _When you must not use it _ Do not take Vimovo if • You are allergic (hypersensitive) to naproxen, esomeprazole, or any of the other ingredients of Vimovo (listed under ‘Ingredients’ section). • You are allergic to other proton pump inhibitor medicines. • You are taking a medicine called “atazanavir” or “nelfinavir” (used to treat HIV). • If aspirin, read_full_document
1 VIMOVO 500 MG/20 MG MODIFIED-RELEASE TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 500 mg naproxen and 20 mg esomeprazole (as 22.3mg magnesium trihydrate). VIMOVO contains very low, non-preserving levels of 0.02 mg methyl parahydroxybenzoate and 0.01 mg propyl parahydroxybenzoate (see sections “Special warnings and precautions for use” and “List of excipients”). For a full list of excipients, see section “List of excipients”. PHARMACEUTICAL FORM Modified-release tablet containing enteric-coated (gastro-resistant) naproxen and film-coated esomeprazole. Oval, biconvex, yellow tablet marked ‘500/20’ in black ink. THERAPEUTIC INDICATIONS Symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)- associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient. POSOLOGY & METHOD OF ADMINISTRATION Posology in adults The dose is 1 tablet (500 mg/20 mg) twice daily. Undesirable effects of naproxen may be minimised by using the lowest effective dose for the shortest duration possible (see section “Special warnings and precautions for use”). In patients not treated with a NSAID previously, a lower daily dose of naproxen or of another NSAID should be considered. When total daily dose of 1000 mg of naproxen is not considered appropriate, alternative therapeutic regimens should be utilized. Treatment should be continued to achieve individual treatment goals, reviewed at regular intervals and discontinued if no benefit seen. Due to the delayed release of naproxen from the enteric-coated formulation, 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. Method of administration VIMOVO must be swallowed whole with water, read_full_document