Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Mefenamic acid
Rowa Pharmaceuticals Limited
M01AG; M01AG01
Mefenamic acid
250 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Fenamates; mefenamic acid
Not marketed
1988-04-28
MEFAC 250MG HARD CAPSULES MEFENAMIC ACID 50 Hard Capsules 100 Hard Capsules 500 Hard Capsules PA Holder: Rowa Pharmaceuticals Ltd., Bantry Co. Cork, Ireland PA 74/15/1 Marketed by: Rowex Ltd., Bantry, Co. Cork, Ireland COMPOSITION: Each hard capsule contains 250mg mefenamic acid. Also includes lactose monohydrate. See leaflet for further information. DOSAGE: For oral use as directed by the Physician. Do not exceed the stated dose. Capsules should be taken preferably with food. Do not store above 25°C. Keep out of the sight and reach of children. Package leaflet: Information for the user MEFAC 250MG HARD CAPSULES Mefenamic Acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Mefac is and what it is used for 2. What you need to know before you take Mefac 3. How to take Mefac 4. Possible side effects 5. How to store Mefac 6. Contents of the pack and other information 1.WHAT MEFAC IS AND WHAT IT IS USED FOR Mefac contains an active substance called mefenamic acid. This belongs to the group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Mefac is used for the relief of mild to moderate pain and inflammation associated with rheumatic, muscular or arthritic disorders, trauma, headache, dental pain, pain following surgery or childbirth, fever in children over 12 years. Mefac is also used for relief of period pains, management of excessively heavy periods and symptoms of premenstrual syndrome (PMS). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEFAC DO NOT TAKE MEFAC IF YOU: • are all Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MEFAC 250 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Mefenamic Acid 250 mg. Excipient(s) with known effect: Also contains lactose monohydrate, 36.0mg per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules. Size 1, opaque, hard gelatin capsules with blue caps and white bodies, printed ‘MEFAC 250’ in grey containing a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As an anti-inflammatory analgesic for symptomatic relief of mild to moderate pain associated with rheumatic muscular or arthritic disorders (including rheumatoid arthritis, Still’s Disease and osteoarthritis), trauma, headache, dental pain, post - operative or post - partum states. 2. For control of pyrexia in children 3. In the management of dysfunctional menorrhagia 4. Primary dysmenorrhoea. 5. Premenstrual syndrome 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Route of Administration Oral. Recommended Dosage Schedule Adults Only: The usual total daily dose is 1500 mg in divided doses. Children: Not recommended for children under 12 years of age. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _7_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _6_ _7_ _5_ _1_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ Baca dokumen lengkap