Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Mefenamic acid
Mercury Pharmaceuticals (Ireland) Ltd
M01AG; M01AG01
Mefenamic acid
250 milligram(s)
Capsule
Product subject to prescription which may be renewed (B)
Fenamates; mefenamic acid
Not marketed
1987-10-23
PONALGIC® 250MG HARD CAPSULES AND PONALGIC® FORTE 500MG FILM-COATED TABLETS (MEFENAMIC ACID) Read all 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 nurse. -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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Ponalgic 250mg hard capsules and Ponalgic Forte 500mg film-coated tablets are and what they are used for 2. What you need to know before you take Ponalgic 3. How to take Ponalgic 4. Possible side effects 5. How to store Ponalgic 6. Contents of the pack and other information 1.WHAT PONALGIC 250MG HARD CAPSULES AND PONALGIC FORTE 500MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Ponalgic 250mg Hard Capsules contain 250mg Mefenamic Acid, the active ingredient. Ponalgic Forte 500mg Film-Coated Tablets contain 500mg Mefenamic Acid. Mefenamic acid belongs to a group of medicines called Non-Steroidal Anti-inflammatory (NSAID) agents. Ponalgic 250mg Hard Capsules and Ponalgic Forte 500mg Film-Coated Tablets may be used • for relief of mild to moderate pain associated with rheumatic muscular or arthritic disorders, including rheumatoid arthritis, and osteoarthritis • for relief of mild to moderate pain due to an injury, headache, toothache, or following an operation or after childbirth • to relieve the type of period pains for which no cause can be shown • in the management of excessively heavy periods(where the irregular excessive bleeding may not have an obvious cause) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONALGIC DO NOT TAKE PONALGIC IF: • you have or ever had an ulcer or inflammation in your stomach or intestine • you have had a history of two or more dis Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ponalgic 250mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg of Mefenamic Acid. Excipients: Also contains 38.75 mg of Lactose Monohydrate "For a full list of excipients, see section 6.1" 3 PHARMACEUTICAL FORM Hard capsule. A white to off white powder is filled in capsules of blue cap and yellow body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) For relief of mild to moderate pain associated with rheumatic muscular or arthritic disorders (including rheumatoid arthritis) trauma, headache, dental pain, and post-operative or post-partum states. 2) In the management of dysfunctional menorrhagia. 3) Primary dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Adults Only: The usual total daily dose is 1500mg in divided doses. Ponalgic capsules should be taken preferably with or after food. Older people: NSAID's should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. See also Section 4.4. Undesirable effects may be minimised by using the shortest duration necessary to control symptoms (see section 4.4). 4.3 CONTRAINDICATIONS 1. Use in patients with gastric and/or intestinal ulceration or inflammation. 2. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/ haemorrhage (two or more distinct episodes of proven ulceration or bleeding). 3. Use in pregnancy or lactation (See section 4.6). 4. Use in patients with renal or hepatic impairment. 5. Hypersensitivity to mefenamic acid or to any of the excipients listed in section 6.1. 6. Hypersensitivity to other non-steroidal anti-inflammatory drugs 7. Use in children. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Baca dokumen lengkap