Země: Jihoafrická republika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
TABLET
EACH TABLET CONTAINS MEFENAMIC ACID 500 MG
Registered
1993-01-06
Date of approval: 18/08/2023 Page 1 of 9 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: FENAMIN-500 EACH FILM COATED TABLET CONTAINS 500MG OF MEFENAMIC ACID. CONTAINS SUGAR: LACTOSE MONOHYDRATE 143 MG WHAT IS IN THIS LEAFLET 1. What FENAMIN-500 is and what it is used for 2. What you need to know before you take FENAMIN-500 3. How to take FENAMIN-500 4.Possible side effects 5. How to store FENAMIN-500 6. Contents of the pack and other information S2 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. FENAMIN-500 is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use FENAMIN-500 carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share FENAMIN-500 with any other person. • Ask your pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve after 3 days. Date of approval: 18/08/2023 Page 2 of 9 1. WHAT FENAMIN-500 IS AND WHAT IT IS USED FOR A 2.7 Antipyretic and anti-inflammatory analgesics FENAMIN-500 is used for the relief of period pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENAMIN-500 DO NOT TAKE FENAMIN-500 • If you are hypersensitive (allergic) to or have had an allergic reaction to mefenamic acid or any other ingredient in FENAMIN-500, aspirin or other related painkillers (see What FENAMIN-500 contains). • If you have or ever had a stomach ulcer, perforation or bleeding due to the use of NSAIDs. • If you have inflammatory bowel disease such as ulcerative colitis and Crohn’s disease (inflammatory conditions of the small intestine or colon). • If you have epilepsy (a disorder that causes seizures). • If you have a liver or kidney problem. • If you have heart problems. • If you are pregnant, do not use NSAIDs at 20 weeks or later in your pregnancy unless specifically advised to do so by your health care professional because these medicines may ca Přečtěte si celý dokument
Date of approval: 18/08/2023 Page 1 of 16 PROFESSIONAL INFORMATION SCHEDULING STATUS 1. NAME OF THE MEDICINE FENAMIN-500 (film-coated tablet) STRENGTH Mefenamic acid 500 mg per film-coated tablet PHARMACEUTICAL FORM Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains mefenamic acid 500 mg Contains sugar: Lactose monohydrate 143 mg For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. A pale yellow, round, film-coated, bevelled edge biconvex tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FENAMIN – 500 is indicated for: • Treatment of primary dysmenorrhoea, for a maximum treatment period of 3 days. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION S2 Date of approval: 18/08/2023 Page 2 of 16 POSOLOGY Use the lowest effective dose for the shortest possible duration of treatment. FENAMIN – 500 must be taken with meals. FENAMIN – 500 should not be given for longer than 3 days. ADULTS FENAMIN - 500 TREATMENT OF PRIMARY DYSMENORRHOEA: A maximum daily dose of 500 mg every 8 hours. PAEDIATRIC POPULATION FENAMIN - 500 is not indicated for use in children 4.3 CONTRAINDICATIONS FENAMIN - 500 is contraindicated in: • Hypersensitivity to mefenamic acid and other NSAIDs, with prostaglandin synthetase inhibiting activity or to any of the ingredients of FENAMIN - 500 (see COMPOSITION section 6.1). • Because of the possibility of cross-sensitivity among NSAIDs exists, FENAMIN – 500 should not be given to patients in whom these medicines induce symptoms of bronchospasm, allergic rhinitis, or urticaria. • History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including FENAMIN - 500. • Patients with an active or a history of recurrent peptic and/or intestinal ulceration /haemorrhage/perforations. • Chronic inflammation of either the upper or lower gastrointestinal tract such as Inflammatory bowel disease. • Epilepsy. Date of approval: 18/08/2023 Page 3 of 16 • Patients with impaired hepatic or renal functio Přečtěte si celý dokument