Šalis: Pietų Afrika
kalba: anglų
Šaltinis: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
CAPSULES
EACH CAPSULE CONTAINS MEFENAMIC ACID 250,0 mg
Registered
1994-03-04
Date of approval: 18/08/2023 Page 1 of 9 PATIENT INFORMATION LEAFLET SCHEDULING STATUS FENAMIN 250, 250 MG CAPSULES MEFENAMIC ACID CONTAINS SUGAR: LACTOSE MONOHYDRATE 55 MG READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU FENAMIN 250 is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use FENAMIN 250 carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share FENAMIN 250 with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve after 5 days. WHAT IS IN THIS LEAFLET 1. What FENAMIN 250 is and what it is used for 2. What you need to know before you take FENAMIN 250 3. How to take FENAMIN 250 4. Possible side effects 5. How to store FENAMIN 250 6. Contents of the pack and other information S2 Date of approval: 18/08/2023 Page 2 of 9 1. WHAT FENAMIN 250 IS AND WHAT IT IS USED FOR FENAMIN 250 contains mefenamic acid. Mefenamic acid is a non-steroidal anti- inflammatory medicine (NSAID) with antipyretic (helps against fever) and analgesic (pain- killing) properties. It is used for the relief of mild to moderate pain and relief of swelling and inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENAMIN 250 DO NOT TAKE FENAMIN 250 • If you are hypersensitive (allergic) to or have had an allergic reaction to mefenamic acid or aspirin or other related painkillers (NSAIDs), or any other ingredient in FENAMIN 250 (listed in section 6). • If you have ever had symptoms of bronchospasm, allergic rhinitis, or urticaria after using a NSAID. • 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 Perskaitykite visą dokumentą
Date of approval: 18/08/2023 Page 1 of 16 PROFESSIONAL INFORMATION SCHEDULING STATUS S2 1. NAME OF THE MEDICINE FENAMIN 250, capsules STRENGTH Mefenamic acid 250 mg per capsule PHARMACEUTICAL FORM Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Mefenamic acid 250 mg Contains sugar : Lactose monohydrate 55 mg For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules. An off-white, free-flowing powder encapsulated within a no. 1 capsule with a turquoise cap and a pale-yellow body. Date of approval: 18/08/2023 Page 2 of 16 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FENAMIN 250 is indicated for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Use the lowest effective dose for the shortest possible duration of treatment. FENAMIN must be taken with meals. FENAMIN 250 should not be given for longer than 5 days. ADULTS TREATMENT OF POST-TRAUMATIC CONDITIONS: RELIEF OF MILD TO MODERATE PAIN: 500 mg three times a day. ACUTE PAIN: An initial dosage of 500 mg, thereafter 250 mg every 6 hours. PAEDIATRIC POPULATION No information available. METHOD OF ADMINISTRATION For oral administration. 4.3 CONTRAINDICATIONS FENAMIN is contraindicated in: • Hypersensitivity to mefenamic acid and other NSAIDs, with prostaglandin synthetase inhibiting activity or to any of the ingredients of FENAMIN (see section 6.1). Date of approval: 18/08/2023 Page 3 of 16 • Because of the possibility of cross-sensitivity among NSAIDs exists, FENAMIN 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. • 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 trac Perskaitykite visą dokumentą