Šalis: Pietų Afrika
kalba: anglų
Šaltinis: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
SUSPENSION
EACH 5 ML SUSPENSION CONTAINS MEFENAMIC ACID 50 MG
Registered
1994-02-04
Date of approval: 18/08/2023 Page 1 of 10 PATIENT INFORMATION LEAFLET SCHEDULING STATUS FENAMIN SUSPENSION EACH 5 ML SUSPENSION CONTAINS 50 MG MEFENAMIC ACID CONTAINS SUGAR: SORBITOL 2,1 G CONTAINS SWEETENER: SODIUM CYCLAMATE 24 MG, SACCHARIN SODIUM 1 MG WHAT IS IN THIS LEAFLET 1. What FENAMIN SUSPENSION is and what it is used for. 2. What you need to know before you take FENAMIN SUSPENSION. 3. How to take FENAMIN SUSPENSION. 4. Possible side effects. 5. How to store FENAMIN SUSPENSION. 6. Contents of the pack and other information. S2 READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. FENAMIN SUSPENSION is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use FENAMIN SUSPENSION carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share FENAMIN SUSPENSION with any other person. • Ask your health care provider if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve after 5 days. Date of approval: 18/08/2023 Page 2 of 10 1. WHAT FENAMIN SUSPENSION IS AND WHAT IT IS USED FOR FENAMIN SUSPENSION contains mefenamic acid as an active substance. Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with antipyretic (helps against fever) and analgesic (pain-killing) properties. FENAMIN SUSPENSION is used for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENAMIN SUSPENSION DO NOT TAKE FENAMIN SUSPENSION: • 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 SUSPENSION, (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 Perskaitykite visą dokumentą
Date of approval: 18/08/2023 Page 1 of 18 PROFESSIONAL INFORMATION SCHEDULING STATUS S2 1. NAME OF THE MEDICINE FENAMIN SUSPENSION STRENGTH Each 5 ml contains 50 mg of mefenamic acid. PHARMACEUTICAL FORM Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains 50 mg of mefenamic acid. Contains sugar: Sorbitol 2,1 g per 5 ml Contains sweetener: Sodium cyclamate 24 mg, saccharin sodium 1 mg per 5 ml _Preservatives: _ Butyl hydroxybenzoate 0,015 % m/v Methyl hydroxybenzoate 0,030 % m/v Propyl hydroxybenzoate 0,015 % m/v For full list of excipients, see section 6.1. Date of approval: 18/08/2023 Page 2 of 18 3. PHARMACEUTICAL FORM Suspension. An off-white suspension with a fruity odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FENAMIN SUSPENSION 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 SUSPENSION should not be given for longer than 5 days. CHILDREN The dosage for children is 25 mg per kg body-weight daily in divided doses. The following dose may be repeated as necessary, up to three times daily: 6 months to 1 year: One medicine measure (5 ml). 2 years to 4 years: Two medicine measures (10 ml). 5 years to 8 years: Three medicine measures (15 ml). 9 years to 12 years: Four medicine measures (20 ml). SPECIAL POPULATIONS No information available. Date of approval: 18/08/2023 Page 3 of 18 PAEDIATRIC POPULATION Refer to posology in children above. METHOD OF ADMINISTRATION For oral administration. 4.3 CONTRAINDICATIONS FENAMIN SUSPENSION is contraindicated in: • Hypersensitivity to mefenamic acid and other NSAIDs, with prostaglandin synthetase inhibiting activity or to any of the ingredients of FENAMIN SUSPENSION (see section 6.1). • Because the possibility of cross-sensitivity among NSAIDs exists, FENAMIN SUSPENSION should not be giv Perskaitykite visą dokumentą