País: África do Sul
Língua: inglês
Origem: South African Health Products Regulatory Authority (SAHPRA)
Biotech Laboratories (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS IBUPROFEN 200,0 mg
Registered
1991-11-11
BIOTECH LABORATORIES (PTY) LTD IBUPROFEN 200 BIOTECH Each tablet contains 200 mg ibuprofen 1.3.1.1 Approved PI Page 1 of 15 PROFESSIONAL INFORMATION FOR IBUPROFEN 200 BIOTECH SCHEDULING STATUS S3 1. NAME OF THE MEDICINE IBUPROFEN 200 BIOTECH tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg ibuprofen. _Excipient with known effect:_ Contains sugar (30,0 mg lactose monohydrate per tablet). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Round biconvex, pink film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IBUPROFEN 200 BIOTECH is indicated for the treatment of mild to moderate pain of inflammatory origin and fever, including: • Soft tissue injuries such as sprains and pains • Headache • Back pain of musculo-skeletal origin • Fever • Muscular aches and pains • Menstrual pain BIOTECH LABORATORIES (PTY) LTD IBUPROFEN 200 BIOTECH Each tablet contains 200 mg ibuprofen 1.3.1.1 Approved PI Page 2 of 15 • Dental pain • Pain associated with migraine • Earache. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: _ADULTS AND CHILDREN OVER 12 YEARS:_ Use the lowest effective dose for the shortest possible duration of treatment. The recommended dosage of IBUPROFEN 200 BIOTECH is 1 200 mg daily in divided doses (1 to 2 tablets every four hours) for the relief of: 1) Mild to moderate pain of: • Soft tissue injuries such as sprains and strains • Dental pain • Back pain of musculo-skeletal origin • Earache • Pain associated with migraine • Muscular aches and pains. 2) Fever 3) Menstrual pain DO NOT EXCEED 6 TABLETS (1 200 MG) IN ANY 24 HOURS. Once the acute phase has been brought under control, it is normal practice to revert to a maintenance dosage. If symptoms persist for more than 7 days, consult your doctor. _CHILDREN: _ Not to be given to children under 12 years. _ _ METHOD OF ADMINISTRATION: BIOTECH LABORATORIES (PTY) LTD IBUPROFEN 200 BIOTECH Each tablet contains 200 mg ibuprofen 1.3.1.1 Approved PI Page 3 of Leia o documento completo