Страна: ПАР
мова: англійська
Джерело: South African Health Products Regulatory Authority (SAHPRA)
Biotech Laboratories (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS CARBAMAZEPINE 200,0 mg
Registered
2000-02-07
BIOTECH LABORATORIES (PTY) LTD BIO-CARBAMAZEPINE 200 (TABLETS) Date of approval: 7 November 2022 Each tablet contains 200 mg carbamazepine Approved PIL Page 1 of 13 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S3 BIO-CARBAMAZEPINE 200 TABLETS CARBAMAZEPINE Sugar free. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BIO-CARBAMAZEPINE 200. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • BIO-CARBAMAZEPINE 200 has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What BIO-CARBAMAZEPINE 200 is and what it is used for 2. What you need to know before you take BIO-CARBAMAZEPINE 200 3. How to take BIO-CARBAMAZEPINE 200 4. Possible side effects 5. How to store BIO-CARBAMAZEPINE 200 6. Contents of the pack and other information 1. WHAT BIO-CARBAMAZEPINE 200 IS AND WHAT IT IS USED FOR Carbamazepine, the active ingredient in BIO-CARBAMAZEPINE 200, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits). It can also modify some types of pain. BIOTECH LABORATORIES (PTY) LTD BIO-CARBAMAZEPINE 200 (TABLETS) Date of approval: 7 November 2022 Each tablet contains 200 mg carbamazepine Approved PIL Page 2 of 13 BIO-CARBAMAZEPINE 200 is used: • To treat some forms of epilepsy. • To treat a painful condition of the face called trigeminal neuralgia. • To treat a painful condition occurring in the back of the throat, tongue and ear called idiopathic glossopharyngeal neuralgia. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIO-CARBAMAZEPINE 200 DO NOT TAKE BIO-CARBAMAZEPINE 200: • If you are allergic (hypersensitive) to carbamazepine, similar medicines such as tricyclic antidepressants (used to treat mood disorders) or to any of the other ingredients of BIO- CARBAMAZEPINE 200 (listed in section 6). • If you have ever had problems wit Прочитайте повний документ
BIOTECH LABORATORIES (PTY) LTD BIO-CARBAMAZEPINE 200 (TABLETS) Date of approval: 7 November 2022 Each tablet contains 200 mg carbamazepine Approved PI Page 1 of 26 PROFESSIONAL INFORMATION FOR BIO-CARBAMAZEPINE 200 SCHEDULING STATUS S3 1. NAME OF THE MEDICINE BIO-CARBAMAZEPINE 200 tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg carbamazepine. Sugar free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White, flat, round bevelled edge tablet. One side scored. Other side engraved TARO 11. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy: Psychomotor or temporal-lobe epilepsy; grand mal; mixed forms; focal seizures. Trigeminal neuralgia. Idiopathic glossopharyngeal neuralgia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Dosage should be adjusted to the needs of the individual patient. A low initial daily dose with a gradual increase is advised. As soon as adequate control is achieved the dosage may be gradually reduced to the minimum effective level. The tablets should be taken with meals. Monitoring of plasma levels may be useful. BIOTECH LABORATORIES (PTY) LTD BIO-CARBAMAZEPINE 200 (TABLETS) Date of approval: 7 November 2022 Each tablet contains 200 mg carbamazepine Approved PI Page 2 of 26 _EPILEPSY _ Adults and children over 12 years: Initially 200 mg twice daily. Increase at weekly intervals by adding up to 200 mg per day until the optimum response is obtained, usually 400 mg twice or three times daily. Doses up to 1 600 mg daily have been used in adults (in divided doses). Children: 10 to 20 mg /kg per day. Dosage should not exceed 1 000 mg daily. _ _ Age up to 1 year: 100 – 200 mg per day 1 to 5 years: 200 – 400 mg per day 5 to 10 years: 400 – 600 mg per day 10 to 15 years: 600 – 1000 mg per day _TRIGEMINAL NEURALGIA _ The initial dose of 100 mg once or twice daily should be increased gradually until a satisfactory clinical response is obtained. Control of pain is achieved in most patients with 400 to 800 mg daily in 2 Прочитайте повний документ