Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
NIFEDIPINE ATENOLOL
Bayer Limited
20mg/50 mg Milligram
Capsule
2007-01-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beta – Adalat 20mg/50mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg nifedipine and 50 mg atenolol. Excipient: contains 10.0mg of lactose monohydrate per capsule For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard. (capsule) Brown – reddish, opaque gelatin capsules overprinted with “BETA – ADALAT ” and the Bayer cross, containing white granules and a pink film-coated, round, biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of hypertension and of chronic stable angina pectoris where therapy with either a calcium channel blocker or a beta-blocker prove inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: _Hypertension: _One capsule daily swallowed with water. If necessary, the dosage may be increased to one capsule dosed every 12 hours. Patients can be transferred to the combination from other antihypertensive treatments with the exception of clonidine (see Section 4.4). _Angina: _One capsule every 12 hours swallowed with water. Where additional efficacy is necessary, prophylactic nitrate therapy or additional nifedipine may be of benefit. ELDERLY: Dosage should not exceed one capsule daily in hypertension or one capsule twice daily in angina. The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients. CHILDREN: There is no paediatric experience with Beta-Adalat and therefore this preparation should not be used in children. GENERAL: Patients with renal or hepatic insufficiency may require lower dosages of Beta-Adalat, (see Section 4.4). Nifedipine should not be taken with grapefruit juice (see Section 4.5). IRI Soma hati kamili