国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE AMLODIPINE BESYLATE
Les Laboratoires Servier
PERINDOPRIL ARGININE AMLODIPINE BESYLATE
10/10
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-07-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT REAPTAN 10mg/10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine Excipient : lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablet engraved with 10/10 on one face and on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REAPTAN is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route. One tablet per day as a single dose, preferably to be taken in the morning and before a meal. The fixed dose combination is not suitable for initial therapy. If a change of posology is required, the dose of REAPTAN could be modified or individual titration with free combination may be considered. _Special populations_ _Patients with renal impairment and elderly (see sections 4.4 and 5.2)_ Elimination of perindoprilat is decreased in the elderly and in patients with renal failure. Therefore, the usual medical follow-up will include frequent monitoring of creatinine and potassium. REAPTAN can be administered in patients with Clcr 60ml/min, and is not suitable for patients with Clcr < 60ml/min. In these patients, an individual dose titration with the monocomponents is recommended. Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care. Changes in 阅读完整的文件