Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE AMLODIPINE BESYLATE
Les Laboratoires Servier
5/10 Milligram
Tablets
2008-07-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT REAPTAN 5mg/10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 3.395 mg perindopril equivalent to 5 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, square-shaped tablet engraved with 5/10 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. _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. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. _Patients with hepatic impairment: see sections 4.4 and 5.2_ A dosage regimen for patients with hepatic impairment has not been establi Прочитајте комплетан документ