Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE AMLODIPINE BESILATE
Clear Pharmacy
PERINDOPRIL ARGININE AMLODIPINE BESILATE
5/10 mg/mg
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACERYCAL 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. _Product imported from Hungary_ White, square-shaped tablet engraved with 5/10 on one face and [Servier logo] on the outer face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ACERYCAL 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 ACERYCAL 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. ACERYCAL 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 mono-components 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 Прочитать полный документ