ACERYCAL Tablets 5 /10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
PERINDOPRIL ARGININE AMLODIPINE BESILATE
Available from:
Clear Pharmacy
Dosage:
5 /10 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2011-03-04
Summary of Product characteristics
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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
on the other 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.
Patients with renal impairment and elderly (see sections 4.4 and 5.2)
Elimination of perindopr
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