ACERYCAL Tablets 5/5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
PERINDOPRIL ARGININE AMLODIPINE
Available from:
Imbat Limited
Dosage:
5/5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2012-01-27
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acerycal 5mg/5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.395mg perindopril equivalent to 5mg perindopril arginine and 6.935mg amlodipine besilate
equivalent to 5mg amlodipine
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
_Product imported from Poland:_
White, rod-shaped tablet engraved with 5/5 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 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 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
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