PERINDOPRIL TERT-BUTYLAMINE 4 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE SALT
Available from:
Les Laboratoires Servier
INN (International Name):
PERINDOPRIL TERT-BUTYLAMINE SALT
Dosage:
4 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-08-27
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine 4mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert-butylamine.
One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert-butylamine.
Excipient: lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet scored on both faces. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension
Heart failure:
Treatment of symptomatic heart failure
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that Perindopril tert-butylamine Tablets is taken once daily in the morning before a meal.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response.
Hypertension:
Perindopril tert-butylamine Tablets may be used in monotherapy or in combination with other classes of
antihypertensive therapy.
The recommended starting dose is 4 mg given once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt
and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood
pressure following the initial dose. A starting dose of 2 mg is recommended in such patients and the initiation of
treatment should take place under medical supervision.
The dose may be increased to 8 mg once daily after one month of treatment.
Symptomatic hypotension may occur following initiation of therapy with Perindopril tert-butylamine Tablets; this is
Read the complete document
