PERINDOPRIL SERVIER 8 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE SALT
Available from:
Les Laboratoires Servier
INN (International Name):
PERINDOPRIL TERT-BUTYLAMINE SALT
Dosage:
8 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2014-07-11
Patient Information leaflet
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
PERINDOPIL SERVIER 8 MG TABLETS
perindopril tert-butylamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions,
ask your doctor, pharmacist or nurse.
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This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
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If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Perindopril Servier is and what it is used for
2.
What you need to know before you take Perinopril Servier
3.
How to take Perindopril Servier
4.
Possible side effects
5.
How to store Perindopril Servier
6.
Content of the pack and other information
1. WHAT PERINDOPRIL SERVIER IS AND WHAT IT IS USED FOR
Perindopril Servier is an angiotensin converting enzyme (ACE)
inhibitor. These work by widening the
blood vessels, which makes it easier for your heart to pump
blood through them.
Perindopril Servier is used:
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to treat _HIGH BLOOD PRESSURE_ (hypertension),
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to reduce the risk of cardiac events, such as heart attack, in patients with _STABLE CORONARY ARTERY _
_DISEASE_ (a condition where the blood supply to the heart is reduced or blocked) and who have
already had a heart attack and/or an operation to improve the blood supply to the heart by
widening the vessels that supply it.
2.
WHAT YOU NEED TO KNOW BEFO
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Servier 8 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril Servier 8 mg Tablets:
Each tablet contains 8 mg perindopril tert-butylamine salt, equivalent to 6.676 mg perindopril
Excipient with known effect: lactose
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
White, round, convex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension.
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
Posology
The dose should be individualised according to the patient profile (see 4.4 “Special warnings and special precautions
for use”) and blood pressure response.
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Hypertension
Perindopril 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 Tablets; this is more likely in
patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may
be volume and/or salt depleted.
If possible, the di
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