Perindopril Aurobindo 8 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERINDOPRIL TERT, BUTYLAMINE SALT

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL TERT-BUTYLAMINE SALT 8 mg

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL TERT-BUTYLAMINE SALT 8 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2012-02-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL AUROBINDO 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 or pharmacist.
•
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.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Perindopril Aurobindo is and what it is used for
2.
What you need to know before you take Perindopril Aurobindo
3.
How to take Perindopril Aurobindo
4.
Possible side effects
5.
How to store Perindopril Aurobindo
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL AUROBINDO IS AND WHAT IT IS USED FOR
Perindopril Aurobindo 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 Aurobindo is used:
•
to treat
_HIGH BLOOD PRESSURE _
(hypertension),
•
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 BEFORE YOU TAKE PERINDOPRIL AUROBINDO
DO NOT TAKE PERINDOPRIL AUROBINDO
•
if you are allergic to perindopril, or any of the other ingredients of
this medicine (listed in
section 6) or any other ACE inhibitor,
•
if you are more than 3 months pregnant. (It is also better to avoid
Perindopril Aurobindo in early
pregnancy – see pregnancy section.),
•
if you have experienced symptoms such as wheezing, sw

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perindopril Aurobindo 8 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg perindopril tert-butylamine salt equivalent
to 6.676 mg perindopril.
Excipient with known effect: 118.660 mg lactose / tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white coloured round biconvex, uncoated tablets with
debossing “D” on one side and
“5” & “9” on either side of the break line on another side.
The tablet can be divided into two equal
doses.
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 individualized according to the patient profile
(see section 4.4) and blood
pressure response.
Hypertension
Perindopril may be used in monotherapy or in combination with other
classes of antihypertensive
therapy(see Sections 4.3, 4.4, 4.5 and 5.1).
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
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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; 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 diuretic should be discontinued 2 to 3 days befor