PRINDACE 4 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
15-05-2018
Summary of Product characteristics
(SPC)
15-05-2018
Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE SALT
Available from:
Les Laboratoires Servier
ATC code:
C09AA04
INN (International Name):
PERINDOPRIL TERT-BUTYLAMINE SALT
Dosage:
4 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors, plain
Authorization status:
Authorised
Authorization date:
2000-12-20
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRINDACE 4 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 of the side effects, talk to your doctor, or pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Prindace is and what it is used for
2.
What you need to know before you take Prindace
3.
How to take Prindace
4.
Possible side effects
5.
How to store Prindace
6.
Content of the pack and other information
1.
WHAT PRINDACE IS AND WHAT IT IS USED FOR
Prindace 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.
Prindace is used:
-
to treat
_HIGH BLOOD PRESSURE_
(hypertension),
-
to treat
_HEART FAILURE_
(a condition where the heart is unable to pump enough blood to meet
the body’s
needs),
-
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 PRINDACE
DO NOT TAKE PRINDACE
-
if you are allergic to perindopril, or any of the other ingredients in
this medicine (listed in Section 6), to
any other ACE inhibitor if you have experienced symptoms such as
wheezing, swelling of the face,
tongue or throat, intense itching or severe skin rashes with previous
ACE inhibitor treatment or if you or
a member of your family have had these sym
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prindace 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert-butylamine.
One tablet contains 3.338 mg perindopril corresponding to 4 mg
perindopril tert-butylamine.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet, scored on both edges.
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
Posology
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure response.
Hypertension
Prindace 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 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
Prindace; 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 before
beginning therapy with Prindace (see section 4.4).
In hypertensive patients in whom the diuretic cannot be
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