Perindopril Arginine TAD 10 mg tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Perindopril arginine

Dostupno od:

TAD Pharma GmbH

ATC koda:

C09AA04

INN (International ime):

Perindopril arginine

Doziranje:

10 milligram(s)

Farmaceutski oblik:

Tablet

Područje terapije:

perindopril

Status autorizacije:

Marketed

Datum autorizacije:

2021-11-19

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL ARGININE TAD 5 MG TABLETS
PERINDOPRIL ARGININE TAD 10 MG TABLETS
perindopril arginine
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 Arginine TAD is and what it is used for
2.
What you need to know before you take Perindopril Arginine TAD
3.
How to take Perindopril Arginine TAD
4.
Possible side effects
5.
How to store Perindopril Arginine TAD
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL ARGININE TAD IS AND WHAT IT IS USED FOR
Perindopril Arginine TAD 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 Arginine TAD 5 mg and 10 mg tablets are 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.
Perindopril Arginine TAD 5 mg tablets are also used:
-
to treat heart failure (a condition where the heart is unable to pump
enough blood to meet the
body’s needs).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE TAD
DO NOT TAKE PERINDOPRIL ARGININE TAD
-
if you are allergic to peridnopril, any other ACE inhibitor or any of
the other ingredients of this
medicine (list

Svojstava lijeka

Health Products Regulatory Authority
06 December 2021
CRN00CPXC
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Arginine TAD 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg perindopril arginine, equivalent to 6.790
mg of perindopril.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White or almost white, round, biconvex tablets marked with V2 on one
side of the tablet. Diameter: approximately 8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension in adults.
Stable coronary artery disease:
Reduction of risk of cardiac events in adult 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:
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 5 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 2.5 mg is recommended
in such patients and the initiation of treatment should
take place under medical supervision.
The dose may be increased to 10 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 before
beginning therapy with perindopril (see section 4.4).
In hypertensive patients in w