Perindopril Krka 4 mg tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Perindopril tert-butylamine

Inapatikana kutoka:

KRKA, d.d., Novo mesto

ATC kanuni:

C09AA; C09AA04

INN (Jina la Kimataifa):

Perindopril tert-butylamine

Kipimo:

4 milligram(s)

Dawa fomu:

Tablet

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

ACE inhibitors, plain; perindopril

Idhini hali ya:

Marketed

Idhini ya tarehe:

2010-08-06

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL KRKA 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 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 Krka is and what it is used for
2.
What you need to know before you take Perindopril Krka
3.
How to take Perindopril Krka
4.
Possible side effects
5.
How to store Perindopril Krka
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL KRKA IS AND WHAT IT IS USED FOR
The active substance of Perindopril Krka tablets belongs to the group
of medicines called angiotensin
converting enzyme (ACE) inhibitors. These work by widening the blood
vessels, which makes it
easier for your heart to pump blood through them.
Perindopril Krka tablets are used:
-
to treat high blood pressure (hypertension),
-
to treat symptomatic 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 PERINDOPRIL KRKA
DO NOT TAKE PERINDOPRIL KRKA
-
if you are allergic to perindopril, any other ACE inhibitor or any of
the other ingredients of this
medicine (listed in section 6);
-
if you have had in the past a hypersensitivity reaction with sudden
swelling of

Tabia za bidhaa

Health Products Regulatory Authority
07 April 2022
CRN00CLLC
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Krka 4 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg perindopril tert-butylamine, equivalent to
3.338 mg perindopril.
Excipient(s) with known effect:
Each tablet contains 60.4 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Tablets are white to almost white, oval (length 8.5 mm, thickness 2.8
- 3.9 mm), slightly biconvex, one side scored tablets with
bevelled 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:
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
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.
After one month of treatment, the daily dose may be increased to 8 mg
once daily.
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 th