Perindopril/amlodipine Krka 4 mg/5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril tert-butylamine; Amlodipine besilate

Available from:

KRKA, d.d., Novo mesto

ATC code:

C09BB; C09BB04

INN (International Name):

Perindopril tert-butylamine; Amlodipine besilate

Dosage:

4/5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

ACE inhibitors and calcium channel blockers; perindopril and amlodipine

Authorization status:

Not marketed

Authorization date:

2017-08-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL/AMLODIPINE KRKA 4 MG/5 MG TABLETS
PERINDOPRIL/AMLODIPINE KRKA 4 MG/10 MG TABLETS
PERINDOPRIL/AMLODIPINE KRKA 8 MG/5 MG TABLETS
PERINDOPRIL/AMLODIPINE KRKA 8 MG/10 MG TABLETS
perindopril tert-butylamine/amlodipine
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/amlodipine Krka is and what it is used for
2.
What you need to know before you take Perindopril/amlodipine Krka
3.
How to take Perindopril/amlodipine Krka
4.
Possible side effects
5.
How to store Perindopril/amlodipine Krka
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL/AMLODIPINE KRKA IS AND WHAT IT IS USED FOR
Perindopril/amlodipine Krka is prescribed for treatment of high blood
pressure (hypertension) and/or
treatment of stable coronary artery disease (a condition where the
blood supply to the heart is reduced
or blocked).
Patients already taking perindopril and amlodipine from separate
tablets may instead receive one tablet
of Perindopril/amlodipine Krka which contains both ingredients.
Perindopril/amlodipine Krka is a combination of two active
ingredients, perindopril and amlodipine.
Perindopril is an ACE (angiotensin converting enzyme) inhibitor.
Amlodipine is a calcium antagonist
(which belongs to a class of medicines called dihydropyridines).
Together they work to widen and
relax the blood vessels so that blood passes through them more easily
and makes it easier for your
heart to maintain a good blood flow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TA

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2024
CRN00D6F0
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril/amlodipine Krka 4 mg/5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg perindopril tert-butylamine (equivalent to
3.34 mg perindopril) and 5 mg amlodipine (as besilate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to almost white, round, slightly biconvex tablets with bevelled
edges, engraved with mark U 1 on one side of the tablet.
Diameter: 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril/amlodipine Krka is indicated as substitution therapy for
treatment of essential hypertension and/or stable coronary
artery disease, in patients already controlled with perindopril and
amlodipine given concurrently at the same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose is one tablet per day.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, the dose of
Perindopril/amlodipine Krka could be modified or individual titration
with free
combination may be considered.
_Special populations_
_Patients with renal impairment and elderly (see sections 4.4 and 5.2)
_
Elimination of perindoprilat is decreased in the elderly and in
patients with renal failure. Therefore, the usual medical follow-up
will include frequent monitoring of creatinine and potassium.
Perindopril/amlodipine Krka can be administered in patients with Clcr
≥ 60ml/min, and is not suitable for patients with Clcr <
60ml/min. In these patients, an individual dose titration with the
monocomponents is recommended.
Amlodipine used at similar doses in elderly or younger patients is
equally well tolerated. Normal dosage regimens are
recommended in the elderly, but increase of the dosage should take
place with care. Changes in amlodipine plasma
concentrations are not correlated with degree of renal impairment.
Amlodipine is not dialysable.
_Patients wi