Perindopril/amlodipine Krka 4 mg/10 mg tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Perindopril tert-butylamine; Amlodipine besilate

제공처:

KRKA, d.d., Novo mesto

ATC 코드:

C09BB; C09BB04

INN (국제 이름):

Perindopril tert-butylamine; Amlodipine besilate

복용량:

4/10 milligram(s)

약제 형태:

Tablet

치료 영역:

ACE inhibitors and calcium channel blockers; perindopril and amlodipine

승인 상태:

Not marketed

승인 날짜:

2017-08-18

환자 정보 전단

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

제품 특성 요약

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/10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg perindopril tert-butylamine (equivalent to
3.34 mg perindopril) and 10 mg amlodipine (as besilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to almost white, capsule shaped, biconvex tablets scored on one
side.The tablets are engraved with mark U on one side
and mark 2 on the other side of the breaker score. Dimensions: 12.5 mm
× 5.5 mm.The score line is only to facilitate breaking
for ease of swallowing and not to divide into equal doses.
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 dosa