Perindopril/Amlodipine Denk 8 mg/5 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERINDOPRIL TERT, BUTYLAMINE SALT, AMLODIPINE BESILATE

Available from:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , Germany

ATC code:

C09BB04

INN (International Name):

PERINDOPRIL TERT-BUTYLAMINE SALT 8 mg AMLODIPINE BESILATE 5 mg

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL TERT-BUTYLAMINE SALT 8 mg AMLODIPINE BESILATE 5 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-04-29

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL/AMLODIPINE DENK 4 MG/5 MG TABLETS
PERINDOPRIL/AMLODIPINE DENK 4 MG/10 MG TABLETS
PERINDOPRIL/AMLODIPINE DENK 8 MG/5 MG TABLETS
PERINDOPRIL/AMLODIPINE DENK 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 Denk is and what it is used for
2.
What you need to know before you take Perindopril/Amlodipine Denk
3.
How to take Perindopril/Amlodipine Denk
4.
Possible side effects
5.
How to store Perindopril/Amlodipine Denk
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL/AMLODIPINE DENK IS AND WHAT IT IS USED FOR
Perindopril/Amlodipine Denk 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 Denk which contains both ingredients.
Perindopril/Amlodipine Denk 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 B

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perindopril/Amlodipine Denk 4 mg/5 mg tablets
Perindopril/Amlodipine Denk 4 mg/10 mg tablets
Perindopril/Amlodipine Denk 8 mg/5 mg tablets
Perindopril/Amlodipine Denk 8 mg/10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril/Amlodipine Denk 4 mg/5 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine (equivalent to
3.34 mg perindopril)
and 5 mg amlodipine (as besilate).
Perindopril/Amlodipine Denk 4 mg/10 mg tablets
Each tablet contains 4 mg perindopril tert-butylamine (equivalent to
3.34 mg perindopril) and 10
mg amlodipine (as besilate).
Perindopril/Amlodipine Denk 8 mg/5 mg tablets
Each tablet contains 8 mg perindopril tert-butylamine (equivalent to
6.68 mg perindopril) and 5 mg
amlodipine (as besilate).
Perindopril/Amlodipine Denk 8 mg/10 mg tablets
Each tablet contains 8 mg perindopril tert-butylamine (equivalent to
6.68 mg perindopril) and 10
mg amlodipine (as besilate).
Excipient with known effect:
These medicines contain less than 1 mmol (23 mg) sodium per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Perindopril/Amlodipine Denk 4 mg/5 mg tablets
White to off-white, oval, biconvex tablets, marked with ‘4/5’ on
one side.
Perindopril/Amlodipine Denk 4 mg/10 mg tablets
White to off-white, rectangular, biconvex tablets, marked with
‘4/10’ on one side.
Perindopril/Amlodipine Denk 8 mg/5 mg tablets
White to off-white, triangular, biconvex tablets, marked with
‘8/5’ on one side.
Perindopril/Amlodipine Denk 8 mg/10 mg tablets
White to off-white, round, biconvex tablets, marked with ‘8/10’ on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Perindopril/Amlodipine Denk 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
Oral route.
On