Perindopril tert-butylamine/Amlodipine Denk 4 mg/10 mg tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; PERINDOPRIL-TERT-BUTYLAMINE 4 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,3 mg/stuk

Beschikbaar vanaf:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; PERINDOPRIL-TERT-BUTYLAMINE 4 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,3 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; GLYCEROLDIBEHENAAT ; MAGNESIUMOXIDE, LICHT (E 530) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; TREHALOSE (Alpha, Alpha-) 2-WATER, CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLDIBEHENAAT ; MAGNESIUMOXIDE, LICHT (E 530) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; TREHALOSE (Alpha, Alpha-) 2-WATER

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-04-09

Bijsluiter

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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine/Amlodipine Denk 4 mg/5 mg tabletten
Perindopril tert-butylamine/Amlodipine Denk 4 mg/10 mg tabletten
Perindopril tert-butylamine/Amlodipine Denk 8 mg/5 mg tabletten
Perindopril tert-butylamine/Amlodipine Denk 8 mg/10 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert-butylamine/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 tert-butylamine/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 tert-butylamine/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 tert-butylamine/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 tert-butylamine/Amlodipine Denk 4 mg/5 mg tablets
White to off-white, oval, biconvex tablets, marked with ‘4/5’ on
one side.
Perindopril tert-butylamine/Amlodipine Denk 4 mg/10 mg tablets
White to off-white, rectangular, biconvex tablets, marked with
‘4/10’ on one side.
Perindopril tert-butylamine/Amlodipine Denk 8 mg/5 mg tablets
White to off-white, triangular, biconvex tablets, marked with
‘8/5’ on one side.
Perindopril tert-butylamine/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 tert-butylamine/Amlodipine Denk is indicated as
substitution therapy for treatment of
essential hyper