Olmesartan medoxomil/Amlodipine RAFARM 40 mg/5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMLODIPINEBESILAAT 6,95 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

Beschikbaar vanaf:

Rafarm S.A. 12 Korinthou street, N. Psihico 154 51 ATHENE (GRIEKENLAND)

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT 6,95 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-10-28

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLMESARTAN MEDOXOMIL/AMLODIPINE RAFARM 20 MG/5 MG, FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE RAFARM 40 MG/5 MG, FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE RAFARM 40 MG/10 MG, FILMOMHULDE
TABLETTEN
Olmesartan medoxomil/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 Olmesartan medoxomil/Amlodipine RAFARM is and what it is used for
2.
What you need to know before you take Olmesartan medoxomil/Amlodipine
RAFARM
3.
How to take Olmesartan medoxomil/Amlodipine RAFARM
4.
Possible side effects
5.
How to store Olmesartan medoxomil/Amlodipine RAFARM
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE RAFARM IS AND WHAT IT IS USED FOR
Olmesartan medoxomil/Amlodipine RAFARM contains two substances called
olmesartan
medoxomil and amlodipine (as amlodipine besilate). Both of these
substances help to
control high blood pressure.
•
Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II
receptor antagonists” which lower blood pressure by relaxing the
blood vessels.
•
Amlodipine belongs to a group of substances called “calcium channel
blockers”.
Amlodipine stops calcium from moving into the blood vessel wall which
stops the blood
vessels from tightening thereby also reducing blood pressure.
The actions of both these substances contribute to stopping the
tightening of blood vessels, so
that blood vessels relax and blood pressure decreases.
Olmesartan medoxomil/Amlodipine

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/Amlodipine RAFARM 20 mg/5 mg, filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine RAFARM 40 mg/5 mg, filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine RAFARM 40 mg/10 mg, filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg olmesartan medoxomil and 5 mg
amlodipine (as amlodipine
besilate).
Each film-coated tablet contains 40 mg olmesartan medoxomil and 5 mg
amlodipine (as amlodipine
besilate).
Each film-coated tablet contains 40 mg olmesartan medoxomil and 10 mg
amlodipine (as amlodipine
besilate).
Excipients with known effect:
Each 20 mg/5 mg film-coated tablet contains 5 mg of lactose
monohydrate.
Each 40 mg/5 mg film-coated tablet contains 10 mg of lactose
monohydrate.
Each 40 mg/10 mg film-coated tablet contains 10 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
FOR THE 20 MG/5 MG FILM-COATED TABLETS:
White, round, film-coated tablets, debossed with “OA1” on
one side and plain on other side.
Dimension: Diameter 6.10 mm ± 0.20 mm
FOR THE 40 MG/5 MG FILM-COATED TABLETS:
White to off-white, round, film-coated tablets debossed
with “OA3” on one side and plain on other side.
Dimension: Diameter 8.10 mm ± 0.20 mm
FOR THE 40 MG/10 MG FILM-COATED TABLETS:
Brownish-red, round, film-coated tablets debossed with
“OA4” on one side and plain on other side.
Dimension: Diameter 8.10 mm ± 0.20 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan medoxomil/Amlodipine RAFARM is indicated in adult patients
whose blood pressure is
not adequately controlled on olmesartan medoxomil or amlodipine
monotherapy (see section 4.2
and section 5.1).
Module 1.3.1
Page 1 of 1
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_ _
The recommended dosage of Olmesartan medoxomil/Amlodipine RAFARM is 1
tablet per day.
Olmesartan medoxomil/Amlodipine RAFA