Olmesartan medoxomil / Amlodipine / HCTZ Win Medica 40/10/12,5 mg, filmomhulde 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 ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

Olmesartan medoxomil/Amlodipine/ Hydrochlorothiazide film-coated
tablets
Module 1.3.1
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL / AMLODIPINE / HCTZ WIN MEDICA 20/5/12,5 MG,
FILMOMHULDE TABLETTEN
OLMESARTAN MEDOXOMIL / AMLODIPINE / HCTZ WIN MEDICA 40/5/12,5 MG,
FILMOMHULDE TABLETTEN
OLMESARTAN MEDOXOMIL / AMLODIPINE / HCTZ WIN MEDICA 40/5/25 MG,
FILMOMHULDE TABLETTEN
OLMESARTAN MEDOXOMIL / AMLODIPINE / HCTZ WIN MEDICA 40/10/12,5 MG,
FILMOMHULDE TABLETTEN
OLMESARTAN MEDOXOMIL / AMLODIPINE / HCTZ WIN MEDICA 40/10/25 MG,
FILMOMHULDE TABLETTEN
olmesartan medoxomil/amlodipine/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains three active substances called olmesartan
medoxomil, amlodipine (as
amlodipine besilate) and hydrochlorothiazide. All three substances
help to control high blood pressure.
•
Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II receptor
antagonists”, which lowers blood pressure by relaxing the blood
vessels.
•
Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine
also lowers blood pressure by relaxing blood vessels.
•
Hydrochlorothiazide is one of a

Productkenmerken

Olmesartan medoxomil/Amlodipine/ Hydrochlorothiazide film-coated
tablets
Module 1.3.1
Page 1 of 34
1.3.1.1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil / Amlodipine / HCTZ Win Medica 20/5/12,5 mg,
filmomhulde tabletten
Olmesartan medoxomil / Amlodipine / HCTZ Win Medica 40/5/12,5 mg,
filmomhulde tabletten
Olmesartan medoxomil / Amlodipine / HCTZ Win Medica 40/5/25 mg,
filmomhulde tabletten
Olmesartan medoxomil / Amlodipine / HCTZ Win Medica 40/10/12,5 mg,
filmomhulde tabletten
Olmesartan medoxomil / Amlodipine / HCTZ Win Medica 40/10/25 mg,
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
20 mg/5 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 20 mg olmesartan medoxomil, 5 mg
amlodipine (as besilate) and 12.5
mg hydrochlorothiazide
40 mg /5 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg
amlodipine (as besilate) and 12.5
mg hydrochlorothiazide.
40 mg/5 mg/25
mg film-coated tablets:
Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg
amlodipine (as besilate) and 25
mg hydrochlorothiazide.
40 mg/10 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg
amlodipine (as besilate) and
12.5 mg hydrochlorothiazide.
40 mg/10 mg/25
mg film-coated tablets:
Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg
amlodipine (as besilate) and 25
mg hydrochlorothiazide.
Excipient with known effect:
20 mg/5 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 9.5 mg lactose (as monohydrate).
40 mg/5 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 14.25 mg lactose (as monohydrate).
40 mg/5 mg/25 mg film-coated tablets:
Each film-coated tablet contains 19 mg lactose (as monohydrate).
40 mg/10 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 14.25 mg la