Olmesartan medoxomil/Amlodipine/HCT STADA 20/5/12,5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMLODIPINEBESILAAT SAMENSTELLING overeenkomend met ; AMLODIPINE ; HYDROCHLOORTHIAZIDE ; OLMESARTANMEDOXOMIL

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT COMPOSITION corresponding to ; AMLODIPINE ; HYDROCHLOROTHIAZIDE ; OLMESARTANMEDOXOMIL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-05-29

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 20/5/12,5 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/5/12,5 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/10/12,5 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/5/25 MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT STADA 40/10/25 MG FILMOMHULDE
TABLETTEN
olmesartan medoxomil/amlodipine/hydrochlorothiazide
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 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 group of medicines called thiazide
diuretics (“water
tablets”). It lowers blood pressure by making your kidneys produce
more urine, thus
helping the body

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAAM VAN HET GENEESMIDDEL
Olmesartan medoxomil/Amlodipine/HCT STADA 20/5/12,5 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 40/5/12,5 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 40/10/12,5 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 40/5/25 mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT STADA 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
amlodipine besilate) and 12.5 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 99.30 mg lactose (as monohydrate).
40 mg/5 mg/12.5 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
5 mg
amlodipine
(as
amlodipine besilate) and 12.5 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 217.07 mg lactose (as monohydrate).
40 mg/10 mg/12.5 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
10 mg
amlodipine
(as
amlodipine besilate) and 12.5 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 210.48 mg lactose (as monohydrate).
40 mg/5 mg/25 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
5 mg
amlodipine
(as
amlodipine besilate) and 25 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 205.19 mg lactose (as monohydrate).
40 mg/10 mg/25 mg film-coated tablets:
Each
film-coated
tablet
contains
40 mg
olmesartan
medoxomil,
10 mg
amlodipine
(as
amlodipine besilate) and 25 mg hydrochlorothiazide.
Excipient with known effect
One film-coated tablet contains 198.61 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
20 mg/5 mg/12.5