Olmesartan medoxomil/Amlodipine/HCT Innovis, 40mg/5mg/12,5mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2021-11-15

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT INNOVIS, 20MG/5MG/12,5MG
FILMOMHULDE TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT INNOVIS, 40MG/5MG/12,5MG
FILMOMHULDE TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT INNOVIS, 40MG/10MG/12,5MG
FILMOMHULDE TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT INNOVIS, 40MG/5MG/25MG FILMOMHULDE
TABLETTEN
OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT INNOVIS, 40MG/10MG/25MG
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 Olmesartan medoxomil/Amlodipine/HCT Innovis is and what it is
used for
2.
What you need to know before you take Olmesartan
medoxomil/Amlodipine/HCT Innovis
3.
How to take Olmesartan medoxomil/Amlodipine/HCT Innovis
4.
Possible side effects
5.
How to store Olmesartan medoxomil/Amlodipine/HCT Innovis
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE/HCT INNOVIS IS AND WHAT IT IS
USED FOR
Olmesartan medoxomil/Amlodipine/HCT Innovis 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 relaxin

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/Amlodipine/HCT Innovis, 20mg/5mg/12,5mg
filmomhulde tabletten
Olmesartan medoxomil/Amlodipine/HCT Innovis, 40mg/5mg/12,5mg
filmomhulde tabletten
Olmesartan medoxomil/Amlodipine/HCT Innovis, 40mg/10mg/12,5mg
filmomhulde tabletten
Olmesartan medoxomil/Amlodipine/HCT Innovis, 40mg/5mg/25mg filmomhulde
tabletten
Olmesartan medoxomil/Amlodipine/HCT Innovis, 40mg/10mg/25mg
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil/Amlodipine/HCT Innovis 20 mg/5 mg/12.5 mg
film-coated tablets
Each tablet contains 20 mg olmesartan medoxomil, 5 mg amlodipine (as
amlodipine besilate) and 12.5
mg hydrochlorothiazide.
Excipient with known effect
Each tablet contains 19 mg of lactose (as monohydrate).
Olmesartan medoxomil/Amlodipine/HCT Innovis 40 mg/5 mg/12.5 mg
film-coated tablets
Each tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as
amlodipine besilate) and 12.5
mg hydrochlorothiazide.
Excipient with known effect
Each tablet contains 38 mg of lactose (as monohydrate).
Olmesartan medoxomil/Amlodipine/HCT Innovis 40 mg/10 mg/12.5 mg
film-coated tablets
Each tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as
amlodipine besilate) and
12.5 mg hydrochlorothiazide.
Excipient with known effect
Each tablet contains 38 mg of lactose (as monohydrate).
Olmesartan medoxomil/Amlodipine/HCT Innovis 40 mg/5 mg/25 mg
film-coated tablets
Each tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as
amlodipine besilate) and 25
mg hydrochlorothiazide.
Excipient with known effect
Each tablet contains 38 mg of lactose (as monohydrate).
Olmesartan medoxomil/Amlodipine/HCT Innovis 40 mg/10 mg/25 mg
film-coated tablets
Each tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as
amlodipine besilate) and 25
mg hydrochlorothiazide.
Excipient with known effect
Each tablet contains 38 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Fi