Nistik 40 mg/5 mg/12,5 mg filmomhulde tabletten

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

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

Saatavilla:

Menarini International Operations Luxembourg S.A. 1,Avenue de la Gare L-1611 LUXEMBURG (LUXEMBURG)

ATC-koodi:

C09DX03

INN (Kansainvälinen yleisnimi):

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

Lääkemuoto:

Filmomhulde tablet

Koostumus:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E 1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Antoreitti:

Oraal gebruik

Terapeuttinen alue:

Olmesartan medoxomil, amlodipine and hydrochlorothiazide

Tuoteyhteenveto:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Valtuutus päivämäärä:

1900-01-01

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NISTIK 20 MG/5 MG/12,5 MG FILMOMHULDE TABLETTEN
NISTIK 40 MG/5 MG/12,5 MG FILMOMHULDE TABLETTEN
NISTIK 40 MG/10 MG/12,5 MG FILMOMHULDE TABLETTEN
NISTIK 40 MG/5 MG/25 MG FILMOMHULDE TABLETTEN
NISTIK 40 MG/10 MG/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 Nistik is and what it is used for
2.
What you need to know before you take Nistik
3.
How to take Nistik
4.
Possible side effects
5.
How to store Nistik
6.
Contents of the pack and other information
1.
WHAT NISTIK IS AND WHAT IT IS USED FOR
Nistik 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 helping the body to get rid of extra fluid by
making your kidneys
produce more urine.
The actions of these substances contribute to decrease your blood
pressure.
Nistik is used for the treatment of high blood pressure:
•
in adult patients whose blood

Valmisteyhteenveto

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Nistik 20 mg/5 mg/12,5 mg filmomhulde tabletten
Nistik 40 mg/5 mg/12,5 mg filmomhulde tabletten
Nistik 40 mg/10 mg/12,5 mg filmomhulde tabletten
Nistik 40 mg/5 mg/25 mg filmomhulde tabletten
Nistik 40 mg/10 mg/25 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nistik 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.
Nistik 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.
Nistik 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.
Nistik 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.
Nistik 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Nistik 20 mg/5 mg/12.5 mg film-coated tablets:
Light orange, round, film-coated tablet of 8 mm debossed C51 on one
side.
Nistik 40 mg/5 mg/12.5 mg film-coated tablets:
Light yellow, round, film-coated tablet of 9.5 mm debossed C53 on one
side.
Nistik 40 mg/10 mg/12.5 mg film-coated tablets:
Greyish red, round, film-coated tablet of 9.5 mm debossed C55 on one
side.
Nistik 40 mg/5 mg/25 mg film-coated tablets:
Light yellow, oval, film-coated tablet of 15 x 7 mm debossed C54 on
one side.
Nistik 40 mg/10 mg/25 mg film-coated tablets:
Greyish red, oval, film-coated tablet of 15 x 7 mm debossed C57 on one
side.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertens