Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 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 ; OLMESARTANMEDOXOMIL 40 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

C09DB02

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; ERWTENZETMEEL, HYDROXYPROPYL (GEMODIFICEERD) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; ERWTZETMEEL, HYDROXYPROPYL (GEMODIFICEERD) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Olmesartan Medoxomil And Amlodipine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); ERWTZETMEEL, HYDROXYPROPYL (GEMODIFICEERD); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); SORBITOL (D-)(E 420); STEARINEZUUR (E 570); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-02-20

Bijsluiter

PIL-NL-OlmeAmlo-3868-Var017
2022-07-05
Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTANMEDOXOMIL/AMLODIPINE STADA 20 MG/5 MG FILMOMHULDE TABLETTEN
OLMESARTANMEDOXOMIL/AMLODIPINE STADA 40 MG/5 MG FILMOMHULDE TABLETTEN
OLMESARTANMEDOXOMIL/AMLODIPINE STADA 40 MG/10 MG FILMOMHULDE TABLETTEN
Olmesartan medoxomil l/ Amlodipine besilate
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 Olmesartanmedoxomil/Amlodipine STADA is and what it is used
for
2. What you need to know before you take
Olmesartanmedoxomil/Amlodipine STADA
3. How to take Olmesartanmedoxomil/Amlodipine STADA
4. Possible side effects
5. How to store Olmesartanmedoxomil/Amlodipine STADA
6. Contents of the pack and other information
1. WHAT OLMESARTANMEDOXOMIL/AMLODIPINE STADA IS AND WHAT IT IS USED
FOR
Olmesartanmedoxomil/Amlodipine
STADA
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 them
from tightening
thereby also reducing blood pressure
The actions of both these substances contribute to stopping the
tightening of blood vessels,
so that they relax and blood pressure decreases.
Olmesartan

Productkenmerken

SPC-NL-OlmAmlo3868-Var0017
2022-07-05
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Olmesartanmedoxomil/Amlodipine STADA 20 mg/5 mg filmomhulde tabletten
Olmesartanmedoxomil/Amlodipine STADA 40 mg/5 mg filmomhulde tabletten
Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartanmedoxomil/Amlodipine STADA 20 mg/5 mg filmomhulde tabletten:
Each film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA
contains 20 mg of
olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).
Olmesartanmedoxomil/Amlodipine STADA 40 mg/5 mg filmomhulde tabletten:
Each film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA
contains 40 mg of
olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).
Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 mg filmomhulde
tabletten:
Each film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA
contains 40 mg of
olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate).
Excipient(s) with known effect
One film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA 20 mg/5
mg contains
29.96 mg lactose monohydrate and 0.45 mg sorbitol
One film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA 40 mg/5
mg contains
66.85 mg lactose monohydrate and 0.90 mg sorbitol
One film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA 40
mg/10 mg> contains
59.91 mg lactose monohydrate and 0.90 mg sorbitol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Olmesartanmedoxomil/Amlodipine STADA 20 mg/5 mg filmomhulde tabletten:
White, round biconvex filmomhulde tabletten.
Olmesartanmedoxomil/Amlodipine STADA 40 mg/5 mg filmomhulde tabletten:
Yellowish-white, round, biconvex filmomhulde tabletten.
Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 mg filmomhulde
tabletten:
Brownish-red, round, biconvex filmomhulde tabletten.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartanmedoxomil/A