Amlodipine/Valsartan Apotex 5 mg/160 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMLODIPINEBESILAAT SAMENSTELLING overeenkomend met ; AMLODIPINE ; VALSARTAN

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

C09DB01

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT COMPOSITION corresponding to ; AMLODIPINE ; VALSARTAN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C ; CALCIUMDIWATERSTOFFOSTAAT 0-WATER ; CELLULOSE, GEPOEDERD (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Valsartan And Amlodipine

Product samenvatting:

Hulpstoffen: ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C; CALCIUMDIWATERSTOFFOSTAAT 0-WATER; CELLULOSE, GEPOEDERD (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-03-21

Bijsluiter

AMLODIPINE/VALSARTAN 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG,
FILMOMHULDE TABLETTEN – RVG 116961-77-78
MODULE 1.3
Product Information
Version: 2018-08-31
MODULE 1.3.1
Package Leaflet
Replaces: 2018-07-02b
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
AMLODIPINE/VALSARTAN APOTEX 5 MG/80 MG, FILMOMHULDE TABLETTEN
AMLODIPINE/VALSARTAN APOTEX 5 MG/160 MG, FILMOMHULDE TABLETTEN
AMLODIPINE/VALSARTAN APOTEX 10 MG/160 MG, FILMOMHULDE TABLETTEN
amlodipine/valsartan
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 Amlodipine/Valsartan Apotex is and what it is used for
2.
What you need to know before you take Amlodipine/Valsartan Apotex
3.
How to take Amlodipine/Valsartan Apotex
4.
Possible side effects
5.
How to store Amlodipine/Valsartan Apotex
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN APOTEXIS AND WHAT IT IS USED FOR
Amlodipine/Valsartan
tablets
contain
two
substances
called
amlodipine
and
valsartan.
Both
of
these
substances help to control high blood pressure.
-
Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine stops
calcium from moving into the blood vessel wall which stops the blood
vessels from tightening.
-
Valsartan belongs to a group of substances called “angiotensin-II
receptor antagonists”. Angiotensin II is
produced by the body and makes the blood vessels tighten, thus
increasing the blood pressure. Valsartan
works by blocking the effect of angiotensin II.
This means that both of these substances help to stop the

Productkenmerken

AMLODIPINE/VALSARTAN 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG,
FILMOMHULDE TABLETTEN – RVG 116961-77-78
MODULE 1.3
Product Information
Version: 2018-08-31
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-07-02
1
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Apotex 5 mg/80 mg, filmomhulde tabletten
Amlodipine/Valsartan Apotex 5 mg/160 mg, filmomhulde tabletten
Amlodipine/Valsartan Apotex 10 mg/160 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg amlodipine (as besylate) and 80 mg
valsartan.
Each tablet contains 5 mg amlodipine (as besylate) and 160 mg
valsartan.
Each tablet contains 10 mg amlodipine (as besylate) and 160 mg
valsartan
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
5 mg/80 mg:
Yellow colored, round shaped, bevel edged, film-coated tablets (size:
7.94 mm) with ‘APO’ engraved on one
side and ‘5’ over ‘80’ on the other side.
5 mg/160 mg:
Yellow colored, modified capsule shaped, film-coated tablets (size:
14.22 mm x 5.555 mm) with ‘APO’
engraved on one side and ‘5/160’ on the other side.
10 mg/160 mg:
Light yellow colored, modified capsule shaped, film-coated tablets
(size: 14.22 mm x 5.555 mm) with ‘APO’
engraved on one side and ‘10/160’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amlodipine/Valsartan tablets is indicated in adults whose blood
pressure is not adequately controlled on
amlodipine or valsartan monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Amlodipine/Valsartan tablets is one tablet per
day.
Amlodipine/Valsartan tablets 5 mg/80 mg may be administered in
patients whose blood pressure is not
adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Amlodipine/Valsartan tablets 5 mg/160 mg may be administered in
patients whose blood pressure is not
AMLODIPINE/VALSARTAN 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG,
FILMOMHULDE TABLETTEN – RVG 11696