Valsamix, 10/160 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

AMLODIPINEBESILAAT SAMENSTELLING overeenkomend met ; AMLODIPINE ; VALSARTAN

Available from:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC code:

C09DB01

INN (International Name):

AMLODIPINEBESILAAT COMPOSITION corresponding to ; AMLODIPINE ; VALSARTAN

Pharmaceutical form:

Filmomhulde tablet

Composition:

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) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administration route:

Oraal gebruik

Therapeutic area:

Valsartan And Amlodipine

Product summary:

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); IJZEROXIDE ROOD (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Authorization date:

2016-03-21

Patient Information leaflet

AMLODIPINE/VALSARTAN 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG,
FILMOMHULDE TABLETTEN – RVG 116985-6-7
MODULE 1.3
Product Information
Version: 2018-08-31
MODULE 1.3.1
Package Leaflet
Replaces: 2018-07-05
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
VALSAMIX, 5 MG/80 MG FILMOMHULDE TABLETTEN
VALSAMIX, 5 MG/160 MG FILMOMHULDE TABLETTEN
VALSAMIX, 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 Valsamix is and what it is used for
2.
What you need to know before you take Valsamix
3.
How to take Valsamix
4.
Possible side effects
5.
How to store Valsamix
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE/VALSARTAN IS 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 blood
vessels tightening. As a result, the blood
vessels relax and blood pressure is lowered.
Amlodipine/Valsartan is used to treat high blo

Summary of Product characteristics

VALSAMIX, 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG, FILMOMHULDE
TABLETTEN – RVG 116985-6-7
MODULE 1.3
Product Information
Version: 2018-08-31
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-07-05
1
1.
NAME OF THE MEDICINAL PRODUCT
Valsamix, 5 mg/80 mg filmomhulde tabletten
Valsamix, 5 mg/160 mg filmomhulde tabletten
Valsamix, 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
adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
VALSAMIX, 5 MG/80 MG, 5 MG/160 MG, 10 MG/160 MG, FILMOMHULDE
TABLETTEN – RVG 116985-6-7
MODUL