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

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; VALSARTAN 160 mg/stuk

Tilgjengelig fra:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-kode:

C09DB01

INN (International Name):

AMLODIPINEBESILAAT 6,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk ; VALSARTAN 160 mg/stuk

Legemiddelform:

Filmomhulde tablet

Sammensetning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administreringsrute:

Oraal gebruik

Terapeutisk område:

Valsartan And Amlodipine

Produkt oppsummering:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

Sandoz B.V.
Page 1/9
Amlodipine/Valasartan Sandoz 5 mg/80 mg, 5 mg/160
mg, 10 mg/160 mg
RVG 116955-6-7
V7
1.3.1.3 Bijsluiter
Juni 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE/VALSARTAN SANDOZ 5 MG/80 MG, FILMOMHULDE TABLETTEN
AMLODIPINE/VALSARTAN SANDOZ 5 MG/160 MG, FILMOMHULDE TABLETTEN
AMLODIPINE/VALSARTAN SANDOZ 10 MG/160 MG, FILMOMHULDE TABLETTEN
Amlodipine (as amlodipine besylate) /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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] 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

Preparatomtale

Sandoz B.V.
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Amlodipine/Valasartan Sandoz 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg
RVG 116955-6-7
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2022
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan Sandoz 5 mg/80 mg, filmomhulde tabletten
Amlodipine/Valsartan Sandoz 5 mg/160 mg, filmomhulde tabletten
Amlodipine/Valsartan Sandoz 10 mg/160 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 80 mg of
valsartan.
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 160 mg of
valsartan.
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate) and 160 mg of
valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
{[NATIONALLY COMPLETED NAME] 5 MG/80 MG FILM-COATED TABLETS}
Dark yellow, round film-coated tablet with beveled edges, debossed
with “NVR” on one side and
“NV” on the other side.
Dimension: approximately 8.20 mm.
{[NATIONALLY COMPLETED NAME] 5 MG/160 MG FILM-COATED TABLETS}
Dark yellow, ovaloid film-coated tablet with beveled edges, debossed
with “NVR” on one side
and “ECE” on the other side.
Dimension: approximately 14.2 mm x 5.7 mm.
{[NATIONALLY COMPLETED NAME] 10 MG/160 MG FILM-COATED TABLETS}
Light yellow, ovaloid film-coated tablet with beveled edges, debossed
with “NVR” on one side
and “UIC” on the other side.
Dimension: approximately 14.2 mm x 5.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Sandoz B.V.
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Amlodipine/Valasartan Sandoz 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg
RVG 116955-6-7
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2022
[Nationally completed name] 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 [Nationally completed name] is one tablet per
day.
[Na