Dipperam/HCT Sandoz 10 mg/160 mg/12,5 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 ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; VALSARTAN 160 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

C09DX01

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; VALSARTAN 160 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Valsartan, amlodipine and hydrochlorothiazide

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/15
Dipperam/HCT Sandoz 5 mg/160 mg/12,5 mg, 10 mg/160 mg/12,5 mg, 5
mg/160 mg/25
mg, 10 mg/160 mg/25 mg, 10 mg/320 mg/25 mg
RVG 122477-78-79-80-81
V7
1.3.1.3 Bijsluiter
Juli 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPPERAM/HCT SANDOZ 5 MG/160 MG/12,5 MG, FILMOMHULDE TABLETTEN
DIPPERAM/HCT SANDOZ 10 MG/160 MG/12,5 MG, FILMOMHULDE TABLETTEN
DIPPERAM/HCT SANDOZ 5 MG/160 MG/25 MG, FILMOMHULDE TABLETTEN
DIPPERAM/HCT SANDOZ 10 MG/160 MG/25 MG, FILMOMHULDE TABLETTEN
DIPPERAM/HCT SANDOZ 10 MG/320 MG/25 MG, FILMOMHULDE TABLETTEN
amlodipine/valsartan/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 {[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 three substances called
amlodipine, valsartan and
hydrochlorothiazide. All 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 t

Productkenmerken

Sandoz B.V.
Page 1/34
Dipperam/HCT Sandoz 5 mg/160 mg/12,5 mg, 10 mg/160 mg/12,5 mg, 5
mg/160 mg/25
mg, 10 mg/160 mg/25 mg, 10 mg/320 mg/25 mg
RVG 122477-78-79-80-81
v5
1.3.1.1 Samenvatting van de Productkenmerken
September 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dipperam/HCT Sandoz 5 mg/160 mg/12,5 mg, filmomhulde tabletten
Dipperam/HCT Sandoz 10 mg/160 mg/12,5 mg, filmomhulde tabletten
Dipperam/HCT Sandoz 5 mg/160 mg/25 mg, filmomhulde tabletten
Dipperam/HCT Sandoz 10 mg/160 mg/25 mg, filmomhulde tabletten
Dipperam/HCT Sandoz 10 mg/320 mg/25 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[NATIONALLY COMPLETED NAME] 5 MG/160 MG/12.5 MG FILM-COATED TABLETS}
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan
and 12.5 mg of hydrochlorothiazide.
{[NATIONALLY COMPLETED NAME] 10 MG/160 MG/12.5 MG FILM-COATED TABLETS}
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan
and 12.5 mg of hydrochlorothiazide.
{[NATIONALLY COMPLETED NAME] 5 MG/160 MG/25 MG FILM-COATED TABLETS}
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan
and 25 mg of hydrochlorothiazide.
{[NATIONALLY COMPLETED NAME] 10 MG/160 MG/25 MG FILM-COATED TABLETS}
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan
and 25 mg of hydrochlorothiazide.
{[NATIONALLY COMPLETED NAME] 10 MG/320 MG/25 MG FILM-COATED TABLETS}
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 320 mg of valsartan
and 25 mg of hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
{[NATIONALLY COMPLETED NAME] 5 MG/160 MG/12.5 MG FILM-COATED TABLETS}
White, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VCL” on the
other side.
Length: approx. 15 mm
Sandoz B.V.
Page 2/34
Dipperam/HCT Sandoz 5 mg/160 mg/12,5 mg, 10 mg/160 mg/12,5