Dipperam 10 mg/160 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 ; VALSARTAN 160 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

C09DB01

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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 And Amlodipine

Product samenvatting:

Hulpstoffen: 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);

Autorisatie datum:

2017-10-05

Bijsluiter

Sandoz B.V.
Page 1/9
Dipperam 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg
RVG 119500-5-6
1313-v7
1.3.1.3 Bijsluiter
Juni 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
DIPPERAM 5 MG/80 MG, FILMOMHULDE TABLETTEN
DIPPERAM 5 MG/160 MG, FILMOMHULDE TABLETTEN
DIPPERAM 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, the blood
vessels relax and blood pressure is lowered.
[Nationally compl

Productkenmerken

Sandoz B.V.
Page 1/21
Dipperam 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg filmomhulde tabletten
RVG 119500-5-6
1311-V5
1.3.1.1 Summary of Product Characteristics
Juni 2022
1.
NAAM VAN HET GENEESMIDDEL
Dipperam 5 mg/80 mg, filmomhulde tabletten
Dipperam 5 mg/160 mg, filmomhulde tabletten
Dipperam 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.
_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.
Approximate size: diameter 8.20 mm.
_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.
Approximate size: 14.2 mm (length) x 5.7 mm (width).
_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.
Approximate size: 14.2 mm (length) x 5.7 mm (width).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
[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.
Sandoz B.V.
Page 2/21
Dipperam 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg filmomhulde tabletten
RVG 119500-5-6
1311-V5
1.3.1.1 Summary of Product Characteristics
Juni 2022
[Nationally completed name] 5 mg/80 mg may be administered in patients
whose blood pressure is not
adequately controlle