EXFORGE 5 MG80 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

AMLODIPINE AS BESYLATE; VALSARTAN

Disponível em:

NOVARTIS ISRAEL LTD

Código ATC:

C08CA01

Forma farmacêutica:

FILM COATED TABLETS

Composição:

AMLODIPINE AS BESYLATE 5 MG; VALSARTAN 80 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

SIEGFRIED BARBERA, S.L., SPAIN

Grupo terapêutico:

AMLODIPINE

Área terapêutica:

AMLODIPINE

Indicações terapêuticas:

Treatment of essential hypertension. Exforge is indicated for patients whose blood pressure is not adequately controlled on monotherapy.

Data de autorização:

2023-04-30

Folheto informativo - Bula

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فقوتت لا عباط صيخشت بجي !

Características técnicas

EXF API FEB23 V1
1
EU SmPC 11.2022
1.
NAME OF THE MEDICINAL PRODUCT
EXFORGE
® 5 MG/80 MG
EXFORGE
® 5 MG/160 MG
EXFORGE
® 10 MG/160 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exforge
®
5 mg/80 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and
80 mg of valsartan.
Exforge
®
5 mg/160 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and
160 mg of valsartan.
Exforge
®
10 mg/160 mg film-coated tablets
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
Exforge 5 mg/80 mg film-coated tablets
Dark yellow, round shaped film-coated tablet with bevelled edges,
debossed with “NVR” on
one side and “NV” on the other side. Approximate size: diameter
8.20 mm.
Exforge 5 mg/160 mg film-coated tablets
Dark yellow, ovaloid shaped film-coated tablet with bevelled edges,
debossed with “NVR” on
one side and “ECE” on the other side. Approximate size: 14.2 mm
(length) x 5.7 mm (width).
Exforge 10 mg/160 mg film-coated tablets
Light yellow, ovaloid shaped film-coated tablet with bevelled 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.
Exforge is indicated for patients whose blood pressure is not
adequately controlled on
monotherapy.
EXF API FEB23 V1
2
EU SmPC 11.2022
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
GENERAL TARGET POPULATION
A patient whose blood pressure is not adequately controlled on
monotherapy may be
switched to combination therapy with Exforge. The recommended dose is
one tablet per day
(see section 2).
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended
before changing to the fixed dose combination. When clinically
appropriate direct chang