Comboprex 5 mg/160 mg/25 mg Filmdragerad tablett

Land: Sverige

Språk: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv ingrediens:

amlodipinbesilat; hydroklortiazid; valsartan

Tilgjengelig fra:

Dymalife Pharmaceutical S.r.l.

ATC-kode:

C09DX01

INN (International Name):

amlodipinbesilat; hydrochlorothiazide; valsartan

Dosering :

5 mg/160 mg/25 mg

Legemiddelform:

Filmdragerad tablett

Sammensetning:

hydroklortiazid 25 mg Aktiv substans; amlodipinbesilat 6,93 mg Aktiv substans; valsartan 160 mg Aktiv substans; laktosmonohydrat Hjälpämne

Resept typen:

Receptbelagt

Produkt oppsummering:

Förpacknings: Blister, 28 tabletter

Autorisasjon status:

Avregistrerad

Autorisasjon dato:

2020-06-04

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Comboprex 10 mg/160 mg/12.5 mg film-coated tablets
Comboprex 5 mg/160 mg/25 mg film-coated tablets
Comboprex 10 mg/160 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Comboprex 10 mg/160 mg/12.5 mg film-coated tablets
Each film-coated tablet contains amlodipine besilate equivalent to 10
mg amlodipine, 160 mg of
valsartan, and 12.5 mg of hydrochlorothiazide.
Comboprex 5 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains amlodipine besilate equivalent to 5
mg amlodipine, 160 mg of
valsartan, and 25 mg of hydrochlorothiazide.
Comboprex 10 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains amlodipine besilate equivalent to 10
mg amlodipine, 160 mg of
valsartan, and 25 mg of hydrochlorothiazide.
Excipient(s) with known effect
Comboprex 10 mg/160 mg/12.5 mg film-coated tablets
Each tablet contains 5 mg of lactose.
Comboprex 5 mg/160 mg/25 mg film-coated tablets
Each tablet contains 5 mg of lactose.
Comboprex 10 mg/160 mg/25 mg film-coated tablets
Each tablet contains 5 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Comboprex 10 mg/160 mg/12.5 mg film-coated tablets
Oval, light yellow, 14.5 mm x 7.5 mm film-coated tablets with bevelled
edges, with debossing VIL on
one side of the tablet.
Comboprex 5 mg/160 mg/25 mg film-coated tablets
Oval, yellow, 14.5 mm x 7.5 mm film-coated tablets with bevelled
edges, with debossing VIH on one
side of the tablet
Comboprex 10 mg/160 mg/25 mg film-coated tablets
Oval, dark yellow, 14.5 mm x 7.5 mm film-coated tablets with bevelled
edges, with debossing VIT on
one side of the tablet.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension as substitution therapy in adult
patients whose blood pressure is
adequately controlled on the combination of amlodipine, valsartan and
hydrochlorothiazide (HCT),
taken either as three single-component formulations or a