Comboprex 10 mg/160 mg/12,5 mg Filmdragerad tablett

Land: Sverige

Sprog: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv bestanddel:

amlodipinbesilat; hydroklortiazid; valsartan

Tilgængelig fra:

Dymalife Pharmaceutical S.r.l.

ATC-kode:

C09DX01

INN (International Name):

amlodipinbesilat; hydrochlorothiazide; valsartan

Dosering:

10 mg/160 mg/12,5 mg

Lægemiddelform:

Filmdragerad tablett

Sammensætning:

amlodipinbesilat 13,86 mg Aktiv substans; hydroklortiazid 12,5 mg Aktiv substans; valsartan 160 mg Aktiv substans; laktosmonohydrat Hjälpämne

Recept type:

Receptbelagt

Produkt oversigt:

Förpacknings: Blister, 28 tabletter

Autorisation status:

Avregistrerad

Autorisation dato:

2020-06-04

Produktets egenskaber

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