Hagkupa 5 mg/160 mg/25 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

amlodipinbesilat; hydroklortiazid; valsartan

Tillgänglig från:

Sigillata Limited

ATC-kod:

C09DX01

INN (International namn):

amlodipinbesilat; hydrochlorothiazide; valsartan

Dos:

5 mg/160 mg/25 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

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

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 28 tabletter

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2020-06-04

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Hagkupa 10 mg/160 mg/12.5 mg film-coated tablets
Hagkupa 5 mg/160 mg/25 mg film-coated tablets
Hagkupa 10 mg/160 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hagkupa 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.
Hagkupa 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.
Hagkupa 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
Hagkupa 10 mg/160 mg/12.5 mg film-coated tablets
Each tablet contains 5 mg of lactose.
Hagkupa 5 mg/160 mg/25 mg film-coated tablets
Each tablet contains 5 mg of lactose.
Hagkupa 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)
Hagkupa 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.
Hagkupa 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
Hagkupa 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 as a
dual-component and a