Fjallirone 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:

Sigillata Limited

ATC-kode:

C09DX01

INN (International Name):

amlodipinbesilat; hydrochlorothiazide; valsartan

Dosering:

10 mg/160 mg/12,5 mg

Lægemiddelform:

Filmdragerad tablett

Sammensætning:

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

Recept type:

Receptbelagt

Produkt oversigt:

Förpacknings: Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Burk, 100 tabletter

Autorisation status:

Avregistrerad

Autorisation dato:

2020-06-04

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fjallirone 10 mg/160 mg/12.5 mg film-coated tablets
Fjallirone 5 mg/160 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fjallirone 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.
Fjallirone 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.
Excipient(s) with known effect
Fjallirone 10 mg/160 mg/12.5 mg film-coated tablets
Each tablet contains 5 mg of lactose.
Fjallirone 5 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)
Fjallirone 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.
Fjallirone 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.
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 single-component
formulation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Fjallirone is one tablet per day, to be taken
preferably in the morning.
3
Before switching to Fjallirone, patients should be controlled on
stable doses of the monocomponents
taken at the same time. The dose of Fjallirone should be based on the
doses of the individual
components of the combination at the time of switching.
The maximum recommended dose of Fja