Fjallirone 5 mg/160 mg/12,5 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/12,5 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

hydroklortiazid 12,5 mg Aktiv substans; valsartan 160 mg Aktiv substans; amlodipinbesilat 6,94 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 30 tabletter; Burk, 100 tabletter

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2020-08-27

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
5 mg/160 mg/12.5 mg film-coated tablet
[Name in the RMS: Fjallirone]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg/160 mg/12.5 mg film-coated tablet
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besilate), 160 mg of valsartan,
and 12.5 mg of hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
5 mg/160 mg/12.5 mg film-coated tablet
White, oval, 7.70 mm x 16 mm tablets with “C12” marked on one
side.
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 is one tablet per day, to be
taken preferably in the
morning.
Before switching to , patients should be controlled on
stable doses of the
monocomponents taken at the same time. The dose of
should be based on the
doses of the individual components of the combination at the time of
switching.
The maximum recommended dose of is 10 mg/320 mg/25 mg.
_Special populations_
_Renal impairment_
Due to the hydrochlorothiazide component, is
contraindicated for use in patients
with anuria (see section 4.3) and in patients with severe renal
impairment (glomerular filtration rate
(GFR) <30 ml/min/1.73 m
2
) (see sections 4.3, 4.4 and 5.2).
No adjustment of the initial dose is required for patients with mild
to moderate renal impairment
(see sections 4.4 and 5.2).
_Hepatic impairment_
3
Due to the valsartan component, is contraindicated in
patients with severe hepatic
impairment (see section 4.3). In