Fjallirone 5 mg/160 mg/25 mg Filmdragerad tablett

देश: स्वीडन

भाषा: स्वीडिश

स्रोत: Läkemedelsverket (Medical Products Agency)

सक्रिय संघटक:

amlodipinbesilat; hydroklortiazid; valsartan

थमां उपलब्ध:

Sigillata Limited

ए.टी.सी कोड:

C09DX01

INN (इंटरनेशनल नाम):

amlodipinbesilat; hydrochlorothiazide; valsartan

डोज़:

5 mg/160 mg/25 mg

फार्मास्यूटिकल फॉर्म:

Filmdragerad tablett

रचना:

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

प्रिस्क्रिप्शन प्रकार:

Receptbelagt

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

Avregistrerad

प्राधिकरण की तारीख:

2020-06-04

उत्पाद विशेषताएं

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