Amlodipine/Valsartan/Hydroklortiazid DOC 10 mg/320 mg/25 mg Filmdragerad tablett

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

amlodipinbesilat; hydroklortiazid; valsartan

Διαθέσιμο από:

DOC Generici Srl

Φαρμακολογική κατηγορία (ATC):

C09DX01

INN (Διεθνής Όνομα):

amlodipinbesilat; hydrochlorothiazide; valsartan

Δοσολογία:

10 mg/320 mg/25 mg

Φαρμακοτεχνική μορφή:

Filmdragerad tablett

Σύνθεση:

hydroklortiazid 25 mg Aktiv substans; valsartan 320 mg Aktiv substans; amlodipinbesilat 13,88 mg Aktiv substans

Τρόπος διάθεσης:

Receptbelagt

Περίληψη προϊόντος:

Förpacknings: Blister, 28 tabletter

Καθεστώς αδειοδότησης:

Godkänd

Ημερομηνία της άδειας:

2020-08-27

Αρχείο Π.Χ.Π.

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: Amlodipine/Valsartan/Hydroklortiazid DOC 5 mg/160
mg/12,5 mg
filmdragerade tabletter]
10 mg/320 mg/25 mg film-coated tablet
[Name in the RMS: Amlodipine/Valsartan/Hydroklortiazid DOC 10 mg/320
mg/25 mg
filmdragerade tabletter]
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.
10 mg/320 mg/25 mg film-coated tablet
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate), 320 mg of valsartan
and 25 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.
10 mg/320 mg/25 mg film-coated tablet
Dark yellow, oval, 9.70 mm x 20 mm tablets with “C72” 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_
3
_Renal i