Valtensam Comp 5 mg/160 mg/12,5 mg Filmdragerad tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

amlodipinbesilat; hydroklortiazid; valsartan

Available from:

Teva Sweden AB

ATC code:

C09DX01

INN (International Name):

amlodipinbesilat; hydrochlorothiazide; valsartan

Dosage:

5 mg/160 mg/12,5 mg

Pharmaceutical form:

Filmdragerad tablett

Composition:

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

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Burk, 100 tabletter

Authorization status:

Godkänd

Authorization date:

2020-08-27

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
5 mg/160 mg/12.5 mg film-coated tablet
10 mg/320 mg/25 mg film-coated tablet
[Name in the RMS: Valtensam Comp]
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_
_Renal impairment_
3
Due to the hydrochlorothiazide component, is
contraindicated for use in patients
with anuria (see section 4.3) and in patients with severe renal
i