Valtensam Comp 10 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 B.V.

ATC code:

C09DX01

INN (International Name):

amlodipinbesilat; hydrochlorothiazide; valsartan

Dosage:

10 mg/ 160 mg/ 12,5 mg

Pharmaceutical form:

Filmdragerad tablett

Composition:

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

Avregistrerad

Authorization date:

2020-04-15

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valtensam Comp 10 mg/160 mg/12.5 mg film-coated tablets
Valtensam Comp 5 mg/160 mg/25 mg film-coated tablets
Valtensam Comp 10 mg/160 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 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.
[Product name] 5 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet containsamlodipine besilate equivalent to 5 mg
amlodipine, 160 mg of
valsartan, and 25 mg of hydrochlorothiazide.
[Product name] 10 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet containsamlodipine besilate equivalent to 10
mg amlodipine, 160 mg of
valsartan, and 25 mg of hydrochlorothiazide.
Excipient(s) with known effect
[Product name] 10 mg/160 mg/12.5 mg film-coated tablets
Each tablet contains 5 mg of lactose.
[Product name] 5 mg/160 mg/25 mg film-coated tablets
Each tablet contains 5 mg of lactose.
[Product name] 10 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)
[Product name] 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.
[Product name] 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
[Product name] 10 mg/160 mg/25 mg film-coated tablets
Oval, dark yellow, 14.5 mm x 7.5 mm film-coated tablets with bevelled
edges, with debossing VIT on
one side of the tablet.
2
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),