Amlodipin/Valsartan/Hydroklortiazid Teva 5 mg/ 160 mg/ 25 mg Filmdragerad tablett

국가: 스웨덴

언어: 스웨덴어

출처: Läkemedelsverket (Medical Products Agency)

유효 성분:

amlodipinbesilat; hydroklortiazid; valsartan

제공처:

Teva B.V.

ATC 코드:

C09DX01

INN (International Name):

amlodipinbesilat; hydrochlorothiazide; valsartan

복용량:

5 mg/ 160 mg/ 25 mg

약제 형태:

Filmdragerad tablett

구성:

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

처방전 유형:

Receptbelagt

제품 요약:

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

승인 상태:

Avregistrerad

승인 날짜:

2020-04-15

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipin/Valsartan/Hydroklortiazid Teva 10 mg/160 mg/12.5 mg
film-coated tablets
Amlodipin/Valsartan/Hydroklortiazid Teva 5 mg/160 mg/25 mg film-coated
tablets
Amlodipin/Valsartan/Hydroklortiazid Teva 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3
Treatment of essential hypertension as substitution therapy in adult
patients whose blood pressure is
adequately contro