Amlodipine/Valsartan/Hydrochlorothiazide Genericon 10 mg/160 mg/25 mg Filmdragerad tablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

amlodipinbesilat; hydroklortiazid; valsartan

Dostopno od:

Genericon Pharma Ges.m.b.H.

Koda artikla:

C09DX01

INN (mednarodno ime):

amlodipinbesilat; hydrochlorothiazide; valsartan

Odmerek:

10 mg/160 mg/25 mg

Farmacevtska oblika:

Filmdragerad tablett

Sestava:

valsartan 160 mg Aktiv substans; amlodipinbesilat 13,86 mg Aktiv substans; laktosmonohydrat Hjälpämne; hydroklortiazid 25 mg Aktiv substans

Tip zastaranja:

Receptbelagt

Povzetek izdelek:

Förpacknings: Blister, 10 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Burk, 100 tabletter

Status dovoljenje:

Avregistrerad

Datum dovoljenje:

2020-06-04

Lastnosti izdelka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 10 mg/160 mg/12.5
mg film-coated tablets
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 5 mg/160 mg/25 mg
film-coated tablets
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 10 mg/160 mg/25 mg
film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 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.
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 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.
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 10 mg/160 mg/25 mg
film-coated tablets
Each film-coated tablet contains amlodipine besilate equivalent to 10
mg amlodipine, 160 mg of
valsartan, and 25 mg of hydrochlorothiazide.
Excipient(s) with known effect
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 10 mg/160 mg/12.5
mg film-coated tablets
Each tablet contains 5 mg of lactose.
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 5 mg/160 mg/25 mg
film-coated tablets
Each tablet contains 5 mg of lactose.
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 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)
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 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.
Amlodipine/Valsartan/Hydrochlorothiazide Genericon 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
Amlodipine/Valsartan/Hydrochloro