Zanidip-Recordati tablets film-coated

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

lercanidipine (lercanidipine hydrochloride)

Dostupno od:

Recordati Industria Chimica e Farmaceutica S.p.A.

ATC koda:

C08CA13

INN (International ime):

lercanidipine (lercanidipine hydrochloride)

Doziranje:

10mg

Farmaceutski oblik:

tablets film-coated

Jedinice u paketu:

(28/2x14/) in blister, (28/1x28/) in blister

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2016-07-11

Svojstava lijeka

Summary of Product Characteristics (SmPC) for
Zanidip®-Recordati
Marketing authorization number:
Trade name:
Zanidip®-Recordati
International non-patented name (INN): lercanidipine
Pharmaceutical form:
film-coated tablets
Contents
Each film-coated tablet contains:
Active component:
lercanidipine hydrochloride 10 mg or 20 mg;
Excipients:
lactose monohydrate 30 mg/60 mg, microcrystalline cellulose 39 mg/78
mg, sodium starch
glycolate 15.5 mg/31 mg, povidone K30 4.5 mg/9 mg, magnesium stearate
1 mg/2 mg;
Film coating:
for 10 mg tablets – Opadry yellow (OY-SR-6479) 3 mg (hypromellose,
talc, titanium dioxide
(E171), macrogol 6000, ferric oxide yellow (E172); for 20 mg tablets -
Opadry pink (OY-SR-6479) 6 mg
(hypromellose, talc, titanium dioxide (E171), macrogol 6000, ferric
oxide red (E172)).
Description
10 mg tablets:
round-shaped biconvex tablet with a light yellow film coating, with a
breaking line on one
side, light yellow at the fracture surface.
20 mg tablets:
round-shaped biconvex tablet with a pink to dark pink film coating,
with a breaking line on
one side, light yellow at the fracture surface.
Therapeutic category
“Slow” calcium channels blocker.
ATC code: C08CA13.
Pharmacological properties
Pharmacodynamics.
“Slow” calcium channels blocker. Lercanidipine is a racemic
mixture of right- (R) and
left- (L) rotating stereomers, a derivative of 1,4-dyhydropyridine,
which is able to selectively block the
calcium
ions
current
into
the
cells
of
blood
vessels
walls,
heart
cells
and
smooth
muscle
cells.
Lercanidipine has prolonged antihypertensive action. The therapeutic
effect is reached 5 to 7 hours after
the oral administration and is maintained during 24 hours. Due to high
selectivity for the cells of smooth
muscles of the blood vessels, there is no negative inotropic effect.
Lercanidipine is a metabolically neutral drug, and it does not have
any substantial effect on serum
lipoproteins and alipoproteins level, as well as does not change the
lipid profile in hypertension patients.
Pharmacokinetics:
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