Atoris tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

atorvastatin (atorvastatin calcium)

Available from:

KRKA d.d.

ATC code:

C10AA05

INN (International Name):

atorvastatin (atorvastatin calcium)

Dosage:

40mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-07-04

Summary of Product characteristics

1.3.1
Atorvastatin calcium
SPC, Labeling and Package Leaflet
AM
SmPCPIL152388_1
03.07.2020 – Updated: 03.07.2020
Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Atoris
®
40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg atorvastatin as 41.44 mg
atorvastatin calcium.
Excipient: lactose monohydrate
Lactose
189,53 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, slightly convex.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atoris is indicated as an adjunct to diet for reduction of elevated
total cholesterol (total-C), LDL-
cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults,
adolescents and children aged 10
years or older with primary hypercholesterolaemia including familial
hypercholesterolaemia
(heterozygous variant) or combined (mixed) hyperlipidaemia
(corresponding to Types IIa and IIb of
the Fredrickson classification) when response to diet and other
nonpharmacological measures is
inadequate.
Atoris is also indicated to reduce total-C and LDL-C in adults with
homozygous familial
hypercholesterolaemia as an adjunct to other lipid-lowering treatments
(e.g. LDL apheresis) or if such
treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first
cardiovascular event (see section 5.1), as an adjunct to correction of
other risk factors.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be placed on a standard cholesterol-lowering diet
before receiving Atoris and
should continue on this diet during treatment with Atoris.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient
response.
CONFIDENTIAL
MODULE 1
VOL: 1; P: 13 / 41
1.3.1
Atorvastatin calcium
SPC, Labeling and Package Leaflet
AM
SmPCPIL152388_1
03.07.2020 – Updated: 03.07.2020
Page 2 of 22
The usual starting dose is 10 mg once a day