Atorvastatin 20mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Atorvastatin calcium trihydrate

Հասանելի է:

Milpharm Ltd

ATC կոդը:

C10AA05

INN (Միջազգային անվանումը):

Atorvastatin calcium trihydrate

Դոզան:

20mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 02120000; GTIN: 8901175022946

Տեղեկատվական թերթիկ

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Atorvastatin Tablets
10,20,40 & 80mg x 28’s (UK)
296x210 (Reel Fed)
50966743
Leaflet for Blisters
3909
R.Wrey
08/04/19
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Details
ATORVASTATIN 10MG, 20MG & 40MG FILM-COATED TABLETS PIL - UK
Black
Profile
BBBA4492
R.Wrey
11/04/19
01/05/19
T. Hull
296 x 210
8pt
Accord UK
n/a
2
Version 2
01.11.2017
page 4
page 1
50966743 BBBA4492
ATORVASTATIN 10MG, 20MG AND 40MG
FILM-COATED TABLETS
Package leaflet: Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
•
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
•
The full name of this medicine is
Atorvastatin 10mg, 20mg and 40mg Film-
coated Tablets but within the leaflet it will
be referred to as Atorvastatin tablets.
WHAT IS IN THIS LEAFLET:
1
WHAT ATORVASTATIN TABLETS ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ATORVASTATIN TABLETS
3
HOW TO TAKE ATORVASTATIN TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ATORVASTATIN TABLETS
6
CON

Ապրանքի հատկությունները

OBJECT 1
ATORVASTATIN 20MG FILM COATED TABLETS
Summary of Product Characteristics Updated 07-Jun-2018 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Atorvastatin 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each film coated tablet contains 20 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect: Lactose monohydrate and soya lecithin
Each 20 mg film coated tablet contains 87.500 mg lactose monohydrate
and 0.122 mg soya lecithin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
White, elliptical [12.3 mm x 6.5 mm], film-coated tablets, debossed
with “Y” on one side and “78” on
other side.
4. Clinical particulars
4.1 Therapeutic indications
Hypercholesterolaemia
Atorvastatin 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.
Atorvastatin 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 Atorvastatin and
should continue on this diet during treatment with Atorvastatin. The
dose should be individualised
according to baseline LDL-C levels, the g