Atorvastatin 10mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Atorvastatin calcium trihydrate

Saadav alates:

Milpharm Ltd

ATC kood:

C10AA05

INN (Rahvusvaheline Nimetus):

Atorvastatin calcium trihydrate

Annus:

10mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02120000; GTIN: 8901175022939

Infovoldik

ATORVASTATIN 10 MG FILM-COATED TABLETS
ATORVASTATIN 20 MG FILM-COATED TABLETS
ATORVASTATIN 40 MG FILM-COATED TABLETS
ATORVASTATIN 80 MG FILM-COATED TABLETS
Atorvastatin
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.
WHAT IS IN THIS LEAFLET
1.
What Atorvastatin is and what it is used for
2.
What you need to know before you take
Atorvastatin
3.
How to take Atorvastatin
4.
Possible side effects
5.
How to store Atorvastatin
6.
Contents of the pack and other information
Atorvastatin belongs to a group of medicines
known as statins, which are lipid (fat) regulating
medicines.
Atorvastatin is used to lower lipids known as
cholesterol and triglycerides in the blood when a
low fat diet and life style changes on their own
have failed. If you are at an increased risk of heart
disease, Atorvastatin can also be used to reduce
such risk even if your cholesterol levels are normal.
You should maintain a standard cholesterol
lowering diet during treatment.
DO NOT TAKE ATORVASTATIN
·
if you are hypersensitive (allergic) to
atorvastatin or to any similar medicines used to
lower blood lipids, peanuts or soya or to any of
the other ingredients of the medicine listed in
Section 6.
·
if you have or have ever had a disease which
affects the liver
·
if you have had any unexplained abnormal
blood tests for liver function
·
if you are a woman able to have children and
not using reliable
contraception
·
if you are pregnant or trying to become
pregnant
·
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
T

Toote omadused

OBJECT 1
ATORVASTATIN 10MG FILM COATED TABLETS
Summary of Product Characteristics Updated 07-Jun-2018 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Atorvastatin 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect: Lactose monohydrate and soya lecithin
Each 10 mg film coated tablet contains 43.750 mg lactose monohydrate
and 0.061 mg soya lecithin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
White, elliptical [9.8 mm x 5.2 mm], film-coated tablets, debossed
with “Y” on one side and “77” 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 go