Atorvastatin 10mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Atorvastatin calcium trihydrate

Tilgjengelig fra:

Sun Pharma UK Ltd

ATC-kode:

C10AA05

INN (International Name):

Atorvastatin calcium trihydrate

Dosering :

10mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02120000; GTIN: 5015525012310

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
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.
1.
WHAT ATORVASTATIN IS AND WHAT IT IS USED FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN
DO NOT TAKE ATORVASTATIN:
•
if you are allergic to Atorvastatin or to any similar medicines used
to lower blood
lipids or to any of the other ingredients of this 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.
2
•
if you are a woman able to have children and not using reliable
contraception.
•
if you are preg

Preparatomtale

OBJECT 1
ATORVASTATIN 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 21-Oct-2016 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Atorvastatin 10 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10mg of atorvastatin as atorvastatin
calcium trihydrate.
Excipient with known effect:
Contains 38.3 mg lactose monohydrate, 2.8 mg sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off white, film-coated oval tablets about 6.1 mm wide and
about 8.6 mm long, debossed with
'A30' on one side and plain 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 goal of therapy, and patient
response.
The