Atorvastatin 30mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Atorvastatin calcium trihydrate

Tilgjengelig fra:

CST Pharma Ltd

ATC-kode:

C10AA05

INN (International Name):

Atorvastatin calcium trihydrate

Dosering :

30mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02120000; GTIN: 5055946806372

Informasjon til brukeren

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. Statins
lower blood cholesterol (and triglycerides).
Atorvastatin is advised when a low-fat diet and lifestyle changes have
not been adequate to lower blood cholesterol as
recommended.
If you are at an increased risk of heart disease, Atorvastatin may
also be used to reduce such risk even if your blood
cholesterol is “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 cholesterol or to any of the other
ingredients of this medicine (listed in section 6)
•
have or have ever had a disease that affects the liver
•
have had any unexplained abnormal blood tests for liver function
•
are a woman able to have children and not using reliable contraception
•
are pregnant or trying to become pregnant
•
are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Atorvastatin.
The following are reasons why Atorvastatin may not be suitable for you
if you have:
•
had a previous stroke caused by bleeding
•
kidney problems
•
an under-active thyroid gland (hypothyroidism)
•
(or have had) repeated or unexplained muscle aches or pains or a
family history of muscle problems. Also tell your
doctor or pharmacist if you have a muscle weakness that is constant.
Additional tests and medicines may be
needed to diagnose and treat this.
•
had previous muscle problems during treatment with other
cholesterol-lowering medicines (i.e. other ‘statin’ or
‘fibrate’ medicines)
•
had liver disease.
also take special care with Atorv

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atorvastatin 30 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of atorvastatin as atorvastatin
calcium.
Excipient: lactose monohydrate 175 mg/tablet
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to almost white, round, slightly convex, film-coated tablets,
bevel-
edged, tablet diameter 9 mm.
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 usual starting dose is 10 mg once a day. Adjustment of dose should
be
made at intervals of 4 weeks or more. The maximum dose is 80 mg once a
day.
_ _
_Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia