Crestor 20 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROSUVASTATIN

Available from:

AstraZeneca AB SE-151 85, Södertälje, Sweden

ATC code:

C10AA07

INN (International Name):

ROSUVASTATIN 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ROSUVASTATIN 20 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2008-10-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CRESTOR
® 5 MG FILM-COATED TABLETS
CRESTOR
® 10 MG FILM-COATED TABLETS
CRESTOR
® 20 MG FILM-COATED TABLETS
CRESTOR
® 40 MG FILM-COATED TABLETS
ROSUVASTATIN
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 Crestor is and what it is used for
2.
What you need to know before you take Crestor
3.
How to take Crestor
4.
Possible side effects
5.
How to store Crestor
6.
Contents of the pack and other information
1. WHAT CRESTOR IS AND WHAT IT IS USED FOR
Crestor belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED CRESTOR BECAUSE:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or
stroke. Crestor is used in adults, adolescents and children 6 years or
older to treat high
cholesterol.
•
You have been advised to take a statin, because changing your diet and
taking more
exercise were not enough to correct your cholesterol levels. You
should continue with
your cholesterol-lowering diet and exercise while you are taking
Crestor.
Or
•
You have other factors that increase your risk of having a heart
attack, stroke or
related health problems.
Heart attack, stroke and other problems can be caused by a disease
called atherosclerosis.
Atherosclerosis is due to build-up of fatty deposits in your arteries.
WHY IT IS IMPORTANT TO KEEP TAKING CRESTOR
Crestor is used to correct the levels of fatty substances in the blood
called lipids, the most
common of which is cholesterol.
2
There are different types

Summary of Product characteristics

Page 1 of 24
1.
NAME OF THE MEDICINAL PRODUCT
Crestor 5 mg film-coated tablets.
Crestor 10 mg film-coated tablets.
Crestor 20 mg film-coated tablets.
Crestor 40 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg: Each tablet contains 5 mg rosuvastatin (as rosuvastatin
calcium). Each
tablet contains 94.88 mg lactose monohydrate.
10 mg: Each tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium). Each
tablet contains 91.3 mg lactose monohydrate.
20 mg: Each tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium). Each
tablet contains 182.6 mg lactose monohydrate.
40 mg: Each tablet contains 40 mg rosuvastatin (as rosuvastatin
calcium). Each
tablet contains 168.32 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
5 mg: Film-coated tablet.
Round, yellow coloured tablets, intagliated with ‘ZD4522’ and
‘5’ on one side
and plain on the reverse.
10 mg: Film-coated tablet:
Round, pink coloured tablets, intagliated with 'ZD4522' and '10' on
one side and
plain on the reverse.
20 mg: Film-coated tablet:
Round, pink coloured tablets, intagliated with 'ZD4522' and '20' on
one side and
plain on the reverse.
40 mg: Film-coated tablet:
Oval, pink coloured tablets, intagliated with 'ZD4522' on one side and
'40' on the
reverse.
Page 2 of 24
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 6 years or older with primary
hypercholesterolaemia (type IIa including heterozygous familial
hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct
to diet
when response to diet and other non-pharmacological treatments (e.g.
exercise,
weight reduction) is inadequate.
Adults, adolescents and children aged 6 years or older with homozygous
familial
hypercholesterolaemia as an adjunct to diet and other lipid lowering
treatments
(e.g. LDL apheresis) or if such treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patie