Crestor 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Rosuvastatin

Available from:

Grunenthal Pharma Ltd

ATC code:

C10AA; C10AA07

INN (International Name):

Rosuvastatin

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

HMG CoA reductase inhibitors; rosuvastatin

Authorization status:

Marketed

Authorization date:

2003-04-17

Patient Information leaflet

                                IE-Package Leaflet – Type IA AZ post code change clean version 003
20/11/2023
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
call
                                
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Summary of Product characteristics

                                Health Products Regulatory Authority
08 January 2024
CRN00DFXD
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crestor 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium).
Each tablet contains 182.6 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, pink coloured tablets, intagliated with 'ZD4522' and '20' on
one side and plain on the reverse.
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 patients who are
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
Before treatment initiation the patient should be placed on a standard
cholesterol-lowering diet that should continue during
treatment. The dose should be individualised according to the goal of
therapy and patient response, using current consensus
guidelines.
Crestor may be given at any time of day, with or without food.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 or 10 mg orally once daily in both
statin-naïve or patients switched from another HMG CoA
reductase inhibitor. The choice of start dose should take into account
the individual patient’s cholesterol level and future
ca
                                
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