ROSUVASTATIN

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

ROSUVASTATIN CALCIUM

Disponible depuis:

Accord Healthcare Limited

Code ATC:

C10AA07

DCI (Dénomination commune internationale):

ROSUVASTATIN CALCIUM

Dosage:

40 Milligram

forme pharmaceutique:

Film Coated Tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

rosuvastatin

Statut de autorisation:

Not Marketed

Date de l'autorisation:

2015-08-28

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN 5 MG
FILM-COATED TABLETS
ROSUVASTATIN 10 MG
FILM-COATED TABLETS
ROSUVASTATIN 20 MG
FILM-COATED TABLETS
ROSUVASTATIN 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 or nurse.
•
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 or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Rosuvastatin tablet is and what it is used for
2. What you need to know before you take
Rosuvastatin tablets
3. How to take Rosuvastatin tablets
4. Possible side effects
5. How to store Rosuvastatin tablets
6. Contents of the pack and other information 1.
WHAT ROSUVASTATIN TABLET IS AND
WHAT IT IS USED FOR
Rosuvastatin tablets belong to a group of medicines
called statins.
You have been prescribed Rosuvastatin tablets
because:
•
You have a high cholesterol level. This means you
are at risk from a heart attack or stroke.
Rosuvastatin tablets 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 Rosuvastatin
tablets
.
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 IS IT IMPORTANT TO KEEP TAKING ROSUVASTATIN
TABLETS?
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Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin
calcium).
Excipient(s) with known effect:
Lactose:
Each 40 mg film-coated tablet contains 164mg lactose.
Allura red AC:
Each 40 mg film-coated tablet contains 0.034 mg allura red AC.
Sunset yellow:
Each 40 mg film-coated tablet contains 0.04 mg sunset yellow.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval, approximately 11.5 mm in length and 6.9 mm in width,
biconvex, film-coated tablet, debossed “40” on one
side and “R” on other side.
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
Posology
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
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