Rosuvastatin 5mg film-coated tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

ROSUVASTATIN

Inapatikana kutoka:

Resolution Chemicals Limited

ATC kanuni:

C10AA07

INN (Jina la Kimataifa):

ROSUVASTATIN

Dawa fomu:

FILM-COATED TABLET

Tungo:

ROSUVASTATIN 5 mg

Dawa ya aina:

POM

Eneo la matibabu:

LIPID MODIFYING AGENTS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2014-12-23

Taarifa za kipeperushi

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.

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 Rosuvastatin is and what it is used for
2.
What you need to know before you take Rosuvastatin
3.
How to take Rosuvastatin
4.
Possible side effects
5.
How to store Rosuvastatin
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN IS AND WHAT IT IS USED FOR
Rosuvastatin belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin because:

You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
Rosuvastatin 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.
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.
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Page 3 of 9
WHY IS IT IMPORTANT TO KEEP TAKING ROSUVASTATIN?
Rosuvastatin is used to correct the levels of fatty substances in

Tabia za bidhaa

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin 5mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg rosuvastatin (as rosuvastatin zinc).
Excipient with known effect:
Each tablet contains 60.6mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, slightly biconvex, white or almost white, 6.0 mm diameter
tablet, with a stylized ‘E’
engraving on one side and ‘591’ on the 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.
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.
Rosuvastatin film-coated tablets 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 cardiovascular
risk as w