Sorvasta 20mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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:

Authorised

Authorization date:

2023-12-06

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
SORVASTA 5 MG FILM-COATED TABLETS
SORVASTA 10 MG FILM-COATED TABLETS
SORVASTA 20 MG FILM-COATED TABLETS
SORVASTA 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 Sorvasta is and what it is used for
2.
What you need to know before you take Sorvasta
3.
How to take Sorvasta
4.
Possible side effects
5.
How to store Sorvasta
6.
Contents of the pack and other information
1.
WHAT SORVASTA IS AND WHAT IT IS USED FOR
Sorvasta belongs to a group of medicines called statins.
You have been prescribed Sorvasta because:
-
You have a
HIGH CHOLESTEROL LEVEL
. This means you are
AT RISK FROM A HEART ATTACK OR STROKE
.
Sorvasta 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 Sorvasta.
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 you arteries.
WHY IS IT IMPORTANT TO KEEP TAKING SORVASTA?
Sorvasta is used to correct the levels of fatty substances in the
blood called lipids, the most common of
which is cholesterol.
Pag

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Sorvasta 5 mg film-coated tablets
Sorvasta 10 mg film-coated tablets
Sorvasta 20 mg film-coated tablets
Sorvasta 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin
calcium).
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium).
Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect:
Each 5 mg film-coated tablet contains 20.0 mg lactose.
Each 10 mg film-coated tablet contains 40.0 mg lactose.
Each 20 mg film-coated tablet contains 80.0 mg lactose.
Each 40 mg film-coated tablet contains 160.0 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
5 mg film-coated tablets: Brown red, round, slightly biconvex,
film-coated tablets with bevelled
edges, engraved with number 5 on one side of the tablet (diameter: 6
mm).
10 mg film-coated tablets: Brownish yellow, round, slightly biconvex,
film-coated tablets with
bevelled edges, engraved with number 10 on one side of the tablet
(diameter: 8 mm).
20 mg film-coated tablets: White or almost white, round, slightly
biconvex film-coated tablets with
bevelled edges, engraved with number 20 on one side of the tablet
(diameter: 10 mm).
40 mg film-coated tablets: Brownish yellow, biconvex, capsule-shaped
film-coated tablets, engraved
with number 40 on one side of the tablet (dimensions: 16 mm x 9 mm).
_ _
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 inade