Rosuvastatin Aurobindo 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROSUVASTATIN

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

C10AA07

INN (International Name):

ROSUVASTATIN 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ROSUVASTATIN 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2013-02-12

Patient Information leaflet

Page
1
of
9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN AUROBINDO 5 MG FILM-COATED TABLETS
ROSUVASTATIN AUROBINDO 10 MG FILM-COATED TABLETS
ROSUVASTATIN AUROBINDO 20 MG FILM-COATED TABLETS
ROSUVASTATIN AUROBINDO 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
Aurobindo is and what it is used for
2.
What you need to know before you take Rosuvastatin
Aurobindo
3.
How to take Rosuvastatin
Aurobindo
4.
Possible side effects
5.
How to store Rosuvastatin
Aurobindo
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN AUROBINDO IS AND WHAT IT IS USED FOR
Rosuvastatin Aurobindo belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED ROSUVASTATIN AUROBINDO BECAUSE:
•
You have a
HIGH CHOLESTEROL LEVEL
. This means you are
AT RISK FROM A HEART ATTACK OR STROKE
.
Rosuvastatin Aurobindo 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
doing 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
Aurobindo.
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

Summary of Product characteristics

Page
1
of
20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Aurobindo 5 mg film-coated tablets
Rosuvastatin Aurobindo 10 mg film-coated tablets
Rosuvastatin Aurobindo 20 mg film-coated tablets
Rosuvastatin Aurobindo 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as
rosuvastatin calcium).
Excipients with known effect
Each 5 mg tablet contains 22.939 mg lactose monohydrate, 0.007 mg
allura red AC and 0.006 mg
Sunset yellow FCF.
Excipients with known effect
Each 10 mg tablet contains 45.878 mg lactose monohydrate, 0.015 mg
allura red AC and 0.013 mg
Sunset yellow FCF.
Excipients with known effect
Each 20 mg tablet contains 91.755 mg lactose monohydrate, 0.029 mg
allura red AC and 0.025 mg
Sunset yellow FCF.
Excipients with known effect
Each 40 mg tablet contains 183.510 mg lactose monohydrate, 0.059 mg
allura red AC and 0.051 mg
Sunset yellow FCF.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Rosuvastatin Aurobindo tablets 5 mg:
Pink coloured, oval shaped, biconvex film-coated tablets, debossed
with ‘J’ on one side and ‘53’ on
the other side. The size is 5.8 mm X 3.8 mm.
Rosuvastatin Aurobindo tablets 10 mg:
Pink coloured, round shaped [diameter 5.8 mm], biconvex film-coated
tablets, debossed with ‘J’ on
one side and ‘54’ on the other side.
Rosuvastatin Aurobindo tablets 20 mg:
Pink coloured, round shaped [diameter 7.4 mm], biconvex film-coated
tablets, debossed with ‘J’ on
one side and ‘55’ on the other side.
Rosuvastatin Aurobindo tablets 40 mg:
Page
2
of
20
Pink coloured, oval shaped, biconvex film-coated tablets, debossed
with ‘J’ on one side and ‘56’ on
the other side. The size is 12.1 mm X 7 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 except heterozygous familial hypercho