ROSUVASTATIN AUROBINDO 20 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ROSUVASTATIN (AS CALCIUM)

Available from:

Milpharm Limited

ATC code:

C10AA07

INN (International Name):

ROSUVASTATIN (AS CALCIUM)

Dosage:

20 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors

Authorization status:

Authorised

Authorization date:

2012-08-24

Patient Information leaflet

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
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 Aurobindo.
WHY IS IT IMPORTANT TO KEEP TAKING ROSUVASTATIN AUROBINDO?
Rosuvastatin Aurobindo is used to correct the levels of fatty
substances in the blood called
lipids, the most common of which is cholesterol.
There are different types of cholesterol found in the blood –
‘bad’ cholesterol (LDL-C) and

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Aurobindo 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium).
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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pink coloured, round shaped [diameter 7.4 mm], biconvex film-coated tablets, debossed with ‘J’ on one side and ‘55’
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 except
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.
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
consensus guidelines.
Rosuvastatin Aurobindo 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