Rosuvastatin - 1 A Pharma 10mg film-coated Tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROSUVASTATIN

Available from:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

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:

Withdrawn

Authorization date:

2016-01-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN – 1 A PHARMA 5 MG FILM-COATED TABLETS
ROSUVASTATIN – 1 A PHARMA 10 MG FILM-COATED TABLETS
ROSUVASTATIN – 1 A PHARMA 20 MG FILM-COATED TABLETS
ROSUVASTATIN – 1 A PHARMA 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 – 1 A Pharma is and what it is used for
2.
What you need to know before you take Rosuvastatin – 1 A Pharma
3.
How to take Rosuvastatin – 1 A Pharma
4.
Possible side effects
5.
How to store Rosuvastatin – 1 A Pharma
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN – 1 A PHARMA IS AND WHAT IT IS USED FOR
Rosuvastatin – 1 A Pharma
belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin – 1 A Pharma because:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or
stroke. Rosuvastatin – 1 A Pharma 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 – 1 A
Pharma.
Or
•
You have other factors that increase your risk of having a heart
attack, stroke or related
health problems.
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Heart attack, stroke and other problems can be caused by a disease
called atherosclerosis.
Atheros

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin – 1 A Pharma 5 mg film-coated tablets
Rosuvastatin – 1 A Pharma 10 mg film-coated tablets
Rosuvastatin – 1 A Pharma 20 mg film-coated tablets
Rosuvastatin – 1 A Pharma 40 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ROSUVASTATIN – 1 A PHARMA 5 MG FILM-COATED TABLETS
Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect: 26 mg lactose anhydrous
ROSUVASTATIN – 1 A PHARMA 10 MG FILM-COATED TABLETS
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect: 53 mg lactose anhydrous
ROSUVASTATIN – 1 A PHARMA 20 MG FILM-COATED TABLETS
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect: 106 mg lactose anhydrous
ROSUVASTATIN – 1 A PHARMA 40 MG FILM-COATED TABLETS
Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect: 212 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
ROSUVASTATIN – 1 A PHARMA 5 MG FILM-COATED TABLETS
Brown, round, film-coated tablets with a diameter of 5 mm.
ROSUVASTATIN – 1 A PHARMA 10 MG FILM-COATED TABLETS
Brown, round, film-coated tablets, with a diameter of 6 mm, with
“RSV 10”debossed on one
side.
ROSUVASTATIN – 1 A PHARMA 20 MG FILM-COATED TABLETS
Brown, round, film-coated tablets, with a diameter of 8 mm, with
“RSV 20”debossed on one
side.
ROSUVASTATIN – 1 A PHARMA 40 MG FILM-COATED TABLETS
Brown, round, film-coated tablets, with a diameter of 10 mm, with
“RSV 40”debossed on one
side.
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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 adjun