Rosuvastatin Galgenicum 10mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROSUVASTATIN

Available from:

Galenicum Health Ltd. The Plaza Commercial Centre, Level 6, Suite 5, Bisazza Street, Sliema SLM 1640, 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:

Withdrawn

Authorization date:

2017-05-26

Patient Information leaflet

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN GALGENICUM 5 MG FILM-COATED TABLETS
ROSUVASTATIN GALGENICUM 10 MG FILM-COATED TABLETS
ROSUVASTATIN GALGENICUM 20 MG FILM-COATED TABLETS
ROSUVASTATIN GALGENICUM 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 childrens 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.
WHY IT IS IMPORTANT TO KEEP TAKING ROSUVASTATIN
Rosuvastatin Galgenicum is used to

Summary of Product characteristics

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Galgenicum 5 mg film-coated tablets.
Rosuvastatin Galgenicum 10 mg film-coated tablets.
Rosuvastatin Galgenicum 20 mg film-coated tablets.
Rosuvastatina Galgenicum 40 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg: Each tablet contains 5 mg rosuvastatin (as rosuvastatin
calcium).
10 mg: Each tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
20 mg: Each tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium).
40 mg: Each tablet contains 40 mg rosuvastatin (as rosuvastatin
calcium).
Excipient(s) with known effect
5 mg: lactose anhydrous 16.6 mg; sunset yellow FCF (E110); tartrazine
(E102) and indigo
carmine (E132).
10 mg: lactose anhydrous 33.3 mg; sunset yellow FCF (E110); tartrazine
(E102); indigo
carmine (E132) and Allura red AC (E129).
20 mg: lactose anhydrous 66.5 mg; sunset yellow FCF (E110); tartrazine
(E102); indigo
carmine (E132) and Allura red AC (E129).
40 mg: lactose anhydrous 133.0 mg; sunset yellow FCF (E110);
tartrazine (E102); indigo
carmine (E132) and Allura red AC (E129).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
5 mg: Film-coated tablet.
Yellow, round, biconvex film-coated tablets
10 mg: Film-coated tablet.
Pink, round, biconvex film – coated tablets.
20 mg: Film-coated tablet.
Pink, oval, biconvex film-coated tablets, with score line on the one
side
The tablet can be divided into equal doses.
40 mg: Film-coated tablet.
Pink, oblong, biconvex film-coated tablets, with score line on the one
side
The tablet can be divided into equal doses.
Page 2 of 22
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 re