Rosutrux 40mg film-coated tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

ROSUVASTATIN

Saatavilla:

Biofarm Sp. zo.o Walbrzyska str 13, 60-198, Poznan, Poland

ATC-koodi:

C10AA07

INN (Kansainvälinen yleisnimi):

ROSUVASTATIN 40 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

ROSUVASTATIN 40 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

LIPID MODIFYING AGENTS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2017-05-26

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUTROX 5 MG FILM-COATED TABLETS
ROSUTROX 10 MG FILM-COATED TABLETS
ROSUTROX 20 MG FILM-COATED TABLETS
ROSUTROX 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 Rosutrox is and what it is used for
2.
What you need to know before you take Rosutrox
3.
How to take Rosutrox
4.
Possible side effects
5.
How to store Rosutrox
6.
Contents of the pack and other information
1.
WHAT ROSUTROX IS AND WHAT IT IS USED FOR
Rosutrox belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED ROSUTROX BECAUSE:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
Rosutrox 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 Rosutrox.
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 ROSUTROX
Rosutrox is used to correct the levels of fatty substances in the
blood called lipids, the most
common of which is cholesterol.
There are different typ

Valmisteyhteenveto

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosutrox 5 mg film-coated tablets.
Rosutrox 10 mg film-coated tablets.
Rosutrox 20 mg film-coated tablets.
Rosutrox 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 18
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
inadequate.
Adults, adolescents and children aged 6 ye