Rosuvastatin Viatris 20 mg film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Rosuvastatin

Dostupné z:

Viatris Limited

ATC kód:

C10AA; C10AA07

INN (Medzinárodný Name):

Rosuvastatin

Forma lieku:

Film-coated tablet

Terapeutické oblasti:

HMG CoA reductase inhibitors; rosuvastatin

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2011-10-07

Príbalový leták

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN VIATRIS 5 MG FILM-COATED TABLETS
ROSUVASTATIN VIATRIS 10 MG FILM-COATED TABLETS
ROSUVASTATIN VIATRIS 20 MG FILM-COATED TABLETS
ROSUVASTATIN VIATRIS 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 Viatris is and what it is used for
2.
What you need to know before you take Rosuvastatin Viatris
3.
How to take Rosuvastatin Viatris
4.
Possible side effects
5.
How to store Rosuvastatin Viatris
6.
Contents of the pack and other information
1. WHAT ROSUVASTATIN VIATRIS IS AND WHAT IT IS USED FOR
Rosuvastatin Viatris contains the active ingredient rosuvastatin,
which belongs to a group of medicines
called statins.
You have been prescribed this medicine because:
•
You have a high cholesterol level. This means you are at risk from a
heart attack or stroke. Rosuvastatin
Viatris 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 Viatris.
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 arte

Súhrn charakteristických

Health Products Regulatory Authority
02 January 2024
CRN00DR17
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Viatris 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains rosuvastatin calcium corresponding to
20 mg rosuvastatin.
Excipients with known effect
Lactose:
Each 20 mg film-coated tablet contains 51.68 mg lactose.
Sunset yellow:
Each 20 mg film-coated tablet contains 0.018 mg Sunset yellow.
Allura Red:
Each 20 mg film-coated tablet contains 0.020 mg Allura red.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
A pink, round, biconvex, film-coated tablet of 7.14 mm diameter_,_
debossed with ‘M’ on one side and ‘RS2’ 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 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 years or older with homozygous
familial hypercholesterolaemia as an adjunct to diet
and other lipid lowering treatments (e.g. LDL apheresis) or if such
treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patients who are
estimated to have a high risk for a first cardiovascular event (see
section 5.1), as an adjunct to correction of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 Viatris may be given at any time of day, with or without
food.
TREATMENT O