Rosuva 10 mg film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Rosuvastatin

Verfügbar ab:

Rowex Ltd

ATC-Code:

C10AA; C10AA07

INN (Internationale Bezeichnung):

Rosuvastatin

Dosierung:

10 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

HMG CoA reductase inhibitors; rosuvastatin

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2010-06-18

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVA 5 MG FILM-COATED TABLETS
ROSUVA 10 MG FILM-COATED TABLETS
ROSUVA 20 MG FILM-COATED TABLETS
ROSUVA 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 Rosuva is and what it is used for
2. What you need to know before you take Rosuva
3. How to take Rosuva
4. Possible side effects
5. How to store Rosuva
6. Contents of the pack and other information
1.
WHAT ROSUVA IS AND WHAT IT IS USED FOR
Rosuva
belongs to a group of medicines called statins (HMG-CoA reductase
inhibitors).
You have been prescribed Rosuva
because:
•
You have a
HIGH CHOLESTEROL LEVEL
. This means you are
AT RISK FROM A HEART ATTACK OR STROKE
.
Rosuva 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 Rosuva.
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 IS IT IMPORTANT TO KEEP TAKING ROSUVA?
Rosuva 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 chole

Fachinformation

Health Products Regulatory Authority
06 June 2023
CRN00DJZ4
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuva 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of rosuvastatin (as
rosuvastatin calcium).
Excipients with known effect
Each film-coated tablet contains 52.9 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Brown, round, film-coated tablets with "RSV 10" debossed on one 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.
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.
Rosuva 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 cholesterol level and future
cardiovascular risk as well as the potential risk for adv