Rosuvastatin Clonmel 10mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Rosuvastatin

Dostupno od:

Clonmel Healthcare Ltd

ATC koda:

C10AA; C10AA07

INN (International ime):

Rosuvastatin

Doziranje:

10 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

HMG CoA reductase inhibitors; rosuvastatin

Status autorizacije:

Marketed

Datum autorizacije:

2015-02-27

Uputa o lijeku

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

Svojstava lijeka

Health Products Regulatory Authority
28 February 2024
CRN00F1VG
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Clonmel 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect: Each tablet contains 83 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Rosuvastatin Clonmel 10 mg are white, round, biconvex film-coated
tablets with a diameter of 7 mm.
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 Clonmel 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 naive or patients switched from another HMG - CoA
reductase inhibitor. The choice of start dose should take into acc