Rosuvastatin Krka 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rosuvastatin

Available from:

KRKA, d.d., Novo mesto

ATC code:

C10AA; C10AA07

INN (International Name):

Rosuvastatin

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors; rosuvastatin

Authorization status:

Marketed

Authorization date:

2011-07-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN KRKA 5 MG FILM-COATED TABLETS
ROSUVASTATIN KRKA 10 MG FILM-COATED TABLETS
ROSUVASTATIN KRKA 20 MG FILM-COATED TABLETS
ROSUVASTATIN KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Rosuvastatin Krka
3.
How to take Rosuvastatin Krka
4.
Possible side effects
5.
How to store Rosuvastatin Krka
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN KRKA IS AND WHAT IT IS USED FOR
Rosuvastatin Krka belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin Krka because:
-
You have a
HIGH CHOLESTEROL LEVEL
. This means you are
AT RISK OF A HEART ATTACK OR STROKE
.
Rosuvastatin Krka 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 Rosuvastatin Krka.
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 ROSUVASTATIN KRKA?
Rosuvastatin Krka is used to correct the level

Summary of Product characteristics

Health Products Regulatory Authority
16 August 2023
CRN00DHYQ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Krka 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect:
Each 20 mg film-coated tablet contains 83.8 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round (diameter 10 mm), film-coated tablets with bevelled
edges.
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
Posology
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 Krka may be given at any time of day, with or without
food.
Not all Rosuvastatin Krka tablet strengths may be available.
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