Rosuvastatin 20 mg Film-coated Tablets

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Rosuvastatin

Հասանելի է:

Brillpharma (Ireland) Limited

ATC կոդը:

C10AA; C10AA07

INN (Միջազգային անվանումը):

Rosuvastatin

Դոզան:

20 milligram(s)

Դեղագործական ձեւ:

Film-coated tablet

Թերապեւտիկ տարածք:

HMG CoA reductase inhibitors; rosuvastatin

Լիազորման կարգավիճակը:

Not marketed

Հաստատման ամսաթիվը:

2017-07-28

Տեղեկատվական թերթիկ

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
ROSUVASTATIN 5 MG FILM-COATED TABLETS
ROSUVASTATIN 10 MG FILM-COATED TABLETS
ROSUVASTATIN 20 MG FILM-COATED TABLETS
ROSUVASTATIN 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. It
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Rosuvastatin is and what is it used for
2. What you need to know before you take Rosuvastatin
3. How to take Rosuvastatin
4. Possible side effects
5. How to store Rosuvastatin
6. Contents of the pack and other information
1.
WHAT ROSUVASTATIN IS AND WHAT IS IT USED FOR
Rosuvastatin belongs to a group of medicines called statins.
_YOU HAVE BEEN PRESCRIBED ROSUVASTATIN BECAUSE: _
•
You have a
HIGH CHOLESTEROL LEVEL
. This means you are at risk from a heart attack or
stroke. Rosuvastatin 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.
Or
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•
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? _
_ _
Rosuvastatin is used to correct the levels of fatty substances

Ապրանքի հատկությունները

Health Products Regulatory Authority
26 July 2023
CRN00CGK7
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect: Also contains 125.2 mg lactose
monohydrate, 0.039 mg sunset yellow (E110), 0.036 mg allura red
AC (E129).
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Light pink to pink, round, biconvex film coated tablets debossed with
'20' on one side and 'plain' on other side. The tablet
diameter is 7.70 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
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.
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 i