Rosuvastatin Actavis 40 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Rosuvastatin

متاح من:

Actavis Group PTC ehf

ATC رمز:

C10AA; C10AA07

INN (الاسم الدولي):

Rosuvastatin

جرعة:

40 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

HMG CoA reductase inhibitors; rosuvastatin

الوضع إذن:

Marketed

تاريخ الترخيص:

2010-11-26

نشرة المعلومات

1/9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN ACTAVIS 5MG FILM-COATED TABLETS,
ROSUVASTATIN ACTAVIS 10 MG FILM-COATED TABLETS,
ROSUVASTATIN ACTAVIS 20 MG FILM-COATED TABLETS,
ROSUVASTATIN ACTAVIS 40 MG FILM-COATED TABLETS
_ Rosuvastatin (as Rosuvastatin calcium) _
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 Actavis is and what it is used for
2.
What you need to know before you take Rosuvastatin Actavis
3.
How to take Rosuvastatin Actavis
4.
Possible side effects
5.
How to store Rosuvastatin Actavis
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN ACTAVIS
IS AND WHAT IT IS USED FOR
Rosuvastatin Actavis belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin Actavis because:

You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
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 Actavis].
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 it is important to keep taking Rosuvastatin Actavis
Rosuvastatin Actavis is used to correct the levels of fatty subs

خصائص المنتج

Health Products Regulatory Authority
22 November 2019
CRN0090X0
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Actavis 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg Rosuvastatin (as Rosuvastatin calcium).
Each tablet contains 234.445 mg lactose monohydrate.
Each tablet contains Sunset yellow FCF (E 110) and Ponceau aluminium
lake (E 124)
For the full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are round, biconvex, red coloured tablets, debossed with "40"
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 10 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.
Rosuvastatin actavis 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’