Rosuvastatin Actavis 5 mg Film-coated Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Rosuvastatin (as calcium)

Dostupno od:

Actavis Group PTC ehf

ATC koda:

C10AA; C10AA07

INN (International ime):

Rosuvastatin (as calcium)

Doziranje:

5 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:

2010-11-26

Uputa o lijeku

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

Svojstava lijeka

Health Products Regulatory Authority
21 August 2019
CRN008RG3
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Actavis 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg Rosuvastatin (as Rosuvastatin calcium).
Each tablet contains 45.720 mg lactose monohydrate.
For the full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are round, biconvex, yellowish coloured tablets, debossed with
5 on one side and 15 on the other 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 individualized 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’s cholesterol level and future
cardiovascular risk as well