Rosuvastatin 5 mg Film-coated Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Rosuvastatin (as calcium)

Dostupno od:

NewLine Pharma S.L.

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:

Not marketed

Datum autorizacije:

2017-06-09

Uputa o lijeku

ROSUVASTATIN
5 MG, 10 MG, 20 MG, 40 MG
FILM-COATED TABLET
1.3.1 SMPC, LABELLING
AND PACKAGE LEAFLET
Version no. 1.3
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 5 MG FILM-COATED TABLETS
10 MG FILM-COATED TABLETS
20 MG FILM-COATED TABLETS
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 is and what it is used for
2) What you need to know before you take >
3) How to take
4) Possible side effects
5) How to store
6) Contents of the pack and other information
1) WHAT IS AND WHAT IT IS USED FOR
belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED BECAUSE:

You have a high cholesterol level. This means you are at risk from a
heart attack or stroke.
is used in adults, adolescents and children 6 years or
older to treat high
cholesterol
ROSUVASTATIN
5 MG, 10 MG, 20 MG, 40 MG
FILM-COATED TABLET
1.3.1 SMPC, LABELLING
AND PACKAGE LEAFLET
Version no. 1.3
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 .
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
c

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect: lactose monohydrate.
Each 5 mg film-coated tablet contains 101.86 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, biconvex, coated tablet, embossed ‘ROS’ over
‘5’ on one side and nothing on the other, with diameter 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.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 mg 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 we