STATEASE XL 80 Milligram Tablet Prolonged Release

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

FLUVASTATIN SODIUM

Prieinama:

McDermott Laboratories Ltd t/a Gerard Laboratories

INN (Tarptautinis Pavadinimas):

FLUVASTATIN SODIUM

Dozė:

80 Milligram

Vaisto forma:

Tablet Prolonged Release

Recepto tipas:

Product subject to prescription which may be renewed (B)

Autorizacija statusas:

Authorised

Leidimo data:

0000-00-00

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER 

Statease XL 80 mg prolonged-release tablets 

Fluvastatin 

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 gets serious, talk to you doctor or
pharmacist. This includes any possible 
side effects not listed in this leaflet.  

WHAT IS IN THIS LEAFLET: 
1. 
What Statease XL is and what it is used for 
2.      What you need to know before you take Statease XL 
3.    How to take Statease XL 
4.    Possible side effects 
5.      How to store Statease XL 
6.      Content of the pack and further information 

1.  WHAT STATEASE XL IS AND WHAT IT IS USED FOR 

Statease XL contains the active fluvastatin sodium which belongs to a
group of medicines known as statins, 
which are lipid-lowering medicines: they lower the fat (lipids) in
your blood. They are used in patients 
whose conditions cannot be controlled by diet and exercise alone. 

Statease XL is a medicine used to TREAT RAISED LEVELS OF FATS IN THE
BLOOD IN ADULTS, in particular total 
cholesterol and so called “bad” or LDL cholesterol, which is
associated with an increased risk of heart 
disease and stroke. 
- 
in adult patients with high blood levels of cholesterol 
- 
in adult patients with high blood levels of both cholesterol and
triglycerides (another sort of 
blood lipid) 

Your doctor can also prescribe Statease XL to prevent further serious
cardiac events (e.g. heart attack) in 
patients after they already went through a heart catheterisation,
with an intervention in the heart vessel.  

2. 
WHAT YOU N

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Statease XL 80 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluvastatin (as fluvastatin sodium)
One prolonged-release tablet contains 80 mg fluvastatin (as fluvastatin sodium)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Yellow, round, biconvex tablet, 10 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dyslipidaemia
Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when
response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Secondary prevention in coronary heart disease
Secondary prevention of major adverse cardiac events in adults with coronary heart disease after
percutaneous coronary interventions (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
Dyslipidaemia
Prior to initiating treatment with Statease XL, patients should be placed on a standard cholesterol lowering diet, which
should be continued during treatment.
Starting and maintenance doses should be individualised according to the baseline LDL-C levels and the treatment goal
to be accomplished.
The recommended dosing range is 20 to 80 mg/day. For patients requiring LDL-C reduction to a goal of < 25% a
starting dose of 20 mg may be used as one capsule in the evening. For patients requiring LDL-C reduction to a goal of
25%, the recommended starting dose is 40 mg as one capsule in the evening. The dose may be uptitrated to 80 mg
daily, administered as a single dose (one prolonged-release tablet) at any time of the day or as one 40 mg capsule given
twice daily (one in the morning and one in the evening).
Statease XL is