Flavustenol XL 80mg Prolonged-release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUVASTATIN

Available from:

Accord Healthcare Limited

ATC code:

C10AA04

INN (International Name):

FLUVASTATIN

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

FLUVASTATIN 80 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2013-02-01

Patient Information leaflet

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Package leaflet: information for the user
FLAVUSTENOL XL 80MG 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, 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 Flavustenol XL 80 mg is and what it is used for
2. What you need to know before you take Flavustenol XL 80 mg
3. How to take Flavustenol XL 80 mg
4. Possible side effects
5. How to store Flavustenol XL 80 mg
6.Contents of the pack and other information
1. WHAT FLAVUSTENOL XL 80 MG IS AND WHAT IT IS USED FOR

Flavustenol XL 80mg contains the active substance fluvastatin sodium
which belongs to a
group of medicines known as statins, which are lipid-lowering
medicines: they reduce the
fat (lipids) level in your blood. They are used in patients whose
conditions cannot be
controlled by diet and exercise alone.

Flavustenol XL 80mg is a medicine used to TREAT RAISED LEVELS OF FAT
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 Flavustenol XL 80mg 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 NEED TO KNOW BEFORE YOU TAKE FLAVUSTENOL XL 80 MG
Follow all instructions given to

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
_ _
Flavustenol XL 80mg Prolonged-release Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged released film coated tablet contains 84.280 mg of
Fluvastatin sodium equivalent
to 80 mg Fluvastatin
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release tablet
Yellow colored, round, biconvex, beveled edged film coated tablets,
debossed with “F80” on one
side and plain on other side.
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 Flavustenol XL 80mg
Prolonged-release Tablets, patients
should be placed on a standard cholesterol-lowering diet, which should
be continued during
treatment.
Starting and maintenance doses should be individualized 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
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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).
The maximum lipid-lowering effect with a given dose is achieved within
4 weeks. Dose
adjustments should be made at intervals of 4