Flavustenol XL 80mg Prolonged-release Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Fluvastatin sodium

Dostupné z:

Accord Healthcare Limited

ATC kód:

C10AA; C10AA04

INN (Medzinárodný Name):

Fluvastatin sodium

Dávkovanie:

80 milligram(s)

Forma lieku:

Prolonged-release tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

HMG CoA reductase inhibitors; fluvastatin

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2012-09-14

Príbalový leták

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 80 mg 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 80 mg 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
80 mg 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 you by

Súhrn charakteristických

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 coloured, 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 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 weeks or more.
Secondary preven