Lescol

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

FLUVASTATIN

Disponibil de la:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

Codul ATC:

C10AA04

INN (nume internaţional):

FLUVASTATIN 20 mg

Forma farmaceutică:

HARD CAPSULE

Compoziție:

FLUVASTATIN 20 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

LIPID MODIFYING AGENTS

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2005-08-03

Prospect

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
LESCOL 20 MG CAPSULES, HARD
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 Lescol is and what it is used for
2.
What you need to know before you take Lescol
3.
How to take Lescol
4.
Possible side effects
5.
How to store Lescol
6.
Contents of the pack and other information
1. WHAT LESCOL IS AND WHAT IT IS USED FOR
Lescol contains the active substance 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.
-
Lescol 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 Lescol to prevent further serious
cardiac events (e.g. heart
attack) in patients who have already had a heart catheterisation, with
an intervention in the heart
vessel.
If you have any questions about how Lescol works or why this medicine
has been prescribed for you,
ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESCOL
Follow all your doctor’s instructions carefully, even if they differ
from the gener

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lescol 20 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluvastatin (as fluvastatin sodium)
Each capsule contains 21.06 mg of fluvastatin sodium equivalent to 20
mg fluvastatin free acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard
Cap: Strong reddish brown opaque.
Body: Pale yellow opaque; imprint: XU 20 mg (red ink).
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 percu-
taneous coronary interventions (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Dyslipidaemia
Prior to initiating treatment with Lescol, 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 fluvastatin may be used in the evening.
For patients requiring LDL-C
reduction to a goal of ≥25%, the recommended starting dose is 40 mg
fluvastatin in the evening. The
dose may be uptitrated to 80 mg fluvastatin daily, administered as a
single dose (80 mg prolonged-
release tablet) at any time of the day or as 40 mg of fluvastatin
given twice daily (one dose in the morn-
ing and one dose 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 prevention in coronary heart diseas