Lescol XL 80 mg prolonged-release tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUVASTATIN

Available from:

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

ATC code:

C10AA04

INN (International Name):

FLUVASTATIN 80 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

FLUVASTATIN 80 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2005-08-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LESCOL 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, 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 XL is and what it is used for
2.
What you need to know before you take Lescol XL
3.
How to take Lescol XL
4.
Possible side effects
5.
How to store Lescol XL
6.
Contents of the pack and other information
1. WHAT LESCOL XL IS AND WHAT IT IS USED FOR
Lescol XL 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 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 Lescol XL 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 XL works or why this
medicine has been prescribed for
you, ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESCOL XL
Follow all your doctor’s instructions carefully, eve

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lescol XL 80 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluvastatin (as fluvastatin sodium)
Each prolonged-release tablet contains 84.24 mg of fluvastatin sodium
equivalent to 80 mg fluvastatin
free acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablets
Yellow, round, slightly biconvex film-coated tablets with beveled
edges, approx. 10 mm in diameter,
debossed with “LE” on one side and “NVR” on the 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
Posology
_Adults _
Dyslipidaemia
Prior to initiating treatment with Lescol XL, 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 daily, administered as a single
dose (one Lescol XL 80 mg
prolonged release tablet) at any time of the day or as one 40 mg dose
of fluvastatin given twice daily
(one dose in the morning and one dose in the ev