Lescol Capsules Hard 40mg

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 40 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

FLUVASTATIN 40 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2005-08-03

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
LESCOL 40 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 Lescolto 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 Lescolworks 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 general

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lescol 40 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluvastatin (as fluvastatin sodium)
Each capsule contains 42.12 mg of fluvastatin sodium equivalent to 40
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: Orange yellow opaque; imprint: XU 40 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 percutane-
ous 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 reduc-
tion 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 fluvastatin given twice daily (one dose in
the morning 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 disease