Lescol XL 80 mg Prolonged-release tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Fluvastatin

Beschikbaar vanaf:

Novartis Ireland Limited

ATC-code:

C10AA; C10AA04

INN (Algemene Internationale Benaming):

Fluvastatin

Dosering:

80 milligram(s)

farmaceutische vorm:

Prolonged-release tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

HMG CoA reductase inhibitors; fluvastatin

Autorisatie-status:

Marketed

Autorisatie datum:

2002-01-23

Bijsluiter

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 IM-
PORTANT 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 ef-
fects 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 particu-
lar total cholesterol and so called “bad” or LDL cholesterol,
which is associated with an in-
creased 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

Productkenmerken

Health Products Regulatory Authority
04 May 2023
CRN00DHZV
Page 1 of 12
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 bevelled
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 e