LESCOL 20 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUVASTATIN

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

C10AA04

INN (International Name):

FLUVASTATIN

Dosage:

20 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors

Authorization status:

Authorised

Authorization date:

1995-09-19

Patient Information leaflet

1 of 2
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Production Site:
Barbera
WO:
1604384
ACC:
Agustin, Alberto
Comp. Description:
LFT LESCOL IR/XL FCT/HGC
20/40/80MG IE
Printing Colours:
PANTONE 314 C
Comp. No. New:
1124949-A17-IE
Comp. No. Old:
1124949-A16-IE
Format/Dimension:
148 x (2x 297) mm
Tech. Drawing No.:
N/A
Technical Colours:
Cutting
Min. Font Size Text:
9.0 pt
Font Type:
News Gothic
Proof No.:
1
Date: 14 May 2017
J.N.: 309688
Braille:
N/A
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Telephone [phone]
[e-mail]
www.perigord-as.com
Unit 1, Lyncon Court
IDA Business & Technology Park
Snugborough Rd
Blanchardstown
Dublin 15
1124949-A17-IE
PACKAGE LEAFLET: INFORMATION FOR THE USER
LESCOL 20 MG CAPSULES, HARD
LESCOL 40 MG CAPSULES, HARD
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/Lescol XL is and what it is used for
2. What you need to know before you take Lescol/Lescol XL
3. How to take Lescol/Lescol XL
4. Possible side effects
5. How to store Lescol/Lescol XL
6. Contents of the pack and other information
1. WHAT LESCOL/LESCOL XL IS AND WHAT IT IS USED FOR
Lescol/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/Lescol XL is a medicine used to TREAT RAISED LEVELS OF

Summary of Product characteristics

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 percutaneous 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 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
In patients