Lescol XL 80 mg Prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluvastatin

Available from:

IMED Healthcare Ltd.

ATC code:

C10AA04

INN (International Name):

Fluvastatin

Dosage:

80 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Administration route:

oral use

Units in package:

28 prolonged-release tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Novartis s.r.o.

Therapeutic group:

CoA reductase inhibitors

Therapeutic area:

fluvastatin

Therapeutic indications:

Dyslipidaemia Treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, 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 adultswith coronary heart disease after percutaneous coronary interventions

Authorization status:

Authorised

Authorization date:

2015-03-13

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, even i

Summary of Product characteristics

Health Products Regulatory Authority
29 September 2023
CRN00DVMX
Page 1 of 2
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 tablet.
_Product imported from Czech Republic_
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
As per PA23517/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23517/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core:_
Cellulose microcrystalline
Hypromellose
Hydroxypropyl cellulose
Potassium hydrogen carbonate
Povidone
Magnesium stearate
_ _
_Coating:_
Hypromellose
Macrogol 8000
Iron oxide yellow (E172)
Titanium dioxide (E 171)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
29 September 2023
CRN00DVMX
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C. Store in the original package in order to
protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Pack size: 28 prolonged-release tablets in blisters contained in a
labelled carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/101/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
March 2015
10 DATE OF REVISION OF THE TEXT
September 2023