Lescol XL 80 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluvastatin

Available from:

PCO Manufacturing Ltd.

ATC code:

C10AA04

INN (International Name):

Fluvastatin

Dosage:

80 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

fluvastatin

Authorization status:

Authorised

Authorization date:

2014-12-05

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 car

Summary of Product characteristics

Health Products Regulatory Authority
19 March 2024
CRN00F6RC
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)
One prolonged-release tablet of Lescol XL contains 84.24 mg
fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
Excipient: For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
_ _
_Product imported from Czech Republic and France:_
Yellow, round, slightly biconvex film-coated tablet with bevelled
edges, approx. 10 mm in diameter, debossed with "LE" on one
side/"NVR" or Nil on the other.
4 CLINICAL PARTICULARS
As per PA23517/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23517/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Cellulose microcrystalline
Hypromellose
Hydroxypropyl cellulose
Potassium hydrogen carbonate
Povidone
Magnesium stearate
Macrogol 8000
Iron oxide yellow (E172)
Titanium dioxide (E 171)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
19 March 2024
CRN00F6RC
Page 2 of 2
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 or 30 prolonged-release tablets in blisters contained in
a carton.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/404/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT
March 2024