Lescol XL 80 mg Prolonged-release tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Fluvastatin sodium

Boleh didapati daripada:

LTT Pharma Limited

Kod ATC:

C10AA; C10AA04

INN (Nama Antarabangsa):

Fluvastatin sodium

Dos:

80 milligram(s)

Borang farmaseutikal:

Prolonged-release tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

HMG CoA reductase inhibitors; fluvastatin

Status kebenaran:

Authorised

Tarikh kebenaran:

2010-11-12

Risalah maklumat

LESCOL XL 80MG 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:
What Lescol XL is and what it is used for
What you need to know before you take Lescol XL
How to take Lescol XL
Possible side effects
How to store Lescol XL
Contents of the pack and other information
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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LESCOL XL
Follow all your doctor’s instructions carefully, even if they differ
from the
general information contained in this leaf

Ciri produk

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 contains 84.24 mg fluvastatin
sodium equivalent of 80 mg Fluvastatin free acid.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet
_Product imported from the Czech Republic_
Yellow round, slightly biconvex film-coated tablet with bevelled
edges, approx. 10mm in diameter, debossed with
“LE” on one side/”NVR” on the other.
4 CLINICAL PARTICULARS
As per PA0013/053/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0013/053/003
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 (E171)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package 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 to protect
from light and moisture.
6.