LESCOL XL 80MG TABLETS

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

FLUVASTATIN

Verfügbar ab:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

FLUVASTATIN

Einheiten im Paket:

28Tablet Tablets

Hergestellt von:

NOVARTIS FARMACEUTICA S.A.

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP)_
LESCOL
® XL TABLET
FLUVASTATIN SODIUM (80 MG)
1
WHAT IS IN THIS LEAFLET
1.
WHAT LESCOL XL IS USED FOR
2.
HOW LESCOL XL WORKS
3.
BEFORE YOU USE LESCOL XL
4.
HOW TO USE LESCOL XL
5.
WHILE YOU ARE USING LESCOL
XL
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
LESCOL XL
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT LESCOL XL IS USED FOR
Cholesterol and triglycerides are the
major lipid components that can be
found in the blood. Cholesterol is
mainly produced by the liver whereas
most of the triglycerides in the blood
are introduced with food. High levels
of low-density lipoprotein cholesterol
(LDL-C, the ‘bad’ cholesterol) have
been associated with an increased risk
of heart disease and stroke. In some
cases, elevated levels of ‘bad’
cholesterol in blood are accompanied
by moderate increases in triglycerides
and low levels of high-density
lipoprotein cholesterol (HDL-C, the
‘good’ cholesterol). However, it is
important that both the ‘bad’
cholesterol and triglycerides in blood
are reduced when elevated. Also it
may be important that the levels of
the ‘good’ cholesterol in blood are
raised. Your doctor
would have
already suggested changes to your
diet or life style in order to lower
your ’bad’ cholesterol and
triglycerides, if elevated, and to raise
the ‘good’ cholesterol. Sometimes
diet and life style changes alone will
not be completely successful in
achieving these targets. Your doctor
will therefore prescribe additional
treatment such as Lescol XL.
HOW LESCOL XL WORKS
_ADULTS _
Lescol XL also slows the progression
of coronary atherosclerosis which
causes a thickening and hardening of
blood vessel walls at the heart and
eventually obstruction.
Your doctor can also prescribe Lescol
XL for the prevention of further
serious cardiac events (e.g. heart
attack) in patients who still suffer
from heart disease after they already
went through a heart catheterisation.
BEFORE YOU USE LESCOL XL
Before t

Fachinformation

Drug Regulatory Affairs
LESCOL

(FLUVASTATIN SODIUM)
Gelatine capsules 20 mg and 40 mg
LESCOL

XL
(FLUVASTATIN SODIUM)
Prolonged release 80 mg tablets
MALAYSIAN PACKAGE LEAFLET – OCT 2014
(WITHOUT PEDIATRIC INDICATION)
FOR PROMOTIONAL MATERIALS PLEASE QUOTE THE FOLLOWING:
PI RD 10 MAY 12; APPR 25 JUL 13
IPL Creator:
CDS Author:
Pedda Reddy
Stéphanie Cébe
GLC approval:
26 May 2011, amended 30 August2011and 24 April 2012
Release date:
10 May 2012
Tracking no.:
2012-PSB/GLC-0544-s
Document status:
Final
Number of pages:
17
Novartis
Page 2
Proposed Malaysian Package Leaflet
10 May 2012 Lescol®/Lescol® XL(without ped)
LESCOL

/ LESCOL

XL
HMG-CoA reductase inhibitors
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Capsules and prolonged release tablets for oral administration.
ACTIVE SUBSTANCE(S)
[R*,S*-(E)]-(

)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-
heptenoate (fluvastatin sodium)
One capsule of Lescol contains 21.06 mg or 42.12 mg fluvastatin sodium
equivalent to 20 mg
or 40 mg fluvastatin free acid.
One prolonged release tablet of Lescol XL contains 84.24 mg
fluvastatin sodium equivalent to
80 mg fluvastatin free acid.
Certain dosage strengths and dosage forms may not be available in all
countries.
DESCRIPTION
LESCOL 20MG CAPSULE
Hard gelatin capsule, cap is strong reddish brown opaque in colour and
the body is pale yellow
opaque with ‘XU 20 mg’ imprint in red.
LESCOL 40MG CAPSULE
Hard gelatin capsule, cap is strong reddish brown opaque in colour and
the body is orange-yellow
opaque with ‘XU 40 mg’ imprint in red.
LESCOL XL 80MG FILM-COATED TABLET
Yellow, round, slightly biconvex film-coated tablet with bevelled
edges, approx. 10mm in
diameter, debossed with “LE” on one side/ “NVR” on the other
EXCIPIENTS
LESCOL 20MG CAPSULE AND 40MG CAPSULES
Magnesium
stearate;
sodium
hydrogen
carbonate;
talc;
cellulose
microcrystalline,
pregelatinised starch, calcium carbonate; titanium dioxide; iron oxide
red, iron oxide yellow,
gelatine; shellac.
LESCO