LESCOL XL TABLET 80 mg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

FLUVASTATIN SODIUM

Saatavilla:

NOVARTIS (SINGAPORE) PTE LTD

ATC-koodi:

C10AA04

Annos:

80 mg

Lääkemuoto:

TABLET, FILM COATED

Koostumus:

FLUVASTATIN SODIUM 80 mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

Siegfried Barbera, S.L.

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2001-04-26

Pakkausseloste

LESCOL
 
/ LESCOL

 XL 
HMG-CoA reductase inhibitor 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Capsules and prolonged release tablets for oral administration. 
ACTIVE SUBSTANCE 
[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. 
EXCIPIENTS 
LESCOL 20 MG AND 40 MG CAPSULES 
Magnesium stearate; sodium hydrogen carbonate; talc; cellulose
microcrystalline, 
pregelatinised starch, calcium carbonate; titanium dioxide; iron
oxide red, iron oxide yellow, 
gelatine; shellac. 
LESCOL XL 80 MG TABLETS 
Cellulose microcrystalline; hypromellose; hydroxypropyl cellulose;
potassium hydrogen 
carbonate; povidone; magnesium stearate; iron oxide yellow;
titanium dioxide; macrogol 
8000. 
Pharmaceutical formulations may vary between countries. 

2 

INDICATIONS 
DYSLIPIDEMIA 
ADULTS 
Lescol/Lescol XL is indicated as an adjunct to diet for the
reduction of elevated total 
cholesterol (total-C),
low-density lipoprotein cholesterol (LDL-C), apolipoprotein B
(apo B) 
and triglycerides (TG) levels and for the increase of
high-density lipoprotein cholesterol 
(HDL-C) in adults with primary hypercholesterolaemia and mixed
dyslipidaemia 
(Fredrickson Types IIa and IIb). 
OTHER INDICATIONS 
Lescol/Lescol XL is indicated to slow the progression
of coronary atherosclerosis in adults 
with primary hypercholesterolaemia, including mild
forms, and coronary heart disease. 
Lescol/Lescol XL is also indicated for the secondary prevention
of major adverse cardiac

Valmisteyhteenveto

1
LESCOL

XL
HMG-CoA reductase inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Capsules and prolonged release tablets for oral administration.
ACTIVE SUBSTANCE
Fluvastatin sodium
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.
ACTIVE MOIETY
Fluvastatin
EXCIPIENTS
LESCOL XL 80 MG TABLETS
Cellulose microcrystalline; hypromellose; hydroxypropyl cellulose;
potassium hydrogen carbonate;
povidone; magnesium stearate; iron oxide yellow; titanium dioxide;
macrogol 8000.
Pharmaceutical formulations may vary between countries.
INDICATIONS
DYSLIPIDEMIA
ADULTS
Lescol XL is indicated as an adjunct to diet for the reduction of
elevated total cholesterol (total-C),
low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B)
and triglycerides (TG) levels
and
for
the
increase
of
high-density
lipoprotein
cholesterol
(HDL-C)
in
adults
with
primary
hypercholesterolaemia and mixed dyslipidaemia (Fredrickson Types IIa
and IIb).
OTHER INDICATIONS
Lescol XL is indicated to slow the progression of coronary
atherosclerosis in adults with primary
hypercholesterolaemia, including mild forms, and coronary heart
disease.
2
Lescol XL is also indicated for the secondary prevention of major
adverse cardiac events in adults
with coronary heart disease after coronary transcatheter therapy.
DOSAGE REGIMEN AND ADMINISTRATION
Lescol XL can be administered as a single dose at any time of the day
with or without food. Lescol XL
must be swallowed whole with a glass of water. The maximum
lipid-lowering effect with a given dose
of the drug is achieved within 4 weeks. Doses should be adjusted
according to the patient's response
and dose adjustment made at intervals of 4 weeks or more. The
therapeutic effect of Lescol XL is
maintained with prolonged administration.
GENERAL TARGET POPULATION
ADULTS
Prior to initiating treatment with Lescol XL, the patient should be
placed on a standa