Lescol XL 80mg prolonged release Tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

fluvastatin 80 mg

Beschikbaar vanaf:

Novartis Pharmaceuticals UK Limited

ATC-code:

C10AA04

INN (Algemene Internationale Benaming):

fluvastatin

farmaceutische vorm:

prolonged-release tablet

Autorisatie-status:

Authorised

Autorisatie datum:

2005-08-03

Bijsluiter

Approval Box and Ready for Print Box only to be used 
in case AWF is not used.
 Hurix 
House,

New No. 34, Old No. 10,
 Taylors 
Road,

Kilpauk, Chennai-600 010.
HURIX SYSTEMS PRIVATE LIMITED 
Tel: + 91-44-4228 4888

Fax: + 91-44-4228 4899
Checking against manuscript according to
SOP-0022667. To be signed by AwOps.
TYPESETTING ORDER/CTM-OWNER: 587040/Riera M.
MATERIAL NO.:
1124946-ST 12 A/B-MT
T NUMBER:
n.a.
REPLACED NO.:
32313-ST 12A/B-MT
NO OF COLOUR:
1
PRODUCT:
LFT LESCOL 20/40 MG CAP / 
LESCOL XL 80 MG FCT MT
COLOUR:                         
314 Blue
PRESENTATION TYPE: MT
Technical approval. To be signed by Manufacturing Site.
CODE-NO.: 1281
CODE TYPE:   Laetuscode
EDGE MARKS:
1/2/3/6/8
DIMENSION:
420 x 148 mm
COLOUR/TECHNICAL: 
Cutting
DRAWING NO.:
n.a.
PERFORATION:
n.a.
PROOF DATE:
26.11.2012
RECEIVING PLANT:
Barbera
USED FONTS: 

News Gothic TL Cond, News Gothic TL Cond Italic, News Gothic TL
Bold Cond
SMALLEST FONT SIZE:     
 9 pt 
    Text (News Gothic TL-Cond)
SMALLEST FONT SIZE: 
 7 pt 
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SMALLEST VECTORIZED TEXT:  n.a.
This information was compiled with utmost care and on completion was
subjected to strict Internal checks. However, the handling of data
always involves a certain degree of risk and the impossibility of
error 
cannot be guaranteed. Therefore we would ask you to check the proof
thoroughly. Hurix assumes no liability for errors identified only
after print approval has been given.
2. Proof
Sridhar
Page 1/2
1124946-ST 12 A/B-MT
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/HVFROPJKDUGFDSVXOHV
/HVFROPJKDUGFDSVXOHV
/HVFRO;/PJSURORQJHG
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Fluvastatin
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Lees het volledige document

Productkenmerken

Page 1 of 15

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF MEDICINAL PRODUCT 

Lescol 20 mg capsules, hard 
Lescol 40 mg capsules, hard 
Lescol XL 80 mg prolonged-release tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active substance: fluvastatin (as fluvastatin sodium) 

Lescol 20 mg capsules: 
One capsule contains 21.06 mg fluvastatin sodium equivalent to 20
mg fluvastatin free acid. 

Lescol 40 mg capsules: 
One capsule contains 42.12 mg fluvastatin sodium equivalent to 40
mg fluvastatin free acid. 

Lescol XL 80 mg prolonged-release tablets: 
One prolonged-release tablet of Lescol XL contains 84.24
mg fluvastatin sodium equivalent to 80 
mg fluvastatin free acid. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Capsule, hard 
Capsule, hard 
Prolonged-release tablet 

Lescol 20 mg capsules: 
Cap: Strong reddish brown opaque
. 
Body: Pale yellow opaque; imprint: XU 20 mg (red ink)
.

Lescol 40 mg capsules: 
Cap: Strong reddish brown opaque
. 
Body: Orange yellow opaque; imprint: XU 40 mg (red ink)
.

Lescol XL 80 mg prolonged-release tablets: 
Yellow, round, slightly biconvex film-coated tablets with beveled
edges, approx. 10 mm in diame-
ter, debossed with “LE” on one side and “NVR” on the other
side. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Dyslipidaemia 

Page 2 of 15 

Treatment of adults with primary hypercholesterolaemia or mixed
dyslipidaemia, as an adjunct to 
diet, when response to diet and other non-pharmacological treatments
(e.g. exercise, weight reduc-
tion) is inadequate. 

Secondary prevention in coronary heart disease 
Secondary prevention of major adverse cardiac events in adults with
coronary heart disease after 
percutaneous coronary interventions (see section 5.1). 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

_Adults _
Dyslipidaemia 
Prior to initiating treatment with Lescol/Lescol XL, p