Lescol XL

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

fluvastatin (fluvastatin sodium)

Inapatikana kutoka:

Novartis Farmaceutica S.A.

INN (Jina la Kimataifa):

fluvastatin (fluvastatin sodium)

Kipimo:

80mg

Dawa fomu:

tablets film-coated

Dawa ya aina:

Prescription

Taarifa za kipeperushi

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.
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.
Content of the pack and other information
1.
WHAT LESCOL XL IS AND WHAT IT IS USED FOR
Lescol XL contains the active 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 after they already went through a heart
catheterisation, with an
intervention in the heart vessel.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESCOL XL
Follow all the doctor‟s instructions carefully. They may differ from
the general information
contained in this leaflet.
Read the following explanations before you take Lescol XL.
DO NOT TAKE LES

Tabia za bidhaa

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)
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
Prolonged-release tablet.
Lescol XL 80 mg prolonged-release tablets:
Yellow, round, slightly biconvex film-coated tablets with beveled
edges, approx. 10 mm in
diameter, debossed with “LE” on one side and “NVR” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dyslipidaemia
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
reduction) 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 XL,patients should be placed
on a standard cholesterol-
lowering diet, which should be continued during treatment.
Starting and maintenance doses should be individualized according to
the baseline LDL-C levels
and the treatment goal to be accomplished.
The recommended dosing range is 20 to 80 mg/day. For patients
requiring LDL-C reduction to a
goal of < 25% a starting dose of 20 mg may be used as one capsule in
the evening. For patients
requiring LDL-C reduction to a goal of ≥25%, the recommended
starting dose is 40 mg as one
capsule in the evening. The dose may be uptitrated to 80 mg daily,
administered as a single dose
(one Lescol XL tablet) at any time of the day or as one 40 mg capsule
given twice daily (one in
the morning and one in the evening).
The maximu