Lescol 20mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluvastatin sodium

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

C10AA04

INN (International Name):

Fluvastatin sodium

Dosage:

20mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5013054120148

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LESCOL
® 20 MG CAPSULES, HARD
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
1.
What Lescol is and what it is used for
2.
What you need to know before you take Lescol
3.
How to take Lescol
4.
Possible side effects
5.
How to store Lescol
6.
Contents of the pack and other information
1. WHAT LESCOL IS AND WHAT IT IS USED FOR
Lescol 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 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 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 works or why this medicine
has been prescribed for
you, ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESCOL
Follow all your doctor’s instructions carefully, even if they differ
from the general
information containe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lescol
®
20 mg capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: fluvastatin (as fluvastatin sodium)
Each capsule contains 21.06 mg of fluvastatin sodium equivalent to 20
mg fluvastatin free acid.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
Cap: Strong reddish brown opaque.
Body: Pale yellow opaque; imprint: XU 20 mg (red ink).
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
Posology
_ _
_Adults _
Dyslipidaemia
Prior to initiating treatment with Lescol, 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 fluvastatin may be used in
the evening. For
patients requiring LDL-C reduction to a goal of
≥
25%, the recommended starting dose is 40
mg fluvastatin in the evening. The dose may be uptitrated to 80 mg
fluvastatin daily,
administered as a single dose (80 mg prolonged-release tablet) at any
time of the day or as 40
mg of fluvastatin given twice daily (one dose in the morning and one
dose in the evening).
The maximum lipid-lowering effect with a given dose is achieved within
4 weeks. Dose
adjustments should be made at intervals of 4 weeks or more.
Secondary prevention in coronary heart disea