Stefluvin XL 80mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Fluvastatin sodium

Tilgængelig fra:

Zentiva Pharma UK Ltd

ATC-kode:

C10AA04

INN (International Name):

Fluvastatin sodium

Dosering:

80mg

Lægemiddelform:

Modified-release tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 02120000; GTIN: 5000283653363

Indlægsseddel

CODE
CODE
STEFLUVIN XL 80MG PROLONGED RELEASE TABLETS
(FLUVASTATIN)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Stefluvin XL is and what it is used for
2. What you need to know before you take Stefluvin XL
3. How to take Stefluvin XL
4. Possible side effects
5. How to store Stefluvin XL
6. Contents of the pack and other information 1. WHAT STEFLUVIN XL IS AND WHAT IT IS USED FOR
Stefluvin XL contains the active ingredient 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.
•
Stefluvin 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 Stefluvin 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 STEFLUVIN XL
Follow all your doctor's instructions carefully. They may differ from
the general information contained in thi

Produktets egenskaber

OBJECT 1
STEFLUVIN XL 80MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 21-Sep-2015 | Zentiva
1. Name of the medicinal product
Stefluvin XL 80 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 84.2 mg fluvastatin sodium
(equivalent to 80 mg fluvastatin).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablet.
Stefluvin XL tablets are dark yellow, round, biconvex tablets. 10.1 ±
0.1 mm in diameter and 3.7 mm ±
0.2 mm in thickness
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 Stefluvin 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 up-titrated to 80 mg daily, administered as a single dose
(one Stefluvin 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 maximum lipid-lowering effect with a given dose is achieved within
4 weeks. Dose adjustments
should be made at i