Fluvastatin 40mg capsules

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Fluvastatin sodium

Disponible des:

Zentiva Pharma UK Ltd

Codi ATC:

C10AA04

Designació comuna internacional (DCI):

Fluvastatin sodium

Dosis:

40mg

formulario farmacéutico:

Oral capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02120000; GTIN: 5000283653264

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUVASTATIN 20MG AND 40MG CAPSULES
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, pharmacist or
nurse.
- 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1. What Fluvastatin Capsules are and what they are used for
2. What you need to know before you take Fluvastatin Capsules
3. How to take Fluvastatin Capsules
4. Possible side effects
5. How to store Fluvastatin Capsules
6. Contents of the pack and other information 1. WHAT FLUVASTATIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Fluvastatin 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.
-
Fluvastain 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 Fluvastatin 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 Fluvastatin works or why this
medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUVASTATIN CAPSULES
Follow all your doctor’s instr

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluvastatin 40mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 42.12mg fluvastatin sodium corresponding to 40mg
fluvastatin.
For a full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Hard gelatine capsule, size 1. The capsule contains pale yellow
powder.
Capsule cap: Swedish orange opaque with imprint 40.
Capsule body: Rich yellow opaque with imprint FST.
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 Fluvastatin, 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 disease