Fluvastatin 40mg capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Fluvastatin sodium

Prieinama:

Teva UK Ltd

ATC kodas:

C10AA04

INN (Tarptautinis Pavadinimas):

Fluvastatin sodium

Dozė:

40mg

Vaisto forma:

Oral capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02120000; GTIN: 5017007050018

Pakuotės lapelis

FLUVASTATIN
20 MG AND 40 MG CAPSULES
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.
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
WHAT FLUVASTATIN CAPSULES ARE AND
WHAT THEY ARE USED FOR
Fluvastatin Capsules contain 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.
Fluvastatin Capsules 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
Capsules 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
Capsules works or why this medicine has been
prescribed for you, ask your doctor.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FLUVASTATIN CAPSULES
Follow all your doct

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluvastatin 40 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 40 mg capsule contains 40 mg fluvastatin (as fluvastatin sodium).
Excipient with known effect:
Each capsule contains 199.2 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
The 40 mg capsules have a yellow opaque body and pink opaque cap
marked
93/7443, and are filled with an off-white to yellowish powder with
small
agglomerates.
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
interval