Fluvastatin 20mg capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Fluvastatin sodium

Prieinama:

Sandoz Ltd

ATC kodas:

C10AA04

INN (Tarptautinis Pavadinimas):

Fluvastatin sodium

Dozė:

20mg

Vaisto forma:

Oral capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02120000; GTIN: 5050650037012

Pakuotės lapelis

FLUVASTATIN
FLUVASTATIN 20 MG HARD CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
• if you are about to have an operation.
• if you have severe metabolic, endocrine or electrolyte
disorders such as decompensated diabetes and low blood
potassium.
While you are on this medicine your doctor will monitor you
closely if you have diabetes or are at risk of developing
diabetes. You are likely to be at risk of developing diabetes if
you have high levels of sugars and fats in your blood, are
overweight and have high blood pressure.
CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING
FLUVASTATIN:
• if you have severe respiratory failure.
If any of these apply to you, TELL YOUR DOCTOR BEFORE TAKING
FLUVASTATIN. Your doctor will take a blood test before prescribing
Fluvastatin.
Also tell your doctor or pharmacist if you have a muscle
weakness that is constant. Additional tests and medicines may
be needed to diagnose and treat this.
If during treatment with Fluvastatin, you develop symptoms or
signs such as nausea, vomiting, loss of appetite, yellow eye or
skin, confusion, euphoria or depression, mental slowing, slurred
speech, sleep disturbance, tremors or easy bruising or bleeding,
these may be signs of liver failure. In such case contact a doctor
immediately.
ELDERLY (OVER 70 YEARS)
If you are over 70 years your doctor may want to check if you
have risk factors for muscular diseases. You may need specific
blood tests.
CHILDREN AND ADOLESCENTS
Fluvastatin has not been investigated and is not intended for the
use in children below 9 years. For dose information in children
and adolescents over 9 years, see section 3.
There is no experience with the use of Fluvastatin in
combination with nicotinic acid, cholestyramine or fibrates in
children and adolescents.
OTHER MEDICINES AND FLUVASTATIN
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
IF YOU NEED TO TAKE ORAL FUSIDIC ACID TO TREAT A BACTERIAL
INFECTION YOU WILL NEED TO TEMPORARILY STOP USING THIS
MEDICINE.

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluvastatin 20 mg hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 21.06 mg fluvastatin sodium corresponding
to 20 mg
fluvastatin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Brown coloured hard gelatine capsule containing off-white to
pale-yellow powder.
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) are 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 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 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
fluvastatin 80 mg
prolonged-release 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 intervals of 4 weeks or more.
Secondary prevention in coronary heart disease
In patients with coronary heart disease after percutaneous coronary
interve