LESCOL XL fluvastatin 80mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

fluvastatin sodium, Quantity: 84.24 mg (Equivalent: fluvastatin, Qty 80 mg)

Boleh didapati daripada:

Novartis Pharmaceuticals Australia Pty Ltd

Borang farmaseutikal:

Tablet, modified release

Komposisi:

Excipient Ingredients: hypromellose; hyprolose; potassium bicarbonate; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; macrogol 8000; iron oxide yellow

Laluan pentadbiran:

Oral

Unit dalam pakej:

7 tablets, 28 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Hypercholesterolaemia: Prior to initiating therapy with fluvastatin for treating hypercholesterolaemia, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Adults: As an adjunct to diet in the treatment of hypercholesterolaemia. Heterozygous familial hypercholesterolaemia in paediatric patients: As an adjunct to diet in adolescent boys and in adolescent girls who are at least one year post-menstruation, 10-16 years of age, with heterozygous familial hypercholesterolaemia whose response to dietary restriction has not been adequate and in whom the following findings are present: 1. LDL-C remains greater than or equal to 4.9 mmol/L (190 mg/dL) or 2. LDL-C remains greater than or equal to 4.1 mmol/L (160 mg/dL) and: there is a positive family history of premature cardiovascular disease - or two or more other cardiovascular disease risk factors are present. Secondary Prevention of Cardiac Events: For the prevention of major adverse cardiac events in adult patients with coronary heart disease who have undergone successful coronary transcatheter therapy.

Ringkasan produk:

Visual Identification: YELLOW, ROUND, SLIGHTLY BICONVEX WITH BEVELLED EDGES APPROX. 10MM IN DIAMETER. DEBOSSED WITH "LE" ON ONE SIDE, "NVR" ON THE OTHER.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

2002-09-17

Risalah maklumat

LESCOL XL
®
_fluvastatin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lescol XL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Lescol XL
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LESCOL XL IS
USED FOR
Lescol XL is used to lower the
amount of cholesterol made by the
body. Everyone has cholesterol in
their blood. It is a type of fat needed
by the body for many things, such as
building cells, making bile acids
(which help to digest food) and
making some hormones. However,
having too much cholesterol in the
blood can contribute to the
development of heart disease.
Cholesterol is present in many foods
and is also made by your body. If
your body does not balance the
amount of cholesterol it makes with
the amount of cholesterol you eat,
then your cholesterol becomes too
high. High cholesterol is more likely
to occur with certain diseases or if
you have a family history of high
cholesterol.
Lescol XL does not reduce the
cholesterol that comes from fat in
food. Therefore, you also need to
follow a low fat diet, control your
weight and exercise regularly.
Lescol XL can also be used to help
prevent further serious cardiac
problems in people with heart disease
who have already had cardiac
catheterisation

Ciri produk

1
AUSTRALIAN PRODUCT INFORMATION – LESCOL
® XL (FLUVASTATIN
SODIUM) TABLETS
1
NAME OF THE MEDICINE
fluvastatin sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluvastatin sodium is a white to pale yellow powder, odourless or weak
odour only. Fluvastatin
sodium is a racemic mixture of the two enantiomers of which the 3R,5S
form possesses more than
30 times the activity of the 3S,5R form.
Each prolonged release tablet contains 84.24 mg fluvastatin sodium
equivalent to 80 mg fluvastatin
free acid.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Prolonged release tablets.
Yellow, round, slightly biconvex, film-coated tablet, marked "LE" on
one side and "NVR" on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HYPERCHOLESTEROLAEMIA
Prior to initiating therapy with fluvastatin for treating
hypercholesterolemia, secondary causes of
hypercholesterolaemia (e.g. poorly controlled diabetes mellitus,
hypothyroidism, nephrotic
syndrome, dysproteinaemias, obstructive liver disease, other drug
therapy, alcoholism) should be
identified and treated.
ADULTS:
•
As an adjunct to diet in the treatment of hypercholesterolaemia.
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN PAEDIATRIC PATIENTS:
•
As an adjunct to diet in adolescent boys and in adolescent girls who
are at least one year
post-menstruation, 10 -16 years of age, with heterozygous familial
hypercholesterolaemia
whose response to dietary restriction has not been adequate and in
whom the following
findings are present:
1. LDL-C remains ≥ 4.9 mmol/L (190 mg/dL) or
2. LDL-C remains ≥ 4.1 mmol/L (160 mg/dL) and:
2
•
there is a positive family history of premature cardiovascular disease
or
•
two or more other cardiovascular disease risk factors are present.
SECONDARY PREVENTION OF CARDIAC EVENTS:
•
For the prevention of major adverse cardiac events in adult patients
with coronary heart
disease who have undergone successful coronary transcatheter therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Prior to ini