PRAVASTATIN GENERICHEALTH pravastatin sodium 80 mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

pravastatin sodium, Quantity: 80 mg

Dostopno od:

Generic Health Pty Ltd

INN (mednarodno ime):

pravastatin sodium

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow

Pot uporabe:

Oral

Enote v paketu:

30 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with Pravastatin generichealth, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. Pravastatin generichealth is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/L) serum cholesterol levels. 3. Pravastatin generichealth is indicated in patients with unstable angina pectoris (see Clinical Trials). 4. Pravastatin generichealth is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 years and older (see Clinical Trials).

Povzetek izdelek:

Visual Identification: yellow coloured, oval shaped, biconvex, film coated tablets debossed with '80' on one side and 'PRV' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

2008-07-07

Navodilo za uporabo

CONSUMER MEDICINE INFORMATION
PRAVASTATIN GENERICHEALTH
(PRAVASTATIN SODIUM) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
The information in this leaflet will
answer some of the questions
you may have about Pravastatin
generichealth. This leaflet does
not tell you everything about this
medicine.
Your doctor and pharmacist
have been provided with full
information and can answer any
questions you may have.
This leaflet is no substitute for
talking with your doctor or
pharmacist. You should follow
all advice from your doctor when
being treated with this
medicine..
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
You should read this leaflet
carefully before starting
Pravastatin generichealth and
keep it in a safe place to refer to
later.
WHAT PRAVASTATIN
GENERICHEALTH IS USED FOR
Pravastatin generichealth is
used to treat people who have
had a heart attack or an episode
of unstable angina, or who have
high blood cholesterol levels. In
these people Pravastatin
generichealth can reduce the
risk of further heart disease,
reduce the possibility of needing
a bypass operation, or reduce
the risk of having a stroke.
Pravastatin generichealth lowers
high blood cholesterol levels
(doctors call this
hypercholesterolaemia). It is
also used if your cholesterol
levels are normal if you have
had a heart attack or an episode
of unstable angina.
Pravastatin generichealth is
used to treat heterozygous
familial hypercholesterolaemia in
children and adolescent patients
aged 8 years and older as an
adjunct to diet and lifestyle
changes.
If you have had a heart attack,
an episode of unstable angina or
you have too much cholesterol
in your blood, then you have an
increased risk of a blood clot
forming in your blood vessels
and causing a blockage. Blood
vessels that become blocked in
this way can lead to further heart
disease, angina or stroke.
Pravastatin generichealth may
be used to lower lipids in heart
or kidney transplant patients,
who are also being given
immunosuppressive medicine.
Pravastatin generi

Lastnosti izdelka

AUSTRALIAN PRODUCT INFORMATION – PRAVASTATIN GENERICHEALTH
(PRAVASTATIN SODIUM) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Pravastatin sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg, 20 mg or 80 mg of pravastatin sodium.
List of excipients with known effect: Lactose monohydrate, sodium
bicarbonate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pravastatin generichealth 10 mg tablets: Yellow coloured, capsule
shaped, biconvex, film-coated tablets
debossed with ‘10’ on one side and plain on the other side.
Pravastatin generichealth 20 mg tablets: Yellow coloured, capsule
shaped, biconvex, film-coated tablets
debossed with ‘20’ on one side and plain on the other side.
Pravastatin generichealth 80 mg tablets: Yellow coloured, oval shaped,
biconvex, film-coated tablets
debossed with ‘80’ on one side and ‘PRV’ on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
As an adjunct to diet for the treatment of hypercholesterolaemia.
Prior to initiating therapy with
Pravastatin
generichealth,
secondary
causes
of
hypercholesterolaemia
(eg.
poorly
controlled
diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinemias, obstructive liver disease,
other drug therapy, alcoholism) should be identified and treated.
2.
Pravastatin generichealth is indicated in patients with previous
myocardial infarction including those
who have normal (4.0-5.5 mmol/L) serum cholesterol levels.
3.
Pravastatin generichealth is indicated in patients with unstable
angina pectoris (see SECTION 5.1
PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
4.
Pravastatin generichealth is indicated as an adjunct to diet and
lifestyle modification for the
treatment of Heterozygous Familial Hypercholesterolaemia in children
and adolescent patients aged
8 years and older (See SECTION 5.1 PHARMACODYNAMIC PROPERTIES –
CLINICAL TRIALS).
4.2 DOSE AND METHOD OF ADMINISTRATION
Prior to initiating Pravastatin generichealth tablets, the patient
should be