PRAVASTATIN SANDOZ pravastatin sodium 80 mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

pravastatin sodium, Quantity: 80 mg

זמין מ:

Sandoz Pty Ltd

INN (שם בינלאומי):

pravastatin sodium

טופס פרצבטיות:

Tablet

הרכב:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; sodium lauryl sulfate; dibasic sodium phosphate; croscarmellose sodium; magnesium stearate; iron oxide red; lactose monohydrate

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, 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. Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels. Patients with unstable angina pectoris (see Clinical Trials). 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).

leaflet_short:

Visual Identification: A light brown, mottled, oval tablet, debossed with "HLP 80" on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Registered

תאריך אישור:

2009-10-12

עלון מידע

PRAVASTATIN SANDOZ
®
1
PRAVASTATIN SANDOZ
®
_pravastatin sodium tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Pravastatin Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PRAVASTATIN
SANDOZ IS USED
FOR
This medicine is used to lower high
blood cholesterol levels (doctors call
this hypercholesterolaemia).
It is also used in people who have
had a heart attack or an episode of
unstable angina, even when their
cholesterol levels are normal.
It is also used to treat heterozygous
familial hypercholesterolaemia in
children and adolescent patients aged
8 years and older as an adjunct to diet
and lifestyle changes.
It contains the active ingredient
pravastatin sodium. Pravastatin
sodium belongs to a group of
medicines called HMG-CoA
reductase inhibitors.
It works by reducing the level of
cholesterol in your blood and helps to
protect you in other ways from heart
attack or stroke.
It is more effective if it is taken with
a diet low in fat.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
PRAVASTATIN
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
pravastatin sodium, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description.
•
any other similar medicines,
especially if they are in the same
drug class as Pravastatin Sandoz
(HMG-CoA reductase inhibitor).
Some of

מאפייני מוצר

180928-pravastatin-sandoz-pi
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
PRAVASTATIN SANDOZ
® (PRAVASTATIN SODIUM)
TABLETS
NAME OF THE MEDICINE
Pravastatin sodium
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pravastatin Sandoz 10 mg tablets contains 10 mg pravastatin
sodium.
Each Pravastatin Sandoz 20 mg tablets contains 20 mg pravastatin
sodium.
Each Pravastatin Sandoz 40 mg tablets contains 40 mg pravastatin
sodium.
Each Pravastatin Sandoz 80 mg tablets contains 80 mg pravastatin
sodium.
_Not all strengths may be marketed in Australia. _
_Excipient with known effect:_
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
PHARMACEUTICAL FORM
Pravastatin Sandoz 10 mg tablet is a light brown, mottled, oval
tablet, scored on both sides and
debossed “P 10” on one side.
Pravastatin Sandoz 20 mg tablet is a light brown, mottled, oval
tablet, scored on both sides and
debossed “P 20” on one side.
Pravastatin Sandoz 40 mg tablet is a light brown, mottled, oval
tablet, scored on both sides and
debossed “P 40” on one side.
Pravastatin Sandoz 80 mg tablet is a light brown, mottled, oval
tablet, debossed “HLP 80” on
one side.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
•
As an adjunct to diet for the treatment of hypercholesterolaemia.
Prior to initiating
therapy with pravastatin, secondary causes of hypercholesterolaemia
(e.g. poorly
controlled diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinemias,
obstructive liver disease, other drug therapy, and alcoholism) should
be identified and
treated.
•
Patients with previous myocardial infarction including those who have
normal (4.0 to
5.5 mmol/L) serum cholesterol levels.
•
Patients with unstable angina pectoris (see Section 5.1
Pharmacodynamic properties -
Clinical trials).
•
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 - Cli