Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
pravastatin sodium, Quantity: 20 mg
Arrotex Pharmaceuticals Pty Ltd
pravastatin sodium
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; magnesium oxide; povidone; microcrystalline cellulose; iron oxide yellow; croscarmellose sodium; magnesium stearate
Oral
30 tablets
(S4) Prescription Only Medicine
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, alcoholism) should be identified and treated. LIPOSTAT is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. LIPOSTAT is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS). LIPOSTAT 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).
Visual Identification: Yellow capsule shaped bi-convex tablet with a "20" engraved on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-08-05
LIPOSTAT CMI Page 1 of 4 LIPOSTAT pravastatin sodium CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET The information in this leaflet will answer some of the questions you may have about LIPOSTAT. This leaflet does not tell you everything about LIPOSTAT. This leaflet is no substitute for talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you taking LIPOSTAT against the benefits they expect it will have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS LIPOSTAT USED FOR? LIPOSTAT tablets contain pravastatin sodium, a drug that reduces 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. LIPOSTAT 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 this medicine can reduce the risk of further heart disease, reduce the possibility of needing a bypass operation, or reduce the risk of having a stroke. LIPOSTAT lowers high blood cholesterol levels. It is also used if your cholesterol levels are normal if you have had a heart attack or an episode of unstable angina. LIPOSTAT 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. LIPOSTAT may be used to lower lipids in heart or kidney transplant patients, who are also being given immunosuppressive medicine. It is used to treat long-term (chronic) conditions so it Lue koko asiakirja
1 AUSTRALIAN PRODUCT INFORMATION – LIPOSTAT (PRAVASTATIN SODIUM) TABLETS 1 NAME OF THE MEDICINE Pravastatin sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LIPOSTAT tablets are available in 10 mg, 20 mg, 40 mg or 80 mg of pravastatin sodium. Excipients with known effect: Sugars as lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM LIPOSTAT are yellow capsule shaped biconvex tablets. The 10 mg tablet (8.8 x 4.4mm) is engraved “10” on one side, the 20 mg tablet (11.0 x 5.5mm) is engraved “20” on one side, the 40 mg tablet (14.0 x 7.0mm) is engraved “40” on one side, the 80 mg tablet (17.6 x 8.8mm) is engraved “80” on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, 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. LIPOSTAT is indicated in patients with previous myocardial infarction including those who have normal (4.0 – 5.5 mmol/L) serum cholesterol levels. 3. LIPOSTAT is indicated in patients with unstable angina pectoris (see section 5.1 PHARMACODYNAMIC PROPERTIES – Clinical Trials). 4. LIPOSTAT 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). 2 4.2 D OSE AND METHOD OF ADMINISTRATION Prior to initiating LIPOSTAT (pravastatin sodium), the patient should be placed on a standard cholesterol-lowering diet (AHA Phase 1 or NCEP Step 1) for a maximum of 3 to 6 months, depending upon the severity of the lipid elevation. Dietary therapy should be continued during treatment. ADULT PATIENTS The recommended starting dose is 10 to 20 mg o Lue koko asiakirja