Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
pravastatin sodium, Quantity: 80 mg
Sandoz Pty Ltd
pravastatin sodium
Tablet
Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; sodium lauryl sulfate; dibasic sodium phosphate; croscarmellose sodium; magnesium stearate; iron oxide red; lactose monohydrate
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, 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).
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
Registered
2009-10-12
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 Lue koko asiakirja
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 Lue koko asiakirja