MEDREICH ROSUVASTATIN 40 rosuvastatin 40 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 41.68 mg (Equivalent: rosuvastatin, Qty 40 mg)

Available from:

Medreich Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; pregelatinised starch; crospovidone; microcrystalline cellulose; meglumine; purified water; titanium dioxide; hypromellose; triacetin; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

15, 30, 45, 60 (dispensing pack) and 90 (dispensing pack) tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MEDREICH ROSUVASTATIN should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of cardiovascular events,MEDREICH ROSUVASTATIN is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). MEDREICH ROSUVASTATIN is indicated to:,? Reduce the risk of nonfatal myocardial infarction,? Reduce the risk of nonfatal stroke,? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia,MEDREICH ROSUVASTATIN is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).,Prior to initiating therapy with MEDREICH ROSUVASTATIN, 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.

Product summary:

Visual Identification: Pink, oval, film-coated, tablets debossed with 40 on one side and R on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-03-03