TIBOLONE GPPL tibolone 2.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tibolone, Quantity: 2.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: pregelatinised potato starch; ascorbyl palmitate; magnesium stearate; lactose monohydrate; lactose

Administration route:

Oral

Units in package:

28 Tablets, 10 Tablets, 84 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women. ? Second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. After careful selection of users, <> (tibolone tablets) should be prescribed for the shortest duration consistent with treatment goals. Review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment (including cardiovascular disease and breast cancer, see CLINICAL TRIALS and PRECAUTIONS). <> (tibolone tablets) should only be continued for as long as the benefit outweighs the risks.

Product summary:

Visual Identification: White to off white, circular with flat face beveled edge, uncoated tablet debossed with TO above 2 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-03-28