Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tibolone, Quantity: 2.5 mg
Actor Pharmaceuticals Pty Ltd
Tibolone
Tablet, film coated
Excipient Ingredients: lactose monohydrate; ascorbyl palmitate; magnesium stearate; potato starch
Oral
1 x 28 film coated tablets (1 blister strip per carton 28 tablets per blister strip)
(S4) Prescription Only Medicine
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, TIBOGEN 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 the moment (including cardiovascular disease and breast cancer, refer CLINICAL TRIALS and PRECAUTIONS). TIBOGEN should only be continued for as long as the benefit outweighs the risks.
Visual Identification: The formulation is presented as white to whitish round tablet, 6.0 mm +/- 0.2 mm in diameter.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-02-09
TIBOGEN® TABLETS 1 TIBOGEN ® _tibolone 2.5mg tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tibogen. 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 Tibogen 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 IS TIBOGEN USED FOR Tibogen contains tibolone, a substance that can replace the natural sex hormones after menopause. The production of sex hormones by the body decreases during and after menopause. Women may then suffer from complaints such as hot flushes, night sweats, vaginal irritation, depression and loss of sexual desire. In addition, menopause may cause thinning of the bones (osteoporosis). Tibogen is used in postmenopausal women at least 12 months since their last natural period. Tibogen is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During menopause, the amount of oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Tibogen alleviates these symptoms after menopause. You will only be prescribed Tibogen if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can take Tibogen to prevent osteoporosis after menopause. Tibogen is not a contraceptive. Tibogen has no effect on alertness and concentration as far as is known. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU Read the complete document
TIBOGEN (tibolone 2.5mg) PI (29-Aug-2014) Page 1 of 11 PRODUCT INFORMATION TRADE NAME TIBOGEN® NAME OF THE MEDICINE TIBOGEN (tibolone) 2.5 mg tablets TIBOLONE _ _ _Molecular formula: C_ _21_ _H_ _28_ _O_ _2_ _ _ _Molecular Weight:_ _312.45_ _[CAS No. 5630-53-5] _ CHEMICAL NAME: 17β-Hydroxy-7α-methyl-19 nor-17α pregn-5(10)-en-20-yn-3-one OTHER NAME: 17α‐ethynyl‐17‐hydroxy‐7α‐methyl‐5(10)‐estren‐3‐one. PHARMACEUTICAL FORM Tablets, each containing 2.5 mg of the steroid tibolone. DESCRIPTION Tibolone exists as white to almost white crystals or crystalline powder. Tibolone is related to and derived from naturally occurring steroids. It is optically pure and has the D-configuration. It is practically insoluble in water, aqueous acid or alkali at 20°C. LIST OF EXCIPIENTS TIBOGEN tablets 2.5 mg contain potato starch, magnesium stearate, ascorbyl palmitate and lactose. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES ATC code: G03CX01 After oral administration tibolone is rapidly metabolised into three compounds which contribute to the pharmacological effects of tibolone. Two of these metabolites (the 3αOH and 3βOH metabolite) have predominantly oestrogenic activity, a third metabolite (Δ 4 -isomer of tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of oestrogen production in postmenopausal women and alleviates menopausal symptoms. Tibolone prevents bone loss following menopause or ovariectomy. Tibolone has various tissue-specific effects. It has oestrogenic effects on the vagina, on bone and on the thermoregulatory centres in the brain (hot flushes). Based on _in vitro_ data, tibolone inhibits the TIBOGEN (tibolone 2.5mg) PI (29-Aug-2014) Page 2 of 11 sulphatase enzyme in cultured breast cancer cells thereby reducing the levels of active oestrogens produced in those cells. Due to local conversion to the Δ 4 -isomer, the endometrial findings have been mainly atrophic or in some cases weakly proliferative, which can, in thems Read the complete document