Indication
1. Treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Women above 60 years of age should only start with TiboTM treatment when they are intolerant of or contraindicated for other medicinal products approved for the treatment of oestrogen deficiency symptoms.
2. 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.
3. After careful selection of users, TiboTM 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 TiboTM should only be continued for as long as the benefit outweighs the risks.
Dosage & Administration
Treatment of symptoms resulting from the natural or surgical menopause:
The recommended dose is 2.5 mg once daily.
Prevention of post-menopausal bone mineral density loss:
The recommended dose is 2.5 mg once daily. The tablets should be swallowed with some water or other drink, preferably at the same time of day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months. TiboTM 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.
Starting TiboTM
Women experiencing a natural menopause should commence treatment with TiboTM at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone may commence immediately.
Switching from combined or oestrogen only hormone replacement therapy
(HT)
In women with a uterus who change from an oestrogen-only preparation, a withdrawal bleed should be induced before starting TiboTM . If changing from a sequential HT preparation, treatment with TiboTM should start after the progestagen phase has been completed. If changing from a continuous-combined HT preparation, treatment can start at any time. If abnormal vaginal bleeding is the reason for switching from combined HT, it is advised to investigate the cause of bleeding before starting TiboTM .
Missed tablets
A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the later case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting.
Monitoring Advice
As for all steroids with hormonal activity, yearly medical examination particularly of the breasts and pelvic areas is advisable. Review the need for continuation of treatment after 6 months (refer to Precautions and Indications). The occurrence of vaginal bleeding or spotting soon after starting treatment with TiboTM may be due to the residual effects of endogenous or exogenous oestrogens. Bleeding commencing after three months of treatment, or recurrent or persistent bleeding should be investigated.
Precautions
Tibolone is not intended for contraceptive use. The use of Tibolone should be avoided until 12 months after the last natural menstrualbleeding. If Tibolone is taken sooner than this, the frequency of irregular bleeding may be increased.
Treatment should be discontinued if signs of thrombo-embolic processes occur, if results of liver function tests become abnormal or if cholestatic jaundice appears. Vaginal bleeding may occur during Tibolone therapy, because of an apparently stimulated endometrium due to some estrogen production. Normally such bleeding is of short duration. Bleedings commencing after three months of treatment, or recurrent or of longer duration should be investigated. In women changing from another form of hormonal substitution therapy to Tibolone therapy, it is always advisable to induce a withdrawal bleeding with a progestagen before starting Tibolone. Tibolone has been shown to be teratogenic in experimental animals.
Use In Pregnancy And Lactation
Tibolone is in pregnancy Category D & contraindicated in lactating women
