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TIBOLONE is a brand name for Tibolone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of oestrogen deficiency symptoms in women more than one year after the menopause. For all women the decision to prescribe tibolone should be based on an assessment of the individual patient´s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke (see sections 4.4…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage is one tablet per day. Method of administration The tablets should be swallowed, with some water or other drink, preferably at the same time every day. Elderly No dose adjustment is necessary for the elderly. 4) should be used.
5 mg tablets treatment. 5 mg tablets at least 12 months after their last natural bleed. 5 mg tablets immediately. 3). 5 mg tablets should start the day following completion of the prior regimen. If changing from a continuous- combined HRT preparation, treatment can start at any time.
Missed dose A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the latter 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.
8. After stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
No data for persistence of risk after stopping are available for tibolone, but a similar pattern cannot be ruled out. HRT, especially oestrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Ovarian cancer Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
8). In the Million Women Study it was shown that the relative risk for ovarian cancer with use of tibolone was similar to the risk associated with use of other types of HRT. e. deep vein thrombosis or pulmonary embolism. 8). In an epidemiological study using a UK database, the risk of VTE in association with tibolone was lower than the risk associated with conventional HRT, but only a small proportion of women were current users of tibolone and a small increase in risk compared with non-use cannot be excluded.
− Patients with known thrombophilic states have an increased risk of VTE and HRT or tibolone may add to this risk. 3). − Generally recognized risk factors for VTE include use of oestrogens, older age, major surgery, prolonged immobilization, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE) and cancer.
There is no consensus about the possible role of varicose veins in VTE. As in all postoperative patients, prophylactic measures need to be considered to prevent VTE following surgery. If prolonged immobilisation is to follow elective surgery temporarily stopping HRT or tibolone 4 to 6 weeks earlier is recommended, if possible.
For the treatment of postmenopausal symptoms, tibolone should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and tibolone should only be continued as long as the benefit outweighs the risk.
8) for each woman should be carefully assessed, in the light of her individual risk factors, and bearing in mind the frequency and characteristics of both cancers and stroke, in terms of their response to treatment, morbidity and mortality.
Evidence regarding the risks associated with HRT or tibolone in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.
Medical examination and follow-up Before initiating or reinstituting HRT or therapy with tibolone, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor (see ´Breast cancer´ below). Investigations, including mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. g. g. 8).
In these studies risk increased with increasing duration of use. Tibolone increases endometrial wall thickness, as measured by transvaginal ultrasound. 1). Women should be advised to report any breakthrough bleeding or spotting if it is still present after 6 months of treatment, if it starts beyond that time or continues after treatment has been discontinued, the reason should be gynaecologically investigated, which may include endometrial biopsy to exclude endometrial malignancy.
g. g. g. 1
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment should not be restarted until the woman is completely mobilised. − In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
g, antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT or tibolone is contraindicated. − Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT or tibolone.
− If VTE develops after initiating therapy, the drug should be discontinued. g. painful swelling of a leg, sudden pain in the chest, dyspnea). Risk of coronary artery disease − There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received combined oestrogen-progestogen or oestrogen-only HRT.
In an epidemiological study using the GPRD no evidence was found of protection against myocardial infarction in postmenopausal women who received tibolone. 8). The baseline risk of stroke is strongly age-dependent and so the effect of tibolone is greater with older age.
5 mg tablets is not intended for contraceptive use. 5 mg dose after 2 years). Total triglycerides and lipoprotein(a) levels were also reduced. The decrease in total cholesterol and VLDL- cholesterol levels was not dose-dependent. Levels of LDL- cholesterol were unchanged.
The clinical implication of these findings is not yet known. − Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed. − Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or HRT, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
5 mg tablets results in a very minor decrease of thyroid binding globulin (TBG) and total T4. Levels of total T3 are unaltered. 5 mg tablets decreases the level of sex hormone-binding globulin (SHBG), whereas the levels of corticoid binding globulin (CBG) and circulating cortisol are unaffected.
− HRT does not improve cognitive function. There is some evidence of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
5 Interaction with other medicinal products and other forms of interaction As tibolone may increase blood fibrinolytic activity, it may enhance the effect of anticoagulants. This effect has been observed with warfarin. Consequently, women simultaneously treated with […]
5 mg dose. 8. After stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
No data for persistence of risk after stopping are available for tibolone, but a similar pattern cannot be ruled out. HRT, especially oestrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Ovarian cancer Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
8). In the Million Women Study it was shown that the relative risk for ovarian cancer with use of tibolone was similar to the risk associated with use of other types of HRT. e. deep vein thrombosis or pulmonary embolism. 8). In an epidemiological study using a UK database, the risk of VTE in association with tibolone was lower than the risk associated with conventional HRT, but only a small proportion of women were current users of tibolone and a small increase in risk compared with non-use cannot be excluded.
− Patients with known thrombophilic states have an increased risk of VTE and HRT or tibolone may add to this risk. 3). − Generally recognized risk factors for VTE include use of […]