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Tibolone tabs 2.5mg

Updated 2 Feb 2023 | Oestrogens and HRT


Tablets containing tibolone

Drugs List

  • LIVIAL 2.5mg tablets
  • tibolone 2.5mg tablets
  • Therapeutic Indications


    Menopausal symptoms
    Secondary prophylaxis of postmenopausal osteoporosis where risk of fracture


    For initiation and continuation of treatment, the lowest effective dose for the shortest duration should be used.


    One 2.5 mg tablet to be taken daily (preferably at the same time each day) without interruption, for all indications.

    Starting treatment
    Patients experiencing a natural menopause should commence treatment at least 12 months after their last natural bleed.

    Patients experiencing a surgical menopause, or being treated with gonadotrophin releasing hormone analogues (for example, for endometriosis) may start treatment immediately.

    Patients transferring from a continuous combined HRT preparation may commence treatment at any time.

    Patients changing from a sequential HRT preparation should begin treatment the after completing their prior regimen.

    Missed tablets
    Patients should be advised that a missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. If this is the case, the missed dose should be omitted and the next dose should be taken at the normal time.

    A missed dose increases the likelihood of breakthrough bleeding or spotting.


    (See Dosage; Adults)

    Additional Dosage Information

    Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.

    An additional progestogen is not recommended with tibolone treatment.


    Predisposition to thromboembolic disease
    Abnormal liver function test
    Breast cancer
    Cerebral ischaemia
    History of breast cancer
    History of hormone dependent neoplasm
    History of thromboembolic disorder
    Ischaemic heart disease
    Oestrogen dependent neoplasm
    Uncontrolled endometrial hyperplasia
    Undiagnosed gynaecological haemorrhage
    Venous thromboembolism

    Precautions and Warnings

    Body mass index above 30kg per square metre
    Family history of venous thromboembolism
    Major surgery
    Prolonged immobilisation
    Risk factor for oestrogen-dependent neoplasm
    Severe headache
    Severe trauma
    Within 1 year of last natural menstrual period
    Cardiac impairment
    Cholestatic jaundice
    Diabetes mellitus
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hepatic adenoma
    Hepatic disorder
    History of endometrial hyperplasia
    History of hepatic disorder
    Lactose intolerance
    Renal impairment
    Systemic lupus erythematosus
    Uterine fibroids

    Assess family medical history prior to commencing treatment
    Exclude breast cancer before treatment
    Exclude oestrogen dependent neoplasm before treatment
    Contains lactose
    Do breast & pelvic exam. before & during treatment if clinically indicated
    Exclude pregnancy prior to initiation of treatment
    Abnormal and/or irregular bleeding should be investigated
    Advise patients of risks/benefits & review need for treatment regularly
    Discontinue treatment if patient develops seizures
    Advise patient that changes in their breasts should be reported to Dr/nurse
    Advise patient to contact a doctor if symptoms of thromboembolism develop
    Avoid immobilisation-treatment may cause increased risk of thromboembolism
    Increased risk of VTE during travel involving >5hr immobilisation
    May affect results of some laboratory tests
    Discontinue 4 - 6 weeks before major surgery
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if cholestatic jaundice occurs
    Discontinue if first occurrence or worsening of migraine/severe headache
    Discontinue if significant rise in blood pressure occurs
    Discontinue if symptoms due to endometriosis are exacerbated
    Discontinue if venous thromboembolism develops
    Advise patient not to take St John's wort concurrently
    Female: Not for contraception.Use non-hormonal contraception, if required

    For the treatment of menopausal symptoms the benefits of short-term HRT are considered to outweigh the risks in the majority of women.
    In all cases, it is good practice to use the lowest effective dose for the shortest possible time and to review the need to continue treatment at least annually.
    For postmenopausal women over 50 years who are at an increased risk of bone fracture, HRT should be used to prevent osteoporosis only in those who are intolerant of, or contraindicated for, other osteoporosis therapies.

    Physical examination should be guided by this and a knowledge of the contraindications and precautions and warnings for use of the product. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified according to the clinical needs of the individual.

    There is an increased risk of breast cancer in women currently or recently using Hormone Replacement Therapy (HRT). The risk of breast cancer increases with the duration of treatment and, after stopping HRT, the risk will decrease with time. When HRT lasts for more than 5 years, the risk may persist for 10 years or more.

    Ovarian cancer is much rarer than breast cancer. Evidence suggests a slight increased risk in women taking oestrogen-only or combined oestrogen and progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.

    Examinations to rule out endometrial abnormalities should be undertaken at regular intervals. Prolonged monotherapy with oestrogens increases the risk of endometrial hyperplasia and carcinoma in postmenopausal women unless supplemented by administration of a progestogen to protect the endometrium. Unless there is a previous diagnosis of endometriosis it is not recommended to add a progestogen in hysterectomised women.

    Pregnancy and Lactation


    Tibolone is contraindicated in pregnancy.

    Discontinue therapy if pregnancy occurs.

    Animal studies have shown reproductive toxicity in mice and rats. The potential risk to humans is unknown.

    The accidental administration has no risk-based reason for a termination of pregnancy. A detailed ultrasound examination could verify a normal morphologic development of the foetus.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Tibolone is contraindicated in breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    "Spotting" bleeding
    Abdominal pain
    Abnormal liver function
    Breast pain
    Cervical dysplasia
    Endometrial hyperplasia
    Erythema multiforme
    Erythema nodosum
    Fungal infection
    Gallbladder disease
    Gastric upset
    Genital pruritus
    Hair growth abnormal
    Increased risk of breast cancer
    Increased risk of oestrogen-dependent neoplasms
    Myocardial infarction
    Risk of endometrial carcinoma
    Seborrhoeic dermatitis
    Vaginal bleeding
    Vaginal discharge
    Vascular purpura
    Venous thrombosis
    Visual disturbances
    Weight changes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Livial 2.5mg tablets. Merck Sharp & Dohme Limited. Revised September 2020.

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