Europe — EMA
Menec (Tibolone)
GNH USA supplies Menec (Tibolone), a synthetic steroid for treatment of menopausal symptoms and prevention of post‑menopausal osteoporosis.
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What is Tibolone?
Tibolone, the active ingredient in Menec, is a synthetic steroid (progestogen/estrogen/androgen) presented as an oral tablet for oral use. It is used to alleviate menopausal symptoms and to help prevent bone loss in post‑menopausal women. GNH USA supplies Menec as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Tibolone used for?
Menec (tibolone) is indicated for conditions within the hormone replacement therapy pathway, addressing menopausal and bone health concerns.
Menopausal symptoms: reduces frequency and severity of hot flashes and night sweats. Post‑menopausal osteoporosis: helps maintain bone mineral density and reduces fracture risk. Vasomotor disturbances: improves overall quality of life related to hormonal changes.
What are the side effects of Tibolone?
Tibolone may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Nausea or abdominal discomfort. - Headache or dizziness. - Breast tenderness or enlargement. - Vaginal bleeding or spotting. - Weight gain or fluid retention. - Mood changes such as irritability.
Serious or Rare Side Effects: - Deep vein thrombosis or pulmonary embolism. - Stroke or transient ischemic attack. - Liver dysfunction or jaundice. - Unexplained vaginal bleeding. - Breast cancer development. - Severe allergic reactions (rash, swelling, difficulty breathing).
What precautions apply to Tibolone?
Before initiating Menec, consider the following safety measures.
Contraindicated in pregnancy: avoid use in pregnant women. Breast cancer history: assess risk before prescribing. Liver disease: monitor hepatic function regularly. Cardiovascular risk: evaluate for thromboembolic disorders. Bone health monitoring: periodic bone density assessments recommended. Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture and light.
What does Tibolone interact with?
Tibolone can interact with several medications, requiring careful management.
Major Interactions (Avoid): - Anticoagulants (e.g., warfarin): increased bleeding risk. - CYP3A4 inhibitors (e.g., ketoconazole): may raise tibolone levels. - Hormonal contraceptives: potential additive estrogenic effects.
Moderate Interactions (Monitor Closely): - Antihypertensives: possible alteration of blood pressure control. - Antidiabetic agents: monitor glucose levels. - Thyroid hormones: may affect thyroid function tests.



