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Goldar

Active Ingredient:
Tibolone
Origin:
EU

Goldar (Tibolone)

Goldar is a prescription oral medication containing the synthetic steroid tibolone; each tablet delivers a standard therapeutic dose (strength not specified) of the active ingredient. It belongs to the hormone replacement therapy class and is marketed in the European Union. Tibolone acts on estrogen, progesterone, and androgen receptors to address hormonal changes associated with menopause. It is prescribed for women experiencing menopausal symptoms and for the management of estrogen deficiency.

Manufacturer / TM Owner

Pentafarma - Sociedade Tecnico-Medicinal S.A.

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Indications & Clinical Uses

Goldar is prescribed for the relief of menopausal symptoms and for the treatment of estrogen deficiency in post‑menopausal women, helping to restore hormonal balance.

  • Reduction of hot flashes and night sweats, providing more comfortable temperature regulation.
  • Alleviation of vaginal dryness, itching, and discomfort, supporting sexual health.
  • Improvement of mood swings, irritability, and sleep disturbances commonly experienced during menopause.
  • Support for bone mineral density to help prevent osteoporosis associated with low estrogen levels.
  • Mitigation of general fatigue and decreased energy levels that often accompany hormonal transition.

Side Effects

Goldar, like other tibolone preparations, may cause a range of side effects that vary in frequency and severity.

Common

  • Mild nausea, abdominal discomfort, or indigestion.
  • Transient headache or dizziness.
  • Breast tenderness or mild swelling.
  • Weight gain, fluid retention, or mild edema.
  • Mood changes such as irritability or mild depression.

Serious

  • Development of blood clots such as deep‑vein thrombosis or pulmonary embolism.
  • Significant liver enzyme elevation indicating hepatic dysfunction.
  • Potential increase in hormone‑dependent tumor growth, including breast or endometrial cancer.
  • Severe allergic reaction with rash, itching, or swelling of the face.

Precautions & Warnings

When prescribing Goldar, clinicians consider several precautions to ensure safe use in women undergoing hormone replacement therapy.

  • History of thromboembolic disorders such as deep‑vein thrombosis or stroke.
  • Active or past breast, uterine, or ovarian cancer.
  • Uncontrolled hypertension or cardiovascular disease.
  • Severe liver disease or abnormal liver function tests.
  • Pregnancy, lactation, or plans to become pregnant.
  • Smoking, especially in women over 35 years of age.
  • Known hypersensitivity to tibolone or any component of the formulation.

Avoid Interactions

Goldar may interact with other medicines, affecting its efficacy or safety profile; certain combinations should be avoided while others require careful monitoring.

Avoid

  • Concurrent use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine) that may reduce tibolone levels.
  • Combination with anticoagulants (e.g., warfarin) that could increase clotting risk.

Use with caution

  • Co‑administration with other hormonal agents such as estrogen or progestin may amplify hormonal effects.
  • Use together with lipid‑lowering drugs (e.g., statins) as tibolone can affect lipid metabolism.
  • Concurrent use with antidepressants, particularly SSRIs, may alter the management of mood‑related side effects.

Frequently Asked Questions

Goldar contains tibolone, a synthetic steroid that is metabolized into compounds that bind estrogen, progesterone, and androgen receptors, providing combined hormonal activity to alleviate menopausal symptoms.

Goldar is prescribed for post‑menopausal women who need relief from menopausal symptoms such as hot flashes, night sweats, vaginal dryness, and mood changes, as well as for treatment of estrogen deficiency.

Goldar may help maintain bone mineral density, which can contribute to osteoporosis prevention in post‑menopausal women, but it is not a first‑line therapy solely for bone health.

Common side effects include mild nausea, abdominal discomfort, headache, breast tenderness, weight gain or fluid retention, and occasional mood changes such as irritability.

Serious reactions include signs of blood clots (e.g., leg pain, swelling, shortness of breath), liver dysfunction (jaundice, dark urine), severe allergic reactions, and any indication of hormone‑dependent tumor growth.

Smoking, especially in women over 35, increases the risk of cardiovascular events and thromboembolism; clinicians usually advise against using Goldar in smokers or recommend smoking cessation.

Goldar is contraindicated during pregnancy and lactation because tibolone can affect hormone balance; women should discontinue the medication if they become pregnant or plan to breastfeed.

Goldar may increase the risk of clot formation; when taken with anticoagulants such as warfarin, careful monitoring of clotting parameters is recommended.

Co‑administration with other estrogen or progestin products can amplify hormonal effects and should be evaluated by a healthcare professional before combining.

Patients with existing liver disease or abnormal liver function tests should be monitored closely, as tibolone can affect hepatic metabolism and may worsen liver impairment.

Tibolone can influence lipid metabolism; periodic lipid profile testing is advisable, especially when patients are also using statins or other lipid‑lowering agents.

There are no specific dietary restrictions, but patients should maintain a balanced diet and avoid excessive alcohol, which can increase liver strain.

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