Estradiol + Dydrogesterone

Estradiol + Dydrogesterone (Femoston) is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. HRT is used in women who require oestrogen replacement and who have not had their womb removed (hysterectomy).

Femoston is used in postmenopausal women at least 6 months since last menses. It alleviates symptoms such as hot flushes and prevents osteoporosis after menopause.

• Relief of menopause symptoms: Used for hot flushes, night sweats and mood changes in postmenopausal women.
• Prevention of osteoporosis: Used for reducing bone loss and fracture risk in postmenopausal women.

Female Sex hormones

Estrogen + Progestogen

Femoston 1/10 and Femoston 2/10 are continuous sequential hormone replacement therapies. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used. In general, treatment should start with Femoston 1/10. Depending on the clinical response, the dosage can afterwards be adjusted to individual need.

Estradiol is an estrogen that helps relieve menopause symptoms. Dydrogesterone is a progestogen that helps prevent endometrial hyperplasia.

Adult Dose:

• Femoston 1/10: 28-day cycle: first 14 days 1 estradiol tablet (1 mg) daily, next 14 days 1 estradiol + dydrogesterone tablet (1 mg + 10 mg) daily.
• Femoston 2/10: 28-day cycle: first 14 days 1 estradiol tablet (2 mg) daily, next 14 days 1 estradiol + dydrogesterone tablet (2 mg + 10 mg) daily.
• Treatment: After 28 days, start new cycle on day 29; continuous without break between packs.

Take 1 tablet daily in a 28-day cycle. First 14 days take estrogen-only tablets (arrow 1 marked part), next 14 days take estrogen + progestogen tablets (arrow 2 marked part). After 28 days, start the next pack. May be taken with or without food.

If you miss a dose, take it as soon as possible. If more than 12 hours have elapsed, skip the missed dose and take the next dose. Breakthrough bleeding or spotting may be increased.

Common Side Effects:

• Headache
• Nausea
• Abdominal pain
• Breast pain and tenderness
• Vaginal bleeding or spotting
• Bloating
• Mood changes
• Leg cramps

Precautions:

• HRT should only be initiated for symptoms that adversely affect quality of life.
• Annual risk-benefit assessment should be undertaken and HRT continued only if benefit outweighs risk.
• Complete personal and family medical history should be taken before initiation.
• Physical (including pelvic and breast) examination should be done.
• Periodic check-ups recommended during treatment.
• Any changes in breasts should be reported to doctor.

Contraindications:

• Known, past or suspected breast cancer
• Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer)
• Known or suspected progestogen-dependent neoplasms (e.g. meningioma)
• Undiagnosed genital bleeding
• Untreated endometrial hyperplasia
• Previous idiopathic or current venous thromboembolism
• Active or recent arterial thromboembolic disease
• Acute liver disease or history of liver disease until LFTs normal
• Porphyria
• Hypersensitivity

Drug Interactions:

• Anticonvulsants (phenobarbital, phenytoin, carbamazepine): May increase metabolism of estrogens and progestogens.
• Rifampicin, rifabutin, nevirapine, efavirenz: May increase metabolism of estrogens and progestogens.
• St. John's Wort (Hypericum perforatum): May increase metabolism of estrogens and progestogens via CYP450 3A4 pathway.

Food Interactions: May be taken with or without food. Caution with alcohol.

Use in Pregnancy: Not indicated during pregnancy. If pregnancy occurs, treatment should be withdrawn.

Use in Lactation: Not indicated during breastfeeding.

Pediatric Use: Not indicated for use in children and adolescents.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: Use with caution in patients with kidney disease.

Hepatic Impairment: Use with caution in patients with liver disease; contraindicated in severe liver disease.

Overdose: Overdose may cause nausea, vomiting and withdrawal bleeding. Symptomatic treatment.

Storage: Store below 30 degree C in a cool and dry place, away from light. Keep out of reach of children.

Estradiol + Dydrogesterone