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| Drug class description : | Oestrogens / progestogens. |
| Generic Name : | Estradiol [oestradiol], dydrogesterone |
| Drug description : | Femapak 40: estradiol - transdermal patch; dydrogesterone - white tablet marked 155 and S. Femapak 80: estradiol - transdermal patch; dydrogesterone - white tablet marked 155 and S. |
| Presentation : | Femapak 40: Patch, estradiol 40 microgram per 24 hours; tablets, dydrogesterone 10 mg . Femapak 80: Patch, estradiol 80 microgram per 24 hours; tablets, dydrogesterone 10 mg . |
| Indications : | Femapak 40: HRT for menopausal oestrogen deficiency in non- hysterectomised patients. Femapak 80: HRT for menopausal oestrogen deficiency in non- hysterectomised patients. Prevention of osteoporosis. |
| Adult Dosage : | Start treatment within 5 days of onset of menses or arbitrarily if absent. Initiate therapy with Femapak 40 in women who have menopausal symptoms, or who have been oestrogen-deficient for a long time, or who are likely to be intolerant of higher doses of oestrogen. Increase to Femapak 80 if necessary, reduce to lowest effective dose for maintenance. Prevention of osteoporosis, use Femapak 80. Apply patch to clean, non-hairy area of skin below the waist and replace with a new patch every 3 - 4 days using a different site. 1 tablet daily for last 14 days of each cycle. |
| Child Dosage : | Not applicable. |
| Contra Indications : | Cancer of breast, genital tract or other oestrogen-dependent carcinoma, undiagnosed vaginal bleeding or endometriosis. Active deep vein thrombosis, thromboembolic disorders or a thromboembolism. Severe cardiac, renal disease, acute or chronic liver disease. Dubin-Johnson or Rotor syndromes. Pregnancy, lactation. |
| Special Precautions : | The patient should undergo thorough examination before commencing therapy and at regular intervals thereafter. Unopposed estradiol therapy should not be used in non-hysterectomised women because of the increased risk of endometrial hyperplasia or carcinoma. An increased risk of being diagnosed with breast cancer has been reported with HRT. Monitor patients with otosclerosis, multiple sclerosis, hypertension, epilepsy, systemic lupus erythematosus, cholelithiasis, porphyria, melanoma, migraine, thyrotoxicosis, surgically confirmed gall bladder disease, asthma, diabetes, a history of uterine fibroids or endometriosis. HRT is associated with an increased risk of venous thromboembolism (VTE). Oestrogens may cause fluid retention: monitor patients with cardiac or renal dysfunction. Women of childbearing potential should be advised to use non-hormonal contraceptive methods. |
| Interactions : | Liver enzyme inducing drugs. |
| Adverse Reactions : | Breast tenderness, abdominal cramps and bloating, oedema, nausea, weight changes, dysmenorrhoea, leg cramps, visual disturbances, breakthrough bleeding, headache, dizziness, migraine, transient erythema, generalised pruritus. REASONS FOR IMMEDIATE DISCONTINUATION OF TREATMENT: Occurence of migraine-type headaches for the first time, frequent severe headaches, acute visual disturbances, signs of thrombophlebitis or thromboembolism, or any other possible prodromal symptoms of vascular occlusion. Rise in blood pressure. Jaundice. Pregnancy. Discontinue four weeks before major elective surgery and during thrombosis. |
| Manufacturer : | Solvay |
| Drug Availability : | (POM) |
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