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ZUMENON is a brand name for Estradiol (also known as Oestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 months since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology One tablet to be taken orally Zumenon is an oestrogen only continuous HRT for women with or without a uterus. In women with a uterus, a progestogen should be added to Zumenon for 12-14 days each month to reduce the risk to the endometrium.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. 4) should be used. In general, treatment should start with Zumenon 1mg. Depending on the clinical response, the dosage can afterwards be adjusted to individual need.
If the complaints linked to oestrogen deficiency are not ameliorated the dosage can be increased by using Zumenon 2mg. Starting Zumenon In women who are not taking hormone replacement therapy and who are amenorrhoeic, are hysterectomised, or women who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day.
In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. If the patient has regular menstruation periods, treatment is started on day one of bleeding Administration The dosage is one tablet per day.
Zumenon should be taken continuously without a break between packs. Zumenon can be taken with or without food. If a dose has been forgotten, it should be taken as soon as possible. When more than 12 hours have elapsed, it is recommended to continue with the next dose without taking the forgotten tablet.
In the case of a missed or delayed dose the likelihood of breakthrough bleeding or spotting may be increased.
Paediatric population:
There is no relevant indication for the use of Zumenon in the paediatric population.
4 ‘Special warnings and precautions for use’. The table below reports undesirable effects, that have been reported in users of hormone replacement therapy (HRT) by MedDRA system organ classes (MedDRA SOCs). MedDRA system organ class Common >1/100, <1/10 Uncommon >1/1,000, <1/100 Rare >1/10,000, <1/1,000 Very rare <1/10,000 incl.
isolated reports Infections and manifestations Vaginal candidiasis Immune system disorders Hypersensitivity Metabolism and nutrition disorders Weight increased, Weight decreased Blood and the lymphatic system disorders Haemolytic anaemia Psychiatric disorders Nervousness, Depressed mood Anxiety, libido decreased, libido increased Nervous system disorders Headache, Dizziness Migraine Eye disorders Visual disturbances Intolerance to contact lenses Cardiac disorders Palpitations Vascular disorders Hypertension, Peripheral vascular disease, Varicose vein, Venous thromboembolism Gastrointestinal disorders Nausea, Abdominal pain Dyspepsia Bloating, Vomiting Hepatobiliary disorders Gall bladder disorder Skin and subcutaneous tissue disorders Rash, Pruritus Urticaria Erythema nodosum, Hirsutism, Acne Musculoskeletal Leg cramps Back pain Muscle cramps and connective tissue disorders Reproductive system and breast disorders Metrorrhagia, Uterine/vaginal bleeding including spotting, Pelvic pain Change in cervical secretion, Menorrhagia, Breast pain/tenderness, Breast enlargement, Premenstrual-like symptoms, Vaginal discharge, Dysmenorrhoea, General disorders and administration site reactions Asthenia Peripheral oedema, Oedema Fatigue Other adverse reactions have been reported in association with estradiol treatment (frequency unknown): Neoplasms benign, malignant and unspecified (incl.
g. e. anginae and myocardial infarctione. 4. e. deep leg or pelvic venous thrombosis and pulmonary embolism. 4. Gastrointestinal disorders Pancreatitis (in women with pre-existing hypertriglyceridaemia) Gastroesophageal reflux disease Hepatobiliary disorders Hepatic function abnormal, sometimes with jaundice Skin and subcutaneous tissue disorders Angioedema, chloasma, erythema multiforme, vascular purpura.
For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.
Medical examination/follow up Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
During treatment, periodic check- ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (See “breast cancer” below).
g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
g. g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or (severe) headache - Systemic lupus erythematosus - A history of endometrial hyperplasia (see below) - Epilepsy - Asthma - Otosclerosis Reasons for immediate withdrawal of therapy: Therapy should be discontinued in cases where a contra-indication is discovered and in the following situations: - Jaundice or deterioration in liver function - Significant increase in blood pressure - New onset of migraine-type headache - Pregnancy Endometrial hyperplasia and carcinoma In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.
g. g. g. angina, myocardial infarction); Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal; Known hypersensitivity to the active substance or to any of the excipients; Porphyria
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Renal and urinary disorders Urinary incontinence Reproductive system and breast disorders Fibrocystic breast disease a. Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years.
• The increased risk in users of oestrogen-only therapy is lower than that seen in users of oestrogen-progestogen combinations. 4). • Absolute risk estimations based on results of the largest randomised placebo-controlled trial (WHI-study) and the largest meta-analysis or prospective epidemiological studies are presented.
0 *1Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
8 *Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
5) +4 (0 – 9) *2WHI study in women with no uterus, which did not show an increase in risk of breast cancer ‡When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than in non-users.
b. Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT. 4). Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and 65.
Adding a progestogen to oestrogen-only therapy for at least 12 days per cycle can prevent this increased risk. In the Million Women Study the use of five years of combined (sequential or continuous) HRT did not […]
8). After stopping treatment risk may remain elevated for at least 10 years. The addition of a progestogen cyclically for at least 12 days per month/28 day cycle or continuous combined oestrogen-progestogen therapy in non-hysterectomised women prevents the excess risk associated with oestrogen-only HRT.
For oral doses of estradiol >2 mg the endometrial safety of added progestogens has not been demonstrated. Break-through bleeding and spotting may occur during the first few months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore, the addition of progestogens to oestrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis, if they are known to have residual endometriosis.
Breast cancer The overall evidence shows an increased risk of breast cancer in women taking combined oestrogen-progestogen or oestrogen-only HRT, that is dependent on the duration of taking HRT. 8). Oestrogen-only therapy • The WHI trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only HRT.
8). Results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of the prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
HRT, especially oestrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer. Ovarian cancer Ovarian cancer is much rarer than breast cancer.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
8). e. deep vein thrombosis or pulmonary embolism. 8). • Patients with known […]