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ELLESTE SOLO 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 post- and peri-menopausal women (see also Section 4.4). 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 daily to be taken orally. Elleste Solo 2 mg may be taken continuously in hysterectomised women. In women with a uterus, a progestogen should be added for 12 - 14 days each cycle to oppose the production of an oestrogen-stimulated hyperplasia of the endometrium.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. Therapy may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses.
In patients who are menstruating, it is advised that therapy starts on the first day of bleeding. Patients changing from a cyclical or continuous sequential preparation should complete the cycle and may then change to Elleste Solo 2 mg without a break in therapy.
Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding.
Elleste Solo Tablets are available in two strengths:
Elleste Solo 1 mg (containing 1 mg estradiol) and Elleste Solo 2 mg (containing 2 mg estradiol). 4) should be used. Elleste Solo 1 mg is not indicated for prophylaxis of osteoporosis.
Missed or Extra Tablet:
If a tablet is missed it should be taken within 12 hours of when normally taken; otherwise the tablet should be discarded, and the usual tablet should be taken the following day. A missed dose may lead to break-through bleeding or spotting in non-hysterectomised women.
If one extra tablet is taken inadvertently, the usual tablet should be taken the following day. Elderly There are no special dosage requirements for elderly patients. Paediatric population Not to be used in children. Method of administration For oral use.
Undesirable effects observed with oestrogens are detailed in the following table. The effects are grouped according to system organ class. 4), chorea, exacerbation of epilepsy Eye disorders Visual disturbances Contact lens intolerance Cardiac disorders Palpitations Skin and subcutaneous tissue disorders Rash, pruritus Erythema nodosum, urticaria hirsutism, acne Angioedema, Erythema multiforme, Vascular purpura, Chloasma Musculoskeletal and connective tissue disorders Muscle cramps General disorders and Oedema administration site conditions Neoplasms benign, malignant and unspecified (incl.
g. e. angina and myocardial infarctione. 4. e. deep leg or pelvic venous thrombosis and pulmonary embolism. 4. Renal and urinary disorders Urinary incontinence *Undesirable effects from spontaneous post-marketing reporting sources, which have not been observed in clinical trials.
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 of prospective epidemiological studies are presented. 0 * 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.
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.
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).
Investigations, including 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 if a contraindication 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. 1; Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5) +4(0-9) ‡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. * WHI study in women with no uterus, which did not show an increase in risk of breast cancer 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. 2)). 4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be […]
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 and patches >50 μg/day the endometrial safety of added progestogens has not been demonstrated. Break-through bleeding and spotting may occur during the first 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 is 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 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 thrombophilic states have an increased risk of VTE and […]