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ESTRADIOL BESINS PUMP-PACK 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. • 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 osteoporosis. (see also Section…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Estradiol Besins should be administered daily on a continuous basis.
Dosing in women without a uterus:
Estradiol Besins is an estrogen-only product particularly indicated for women without a uterus. Estradiol Besins should be administered daily on a continuous basis. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
Dosing in women with an intact uterus:
In women with a uterus, consideration should be given to the addition of a progestogen including progesterone for at least 12 to 14 days every month / 28-day cycle to reduce the risk of endometrial hyperplasia and carcinoma. Estradiol Besins should be administered daily on a continuous sequential basis.
25 g of Estradiol Besins. 5 mg estradiol) is the usual starting dose, which in the majority of women will provide effective relief of symptoms. 0 mg estradiol). 4) should be used.
Initiation of treatment:
Women who have never taken HRT and are post-menopausal or have very infrequent menstrual cycles: • Treatment with Estradiol Besins can be started on any day. Switching from a continuous oestrogen-progestogen combined HRT: • Treatment with Estradiol Besins can be started on any day of the cycle.
Switching from a cyclic or continuous sequential HRT treatment: • Finish the therapeutic sequence before beginning treatment with Estradiol Besins. 5 mg estradiol) once daily. The lowest effective dose for the prevention of osteoporosis is not known.
Method of Administration For local cutaneous use:
Before using a new pump pack, it will require priming; the first dose of gel dispensed should be discarded. The gel should be applied by the patient herself, not by anyone else, and skin contact, particularly with a male partner, should be avoided for one hour after application.
Wash hands with soap and water after applying the gel. Washing the skin or contact with other skin products should be avoided until at least one hour after application of Estradiol Besins. Secondary exposure to estradiol can potentially occur as a result of passive transfer following skin-to-skin contact.
Undesirable effects are generally mild and rarely require treatment withdrawal. Undesirable effects, if any, usually occur during the first months of treatment. Adverse effects have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100; ≤ 1/10); uncommon (≥ 1/1,000; ≤ 1/100); rare (≥ 1/10,000; ≤ 1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).
Table 1:
Adverse Reaction Tabulation based on the Frequency Report for Estradiol total spontaneous cumulative MeDRA Term Frequency calculations based on the Frequency Report for Estradiol total spontaneous cumulative ADRs: 20,193 ADR Frequency report - 01/01/1900 - 07/31/2023 Adverse reactions – preferred termsOrgan System Class Very Common (≥10) (No adverse Common (≥1/100, <1/10) Uncommo n (≥1/1000, <1/100) Rare (≥1/10000 to ≤1/1000) Very rare (<1/10,000 ) Frequency not known (No adverse reactions reactions noted for this frequency) noted for this frequency) Metabolism and nutrition disorders Glucose intolerance Psychiatric disorders Depression , Mood swings Change in libido Nervous system disorders Headache Vertigo, migraine Aggravation of epilepsy Gastrointestina l disorders Nausea, abdominal pain Flatulence, vomiting Eye disorders Contact lens intolerance Vascular disorders Venous thromboem bolic disease Arterial hypertension Hepatobiliary disorders Liver function test abnormalities, cholestasis and jaundice Skin and subcutaneous tissue disorders Pruritus Skin discolouration , acne Musculoskelet al and connective tissue disorders Bone pain Reproductive system and breast disorders Breast swelling/pain, breast enlargement, increased volume of uterine fibroids, dysmenorrhoe a, menorrhagia, metrorrhagia, leucorrhoea discharge, endometrial hyperplasia leiomyoma , vaginitis/v aginal candidiasis General disorders and administration site conditions Weight change (increase or decrease), water retention with peripheral oedema Asthenia Anaphylactic reaction (in women a history of allergic reaction) 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.
This medicine is for external use only and should not therefore be swallowed. Care should be taken to ensure cleanliness of the skin and hands during application. Do not apply to damaged skin. 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 and 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 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. 3) and in the following situations: • Jaundice or deterioration in liver function • Significant increase in blood pressure • New onset of migraine-type headache • Pregnancy Warnings: 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.
3. g. 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; • Porphyria
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). g. on the arms and shoulders, or inner thighs. A thin layer of the gel should be applied to the entire arm on the inside and outside from wrist to shoulder or inner thigh. The area of application should be as large as possible Estradiol Besins should NOT be applied on or near the breasts or on the vulval region.
A frequent change in application sites is recommended.
Application Areas:
Arms from wrist to shoulder Inner thighs Estradiol Besins must be allowed to dry for 5 minutes before covering the skin with clothing. If the patient forgets to apply a dose and it is more than 12 hours until the next dose, the missed dose should be applied and normal dosing resumed the next day.
If the next dose is less than 12 hours away, it is best just to wait and apply the next dose normally. Forgetting a dose may increase the likelihood of break-through bleeding and spotting. Patients should be advised not to apply two doses at the same time.
Elderly People As for adults. The experience treating women older than 65 years is limited. Paediatric population There is no relevant use of Estradiol Besins in children aged less than 12 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. 5) +4 (0 – 9) *: WHI 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. 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 diagnosed with ovarian cancer over a 5-year period.
3-3-fold […]
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.
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 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 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. The occurrence of such an event is more likely in the first year […]