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ESTRADIOL 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: Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1). The experience treating women older than 65 years is limited.
Verbatim from this product's MHRA label. Tap a section to expand.
Estradiol is administered intravaginally as a local oestrogen therapy by use of an applicator.
Initial dose:
One vaginal tablet daily for two weeks.
Maintenance dose:
One vaginal tablet twice a week. Treatment may be started on any convenient day. If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided. 4) should be used. 4, 'Special warnings and precautions for use', 'Endometrial hyperplasia and carcinoma').
Estradiol may be used in women with or without an intact uterus. Vaginal infections should be treated before start of the Estradiol therapy. Method of Administration: 1. Remove the applicator from its packaging 2. Gently pull the plunger out of the applicator until it comes to a stop 3.
Take a vaginal tablet from the separate blister and place it firmly in the holder of the applicator end (wide end). 4. Insert the applicator carefully into the vagina until resistance is met (8-10 cm). 5. Release the tablet by slowly pressing the push-button until the end of the plunger stops.
The tablet will stick to the wall of the vagina straight away. It will not fall out if you stand up or walk. 6. After each use and before it is used again, clean the applicator according to the following cleaning procedure: i. Withdraw the plunger from the applicator ii.
Clean both parts (tube and plunger) with mild soap and rinse with warm tap water for 5 seconds. Rinse tubes inner and outer surface. iii. If necessary, remove larger amounts of remaining water from both parts (tube and plunger) by short shaking-off the water.
iv. g. clean paper fleece). v. Introduce the plunger again in the applicator-tube for the subsequent use of the applicator. 7. Use the applicator until you have completed the treatment pack. Thereafter throw it away. If required, an additional applicator is included in the pack.
Adverse events from clinical trials:
More than 673 patients have been treated with Estradiol 10 micrograms in clinical trials, including over 497 patients treated up to 52 weeks. Oestrogen-related adverse events such as breast pain, peripheral oedema and postmenopausal bleedings have been reported with Estradiol 10 micrograms at very low rates, similar to placebo, but if they occur, they are most likely present only at the beginning of the treatment.
The adverse events observed with a higher frequency in patients treated with Estradiol 10 micrograms as compared to placebo and which are possibly related to treatment are presented below. System organ class Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Infections and infestation Vulvovaginal mycotic infection Nervous system disorders Headache Gastrointestinal disorders Abdominal pain Nausea Reproductive system and breast disorders Vaginal haemorrhage, vaginal discharge or vaginal discomfort Skin and subcutaneous tissue disorders Rash Investigations Weight increased Vascular disorders Hot flush Hypertension Post-marketing experience: In addition to the above-mentioned adverse drug reactions, those presented below have been spontaneously reported for patients being treated with Estradiol 10 micrograms and are considered possibly related to treatment.
The frequencies for the below mentioned adverse drug reactions cannot be interpreted because these reactions are reported voluntarily from a population of uncertain size. g. anaphylactic reaction/shock) • Metabolism and nutrition disorders: fluid retention • Psychiatric disorders: insomnia • Nervous system disorders: migraine aggravated • Vascular disorders: deep venous thrombosis • Gastrointestinal disorders: diarrhoea • Skin and subcutaneous tissue disorders: urticaria, rash , pruritus • Reproductive system and breast disorders: endometrial hyperplasia, vulvovaginal pain1, pruritus genital • General disorders and administration site conditions: application site reaction2, drug ineffective, injury associated with device3 1Including Vulvovaginal burning sensation 2Local allergic reactions including Vulvovaginal erythema, Genital erythema, Vulvovaginal rash, Genital rash 3Minor local trauma caused by intravaginal applicator Other adverse reactions have been reported in association with systemic oestrogen/progestagen treatment.
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.
Medical examination/follow-up Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained. 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. 2), however, being an HRT product the following need to be considered, especially for long-term or repeated use of this product.
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.
2). Due to this, the recurrence or aggravation of the above mentioned conditions is less likely than with systemic oestrogen treatment. Reasons for immediate withdrawal of therapy Therapy should be discontinued in case 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 Women with an intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with Estradiol.
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.
Other brands of Estradiol in United Kingdom.
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4). Class effects associated with systemic HRT The following risks have been associated with systemic HRT and apply to a lesser extent for oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range.
4). 56). For women aged 50 to 54 years who have been taking HRT for 5 years, this results in about 1 extra case per 2,000 users. In women aged 50 to 54 who do not take HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
e. deep vein thrombosis or pulmonary embolism. 4). 5-fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during the use of HRT. 4). 6) 3 (1 – 5) * No differentiation was made between ischaemic and haemorrhagic stroke Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when systemic oestrogens are administered alone for prolonged periods. For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, such as Estradiol, it is not recommended to add a progestagen.
During Estradiol treatment, a minor degree of systemic absorption may occur in some patients, especially during the first two weeks of once-daily administration. 2). Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered oestrogen is uncertain.
Therefore, if repeated, treatment should be reviewed at least annually, with special consideration given to any symptoms of endometrial hyperplasia or carcinoma. As a general rule, oestrogen replacement therapy should not be prescribed for longer than one year without another physical, including gynaecological, examination being performed.
If bleeding or spotting appears at any time during therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with Estradiol.
Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore, caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.
The following risks have been associated with systemic HRT and apply to a lesser extent for oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range. However, they should be considered in case of long term or repeated use of this product.
Breast cancer Epidemiological evidence from a large meta-analysis suggests no increase in risk of breast cancer in women with no history of breast cancer taking low dose vaginally applied oestrogens. It is unknown if low dose vaginal oestrogens stimulate recurrence 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 systemic HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
e. deep vein thrombosis or pulmonary embolism. 8). Patients with known thrombophilic states have an increased risk of VTE and HRT may add […]