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ESTRIOL is a brand name for Estriol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Treatment of vaginal oestrogen deficiency symptoms: • Treatment of symptoms of vaginal atrophy due to oestrogen deficiency in postmenopausal women. • As pre-surgery therapy for vaginal operations and during subsequent convalescence.
Verbatim from this product's MHRA label. Tap a section to expand.
Estriol 1mg/g cream is an estrogen-only product for intravaginal use. g. 1 application twice a week) is reached. • Pre-surgery therapy One applicator-dose per day should begin 2 weeks before the operation. • Post-surgery therapy Following surgery a period of at least 2 weeks should be allowed before resuming therapy using one applicator-dose twice a week.
A missed dose should be administered as soon as remembered, unless it is more than 12 hours overdue. In the latter case the missed dose should be skipped and the next dose should be administered at the normal time. Two doses should never be administered on the same day.
Route of Administration Estriol 1mg/g cream is administered intravaginally by means of a calibrated applicator. 5 mg estriol. The following ‘Instructions for Use’ should be given to the patient and are included in the Patient Information Leaflet: How to Apply the Cream Use the applicator to apply the cream in the vagina.
A good time to do this is before going to bed. The applicator has a ring marked on the body. Fill the applicator up to the ring mark with Estriol 1mg/g cream to get the correct dose. 1. Remove the cap from the tube and turn it upside down.
Then use the sharp point to open the tube. 2. Screw the end of the applicator onto the tube. 3. Squeeze the tube to fill the applicator with the cream up to the red ring mark (the plunger will stop at the ring mark). 4. Unscrew applicator from the tube and put the cap back on the tube.
5. To apply the cream, lie down, put the end of the applicator deep into the vagina and slowly push plunger all the way in. Cleaning the applicator After use, pull the plunger out of the barrel. Wash the plunger and barrel in hand hot, soapy water.
Do not use detergents. Rinse well with clean water afterwards. DO NOT PUT THE APPLICATOR IN BOILING WATER. 4) should be used. 4). In women not taking HRT or women who switch from another continuous combined HRT product, treatment with Estriol 1mg/g cream may be started on any day.
Women who switch from cyclic HRT regimen should start Estriol 1mg/g cream treatment one week after completion of the cycle. Children There are no clinical trials to support the use in children.
The following adverse reactions, associated with estrogen treatment may occur during estriol therapy or overdose: Nausea and vomiting, breast tenderness or pain in the breasts, vaginal bleeding or spotting during or on withdrawal of therapy, excessive production of cervical mucus, headache.
From Literature and safety surveillance monitoring, the following adverse reactions have been reported: Tabulated list of adverse reactions The following convention has been utilised for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
0 These adverse reactions are usually transient, but may also be indicative of too high a dosage. Class effects associated with systemic HRT The following risks have been associated with systemic HRT and apply to a lesser extent for Estriol vaginal cream and pessaries of which the systemic exposure to estriol remains closely to the normal postmenopausal range when used in a twice weekly administration.
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.
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 use of HRT. 4. 6) 3 (1-5) *no differentiation was made between ischaemic and haemorrhagic stroke.
g. endometrial cancer. 4 • Gall bladder disease. • Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
• 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 favorable 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. In case of vaginal infections, these should be treated before therapy with Estriol 1mg/g cream is started.
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 case 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 • In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when systemic 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.
Other brands of Estriol in United Kingdom.
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It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
• For Estriol vaginal cream and pessaries, the systemic exposure of estriol remains closely to the normal postmenopausal range when used in a twice weekly administration, it is not recommended to add a progestagen. • Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered estrogens is uncertain.
Therefore, if repeated, treatment should be reviewed at least annually. • Unopposed estrogen stimulation may lead to premalignant 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.
• If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. 5 mg estriol) nor should this maximum dose be used for longer than several weeks (maximum 4 weeks).
One epidemiological study has shown that long-term treatment with low doses of oral estriol, but not vaginal estriol, may increase the risk for endometrial cancer. This risk increased with the duration of treatment and disappeared within one year after the treatment was terminated.
The increased risk mainly concerned less invasive and highly differentiated tumors. The following risks have been associated with systemic HRT and apply to a lesser extent for Estriol vaginal cream and pessaries of which the systemic exposure to estriol remains within the normal postmenopausal range when used in a twice weekly administration.
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. HRT, especially estrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Clinical studies reported that the likelihood of developing increased mammographic density was lower in subjects treated with estriol than in subjects treated with other estrogens. It is unknown whether Estriol 1mg/g cream carries the same risk.
In a several population-based case-control studies, estriol was found not to be associated with an increased risk of breast cancer, in contrast to other estrogens. However, the clinical implications of these findings are as yet unknown.
Therefore, it is important that the risk of being diagnosed with breast cancer is discussed with the patient and weighed against the known benefits of HRT. 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 […]