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ESTRADERM MX 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Estraderm MX 75 is an oestrogen only patch. g. medroxyprogesterone acetate 10mg, norethisterone 5mg, norethisterone acetate 1-5mg or dydrogesterone 20mg per day) to be taken at least on the last 12 days of each 4-week treatment cycle.
Withdrawal bleeding usually occurs following 12 days or more of progesterone administration. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. 4). Depending on the clinical response the dose can then be adjusted to the patient’s individual needs.
If, after three months, there is insufficient response in the form of alleviated symptoms, the dose can be increased. A maximum dose of 100 micrograms per day should not be exceeded. g. breast discomfort, water retention or bloating are often observed at the start of treatment, especially in patients receiving hormone replacement therapy for the first time.
However, if symptoms persist for more than six weeks the dose should be reduced.
Postmenopausal osteoporosis:
Estraderm MX 75 is recommended as an effective bone-sparing dose.
General instructions:
Estraderm MX is administered as a continuous sequential treatment (uninterrupted application twice weekly). For most postmenopausal women not taking HRT Estraderm MX therapy may be started at any convenient time. However, for women with an intact uterus who are still menstruating regularly, commencement within 5 days of the onset of bleeding is recommended.
In women with an intact uterus transferring from a continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. In women transferring from a continuous-combined HRT regimen, or hysterectomised women transferring from other oestrogen-only HRT treatment, treatment may be started on any convenient day.
), to an area of clean, dry, and intact skin on the trunk below the waistline. g. buttock. Estraderm MX should never be applied to, or near the breasts. Estraderm MX should be applied twice weekly on a continuous basis, each used patch being removed after 3-4 days and a fresh system applied to a slightly different site.
Adverse drug reactions from multiple sources including clinical trials and post- marketing experience (Table 1) are listed according to the system organ class in MedDRA. Within each system organ class, the adverse drug reactions are ranked by frequency, the most frequent first.
Within each frequency grouping, adverse drug reactions are presented in the order of decreasing seriousness. In addition the corresponding frequency using the following convention (CIOMS III) is also provided for each adverse drug reaction: 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), and not known (cannot be estimated from the available data).
Table 1 Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Breast cancer.
Immune system disorders Very rare:
Anaphylactoid reaction.
Not known*:
Hypersensitivity (incl. anaphylactic reaction and angioedema).
Psychiatric disorders Not known*:
Depression, nervousness, affect lability, libido disorder.
Nervous system disorders Common:
Headache.
Rare:
Dizziness.
Not known*:
Migraine.
Vascular disorders Very rare:
Embolism, hypertension, varicose veins (including exacerbation).
Gastrointestinal disorders Common:
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 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 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.
Other brands of Estradiol in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. The subsequent patch should be applied according to the original treatment schedule. The interruption of treatment might increase the likelihood of recurrence of symptoms and include breakthrough spotting and bleeding.
In the event that a patch should fall off a new patch may be applied. The original treatment schedule should be continued. The patch should not be exposed to sunlight. Special populations Patients with renal and /or hepatic impairment.
No studies were performed in patients with renal and hepatic impairment. 3 contra-indications). Children Estraderm MX is not indicated for use in children.
Nausea, abdominal pain, abdominal distension.
Not known*:
Vomiting, diarrhoea.
Hepatobiliary disorders Very rare:
Liver function tests abnormal, jaundice cholestatic.
Not known*:
Cholelithiasis, gallbladder disorder.
Skin and subcutaneous tissue disorders Very rare:
Contact dermatitis, pigmentation disorders, generalised pruritus, generalised exanthema.
Not known*:
Alopecia, chloasma, urticaria.
Musculoskeletal and connective tissue disorders Rare:
Pain in extremity (leg pain).
Not known*:
Back pain.
Reproductive system and breast disorders Very common:
Breast discomfort, breakthrough bleeding.
Not known*:
Endometrial hyperplasia, uterine leiomyoma, breast pain, breast tenderness, dysmenorrhoea, fibrocystic breast disease, breast enlargement, breast discharge.
General disorders and administration site conditions Very common:
Application site reactions**.
Rare:
Oedema, weight increased or decreased. (*) Reported in post-marketing experience. (**)Application site reactions includes localised bleeding, bruising, burning, discomfort, dryness, eczema, oedema, erythema, inflammation, irritation, pain, papules, paraesthesia, pruritus, rash, skin discolouration, skin pigmentation, swelling, urticaria, and vesicles.
Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years. • The increased risk in users of oestrogen-only therapy is lower than that seen in users of oestrogen-progestagen 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 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) ‡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 progestagen to oestrogen-only therapy for at least 12 days per cycle can prevent this increased risk. 2)). 4). A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women […]
8). After stopping treatment risk may remain elevated for at least 10 years. The addition of a progestagen cyclically for at least 12 days per month/28 day cycle or continuous combined oestrogen-progestagen therapy in non-hysterectomised women prevents the excess risk associated with oestrogen-only HRT.
Withdrawal bleeding usually occurs following the 12 days or more of progestagen administration. 625 mg and patches >50 ug/day the endometrial safety of added progestagens has not been demonstrated. For Estraderm MX 75 the endometrial safety of added progestogens has not been studied.
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 progestagens 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 - progestagen 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-progestagen 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-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
8). 3-3 fold risk of […]