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EVOREL 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 peri- and post-menopausal 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 Section…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults Evorel is an oestrogen-only HRT patch applied to the skin twice weekly. 4) should be used. g. hyperplasia and cancer. The regimen may be either cyclic or continuous sequential. g. 5 mg/day) and should be added for at least 12-14 days every month/28 day cycle.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. Treatment of oestrogen deficiency symptoms Therapy should be started with one Evorel 50 patch (delivering 50 micrograms of estradiol/24 hours) and the dose adjusted after the first month if necessary depending on efficacy and signs of over-oestrogenisation (eg breast tenderness).
For maintenance therapy the lowest effective dose should be used; a maximum dose of 100 micrograms of estradiol/24 hours should not be exceeded. Prevention of post-menopausal osteoporosis Therapy should be started with Evorel 50. The dose may be adjusted depending on efficacy and signs of over-oestrogenisation (eg breast tenderness).
Note, however, that the efficacy of Evorel 25 for the prevention of post-menopausal osteoporosis has not been demonstrated. For maintenance therapy, the lowest effective dose should be used. A dose of 100micrograms of estradiol/24 hours should not be exceeded.
Guidance on how to start therapy:
Post-menopausal women currently not on HRT may start Evorel at any time. Peri-menopausal women who are still having regular menstrual cycles and are not currently on HRT should start Evorel within 5 days of the start of bleeding. Peri- menopausal women with irregular menstrual cycles, for whom pregnancy has been excluded, can start Evorel at any time.
Switching from other HRT The switch from another oestrogen-only therapy in post-menopausal women to Evorel may occur at any time. Women on a continuous combined regimen wishing to switch from another oestrogen to Evorel may do so at any time.
Women on a cyclic or continuous sequential regimen wishing to switch from a sequential combined HRT preparation to Evorel may do so at the end of a cycle of the current therapy or after a 7 day hormone free interval. Method of Administration Evorel should be applied to the skin as soon as it is removed from the wrapper.
Recommended application sites are on clean, dry, healthy, intact skin and each application should be made to a slightly different area of skin on the trunk below waistline. Evorel should not be applied on or near the breasts. Evorel should remain in place during bathing and showering.
The safety of Evorel was evaluated in 2584 subjects who participated in 15 clinical trials and received at least one administration of Evorel. Subjects were also asked about application site signs and symptoms in 8 of the 15 clinical trials (N = 1739 subjects).
6%). Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of Evorel from either clinical trial or post-marketing experiences.
The displayed frequency categories use the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data). Adverse Drug Reactions Infections and Infestations Uncommon Genital candidiasis Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare Breast cancer Frequency not known Endometrial cancer Immune System Disorders Uncommon Hypersensitivity Psychiatric disorders Common Depressed mood Nervous system disorders Common Migraine, Dizziness, Headache Rare Epilepsy Frequency not known Cerebrovascular accident Cardiac disorders Uncommon Palpitations Frequency not known Myocardial infarction Vascular disorders Rare Thrombosis Frequency not known Deep vein thrombosis Respiratory, Thoracic and Mediastinal Disorders Frequency not known Pulmonary embolism Gastrointestinal disorders Common Abdominal pain, Diarrhoea, Nausea Uncommon Flatulence Rare Abdominal distension Hepato-biliary disorders Rare Cholelithiasis Skin and subcutaneous tissue disorders Common Pruritus, Rash Frequency not known Angioedema Musculoskeletal and Connective Tissue Disorders Common Arthralgia Uncommon Myalgia Reproductive system and breast disorders Common Breast pain, Metrorrhagia Uncommon Breast enlargement, Dysmenorrhoea General disorders and administration site conditions Very Common Application site pruritus*, Application site rash* Common Pain, Application site erythema*, Application site oedema*, Application site reaction Uncommon Oedema, Generalised oedema, Oedema peripheral Investigations Common Weight increased * Additional adverse drug reactions reported in clinical trials of Evorel (estradiol only) The table below reports additional undesirable effects that have been reported in users of other hormone replacement therapy (HRT) by MedDRA system organ classes (MedDRA SOCs).
For the treatment of menopausal 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 re-instituting 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 - Hereditary angioedema - Mastopathy.
Conditions which require monitoring while on oestrogen therapy • Oestrogens may cause fluid retention. Cardiac or renal dysfunction should be carefully observed • Disturbances or mild impairment of liver function • History of cholestatic jaundice • Pre-existing hypertriglyceridaemia.
g. 4); - Active or recent past arterial thrombo-embolic disease (eg cerebrovascular accident, 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 substances 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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Should it fall off during bathing or showering the patient should wait until cutaneous vasodilation ceases before applying a replacement patch to avoid potential excessive absorption. Should a patch fall off at other times it should be replaced immediately.
Patients can be advised to use baby oil to help remove any gum/glue which may remain on their skin after patch removal. Missed dose If the patient forgets to change their patch, they should change it as soon as possible and apply the next one at the normal time.
However, if it is almost time for the next patch, the patient should skip the missed one and go back to their regular schedule. Only one patch should be applied at a time. There is an increased likelihood of break-through bleeding and spotting when a patch is not replaced at the normal time.
Children Evorel is not indicated in children. Elderly Data are insufficient in regard to the use of Evorel in the elderly (>65 years old). Route of administration Transdermal use.
Metabolism and nutrition disorders Common Weight decrease Psychiatric disorders Rare Anxiety, Libido decreased, Libido increased Eye disorders Uncommon Visual disturbances Rare Contact lens intolerance Gastrontestinal disorders Common Nausea Uncommon Dyspepsia Rare Vomiting Skin and subcutaneous tissue Uncommon Erythema nodosum, Rare Hirsutism, Acne Musculoskeletal and connective tissue disorders Rare Muscle cramps Reproductive system and breast disorders Uncommon Breast tenderness Rare Vaginal discharge, Premenstrual like syndrome General disorders and administration conditions Rare Fatigue Other adverse reactions have been reported in association with oestrogen/progestogen treatment: • Gall bladder disease.
• Skin and subcutaneous disorders: chloasma, erythema multiforme, • Vascular purpura. 4). 4 Special warnings and precautions for use 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). 0 * Taken from baseline incidence rates in England in 2015 in 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 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 […]
Rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition. 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 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. 8). After stopping treatment, the risk may remain elevated for at least 10 years.
• The addition of a progestogen cyclically for at least 12 days per months/28 day cycle or continuous combined oestrogen-progestagen therapy in non0hysterectomised women prevents the excess risk associated with oestrogen- only HRT.
625 mg and patches >50 ug/day the endometrial safety of added progestagens has not been demonstrated. • Beak-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.
Oestrogen-only therapy From 1 to 5 years in women with a uterus has been estimated to increase the risk of endometrial cancer 3-fold (from a baseline lifetime risk of about 3% for a woman aged 50 years), with effects persisting for several years after oestrogen is stopped.
The addition of a progestogen for 12 14 days per cycle or continuous combined oestrogen/progestogen therapy in non-hysterectomised women greatly reduces this risk. Although progestogen treatment for at least 10 days per cycle reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer, 12-14 days per cycle is recommended to maximise endometrial protection.
Such a sequential oestrogen/oestrogen-progestogen regimen results in cyclic bleeding in the majority of women. Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis.
Therefore, the addition of a progestogen to oestrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis if they are known to have residual endometriosis. For Evorel 75 and 100 the endometrial safety of added progestogens has not been studied.
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. Observational studies have mostly reported a small increase in risk of having breast cancer […]