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ELLESTE SOLO 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 estrogen deficiency symptoms in peri- menopausal 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Elleste Solo MX 40 Transdermal Patch is an oestrogen-only patch applied to the skin twice weekly in order to ensure a continuous supply of estradiol to the body; thus, each used system is removed every 3-4 days and replaced by a new one.
4) should be used. Therapy should be initiated with Elleste Solo MX 40 in women who have menopausal symptoms. The dosage may be increased if required by using Elleste Solo MX 80. The treatment is generally initiated with Elleste Solo MX 40, but the selection of the initial dose can be based on the severity of the patient’s symptoms.
g. breast tenderness and/or vaginal bleeding, the dose is probably excessive and should be reduced. If the dose selected does not alleviate the symptoms of oestrogen deficiency, it should be increased. In women with a uterus, a progestogen approved for addition to oestrogen treatment must be additionally administered for at least 12 -14 days every month/28 day cycle to oppose the development of an oestrogen-stimulated hyperplasia of the endometrium.
Dosage Schedule:
Therapy may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses. In women who are menstruating, it is advised that therapy starts within five days of the start of bleeding.
Patients changing from a cyclical or continuous sequential preparation should complete the cycle, and after a withdrawal bleed, may then change to Elleste Solo MX 40. Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start within five days of the start of bleeding.
Elleste Solo MX 40 should be given continuously and, in women with an intact uterus, a progestogen is recommended and should be added for at least 12-14 days each cycle. 8). Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
Method of administration Elleste Solo MX 40 transdermal patch should be applied twice weekly on a continuous basis. Each patch should be removed after 3 to 4 days and replaced with a new patch applied to a slightly different site. Apply the Elleste Solo MX 40 Transdermal Patch to the skin of the hip, upper quadrant of the buttock, lumbar region, or abdomen and press firmly over the whole surface and along the edges to ensure good adhesion.
Elleste Solo MX 40 is generally well tolerated. The most frequent side effects, (reported in 10 to 20 % of patients, on at least one occasion, in clinical trials with Elleste Solo MX 40) which do not normally prevent continued treatment include: breast tenderness, headaches and breakthrough bleeding.
Some patients experience mild and transient local erythema at the site of application with or without itching; this usually disappears rapidly on removal of the patch. The overall incidence of general patch irritation in clinical studies is less than 5 %.
In a clinical study 3 % of 102 patients showed well defined erythema (Draize scale) 30 minutes after patch removal. No instances of permanent skin damage have been reported. If unacceptable topical side effects do occur discontinuation of treatment should be considered.
The following adverse reactions have been reported with Elleste Solo MX 40 and/or oestrogen therapy: System Organ Class Common ADRs ≥ 1/100, < 1/10 Uncommon >1/1,000, <1/100 Rare ADRs ≥ 1/10,000, < 1/1000 Frequency Not Known* Infections and infestations Vaginal candidiasis Immune system disorders Hypersensit ivity Neoplasms, benign, malignant and unspecified (incl.
g. e. anginae and myocardial infarctione. 4. e. deep leg or pelvic venous thrombosis and pulmonary embolism. 4. Gastrointestina l disorders Abdomina l pain; Nausea Dyspepsia Bloating, Vomiting Pancreatitis (in women with pre-existing hypertriglyceri daemia); Gastroesophag eal reflux disease Hepatobiliary disorders Gall bladder disorder Hepatic function abnormal, sometimes with jaundice; Cholelithiasis; Skin and subcutaneous tissue disorders Rash, Pruritus Erythema nodosum, Urticaria Hirsutism, Acne Angioedema; Chloasma; Erythema multiforme; Vascular purpura; ; Application site reactions: erythema with or without pruritus Musculoskeleta l and connective tissue disorders Muscle cramps Renal and urinary disorders Urinary incontinence Reproductive system and breast disorders Metrorrha gia, Uterine/va ginal bleeding including spotting Breast pain, Breast tenderness Dysmenorrh oea, Vaginal discharge, Breast enlargement .
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); - Leiomyoma (uterine fibroids) or endometriosis; - Otosclerosis; - Cholelithiasis; - A history of endometrial hyperplasia (see below); - Hypertension; - Asthma.
Reasons for immediate withdrawal of therapy:
Therapy should be discontinued in case a contra-indication is discovered and in the following situations: - hepatitis, jaundice. liver enlargement or deterioration in liver function; - significant increase in blood pressure or blood pressure above systolic 160 mmHg or diastolic 95 mmHg; - serious neurological effects including new onset of migraine-type headache, unusual severe, prolonged headache especially if first time or getting progressively worse or sudden partial or complete loss of vision or sudden disturbance of hearing or other perceptual disorders or dysphasia or bad fainting attack or collapse or first unexplained epileptic seizure or weakness, motor disturbances, very marked numbness suddenly affecting one side or one part of body; - sudden severe chest pain (even if not radiating to left arm); - sudden breathlessness (or cough with blood-stained sputum); - unexplained swelling or severe pain in calf of one leg; - severe stomach pain; - prolonged immobility after surgery or leg injury; - 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; Dubin-Johnson and Rotor Syndromes (or monitor closely); Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The absorption capacity of the skin is the rate-determining factor in the release of estradiol from Elleste Solo MX 40 Transdermal Patch. The application on another (higher) skin region than on the mentioned preferred regions is not recommended, as this might have an influence on the release of estradiol.
The skin of the application site has to be clean, dry, not greasy and free of redness or irritation. Areas of the body that form lots of folds during movement as well as sites from which the patch could fall off due to movement or rubbing should be avoided.
Elleste Solo MX 40 Transdermal Patch should not be applied on or near the breasts. It is possible to take a shower or a bath while wearing the patch. In the unlikely event that a patch should fall off (excess sweating, abnormal rubbing of clothing), it is recommended to re-stick it onto dry skin.
In the event that a patch does come off, it should be replaced with a new patch. The patch should then be changed again at the regular time to re-establish the patient’s routine schedule. Similarly, if the patch is not changed on the scheduled day, it should be replaced as soon as possible and changed again on the next scheduled day.
Forgetting to apply a new patch at the scheduled time may increase the likelihood of break-through bleeding and spotting.
Paediatric population:
There is no relevant indication for the use of Elleste Solo MX 40 Transdermal Patch in the paediatric population.
Premenstrua l syndrome Fibrocystic breast disease; Endometriosis; General disorders and administration Oedema Fatigue site conditions *Undesirable effects from spontaneous post-marketing reporting sources, which have not been observed in clinical trials.
a 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. • 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) ‡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. *2 WHI study in women with no uterus, which did not show an increase in risk of breast cancer b 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 […]
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.
The endometrial safety of added progestogen has not been demonstrated for oral doses of estradiol >2 mg and patches >50 μg/day. 8). Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough 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, (but see above).
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 […]