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    / Janssen


    Active Ingredient *
    Estradiol (as Hemihydrate) 3.2 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Transdermal Patch

    8

    full basket chart 3046 5180

    Dosage

    The drug should be placed on a clean, dry, healthy, intact area of skin, on the trunk of the body below the waist. Creams, lotions or powders may interfere with the adhesive properties of the patch. The TDS should not be applied on or near the breasts. The area of application should be changed, with an interval of at least one week allowed between applications to a particular site. The skin area selected should not be damaged or irritated. The waistline should not be used because excessive rubbing of the TDS may occur. The TDS should be used immediately after opening the sachet. Remove one part of the protecting foil. Apply the exposed part of adhesive to the application site from the edge to the middle; avoid wrinkling of the TDS. The second part of the protective foil should now be removed and the freshly exposed adhesive applied. Wrinkling should again be avoided and the palm of the hand used to press the TDS onto the skin and to bring the TDS to skin temperature at which the adhesive effect is optimized. The patient should avoid contact between fingers and the adhesive part of the TDS during application. Should a patch fall off, a new patch should be applied immediately. However, the usual day of changing patches should be maintained. It is not necessary to remove the patch during bathing or showering. It is recommended, however, that the patch be removed prior to a sauna bath, and that a new patch is applied immediately thereafter.
    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. Forgetting a dose may increase the likelihood of break-through bleeding and spotting. To remove the patch, peel away an edge of the patch and pull smoothly away from the skin. Any adhesive that remains on the skin after removal of the drug may be removed washing with soap and water or by rubbing it off with the fingers.
    See prescribing information for full details.


    Indications

    Hormone replacement therapy (HRT) for the relief of menopausal symptoms.


    Contra-Indications

    Known hypersensitivity to the active substances or to any of the excipients. Known current or past or suspected  breast cancer. Known or suspected  estrogen-dependent  malignant tumors (e.g. endometrial cancer) or pre-malignant tumors (e.g. untreated atypical endometrial hyperplasia).  Undiagnosed genital bleeding. Pregnancy / lactation. Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal. Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism). Known thrombophilic conditions (e.g. protein C, protein S or antithrombin deficiency. Active or recent past arterial thromboembolic disease  (e.g. cerebrovascular accident, angina, myocardial infarction). Porphyria.


    Special Precautions

    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 contra-indications and warnings for use.
    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. It should be taken into account that these conditions may recur or be aggravated during treatment in particular: Leiomyoma (uterine fibroids) or endometriosis. A history or risk factors for thromboembolic disorders (see below). Risk factors for estrogen dependent tumors, e.g. first degree heredity for breast cancer. Hypertension, Liver disorders (e.g. liver adenoma), Diabetes mellitus with or without vascular involvement, Cholelithiasis, Migraine or severe headache, Systemic lupus erythematosus,  A history of endometrial hyperplasia. Epilepsy, Asthma, Otosclerosis, 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. 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 if 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: The risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods. The reported increase in endometrial cancer risk among oestrogen-only users varies from 2 to 12 fold greater compared with non-users, depending on the duration of treatment and oestrogen dose. The addition of a progestogen for 12-14 days per cycle in non-hysterectomised women greatly reduces this risk. 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.
    Breast cancer: The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestagen and possibly also oestrogen-only HRT, that is dependent on the duration of taking HRT.
    Combined oestrogen-progestagen therapy: The randomised placebo-controlled trial the (Women’s Health Initiative study (WHI), and epidemiological studies are consistent in finding an increased risk of breast cancer in women taking combined oestrogen-progestagen for HRT that becomes apparent after about 3 years. 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 diagnosed that is lower than that found in users of oestrogen-progestagen combinations. The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment. 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. Long- term (at least 5 to 10 years) use of oestrogen- only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. Some studies including the WHI trial suggest that the long-term use of combined HRTs may confer a similar, or slightly smaller, risk.
    See prescribing information for full details.


    Side Effects

    Hypersenstivity, candidiasis, insomia, anaexiety, nervosness.
    See prescribing information for full details.


    Drug interactions

    The metabolism of oestrogens and progestogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g.,phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz) and also bosentan. Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St. John’s Wort (Hypericum perforatum) may raise the metabolism of oestrogens and progestogens. With transdermal administration, the first-pass effect in the liver is avoided and thus, transdermally applied oestrogens and progestogens might be less affected by enzyme inducers than oral hormones. Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile. Estrogen-containing oral contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered due to induction of lamotrigine glucuronidation. This may reduce seizure control.  Although the potential interaction between estrogen-containing hormone replacement therapy and lamotrigine has not been studied, it is expected that a similar interaction exists, which may lead to a reduction in seizure control among women taking both drugs together. Therefore, dosage adjustment of lamotrigine may be necessary.


    Pregnancy and Lactation

    The use of this product is contraindicated in pregnancy and lactation. If pregnancy occurs during medication with this product, treatment should be withdrawn immediately.


    Overdose

    Symptoms of overdose of estrogen and progestogen therapy may include nausea, break-through bleeding, breast tenderness, abdominal cramps and/or bloating. These symptoms can be reversed by removing the TDS.


    Important notes

    Storage: Store at or below 25°C, within the original sachet and box. Keep out of reach of children. This also applies to used and disposed TDSs.


    Manufacturer
    Janssen Pharmaceutica, Beerse, Belgium
    Licence holder
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