EVOREL CONTI

Adults Evorel Conti is a continuous combined HRT preparation. Patches are applied to the skin twice weekly. One Evorel Conti patch should be worn at all times, without interruptions. 4) should be used.

Guidance on how to start therapy:

Post-menopausal women currently not on HRT may start Evorel Conti at any time. Switching from other HRT Women on a continuous combined regimen wishing to switch from another oestrogen to Evorel Conti 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 Conti may do so at the end of a cycle of the current therapy or after a 7 day hormone free interval.

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. Method of Administration The sachet containing one Evorel Conti patch should be opened and one part of the protective foil removed at the S-shaped incision.

The patch should be applied to clean, dry, healthy, intact skin as soon as it is removed from the sachet. The patient should avoid contact between fingers and the adhesive part of the patch during application. Each application should be made to a different area of the skin, on the trunk below the waist.

The patch should not be applied on or near the breasts. Evorel Conti patch should remain in place during bathing and showering. Should a patch fall off, it should be replaced immediately with a new patch. However the usual day of changing Evorel Conti patches should be maintained.

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. Wearing a patch for more than 4 days by mistake or any period without a patch may increase the likelihood of breakthrough bleeding or spotting. Children Evorel Conti is not indicated in children.

Elderly Data are insufficient in regard to the use of Evorel Conti in the elderly (>65 years old). Route of administration Transdermal use.

The safety of Evorel Conti was evaluated in 196 subjects who participated in 3 clinical trials and received at least one administration of Evorel Conti. 1%). Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of Evorel Conti from either clinical trial or post-marketing experiences, and additional ADRs that have been reported with the use of Evorel (estradiol alone) from clinical trial data.

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 Candidiasis Neoplasms benign, malignant and unspecified (including cysts and polyps) Frequency not known Breast neoplasms, Endometrial cancer Immune System Disorders Common Hypersensitivity Psychiatric disorders Common Depression, Insomnia, Anxiety, Nervousness Uncommon Libido decreased Frequency not known Mood swings Nervous system disorders Common Paraesthesia, Headache Uncommon Migraine Rare Epilepsy* Frequency not known Cerebrovascular accident, Dizziness Cardiac disorders Common Palpitations Vascular disorders Common Hypertension, Varicose vein, Vasodilatation 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* Frequency not known Abdominal distension Hepato-biliary disorders Frequency not known Cholelithiasis Skin and subcutaneous tissue disorders Common Rash erythematous Uncommon Pruritus, Rash*, Frequency not known Stevens-Johnson syndrome Musculoskeletal and Connective Tissue Disorders Common Arthralgia, Back pain Uncommon Myalgia* Reproductive system and breast disorders Common Breast pain, Cervical polyp, Endometrial hyperplasia, Genital discharge, Dysmenorrhoea, Menorrhagia, Menstrual disorder, Metrorrhagia Frequency not known Breast enlargement General disorders and administration site conditions Very Common Application site erythema, Application site pruritus, Application site rash, Application site reaction Common Pain*, Oedema, Application site oedema* Fatigue Uncommon 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 contra-indications 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 - 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 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.

g. g. 1) - Porphyria