KLIMEDIX

Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined product may start treatment at any time. Women changing from a cyclic, sequential combined HRT regimen, treatment should begin the day following completion of the prior regimen.

Posology One tablet is taken daily. Each blister is for 28 days of treatment. Method of administration For oral use. The tablets are to be swallowed whole with some liquid irrespective of food intake. Treatment is continuous, which means that the next pack follows immediately without a break.

The tablets should preferably be taken at the same time every day. If a tablet is forgotten it should be taken as soon as possible. If more than 24 hours have elapsed no extra tablet needs to be taken. If several tablets are forgotten, vaginal bleeding may occur.

For treatment of post-menopausal symptoms, the lowest effective dose should be used. 4) should be used. Additional information on special populations Paediatric population Klimedix is not indicated for use in children and adolescents.

Elderly There are no data suggesting a need for dosage adjustment in elderly patients. In women aged 65 years or older, see section

The table below reports adverse reactions by MedDRA system organ classes (MedDRA SOCs). The frequencies are based on clinical trial data. 5, 1, 2, or 3 mg). The most commonly reported adverse reactions were breast pain (> 10%) and during the first few months of treatment, bleeding and spotting (> 10%).

1). The frequency of bleeding decreases with the duration of treatment. System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1000 to < 1/100) Rare (< 1/1000) Blood and lymphatic system disorders Anaemia Metabolism and nutrition disorders Weight increase or weight decrease, anorexia, increased appetite, hyperlipidaemia Psychiatric disorders Depression, emotional lability, nervousness Sleep disorder, anxiety, libido decreased Nervous system disorders Headache Paraesthesia, concentration ability impaired, dizziness Vertigo Eye disorders Eye disorder, visual disturbance Ear and labyrinth disorders Tinnitus Cardiac disorders Palpitation Vascular disorders Embolism, venous thrombosis, hypertension, migraine, thrombophlebitis, varicose veins Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Abdominal pain, nausea, abdomen enlarged Gastrointestinal disorder, diarrhoea, constipation, vomiting, dry mouth, flatulence, taste disturbance Hepatobiliary disorders Liver function test abnormal Cholelithiasis Skin and subcutaneous tissue disorders Skin disorder, acne, alopecia, pruritus, rash, hirsutism, hair disorder Musculoskeletal and connective tissue disorders Pain in extremity, back pain, arthralgia, muscle cramps Myalgia Renal and urinary disorders Urinary tract disorder, urinary tract infection Reproductive system and breast disorders Benign breast neoplasm, breast enlargement, uterine fibroids enlarged, benign neoplasm of cervix uteri, menstrual disorder, vaginal discharge Breast carcinoma, endometrial hyperplasia, benign uterine neoplasm, fibrocystic breast, uterine disorder, ovarian disorder, cervix disorder, pelvic pain, vulvovaginal disorder, vaginal candidiasis, vaginitis, vaginal dryness Salpingitis, galactorrhoea General disorders and administration site conditions Asthenia, localized oedema Generalized oedema, chest pain, malaise, sweating increased Chills The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.

4. 2). 3). 2). 3). g. g. g. 1 - Hypersensitivity to peanut or soya. 4 Special warnings and precautions for use 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. 4). 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 (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. 1 - Hypersensitivity to peanut or soya.