UTROGESTAN

Posology In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration. The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and ending on Day 26).

Withdrawal bleeding may occur in the following week. Alternatively 100 mg can be given at bedtime from Day 1 to Day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule. 4) should be used. Paediatric population There is no relevant use of Utrogestan in pre-pubescent children.

Older people As for adults Method of Administration:

Oral Utrogestan 100mg Capsules should not be taken with food and should be taken at bedtime. Concomitant food ingestion increases the bioavailability of micronised progesterone.

a. Summary of the safety profile Post-Marketing experience The information given below is based on extensive post marketing experience, from oral administration of progesterone. Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000;<1/100); rare (≥1/10,000;<1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).

System organ class Common (≥1/100; <1/10) Uncommon (≥1/1,000; <1/100); Rare (≥1/10,000; <1/1,000) Very rare (<1/10,000) Frequency Not known (cannot be estimated from the available data) System organ class Common (≥1/100; <1/10) Uncommon (≥1/1,000; <1/100); Rare (≥1/10,000; <1/1,000) Very rare (<1/10,000) Frequency Not known (cannot be estimated from the available data) Infections and infestations Urinary tract infections, Vaginitis Blood and lymphatic disorders Thromboembolic disorders Anaemia.

Metabolism and nutrition disorders Weight fluctuation Fluid retention Change in glucose tolerance Psychiatric disorders Insomnia Agitation, Anxiety, Apathy, Depression, Disorientation, Mood swings, Nervousness Change in libido Nervous system disorders Dizziness, Headache, Somnolence Amnesia, Migraine, Paraesthesia, Speech disorder, Syncope Eye disorders Visual Disturbance Eye irritation Ear and labyrinth disorders Tinnitus, Vertigo Cardiac disorders Palpitations, Tachycardia Vascular disorders Haemorrhage, Hot flush, Hypotension Thrombotic events (mainly when taken in combination with estrogen), Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Abdominal distension, Abdominal pain, Nausea Constipation, Diarrhoea, Vomiting Loss of appetite Taste disturbances Hepatobiliary disorders Non-severe and reversible liver disorders Cholestatic jaundice System organ class Common (≥1/100; <1/10) Uncommon (≥1/1,000; <1/100); Rare (≥1/10,000; <1/1,000) Very rare (<1/10,000) Frequency Not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders Pruritus Acne, Alopecia, Erythema, Hyperhidrosis, Rash, Urticaria Chloasma Musculoskeletal and connective tissue disorders Arthralgia, Back pain, Limb discomfort, Muscle spasms, Myalgia Renal and urinary disorders Dysuria Reproductive system and breast disorders Intermenstrual bleeding, Vaginal haemorrhage Menstruation irregular, Amenorrhoea, Metrorrhagia Breast pain and breast tenderness Breakthrough bleeding or irregular withdrawal bleeding Abnormal withdrawal bleeding, Breast discomfort Endometrial hyperplasia, Vaginal discharge, Vulvovaginal discomfort, Menstrual cycle abnormal, Mastodynia Hirsutism Dysmenorrhea, Cervical erosion, Cervical secretions Immune system disorders Anaphylactoid reactions General disorders and administration site conditions Fatigue Malaise Asthenia, Chest discomfort, Chest pain, Oedema Pyrexia b.

1.

Warnings:

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.

Precautions 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) • Diabetes mellitus with or without vascular involvement • Cholelithiasis • Migraine or (severe) headache • Systemic lupus erythematosus. g. cardiac, disease, renal disease) • Depression • Photosensitivity 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 • Sudden or gradual, partial or complete loss of vision • Venous or thrombotic thromboembolic accidents regardless of the territory • Proptosis or diplopia • Papilloedema • Retinal vascular lesions Endometrial hyperplasia and carcinoma In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods.

g. g. 6)