CLINORETTE

Clinorette is continuous sequential HRT product. The calendar pack consists of 28 tablets. The 16 white tablets contain 2 mg of 17-β oestradiol and the 12 pink tablets contain 2 mg of 17-β oestradiol and 1 mg of norethisterone. One tablet is taken each day; a treatment cycle consists of 28 days.

A menstrual type vaginal bleed usually occurs at the end of the treatment cycle or after administration of the last pink, norethisterone containing, tablet. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.

4) should be used. Starting Clinorette Menstruating women take the first tablet on the fifth day of menstrual bleeding. If menstruation has stopped, or is infrequent or sporadic, the first tablet can be taken at any time. Patients changing from a cyclic or continuous sequential preparation should complete the cycle and then start Clinorette without a break in therapy.

Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding. Missed doses If a dose is forgotten the patient should be advised to take it as soon as they remember.

However, if a whole day has passed, patients should be advised not to take the missed tablet but to continue to take one tablet daily. A missed dose may increase the likelihood of break-through bleeding and spotting.

Children or males:

Clinorette is not intended for children or males.

Use in the elderly:

There are no special dosage requirements.

Genito-urinary system – breakthrough bleeding, spotting, change in menstrual flow, dysmenorrhoea, premenstrual like syndrome, increase in size of uterine fibroids, vaginal candidiasis, change in cervical erosion and in degree of cervical secretion, cystitis like syndrome.

Breasts – tenderness, enlargement, secretion, breast cancer (see below) Gastrointestinal – nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice. Skin – chloasma or melasma which may persist when drug is discontinued, erythema multiforme, erythema nodosum, haemorrhagic eruption, loss of scalp hair, hirsutism.

Eyes – steepening of corneal curvature, intolerance to contact lenses. CNS – headaches, migraine, dizziness, mental depression, chorea. Miscellaneous – increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, oedema, change in libido, leg cramps.

Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years. • Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations.

4). • Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented. 7 6 (5-7) #Overall risk ratio. The risk ratio is not constant but will increase with increasing duration on use.

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.

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.

Medical examination/follow-up Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. 4) 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). Investigations, including 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 when 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.

8). The addition of a progestogen for at least 12 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.

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; Known hypersensitivity to the active substances or to any of the excipients; Porphyria;