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Medical Information:

COMPOSITION11 white tablets each containing estradiol-17-valerate (estra-1,3,5(10)-triene-3,17beta-diol-17-valerate) 2 mg, plus10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate (6-chloro-17-hydroxy-1alpha,2alpha-methylene-pregna-4,6-diene-3,20-dione-acetate) 1 mg, plus7 non-hormonal tablets.

INDICATIONS:Climen is indicated in patients (with intact uteri) suffering from climacteric symptomatology.Climen therapy may be used as an adjunct in preventing osteoporosis in postmenopausal women.

CONTRA-INDICATIONSPregnancy, lactation, severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, previous or existing tumours of the liver, uterus, ovaries or breast or a suspicion of such tumours, endometriosis, existing or previous thromboembolic processes, severe diabetes mellitus with vascular changes, sickle-cell anaemia, disturbances of lipometabolism, a history of herpes of pregnancy, otosclerosis with deterioration during pregnancy.

DOSAGE AND DIRECTIONS FOR USEBefore Climen is used, a thorough general medical (including measurement of blood pressure, analysis of urine for sugar, if applicable performance of special liver diagnostics as well) and gynaecological (including the breast and a cytological smear of the cervix and portio) examination should be performed in order to detect any diseases requiring treatment or risk factors and, where applicable, to rule out pregnancy. During the use, checks are recommended at intervals of about 6 months.

The pack contains seven self-adhesive strips marked with the days of the week. Each strip starts with a different day of the week. Stick the strip that starts with your "Start" day along the top of the memo-pack where indicated. For example, if the tablets are started on a Wednesday, the strip that starts with "Wed" should be selected. Each tablet is thus marked with the corresponding day of the week and one can see at a glance whether the tablet for that day has been taken or not.Tablet-taking is always started from the blister marked "Start" and continued daily in the direction of the arrows until all 28 tablets have been taken. At the start of therapy the first tablet is taken on day 5 of the cycle (1st day of menstruation = 1st day of cycle). Menstruation will usually take place whilst the 7 non-hormonal tablets are being taken, before the next pack is started. The tablets are to be swallowed whole with some liquid.

Patients with amenorrhoea (rule out pregnancy beforehand) and postmenopausal women can start taking the tablets - 1 per day over 28 days - on any day they like.

After the 1st pack has been finished, the next pack of Climen is started on the following day.If no withdrawal bleeding occurs whilst taking the 7 non-hormonal tablets at the end of the pack, tablet-taking from the new pack should not be commenced until pregnancy has been ruled out.

If a tablet is not taken at the usual time, it should be taken within 12 hours of that time in order to avoid the occurrence of intermenstrual bleeding.