Dydrogesterone tablet 10 mg What Dydrogesterone is and what it is used for: Dydrogesterone is a synthetic progestogen and has a similar action to the female hormone, progesterone. It is used to treat menstrual disorders in women caused due to a lack of hormones. It is also used to reduce the risk of miscarriages or abortions. This medicine is not recommended for use in patients below 18 years of age. Dydrogesterone is used in the following cases: Hormone replacement therapy To counteract the eﬀects of unopposed oestrogen on the endometrium in hormone replacement therapy for women with disorders due to natural or surgical induced menopause with an intact uterus. Progesterone deﬁciencies Treatment of progesterone deﬁciencies such as: Treatment of dysmenorrhoea Treatment of endometriosis Treatment of secondary amenorrhoea Treatment of irregular cycles Treatment of dysfunctional uterine bleeding Treatment of pre-menstrual syndrome Treatment of threatened and habitual abortion, associated with proven progesterone deﬁciency Treatment of infertility due to luteal insuﬃciency What you need to know before you use Dydrogesterone: Do not use Dydrogesterone: If you have allergy to Dydrogesterone or to any substance of this medicine If you have known or suspected progesteron dependent neoplasms (e.g. meningioma) If you have undiagnosed vaginal bleeding If used to prevent endometrial hyperplasia (in women using estrogens) If you have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Warnings and precautions: Talk to your doctor before taking Dydrogesterone. In case of abnormal liver function In case of previous or present depression In case of porphyria In case of unexplained vaginal bleeding Other medicines and Dydrogesterone: Tell your doctor if you are taking, have recently taken, or might take any other medicines. The metabolism of dydrogesterone and DHD may be increased by concomitant use of substances known to induce CYP enzymes such as: anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz) herbal preparations containing e.g. St John’s Wort (Hypericum perforatum), valerian root, sage, or gingko biloba anti-HIV (Ritonavir and nelﬁnavir) How to use Dydrogesterone: Posology: The following dosage regimens are recommended for treatment with Dydrogesterone. The quantities can be adjusted according to the seriousness of the disorder to be treated and the individual patients’ responses to the treatment. Regulation of the cycle: It is possible to achieve a cycle lasting 28 days by giving 1 tablet of Dydrogesterone a day from the 11th to the 25th day of the cycle. Endometriosis 1 to 3 tablets of Dydrogesterone a day from the 5th to the 25th day of the cycle or for the entire cycle. Dosages of 10 mg several times a day should be spread over the day. It is recommended that treatment should start at the highest dose. Dysmenorrhoea 1 to 2 tablets of Dydrogesterone a day from the 5th to the 25th day of the cycle. Dosages of 10 mg several times a day should be spread over the day. It is recommended that treatment should start at the highest dose. Infertility as a result of corpus luteum insufficiency 1 tablet of Dydrogesterone a day from the 14th to the 25th day of the cycle. Treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment for the first months of any pregnancy at dosages as indicated for habitual abortion. Threatened abortion Starting dose: 4 tablets of Dydrogesterone at once followed by 1 tablet of Dydrogesterone mg every 8 hours. Dosages of 10 mg several times a day should be spread over the day. It is recommended that treatment should start at the highest dose. If the symptoms persist or recur during the treatment, the dose should be increased by 1 tablet of Dydrogesterone every 8 hours. The effective dose should be maintained for one week after symptoms have ceased; it can then be gradually reduced. If the symptoms recur, the treatment should be resumed immediately at the effective dose. Habitual abortion: 1 tablet of Dydrogesterone a day up to the 20th week of pregnancy; the dose can then be gradually reduced. Treatment should preferably be started before conception. If the symptoms of threatened abortion occur during treatment, treatment should be continued as described for that indication. Dysfunctional uterine bleeding: Bleeding is stopped by 2 tablets of Dydrogesterone a day for 5 to 7 days. The blood loss is reduced considerably within a few days. A few days after the end of this treatment, a heavy withdrawal bleed occurs and the patient should be warned about this. Subsequent heavy bleeding can be prevented by prescribing a prohylactic dose of 1 tablet of Dydrogesterone a day from the 11th to the 25th day of the cycle, if necessary combined with an oestrogen for 2 to 3 cycles. After this the treatment can be discontinued, in order to check that the patient has a normal cycle again. Secondary amenorrhoea: 1 or 2 tablets of Dydrogesterone per day from the 11th to the 25th day of the cycle to give optimum secretion transformation of the endometrium, that is adequately prepared with an endogenous or exogenous oestrogen. Pre-menstrual syndrome: 10 mg twice daily from day 11 to day 26 of the cycle. There is no relevant use of dydrogesterone before the menarche. The safety and efficacy of dydrogesterone in adolescents aged from 12 to 18 years has not been established. Method of administration: For oral use. For administration of higher doses the tablets should be taken in divided doses over the day. Possible side effects: Stop using the product and seek immediate medical attention if you develop urticaria, rash, tightness of the chest, wheezing, hypotension How to store Dydrogesterone: Keep this medicine out of the sight and reach of children. Store in a dry place, below 30˚C Protect from light A valid prescription should be available upon delivery

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