Progerix is a white, round shaped, standard bi-convex film coated tablet with both side plain surface.

Composition

Progerix Tablet: Each film coated tablet contains 10 mg Dydrogesterone USP.

Pharmacodynamic Properties

Pharmacotherapeutic Category: Urogenital system and sex hormones, ATC code: G030B01

Dydrogesterone is a synthetic progesterone with an oral biological availability that causes a secretory phase of the endometrium in a uterus prepared by oestrogen. It gives protection against the increased risk of

oestrogens. Dydrogesterone has no oestrogenic, androgenic, anabolic and corticoid properties.

Dydrogesterone does not suppress ovulation. As a result, conception remains possible if Dydrogesterone is used by women of child-bearing age.

In postmenopausal women with a uterus, oestrogen replacement leads to an increase in the risk of endometrial hyperplasia and endometrial carcinoma. The addition of a progestogen prevents this additional risk.

Pharmacokinetics Properties

The following is a detailed description of how the active ingredients of Progerix are metabolized by the body. For further explanations please consult your doctor.

After oral administration of labelled Dydrogesterone, on average 63% of the dose is excreted into the urine. Within 72 hours excretion is complete. Dydrogesterone is completely metabolized. The main metabolite of Dydrogesterone is 20a-dihydrodydrogesterone (OHO) and is present in the urine predominantly as the glucuronic acid conjugate. A common feature of all metabolites characterized is the retention of the 4,6-diene-3-one configuration of the parent compound and the absence of 17a-hydroxylation. This explains the lack of oestrogenic and androgenic effects of Dydrogesterone.

After oral administration of Dydrogesterone, plasma concentrations of OHO are substantially higher as compared to the parent drug. The AUC and Cmax ratios of OHO to Dydrogesterone are in the order of 40 and 25, respectively. Dydrogesterone is rapidly absorbed. The Tmax values of Dydrogesterone and OHO vary between 0.5 and 2.5 hours. Mean terminal half-lives of Dydrogesterone and DHD vary between 5 to 7 and 14 to 17 hours, respectively.

Dydrogesterone is not excreted in urine as pregnanediol, like progesterone. Analysis of endogenous progesterone production based

on pregnanediol excretion therefore remains possible.

Indications

Progesterone Deficiencies:

• Treatment of threatened miscarriage
• Treatment of habitual miscarriage • Treatment of dysmenorrhea
• Treatment of endometriosis • Treatment of secondary amenorrhoea
• Treatment of irregular cycles • Treatment of dysfunctional uterine bleeding • Treatment of infertility due to luteal insufficiency
• Luteal support as part of an Assisted Reproductive Technology (ART).

Hormone Replacement Therapy: To counteract the effects of unopposed oestrogen on the endometrium in hormone replacement therapy for 1NQmen with disorders-due ’10 natural or surgical induced menopause with an intact uterus.

Method of Administration

For oral use only.

How to take Progerix:

Always take Progerix exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will adjust the dose to suit you.

While you are taking Progerix, you should see your doctor regularly (at least once a year). Your doctor may wish to carry out medical checks,

Dosage & Administration

Always take Progerix 10 mg tablet exactly as your doctor has prescribed. If you forget to take your tablet(s), do not take a double dose to compensate for it. If you require further information, please ask your doctor or pharmacist for advice.

Hormone Replacement Therapy: In combination with continuous oestrogen therapy, take one tablet daily for 14 consecutive days of a 28-day cycle. In combination with cyclical oestrogen therapy take one tablet daily during the last 12 to 14 days of oestrogen therapy.

For Doctors: If endometrial biopsies or-ultrasound reveal inadequate progestational response, 20 mg Dydrogesterone should be prescribed.

For Patients: If you are not sure what type of oestrogen therapy you are on, talk to your doctor before taking Progerix. There is no relevant use of Dydrogesterone before menarche. The safety and efficacy of Dydrogesterone in adolescents aged 12 to 18 years has not been established.

How much to take:

The number of tablets you take and the days you take them on will depend on what you are being treated for. Your doctor will decide the best time for you to take Progerix. If you are still having natural periods, day 1 of your cycle is when you start bleeding. If you are not having natural periods, your doctor will decide with you when to start day 1 of the cycle and when to start taking your tablets.

Posology for Specific Indications

Progesterone Deficiencies: • Threatened miscarriage: 40 mg (four tablets) at once, then 10 mg (one tablet) every eight hours until symptoms remit. • Habitual miscarriage: 10 mg (one tablet) twice daily until the twentieth week of pregnancy. • Dysmenorrhea: 10 mg (one tablet) twice daily from day 5 to day 25 of the menstrual cycle. • Endometriosis: 10 mg (one tablet) two or three times daily from day 5 to day 25 of the cycle or continuously. • Dysfunctional bleeding (to arrest bleeding): 10 mg (one tablet) twice daily for five to seven days. Progerix should be given with oestrogen. • Dysfunctional bleeding (to prevent bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Progerix should be given with oestrogen. • Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Progerix twice daily from day 11 to day 25 of the cycle. Irregular cycles: 10 mg (one tablet) twice daily from day 11 to day 25. other cycle. • Infertility due to luteal insufficiency: 10 mg (one tablet) daily from day 14 to day 25 of the cycle. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first month of any pregnancy using the doses stated with respect to habitual miscarriage.

Luteal support as part of an Assisted Reproductive Technology (ART} treatment: 10 mg three times daily (three tablets daily) starting at the day of oocyte retrieval and continuing for 1 O weeks if pregnancy is confirmed.

Hormone Replacement Therapy: In combination with continuous oestrogen therapy, take one tablet daily for 14 consecutive days of a 28-day cycle. In combination with cyclical oestrogen therapy take one tablet

daily during the last 12 to 14 days of oestrogen therapy.

For Doctors: If endometrial biopsies -or ultrasound reveal inadequate progestational response, 20 mg Dydrogesterone should be prescribed.

For Patients: If you are not sure what type of oestrogen therapy you are on, talk to your doctor before taking Progerix. There is no relevant use of Dydrogesterone before menarche. The safety and efficacy of Dydrogesterone in adolescents aged 12 to 18 years has not been established.