PROGYNOVA TABLET 2 mg

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

TABLET, SUGAR COATED

**4.2 DOSAGE AND METHOD OF ADMINISTRATION** **4.2.1 Method of administration** Oral use **4.2.2 Dosage regimen** Hormonal contraception should be stopped when HRT is started and the patient should be advised to take non-hormonal contraceptive precautions, if required. **4.2.3** **How to start Progynova** If the patient has an intact uterus and is still menstruating, a combination regimen with Progynova and a progestogen (see section “Combination regimen”) should begin within the first 5 days of menstruation. Patients with amenorrhea or very infrequent periods or who are post-menopausal, may start a combination regimen (see section “Combination regimen”) at any time, provided pregnancy has been excluded. Estrogen with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual women. **Change from other HRT (cyclic, sequential or continuous combined)** Women changing from other HRT should complete the current cycle of therapy before initiating Progynova therapy. **Dosage** One beige tablet Progynova 1.0mg tablet (or one white tablet Progynova 2.0mg tablet) is taken daily. **Administration** Each pack covers 28 days of treatment. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets are to be swallowed whole with some liquid. The tablets should preferably be taken at the same time every day. **Combination regimen** In women with intact uterus, the concomitant use of an appropriate progestogen is advised for 10–14 days every 4 weeks (sequentially combined HRT) or with each tablet of estrogen (continuous combined HRT). Adequate provision should be made by the physician to facilitate and assure a proper compliance of the patient with the recommended combined regimen. **_Missed tablets_** In case a tablet is forgotten, it should be taken as soon as possible. If more than 24 hours have elapsed, no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur. **4.2.3 Additional information on special populations** 4.2.3.1 Children and adolescents Progynova is not indicated for use in children and adolescents. 4.2.3.2 Geriatric patients There are no data suggesting a need for dosage adjustment in elderly patients. In women aged 65 years or older, see section 4.4, “Special warnings and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. 4.2.3.3 Patients with hepatic impairment Progynova has not been specifically studied in hepatic-impaired patients. Progynova is contraindicated in women with severe hepatic diseases (see section “Contraindications”). 4.2.3.4 Patients with renal impairment Progynova has not been specifically studied in renally-impaired patients. Available data does not suggest a need for dosage adjustment in this patient population. Estrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.