PROGYNOVA TABLET 2 MG [SIN04456P]

Product Info

PROGYNOVA TABLET 2 MG

[SIN04456P]

4.1 Indications
Hormone replacement therapy (HRT) for the treatment of signs and symptoms of estrogen deficiency due to natural menopause or castration.

Prevention of postmenopausal osteoporosis.

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.

4.3 Contraindication

Hormone replacement therapy (HRT) should not be started in the presence of any of the conditions listed below. Should any of the conditions appear during HRT use, the product should be stopped immediately.

• Pregnancy and lactation

• Undiagnosed vaginal bleeding

• Known or suspected cancer of the breast

• Known or suspected premalignant conditions or malignancies, if sex steroid-influenced

• Presence or history of liver tumours (benign or malignant)

• Severe hepatic disease

• Acute arterial thromboembolism (e.g. myocardial infarction, stroke)

• Active deep venous thrombosis, thromboembolic disorders, or a documented history of these conditions

• A high risk of venous or arterial thrombosis

• Severe hypertriglyceridemia

• Hypersensitivity to the active substance or to any of the excipients