Details
Progynova Indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in peri- and postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
Contraindications
- Known, past or suspected breast cancer
- Known or suspected oestrogen-dependent malignant tumours e.g. endometrial cancer
- Undiagnosed genital bleeding
- Untreated endometrial hyperplasia
- Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
- Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4)
- Active or recent arterial thromboembolic disease e.g. angina, myocardial infarction
- Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
- Porphyria
Dosage & Administration
For the beginning, and also continuation of treatment of postmenopausal symptoms it is always necessary to appoint the minimum effective dosage for the shortest possible term (see the section "Features of use").
In general, 1 tablet of Proginova should be taken daily at the beginning of treatment.
After 3 weeks of reception it is necessary to take a break for at least 1 week in order to avoid significant endometrial hyperplasia. Calendar blister of the drug Proginov, containing 21 coated tablets of 2 mg, facilitates the treatment process for patients according to this scheme. This blister ensures regular intake and helps to avoid overdose.
Treatment of women after hysterectomy and postmenopausal women can be started any day.
In patients who have not undergone a hysterectomy, Proginov treatment should be combined with the monoprogestogen indicated for this clinical situation for at least 12–14 days per month or for a 28-day cycle. Dosage, nature and duration of treatment are determined depending on the method of application of the progestogen (see section "Peculiarities of use").
Progestogen supplementation is not recommended for women with a removed uterus unless endometriosis is diagnosed.
If you miss a tablet, do not take it in addition to the next tablet. Skipping the pill increases the likelihood of discharge or intermittent bleeding.
Elderly patients
There is no evidence of a need for dose adjustment in elderly patients. For use in women over 65, see section "Features of application".
Patients with hepatic insufficiency
The use of Proginov in patients with hepatic impairment has not been specifically studied. The use of Proginov is contraindicated in women with severe hepatic insufficiency (see section "Contraindications").
Patients with renal insufficiency
The use of Proginova in patients with impaired renal function has not been specifically studied. The available data do not indicate the need for dose adjustment.
Method of application and duration of administration
The tablets should be swallowed whole without chewing, drinking plenty of fluids. It is advisable to take the drug at the same time each day.
The duration of treatment is determined by the doctor.