Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Before starting treatment with dydrogesterone because of disfunctional uterine bleeding an organic cause should be excluded.

Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeeding and spotting continue to occur when treatment has already been underway for some time, or continue when treatment is discontinued, the cause of this should be ascertained, if necessary by taking an endometrial biopsy to exclude malignancy of the endometrium.

If one of the following disorders occurs during use for the first time or gets worse, stopping the treatment should be considered.
-        exceptionally severe headache, migraine or symptoms that may indicate cerebral ischemia.
-        marked increase in blood pressure.
-        occurrence of venous thromboembolism.

In cases of habitual or threatened abortion, the viability of the foetus should be ascertained, and it is necessary to monitor during treatment whether the pregnancy is still progressing and whether the embryo is still alive.

Conditions for which monitoring is necessary:
It is known that the following rarely occurring conditions may be affected by sex hormones and may arise or get worse during pregnancy or during the use of sex hormones: cholestatic icterus, herpes gestationis, severe pruritus, otosclerosis and porphyria.

Patients with a history of depression must be carefully monitored; if severe depression recurs, treatment with dydrogesterone must be stopped.

Other conditions
Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.

Excipients
This medicinal product contains lactose monohydrate.
Patients with rare hereditary conditions, such as galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Effects on Driving

4.7   Effects on ability to drive and use machines
Dydrogesterone has a slight effect on ability to drive and to use machinery.
In rare cases dydrogesterone may cause somnolence and/or dizziness, in particular during the first couple of hours afer taking it. Caution is therefore advised when driving and operating machinery.