- Vaginal bleeding, where the cause has not been established.
- Presence of serious liver disorders, or serious liver disorders in the medical history until the liver function values have returned to normal.
- Contraindications for use of oestrogens in combination with progestogens such as dydrogesterone in combined therapy.
- Known hypersensitivity to dydrogesterone or any of the excipients.
- Known or suspected sex hormone dependent malignancies.
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.
The adverse effects of this product most commonly reported in patients who were treated with drydrogesterone during clinical trials into indications without the use of oestrogen were metrorrhagia, painful/ sensitive breasts and migraine/headache.
Dydrogesterone is a substance with very low toxicity. Nausea, vomiting, lethargy and dizziness are side effects which may theoretically occur in the event of an overdose. There are no known cases in which an overdose of dydrogesterone led to harmful effects. Specific treatment is clearly not necessary. In case of overdose symptomatic treatment may be considered.