4.4. Special Warnings and Precautions for Use
Addition of the following:
Patients known to suffer from depression should be carefully monitored and treated if necessary during treatment with Suprecur.
It is not expected that pregnancy will occur during the course of the treatment if the recommended doses are taken regularly. However, if treatment is interrupted for only a few days, ovulation and pregnancy may occur. If pregnancy does occur, treatment with buserelin must be discontinued immediately and a physician must me informed (see also section 4.6).
Repeated courses of treatment must only be administered after a careful review of the risk/benefit ratio by the attending physician since the possibility of additive effects on bone mass (reduction in bone mass) cannot be excluded (see also section 4.8).
Before treatment is started, it is recommended that a pregnancy test be performed.
4.6. Pregnancy and Lactation
Addition of the following:
Buserelin passes into breast milk in small amounts. Although negative effects on the infant have not been observed, it is recommended that breast-feeding be avoided during treatment with Suprecur in order to prevent the infant from ingesting small quantities of buserelin with breast milk.
In endometriosis: It is unlikely that pregnancy will occur in the later stages of treatment if the recommended doses are taken regularly. However, if treatment is interrupted even for only a few days, ovulation may occur and the patient may become pregnant. In this event, Suprecur must be withdrawn immediately and a physician must be informed (see also section 4.4).
4.8. Undesirable Effects
Addition of the following:
Treatment with buserelin inhibits oestrogen production. As evidence of the biological response to hormone deprivation, patients may experience menopausal-like symptoms and withdrawal bleeding, which are directly related to the pharmacological action of the drug. Symptoms such as hot flushes, increased sweating, dry vagina, dyspareunia, loss of libido generally occur some weeks after starting treatment and may be severe in some patients. Withdrawal bleeding may occur during the first few weeks of treatment. Breakthrough bleeding may occur during continuing treatment. After several months’ treatment, a decrease in bone mass may occur.
Psychiatric disorders – Frequent nervousness, emotional instability. Occasional anxiety, depression or worsening of existing depression.
Nervous system disorders – Dizziness, headache (in women in rare cases migraine-like), sleep disturbances, tiredness, drowsiness. Occasional paraesthesia (especially in the arms and legs), disturbances of memory and concentration.
Musculoskeletal and bone disorders – Frequent musculoskeletal discomfort and pain (including shoulder pain/stiffness). The use of LHRH-agonists may be associated with decreased bone density and may lead to osteoporosis and an increased risk of bone fracture. The risk of skeletal fracture increases with the duration of therapy.
Reproductive system and breast disorders – Frequent Vaginal discharge, increase or decrease in breast size, breast tenderness.Occasional lactation.
In the initial phase of treatment with buserelin, ovarian cysts may develop (see also section 4.4).
Combined use of buserelin with gonadotrophins may bear a higher risk of ovarian hyperstimulation syndrome (OHSS) than the use of gonadotrophins alone (see also section 4.4).
