4.4 Special warnings and precautions for use
Addition of the line:
Before treatment is started, it is recommended that a pregnancy test be performed
4.5 Interaction with other medicaments and other forms of interaction
Addition of the following:
In concomitant treatment with sexual hormones ("add back"), the dosage is to be selected so as to ensure that the overall therapeutic effect is not affected.
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.
4.8 Undesirable effects
Addition of the following (see highlighted text):
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 and 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 section 4.4).
4.9 Overdose
Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, oedemas of the lower extremities, and mastodynia as well as to local reactions at the injection site such as pain, haemorrhage and induration. Treatment should be symptomatic.
