|In isolated cases severe hypersensitivity reactions with shock can occur. These may become manifest as reddening of the skin, itching, skin rashes (including urticaria) and allergic asthma with dyspnoea as well as, in isolated cases leading to anaphylactic / anaphylactoid shock.After administration of the injection, pain or local reaction at the injection site is possible.At the beginning of treatment, a transient rise in the serum testosterone level usually develops and may lead to temporary activation of the tumour with secondary reactions such as:- occurrence of exacerbation of bone pain in patients with metastases.- signs of neurological deficit due to tumour compression with eg. muscle weakness in the legs.- impaired micturition, hydronephrosis or lymphostasis.- thrombosis with pulmonary embolism.Such reactions can be largely avoided when an anti-androgen is given concomitantly in the initial phase of buserelin treatment (see section 4.4 Precautions and Warnings). However, even with concomitant anti-androgen therapy, a mild but transient increase in tumour pain as well as a deterioration in general well being may develop in some patients.Suprefact treatment may also lead to: Neoplasms benign and malignant - Very rare cases of pituitary adenomas were reported during treatment with LH-RH agonists, including buserelin.Blood disorders - Very rare cases of thrombocytopenia or leucopenia.Metabolism and nutrition disorders Frequent increase or decrease in weight Occasional changes in appetite and increased thirst. Rarely increase or decrease in blood lipid levels. Very rarely, reduction in glucose tolerance which may lead to the worsening of metabolic control in diabetics. Psychiatric disorders Frequent nervousness, emotional instability. Occasional anxiety, depression or worsening of existing depression.
Nervous system disorders Dizziness, headache, sleep disturbances, tiredness, drowsiness. Occasional paraesthesia (especially in the arms or legs), disturbances of memory and concentration.Eye disorders Occasional dry eyes (possibly leading to eye irritations in people who wear contact lenses), impaired vision (eg blurred vision), feeling of pressure behind the eyes.Ear and labyrinth disorders Rare cases of tinnitus, hearing disorders found.Cardiac disorders Frequent palpitations.Vascular disorders Occasional oedema (of face and extremities) and hot flushes. Very rare cases of a deterioration of blood pressure levels in patients with hypertension.Gastrointestinal disorders Frequent lower abdominal pain, stomach ache, nausea, vomiting, diarrhoea, constipation.Hepato-biliary disorders Occasional, increase in serum liver enzyme levels (e.g. transaminases), increase in serum bilirubin.Skin and subcutaneous tissue disorders Frequent dry skin, acne, increase or decrease in scalp hair (alopecia, hirsutism). Occasional increase or decrease in body hair, splitting nails.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 Occasional gynaecomastia (increase in breast size) which is usually painless, atrophy of the testes, decrease in libido and potency (in most patients; result of hormone deprivation).Most of the effects listed above are directly or indirectly related to the suppression of testosterone by buserelin (symptoms of androgen deficiency).
|Mood changes, depression. Frequency:
||Long term use: Common
| ||Short term use: Uncommon
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard