| Section 4.8 has been updated as follows(changes in bold):
Side effects seen with PROSTAP are due mainly to the specific pharmacological action, namely increases and decreases in certain hormone levels.
Adverse events which have been reported infrequently include peripheral oedema, pulmonary embolism, hypertension, palpitations, fatigue, muscle weakness, diarrhoea, nausea, vomiting, anorexia, fever/chills, headache (occasionally severe), hot flushes, arthralgia, myalgia, dizziness, insomnia, depression, paraesthesia, visual disturbances, weight changes, hepatic dysfunction, jaundice, increases in liver function test values (usually transient) and irritation at the injection site. Changes in blood lipids and alteration of glucose tolerance have also been reported which may affect diabetic control. Thrombocytopenia and leucopenia have been reported rarely. Hypersensitivity reactions including rash, pruritis, urticaria and, rarely, wheezing or interstitial pneumonitis have also been reported. Anaphylactic reactions are rare.
Spinal fracture, paralysis, hypotension and worsening of depression have been reported (see ‘Special Warnings and Precautions for Use’ section 4.4).
A reduction in bone mass may occur with the use of GnRH agonists.
Infarction of pre-existing pituitary adenoma has also been reported rarely after administration of both short- and long-acting GnRH agonists.
Men: In cases where a "tumour flare" occurs after PROSTAP therapy, an exacerbation may occur in any symptoms or signs due to disease, for example, bone pain, urinary obstruction, weakness of the lower extremities and paraesthesia. etc. These symptoms subside on continuation of therapy.
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