Side Effects

POSSIBLE SIDE EFFECTS

Like all medicines, GONAPEPTYL Depot can cause side effects, although not everybody gets them. General (all patients): If you experience swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing tell your doctor immediately or go to your nearest casualty department. Cases of pre-existing pituitary tumour enlargement were reported during treatment with LH-RH agonists, however it has not yet been observed with triptorelin therapy.

In Men:

The symptoms you are being treated for (e.g. urinary obstruction, skeletal pain, compression of the spinal cord, muscular discomfort and oedema of the legs, weakness and tingling in the feet and hands) may worsen initially, due to the increased levels of testosterone at the start of treatment. Very common, more than 1 patient out of every 10 patients treated: most of the side effects of GONAPEPTYL Depot in men result from lowered testosterone levels. Impotence, decreased libido, hot flushes, bone pain and difficulty and pain in passing urine can be seen. Common, between 1 and 10 patients out of every 100 patients treated: allergic reaction, depressed mood, mood changes, depression, sleep disorder, nausea, muscle and joint pain, tiredness, injection site reaction, injection site pain, irritability, excessive sweating, headache and breast enlargement in males. Uncommon, between 1 and 10 patients out of every 1000 patients treated: elevated values of some liver enzymes, anaphylactic reaction, testicular wasting, high blood pressure, decreased appetite, dry mouth, upper abdominal pain, asthma aggravated, weight changes, embolism, hair loss and reduced hair growth.

Not known, frequency cannot be estimated from the available data: • common cold • diabetes mellitus • gout • abdominal bloating • vertigo • constipation • diarrhoea • shortness of breath • injection site redness • influenza like symptoms • sleepiness • blurred vision • sensation of tingling, pricking or numbness • memory impairment • taste disturbances • visual impairment • abnormal sensation in eye • tinnitus • increased appetite • general discomfort • anxiety • loss of libido • dizziness • insomnia • chest pain • confusional state • chills • decreased activity • breast pain • fever • testicular pain • weakness • joint swelling • ejaculation failure • musculoskeletal stiffness • osteoarthritis • back pain • shortness of breath when lying flat • purple discoloration of skin • joint stiffness • musculoskeletal pain • pain in extremities • flatulence • muscular weakness • blisters • hives • angioedema (swelling that occurs under the skin) • muscle spasms • vomiting • itching • abdominal pain • acne • low blood pressure • rash • euphoric mood • nose bleeds • body temperature increased • difficulty in standing • oedema • elevated values of some liver and kidney enzymes • increased blood pressure • changes in ECG (QT prolongation) • injection site inflammation • pain

In Women:

Very common, more than 1 patient out of every 10 patients treated: decreased libido, mood changes, sleep disorder, hot flushes, abdominal pain, bone pain, excessive sweating, vaginal bleeding/spotting, vulvovaginal dryness, painful sexual intercourse, painful menstruation, enlargement of ovaries, pelvic pain, weakness and headache. Common, between 1 and 10 patients out of every 100 patients treated: allergic reaction, depressed mood, depression, nausea, muscle and joint pain, tiredness, injection site reaction, injection site pain, irritability. Uncommon, between 1 and 10 patients out of every 1000 patients treated: anaphylactic reaction, visual impairment, sensation of tingling, pricking or numbness, back pain, increased blood cholesterol, elevated values of some liver enzymes. Not known, frequency cannot be estimated from the available data: • abdominal discomfort • fever • heavy, prolonged and/or irregular periods • dizziness • angioedema (swelling that occurs under the skin) • blood pressure increased • loss of menstrual period • breast pain • loss of bone mineral leading to increased bone weakness • injection site redness • itching • rash • anxiety • general discomfort • diarrhoea • vomiting • vertigo • muscle weakness • blurred vision • hives • confusional state • shortness of breath • weight changes • muscle spasms • injection site inflammation

In Children:

Common, between 1 and 10 patients out of every 100 patients treated: mood changes, depression. Uncommon, between 1 and 10 patients out of every 1000 patients treated: in girls vaginal bleeding or discharge may occur. Nausea, vomiting and anaphylactic reaction have been seen. Not known, frequency cannot be estimated from the available data: • pain • headache • blurred vision • abdominal discomfort • genital haemorrhage • blood pressure increase • weight gain • Injection site pain, inflammation and redness • general discomfort • muscle pain • emotional lability • allergic reactions • nervousness • abdominal pain • visual impairment • nose bleeds • hot flushes • rash • hives • hair loss • angioedema (swelling that occurs under the skin) • redness • loosening or separation of growth zone of tubular bones • idiopathic intracranial hypertension (increased intracranial pressure around the brain characterised by headache, double vision and other visual symptoms, and ringing or buzzing in the ears) Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.