Talk to your doctor before taking this medicine, if you:

• are allergic to testosterone undecanoate or any of the other ingredients of this medicine
• have androgen-dependent cancer or suspected cancer of the prostate or of the breast
• have or ever had epilepsy
• have heart, kidney or liver problems
• suffer from migraine
• suffer from temporary interruptions in your breathing during sleep (apnoea)
• suffer from cancer
• have high blood pressure
• have blood clotting problems

• TESTOKI is not for use in women and must not be used in pregnant or breast-feeding women

NA

• TESTOKI has no observed effect on your ability to drive or use machines

NA

• abnormally high levels of red blood cells
• weight gain
• hot flushes
• acne
• enlarged prostate and associated problems
• pain, bruising or irritation at the injection site

• increased appetite, changes in blood test results (e.g. increased blood sugars or fats)
• depression, emotional disorder, insomnia, restlessness, aggression or irritability
• headache, migraine, or tremor
• cardiovascular disorder, high blood pressure, or dizziness
• bronchitis, sinusitis, cough, shortness of breath, snoring, or voice problems
• diarrhea or nausea
• hair loss or various skin reactions (e.g. itching, reddening, or dry skin)
• joint pain, pain in limbs, muscle problems (e.g. spasm, pain or stiffness) or an increased creatine phosphokinase in the blood
• urinary tract disorders (e.g. decreased flow of urine, urinary retention, urge to pass urine at night)
• prostatic disorders (e.g. prostatic intraepithelial neoplasia or hardening or inflammation of the prostate), changes in sexual appetite, painful testicles, painful, hardened or enlarged breasts, or increased levels of male and female hormones
• tiredness, general feeling of weakness, excessive sweating or night sweats

• cough, shortness of breath, feeling generally unwell, excessive sweating, chest pain, dizziness, pins and needles, or fainting
• nervousness, hostility, brief interruptions in breathing during sleep
• various skin reactions including dandruff and oily skin, increased hair growth, more frequent erections, and very rare cases of yellowing of the skin and eyes (jaundice)
• persistent, painful erections (priapism)
• high-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema (swelling due to fluid retention)
• increased red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), were observed by periodic blood tests

NA

Medical examination/Follow-up

• Male hormones may increase the growth of prostate cancer and enlarged prostate glands (benign prostatic hypertrophy). Before your doctor injects TESTOKI, he/she will examine you to check that you do not have prostate cancer
• Your doctor will regularly examine your prostate and breast, especially if you are elderly
• He/she will also take regular blood samples
• Following the use of hormonal substances such as androgen compounds, cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed to occur

• Keep this medicine out of reach of children
• Do not use this medicine after the expiry date
• Store at room temperature (15-25C)