• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Nebido is and what it is used for
2. What you need to know before you are given Nebido
3. How to use Nebido
4. Possible side effects
5. How to store Nebido
6. Contents of the pack and other information

• if you are allergic to testosterone undecanoate or any of the other ingredients of this medicine (listed in section 6)
• if you have androgen-dependent cancer or suspected cancer of the prostate or of the breast
• if you have or had a liver tumour

Nebido is not intended for use in women.

Talk to your doctor before using Nebido if you have or have ever had:

• epilepsy
• heart, kidney or liver problems
• migraine
• temporary interruptions in your breathing during sleep (apnoea), as these may get worse
• cancer, as the level of calcium in your blood may need to be tested regularly
• high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure
• blood clotting problems
  • bleeding disorders (i.e. haemophilia)
  • thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis - blood clots in blood vessels).
  • factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50); or as you get older.
    How to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g. turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.

If you are suffering from severe heart, liver or kidney disease, treatment with Nebido may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.

The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.

No formal studies have been performed in patients with liver impairment. You will not be prescribed Nebido if you have ever had a liver tumour (see “Do not use Nebido”).

Nebido is not for use in children and adolescents. There is no data available on the use of Nebido in males under 18 years of age.

There is no need for your doctor to adjust the dose if you are over 65 (see “Medical examination/follow-up”).

Nebido is not suitable for building muscles in healthy individuals or for increasing physical strength.

Nebido might lead to positive results in drug tests.

Always take this medicine exactly as your doctor or pharmacist has told you.

Abuse of testosterone, especially if you take too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver.

Individuals who have abused testosterone may become dependent and may experience withdrawal symptoms when the dosage changes significantly or is stopped immediately.

You should not abuse this medicine alone or with other anabolic androgenic steroids because it carries serious health risks. (See "Possible side effects".)

Male hormones may increase the growth of prostate cancer and enlarged prostate glands (benign prostatic hypertrophy). Before your doctor injects Nebido, 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.

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including medicines obtained without a prescription. The doctor may need to adjust the dose if you are using any of the following:

• the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma): Nebido may increase the risk of water retention, especially if your heart and liver are not working properly
• blood-thinning tablets (coumarin derived oral anticoagulants) since this can increase the risk of bleeding. Your doctor will check the dose
• medicines used to treat diabetes. It may be necessary to adjust the dose of your blood sugar reducing medicine. Like other androgens, testosterone may increase the effect of insulin.

Please be sure to inform your doctor if you suffer from a disturbance of blood clotting, because this is important for your doctor to know before deciding to inject Nebido.

Nebido may also affect the results of some laboratory tests (e.g. thyroid gland). Tell your doctor or the laboratory staff that you are using Nebido.

Nebido is not for use in women and must not be used in pregnant or breast-feeding women.

Treatment with high doses of testosterone preparations commonly may reversibly stop or reduce sperm production (see also under “Possible side effects”).

Nebido has no observed effect on your ability to drive or use machines.

This medicine contains 2000 mg benzyl benzoate in each 4 ml ampoule/vial which is equivalent to 500 mg/ml.

Your doctor will measure your blood testosterone levels before starting treatment and during the early stages of treatment. Your doctor may give you the second injection after only six weeks in order to quickly reach the necessary testosterone level. This will depend on your symptoms and testosterone levels.

The injection interval should always be within the recommended range of 10 to 14 weeks. Your doctor will measure your testosterone levels regularly at the end of an injection interval to make sure it is at the right level. If the level is too low, your doctor may decide to give you injections more often. If your testosterone levels are high, your doctor may decide to give you injections less often. Do not miss your injection appointments. Otherwise, your optimum level of testosterone will not be maintained.

If you think that the effect of Nebido is too strong or too weak, talk to your doctor.

Symptoms of having too much Nebido include:

• irritability
• nervousness
• weight gain
• long-lasting or frequent erections

Tell your doctor, if you have any of these. Your doctor will inject it less often or will stop treatment.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is testosterone undecanoate 250 mg/ml (corresponding to 157.9 mg testosterone). One ampoule / vial contains 1000 mg testosterone undecanoate (corresponding to 631.5 mg testosterone).

The other ingredients are benzyl benzoate and refined castor oil.

Nebido is a clear, colourless to yellowish-brown oily liquid. The contents of the packs are:

1 brown glass ampoule / brown glass vial with 4 ml solution for injection

Marketing Authorisation Holder

Manufacturer's

Or