Patient Leaflet Updated 15-Jul-2024 | Grunenthal Ltd
Nebido 1000 mg/4 ml, solution for injection
Nebido 1000 mg/4 ml, solution for injection
Testosterone undecanoate
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
Nebido contains testosterone, a male hormone, as the active ingredient. Nebido is injected into a muscle in your body. There it can be stored and gradually released over a period of time. Nebido is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). These should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:
Nebido is not intended for use in women.
Talk to your doctor before using Nebido if you have or have ever had:
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:
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 inject Nebido (1 ampoule / vial) very slowly into a muscle. He/she will give you the injections every 10 to 14 weeks. This is enough to maintain sufficient testosterone levels without leading to a build-up of testosterone in the blood.
Nebido is strictly for intramuscular injection. Special care will be taken to avoid injection into a blood vessel (see “Administration”).
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:
Tell your doctor, if you have any of these. Your doctor will inject it less often or will stop treatment.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are acne and pain where the injection is given.
Common side effects (may affect up to 1 in 10 patients):
Uncommon side effects (may affect up to 1 in 100 patients):
Rare side effects (may affect up to 1 in 1000 patients):
Suspected anaphylactic reactions after Nebido injection have been reported.
In addition to the side effects listed above the following have been reported following treatment with preparations containing testosterone: 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).
Treatment with high doses of testosterone preparations commonly stops or reduces sperm production, although this returns to normal after treatment ceases. Testosterone replacement therapy of poorly functioning testicles (hypogonadism) can in rare cases cause 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).
For testosterone products in general a common risk of 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.
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.
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and the label after "EXP". The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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
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This leaflet was last revised in December 2023.
TOR Building, Saint Cloud Way, Maidenhead, Berkshire, SL6 8BN, UK
+44 (0)800 254 5540
http://www.grunenthal.co.uk
