Skip to Content

UK Edition. Click here for US version.



View full screen / Print PDF » Download PDF ⇩
Mock up 

To include "POM" on the leaflet.
Previously assessed against UK PIL dated August 2015.

► tablets that thin your blood (anticoagulants)
If you are diabetic, it may be necessary to adjust your insulin.
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.


1000mg/4ml solution for injection
(testosterone undecanoate)
Read all of this leaflet carefully before you are given this
medicine because it contains important information for
► 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.
The name of your medicine is Nebido 1000mg/4ml solution for
injection but will be referred to as Nebido throughout this
What is in this leaflet:
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
1. What Nebido is and what it is used for
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
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:

low sex drive
depressive moods
bone loss caused by low hormone levels

2. What you need to know before you are given
Do NOT use Nebido
► if you are allergic to testosterone undecanoate or any of
the other ingredients of this medicine (listed in section 6)
► if you have ever had androgen-dependent cancer or
suspected cancer of the prostate or of the breast
► if you have or have ever had a liver tumour

By Aneela Mahmood at 4:07 pm, May 24, 2016

Nebido is not intended for use in women.
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.
Warnings and precautions
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
► blood clotting problems
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.
Tell your doctor if you have high blood pressure or if you
are treated for high blood pressure, as testosterone may
cause a rise in blood pressure.
If your liver is not working
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’).
Elderly patients (65 years or older)
There is no need for your doctor to adjust the dose if you are
over 65 (see ‘Medical examination/follow up’).
Muscle building and drug tests
Nebido is not suitable for building muscles in healthy
individuals or for increasing physical strength.
Nebido might lead to positive results in drug tests.
Medical examination/Follow-up
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.
Other medicines and Nebido
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:

Pregnancy, breast-feeding and fertility
Nebido is not for use in women and must not be used in
pregnant or breast-feeding women.
Testosterone replacement therapy may reversibly reduce
Driving and using machines
Nebido has no effect on your ability to drive or use machines.
3. How to use Nebido
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
Nebido is strictly for intramuscular injection. Special care will
be taken to avoid injection into a blood vessel (see ‘Notes on
handling the OPC (One-Point-Cut) ampoule’).
Start of treatment
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
Maintaining your Nebido levels during treatment
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.
If you used more Nebido than you should
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.

► 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

The following information is intended for medical or
healthcare professionals only:
The solution for intramuscular injection is to be visually
inspected prior to use and only clear solutions free from
particles should be used.
The contents of an ampoule / vial are to be injected
intramuscularly immediately after opening the ampoule / vial.
The medicinal product is for single use only and any unused
solution should be discarded.
Special care must be given to avoid intravasal injection.
As with all oily solutions, Nebido must be injected strictly
intramuscularly and very slowly.

Pulmonary microembolism of oily solutions can in rare cases
lead to signs and symptoms such as cough, dyspnoea,
malaise, hyperhidrosis, chest pain, dizziness, paraesthesia,
or syncope. These reactions may occur during or immediately
after the injection and are reversible. Treatment is usually
supportive, e.g. by administration of supplemental oxygen.
Suspected anaphylactic reactions after Nebido injection have
been reported.
Careful and regular monitoring of the prostate gland and
breast must be performed in accordance with recommended
methods (digital rectal examination and estimation of serum
PSA) in patients receiving testosterone therapy at least once
yearly and twice yearly in elderly patients and at risk patients
(those with clinical or familial factors).

Besides laboratory tests of the testosterone concentrations in
patients on long-term androgen therapy the following
laboratory parameters should be checked periodically:
haemoglobin, haematocrit, and liver function tests and lipid
In patients suffering from severe cardiac, hepatic or renal
insufficiency or ischaemic heart disease, treatment with
testosterone may cause severe complications characterised
by oedema with or without congestive cardiac failure. In such
case, treatment must be stopped immediately.

4. Possible side effects
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):
► abnormally high levels of red blood cells
► weight gain
► hot flushes
► acne
► enlarged prostate and associated problems
► various reactions where the injection was given (e.g. pain,
bruising, or irritation)
Uncommon side effects (may affect up to 1 in 100 patients):
► allergic reaction
► 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
► diarrhoea, or nausea
► changes in liver test results
► 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 increase in the blood substance
creatine phosphokinase
► 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
► tiredness, general feeling of weakness, excessive
sweating, or night sweats
The oily liquid Nebido may reach the lungs (pulmonary
microembolism of oily solutions) which can in rare cases lead
to signs and symptoms such as cough, shortness of breath,
feeling generally unwell, excessive sweating, chest pain,
dizziness, ‘pins and needles’, or fainting. These reactions may
occur during or immediately after the injection and are
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, more frequent erections, and very rare
cases of yellowing of the skin and eyes (jaundice).

Notes on handling the OPC (One-Point-Cut) ampoule:
There is a pre-scored mark beneath the coloured point on the
ampoule eliminating the need to file the neck. Prior to
opening, ensure that any solution in the upper part of the
ampoule flows down to the lower part. Use both hands to
open; while holding the lower part of the ampoule in one
hand, use the other hand to break off the upper part of the
ampoule in the direction away from the coloured point.

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store Nebido
Keep out of the sight and reach of children
This medicinal product does not require any special
storage conditions.
Do not take your Nebido after the expiry date which is
stated on the carton and vial labels after ‘Exp’. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Nebido contains
Each 1ml contains testosterone undecanoate 250 mg
(equivalent to 157.9mg testosterone). Also contains benzyl
benzoate and refined castor oil for parenteral use.
What Nebido looks like and contents of the pack
Nebido is a clear, yellowish oily solution for injection.
Each pack contains 1 × 4ml vial with solution for injection.
Manufacturer by:
BAYER PNARMA AG, D -13342 Berlin, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Nebido 1000mg/4ml solution for injection;
PL 18799/2866
Leaflet date: 23.05.2016


Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.