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Package leaflet: Information for the user

Nebido® 1000 mg/4 ml, solution for injection
(testosterone undecanoate)
Read all of this leaflet carefully before you are
given this medicine because it contains
important information for you.
> Keep this leaflet. You may need to read it
> If you have any further questions, ask your
> 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.
> This medicine is called Nebido 1000 mg/4ml,
solution for injection but will be referred to as
Nebido throughout this leaflet.
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
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 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:
> impotence
> infertility
> low sex drive
> tiredness
> depressive moods
> bone loss caused by low hormone levels

heart, kidney or liver problems
temporary interruptions in your breathing
during sleep (apnoea), as these may get
> cancer, as the level of calcium in your blood
may need to be tested regularly
> blood clotting problems
> high blood pressure or if you are treated for
high blood pressure, as testosterone may
cause a rise in blood pressure.

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.
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
2. What you need to know before you are
blood samples.
given Nebido
Following the use of hormonal substances such
as androgen compounds, cases of benign (nonDo NOT use Nebido
cancerous) and malignant (cancerous) liver
> if you are allergic to testosterone undecanoate tumours have been observed to occur.
or any of the other ingredients of this medicine
Other medicines and Nebido
(listed in section 6)
Tell your doctor or pharmacist if you are using
> if you have androgen-dependent cancer or
or have recently used or might use any other
suspected cancer of the prostate or of the
medicines, including medicines obtained without
a prescription. The doctor may need to adjust the
> if you have or had a liver tumour
dose if you are using any of the following:
Nebido is not intended for use in women.
> the hormone ACTH or corticosteroids (used to
Nebido is not for use in children and
treat various conditions such as rheumatism,
adolescents. There is no data available on the
arthritis, allergic conditions and asthma):
use of Nebido in males under 18 years of age.
Nebido may increase the risk of water
Warnings and precautions
retention, especially if your heart and liver are
Talk to your doctor before using Nebido if you
not working properly
have or have ever had:
> blood-thinning tablets (coumarin derived oral

The following information is intended for
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.

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
Careful and regular monitoring of the prostate
gland and breast must be performed in
accordance with recommended methods (digital
Special care must be given to avoid intravasal
rectal examination and estimation of serum PSA)
As with all oily solutions, Nebido must be injected in patients receiving testosterone therapy at least
once yearly and twice yearly in elderly patients
strictly intramuscularly and very slowly.

anticoagulants) since this can increase the
risk of bleeding. Your doctor will check the
> 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.
Pregnancy and breast-feeding
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”).
Driving and using machines
Nebido has no observed 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 blood.
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 levels.
Maintaining your Nebido levels during
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 use more Nebido than you should
Symptoms of having too much Nebido include:
> irritability
> nervousness
> weight gain
> long-lasting or frequent erections

and at risk patients (those with clinical or familial
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.

Tell your doctor, if you have any of these. Your
doctor will inject it less often or will stop
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
> 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 increased
creatine phosphokinase in the blood
> urinary tract disorders (e.g. decreased flow of
urine, urinary retention, urge to pass urine at
> 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
Rare side effects (may affect up to 1 in 1000
> 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 reversible.
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

Notes on handling the vial
The vial is for single use only. The
content of a vial is to be injected
intramuscularly immediately after
drawing up into the syringe. After
removal of the plastic cap (A) do
not remove the metal ring (B) or the
crimp cap (C).

cases of yellowing of the skin and eyes
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). Highdosed or long-term administration of testosterone
occasionally increases the occurrences of water
retention and oedema (swelling due to
fluid retention).

Bayer Pharma AG
D – 13342 Berlin
Procured from within the EU and repackaged
by the Product Licence holder:
Shakespeare Pharma Ltd., 1B Harrison Court,
Hilton Business Park, Hilton, DE65 5UR, UK.
Nebido 1000mg/4ml, solution for injection
PL 40593/0053


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.

This leaflet was last revised on
29th November 2016

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 at: By
reporting side effects you can help provide more
information on the safety of this medicine.

Leaflet code: NEB/1/GR/PIL

5. How to store Nebido
Keep this medicine out of the sight and reach of
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.
If your medicine shows visible signs of
deterioration, show it to your pharmacist who will
advise you what to do.
6. Contents of the pack and other information
What Nebido contains
The active substance is testosterone
undecanoate. Each ml of solution contains
250 mg testosterone undecanoate equivalent to
157.9 mg testosterone.
Also contains benzyl benzoate and refined castor
What Nebido looks like and contents of the
Nebido is a clear, yellowish oily solution for
The contents of the packs are:
1 brown glass vial with 4 ml solution for injection.

Nebido® is registered trademark of Bayer
Intellectual Property GmbH.

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