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NEBIDO 1000MG/4ML SOLUTION FOR INJECTION

Active substance: TESTOSTERONE UNDECANOATE

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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.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your doctor.
R 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.
R If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. See section 4.
In this leaflet:
1. What Nebido is and what it is used for
2. Before you are given Nebido
3. How to use Nebido
4. Possible side effects
5. How to store Nebido
6. Further 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 include:
R impotence
R infertility
R low sex drive
R tiredness
R depressive moods
R bone loss caused by low hormone levels

2. BEFORE YOU ARE GIVEN NEBIDO
Do NOT use Nebido
R if you are allergic to testosterone undecanoate or any of
the other ingredients of Nebido (see “What Nebido
contains”)
R if you have ever had androgen-dependent cancer or
suspected cancer of the prostate or of the breast
R if you have or have ever had a liver tumour
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.

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.
Administration
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

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Warnings and precautions
Talk to your doctor before using Nebido if you have or
have ever had:
R epilepsy
R heart, kidney or liver problems
R migraine
R temporary interruptions in your breathing during sleep
(apnoea), as these may get worse
R cancer, as the level of calcium in your blood may need to
be tested regularly
R 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.
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”).
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”).
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:
R 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
R tablets that thin your blood (anticoagulants)
If you are diabetic, it may be necessary to adjust your
insulin.

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.

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.
Testosterone replacement therapy may reversibly reduce
spermatogenesis.
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
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 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:
R irritability
R nervousness
R weight gain
R 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.

Warnings
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.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Nebido 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 (between 1 and 10 in every
100 patients are likely to get these):
R abnormally high levels of blood cells
R weight gain
R hot flushes
R acne
R enlarged prostate and associated problems
R various reactions where the injection was given (eg pain,
bruising, or irritation)
Uncommon side effects (between 1 and 10 in every
1000 patients are likely to get these):
R allergic reaction
R increased appetite, changes in blood test results (eg
increased blood sugars or fats)
R depression, emotional disorder, insomnia, restlessness,
aggression, or irritability
R headache, migraine, or tremor
R cardiovascular disorder, high blood pressure, or
dizziness
R bronchitis, sinusitis, cough, shortness of breath,
snoring, or voice problems
R diarrhoea, or nausea
R changes in liver test results
R hair loss, or various skin reactions (eg itching,
reddening, or dry skin)
R joint pain, pain in limbs, muscle problems (eg spasm,
pain or stiffness), or an increase in the blood substance
creatine phosphokinase
R urinary tract disorders (eg decreased flow of urine,
urinary retention, urge to pass urine at night)
R prostatic disorders (eg 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
R 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 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, 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).
Reporting of side effects
If you get any side effects, talk to your doctor or 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: www.mhra.gov.uk/yellowcard.
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 reach and sight of children.
This medicinal product does not require any special storage
conditions.
Do not use Nebido 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.
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. FURTHER INFORMATION
What Nebido contains
The active substance is testosterone undecanoate
250 mg/ml (corresponding to 157.9 mg testosterone). One
ampoule / vial contains 1000 mg testosterone undecanoate.
The other ingredients are benzyl benzoate and refined
castor oil.
What Nebido looks like and contents of the pack
Nebido is a clear, yellowish oily liquid. The contents of the
packs are:
1 brown glass ampoule / brown glass vial with 4 ml solution
for injection

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
United Kingdom
Manufacturer
Bayer Pharma AG
D – 13342 Berlin
Germany
This medicinal product is authorised in the Member States
of the EEA under the following names:
R Cyprus, Czech Republic, Greece, Denmark, Estonia,
Latvia, Luxembourg, Malta, Poland and Portugal:
Nebido
R Austria: Nebido 1000 mg/4 ml Injektionslösung
R Belgium: Nebido 1000 mg/4 ml, oplossing voor
injectie
R Finland: Nebido 1000 mg/4 ml injektioneste, liuos
R France: Nebido 1000 mg/4 ml, solution injectable
R Germany: Nebido 1000 mg Injektionslösung
R Hungary: Nebido 250 mg/ml oldatos injekció
R Iceland: Nebido 1000 mg/4 ml stungulyf, lausn
R Italy: NEBID 1000 mg/4ml soluzione iniettabile
R Lithuania: Nebido 1000 mg/4 ml injekcinis tirpalas
R Netherlands: Nebido 1000 mg/4 ml
R Norway: Nebido 1000 mg/4 ml injeksjonsvæske,
oppløsning
R Slovak Republic: Nebido 1000 mg/4 ml injekčný roztok
R Slovenia: Nebido 1000 mg/4 ml raztopina za
injiciranje
R Spain: REANDRON 1000 MG/ 4 ML SOLUCIÓN
INYECTABLE
R Sweden: Nebido, 1000 mg/4 ml injektionsvätska,
lösning
R UK and Ireland: Nebido 1000mg/4ml, solution for
injection
This leaflet was last revised in July 2014

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.

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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.

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