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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.
5 Keep this leaflet. You may need to read it
again.
5 If you have any further questions, ask your
doctor.
5 This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
5 If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor.
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:
5 impotence
5 infertility
5 low sex drive
5 tiredness
5 depressive moods
5 bone loss caused by low hormone levels

2. BEFORE YOU ARE GIVEN NEBIDO
Do NOT use Nebido
5 if you are allergic to testosterone undecanoate
or any of the other ingredients of Nebido (see
“What Nebido contains”)
5 if you have ever had androgen-dependent cancer
or suspected cancer of the prostate or of the
breast
5 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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Take special care with Nebido
Tell your doctor if you have or have ever had:
5 epilepsy
5 heart, kidney or liver problems
5 migraine
5 temporary interruptions in your breathing
during sleep (apnoea), as these may get worse
5 cancer, as the level of calcium in your blood
may need to be tested regularly
5 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.
Using other medicines
Tell your doctor or pharmacist if you are using or
have recently used 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:
5 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
5 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 OPC (One-PointCut) 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:
5 irritability
5 nervousness
5 weight gain
5 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. If any of the
side effects gets serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or
pharmacist.
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):
5 abnormally high levels of blood cells
5 weight gain
5 hot flushes
5 acne
5 enlarged prostate and associated problems
5 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):
5 allergic reaction
5 increased appetite, changes in blood test results
(eg increased blood sugars or fats)
5 depression, emotional disorder, insomnia,
restlessness, aggression, or irritability
5 headache, migraine, or tremor
5 cardiovascular disorder, high blood pressure, or
dizziness
5 bronchitis, sinusitis, cough, shortness of breath,
snoring, or voice problems
5 diarrhoea, or nausea
5 changes in liver test results
5 hair loss, or various skin reactions (eg itching,
reddening, or dry skin)
5 joint pain, pain in limbs, muscle problems (eg
spasm, pain or stiffness), or an increase in the
blood substance creatine phosphokinase
5 urinary tract disorders (eg decreased flow of
urine, urinary retention, urge to pass urine at
night)
5 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
5 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 longterm administration of testosterone occasionally
increases the occurrences of water retention and
oedema (swelling due to fluid retention).

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
5 The active substance is testosterone
undecanoate 250 mg/ml (corresponding to 157.9
mg testosterone). One ampoule/vial contains
1000 mg testosterone undecanoate.
5 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:
5 Cyprus, Czech Republic, Greece, Denmark,
Estonia, Latvia, Luxembourg, Malta, Poland and
Portugal: Nebido
5 Austria: Nebido 1000 mg/4 ml
Injektionslösung
5 Belgium: Nebido 1000 mg/4 ml, oplossing
voor injectie
5 Finland: Nebido 1000 mg/4 ml injektioneste,
liuos
5 France: Nebido 1000 mg/4 ml, solution
injectable
5 Germany: Nebido 1000 mg Injektionslösung
5 Hungary: Nebido 250 mg/ml oldatos injekció
5 Iceland: Nebido 1000 mg/4 ml stungulyf,
lausn
5 Italy: NEBID 1000 mg/4ml soluzione
iniettabile
5 Lithuania: Nebido 1000 mg/4 ml injekcinis
tirpalas
5 Netherlands: Nebido 1000 mg/4 ml
5 Norway: Nebido 1000 mg/4 ml
injeksjonsvæske, oppløsning
5 Slovak Republic: Nebido 1000 mg/4 ml
injekûný roztok
5 Slovenia: Nebido 1000 mg/4 ml raztopina za
injiciranje
5 Spain: REANDRON 1000 MG/ 4 ML SOLUCIÓN
INYECTABLE
5 Sweden: Nebido, 1000 mg/4 ml
injektionsvätska, lösning
5 UK and Ireland: Nebido 1000mg/4ml, solution
for injection
This leaflet was revised in April 2012

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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