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TESTOSTERONE UNDECANOATE 250 MG/ML SOLUTION FOR INJECTION

Active substance(s): TESTOSTERONE UNDECANOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

2716
04.12.15[3]

Nebido® 1000 mg/4 ml, solution for
injection
(Testosterone undecanoate)
Read all of this leaflet carefully before you are given this medicine.
- 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.
Your medicine is available using the above name, but will be referred to as
Nebido throughout this leaflet.
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:
- impotence
- infertility
- low sex drive
- tiredness
- depressive moods
- bone loss caused by low hormone levels
2. BEFORE YOU ARE GIVEN NEBIDO
Do NOT use Nebido
- if you are allergic to testosterone undecanoate or any of the other
ingredients of Nebido (see “What Nebido contains”)
- 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
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

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:
- 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
- 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.
Pregnancy and breast-feeding
Nebido is not for use in women and must not be used in pregnant or breastfeeding 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 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.
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.

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 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 a vial are to be injected intramuscularly immediately after
opening the 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 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.

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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nebido can cause side effects, although not everybody
gets them.

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.

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):
- abnormally high levels of blood cells
- weight gain
- hot flushes
- acne
- enlarged prostate and associated problems
- 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):
- allergic reaction
- increased appetite, changes in blood test results (eg 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 (eg itching, reddening, or dry skin)
- joint pain, pain in limbs, muscle problems (eg spasm, pain or stiffness), or
an increase in the blood substance creatine phosphokinase
- urinary tract disorders (eg decreased flow of urine, urinary retention, urge
to pass urine at night)
- 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
- 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.

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.

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
Each ml of solution contains 250mg Testosterone undecanoate equivalent
to 157.9mg Testosterone. One 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 available as a brown glass vial with a grey bromobutyl (foil clad
ETFE) injection stopper and brown bordered cap containing a clear
yellowish oily solution.
The contents of the packs are:
1 brown vial with 4 ml solution for injection.
Manufacturer
Manufactured by Bayer Pharma AG, D-13342 Berlin, Germany. Procured
from within the EU by Product Licence holder Star Pharmaceuticals Ltd, 5
Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL 20636/2716

Leaflet revision and issue date (Ref) 04.12.15[3]
Nebido is a trademark of Bayer Intellectual Property GmbH.

PACKAGE LEAFLET: INFORMATION FOR THE USER

2716
04.12.15[3]

Testosterone Undecanoate
250 mg/ml, solution for injection
Read all of this leaflet carefully before you are given this medicine.
- 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.
Your medicine is available using the above name, but will be referred to as
Testosterone Undecanoate throughout this leaflet.
In this leaflet:
1. What Testosterone Undecanoate is and what it is used for
2. Before you are given Testosterone Undecanoate
3. How to use Testosterone Undecanoate
4. Possible side effects
5. How to store Testosterone Undecanoate
6. Further information
1. WHAT TESTOSTERONE UNDECANOATE IS AND WHAT IT IS USED
FOR
Testosterone Undecanoate contains testosterone, a male hormone, as the
active ingredient. Testosterone Undecanoate is injected into a muscle in
your body. There it can be stored and gradually released over a period of
time.
Testosterone Undecanoate 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:
- impotence
- infertility
- low sex drive
- tiredness
- depressive moods
- bone loss caused by low hormone levels
2. BEFORE YOU ARE GIVEN TESTOSTERONE UNDECANOATE
Do NOT use Testosterone Undecanoate
- if you are allergic to testosterone undecanoate or any of the other
ingredients of Testosterone Undecanoate (see “What Testosterone
Undecanoate contains”)
- 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
Testosterone Undecanoate is not intended for use in women.
Testosterone Undecanoate is not for use in children and adolescents.
There is no data available on the use of Testosterone Undecanoate in
males under 18 years of age.
Warnings and precautions
Talk to your doctor before using Testosterone Undecanoate 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 Testosterone Undecanoate may cause severe complications in the
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 a vial are to be injected intramuscularly immediately after
opening the vial.
The medicinal product is for single use only and any unused solution
should be discarded.

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 Testosterone Undecanoate if you have ever had
a liver tumour (see “Do not use Testosterone Undecanoate”).
Testosterone Undecanoate is not suitable for building muscles in healthy
individuals or for increasing physical strength.
Testosterone Undecanoate 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
Testosterone Undecanoate, 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 Testosterone Undecanoate
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:
- the hormone ACTH or corticosteroids (used to treat various conditions
such as rheumatism, arthritis, allergic conditions and asthma):
Testosterone Undecanoate may increase the risk of water retention,
especially if your heart and liver are not working properly
- tablets that thin your blood (anticoagulants)
If you are diabetic, it may be necessary to adjust your insulin.
Testosterone Undecanoate may also affect the results of some laboratory
tests (e.g. thyroid gland). Tell your doctor or the laboratory staff that you are
using Testosterone Undecanoate.
Pregnancy and breast-feeding
Testosterone Undecanoate 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
Testosterone Undecanoate has no effect on your ability to drive or use
machines.
3. HOW TO USE TESTOSTERONE UNDECANOATE
Your doctor will inject Testosterone Undecanoate (1 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 buildup of testosterone in the blood.
Testosterone Undecanoate is strictly for intramuscular injection. Special
care will be taken to avoid injection into a blood vessel.
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.

Administration
Special care must be given to avoid intravasal injection.
As with all oily solutions, Testosterone Undecanoate 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 Testosterone Undecanoate
injection have been reported.

Maintaining your Testosterone Undecanoate 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 Testosterone Undecanoate is too strong or too
weak, talk to your doctor.
If you used more Testosterone Undecanoate than you should
Symptoms of having too much Testosterone Undecanoate 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Testosterone Undecanoate can cause side effects,
although not everybody gets them.

Suspected anaphylactic reactions after Testosterone Undecanoate 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 TESTOSTERONE UNDECANOATE
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.

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):
- abnormally high levels of blood cells
- weight gain
- hot flushes
- acne
- enlarged prostate and associated problems
- 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):
- allergic reaction
- increased appetite, changes in blood test results (eg 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 (eg itching, reddening, or dry skin)
- joint pain, pain in limbs, muscle problems (eg spasm, pain or stiffness), or
an increase in the blood substance creatine phosphokinase
- urinary tract disorders (eg decreased flow of urine, urinary retention, urge
to pass urine at night)
- 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
- tiredness, general feeling of weakness, excessive sweating, or night
sweats
The oily liquid Testosterone Undecanoate 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.

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.

Do not use Testosterone Undecanoate 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 Testosterone Undecanoate contains
Each ml of solution contains 250mg Testosterone undecanoate equivalent
to 157.9mg Testosterone. One vial contains 1000 mg testosterone
undecanoate.
The other ingredients are benzyl benzoate and refined castor oil.
What Testosterone Undecanoate looks like and contents of the pack
Testosterone Undecanoate is available as a brown glass vial with a grey
bromobutyl (foil clad ETFE) injection stopper and brown bordered cap
containing a clear yellowish oily solution.
The contents of the packs are:
1 brown vial with 4 ml solution for injection.
Manufacturer
Manufactured by Bayer Pharma AG, D-13342 Berlin, Germany. Procured
from within the EU by Product Licence holder Star Pharmaceuticals Ltd, 5
Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL 20636/2716

Leaflet revision and issue date (Ref) 04.12.15[3]

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.

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