Nebido
1000 mg/4 ml, solution for injection
Testosterone undecanoate
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 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:
R impotence
R infertility
R low sex drive
R tiredness
R depressive moods
R bone loss caused by low hormone levels
2. What you need to know before you are
given Nebido
Do NOT use Nebido
R if you are allergic to testosterone
undecanoate or any of
the other ingredients of this medicine (listed
in
section 6)
R if you have androgen-dependent cancer or
suspected
cancer of the prostate or of the breast
R if you have or 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:
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
R 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
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 following information is intended for
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
85065211_06.indd 1
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 use more Nebido than you should
Symptoms of having too much Nebido include:
R irritability
R nervousness
&
Read all of this leaflet carefully before you
are given
this medicine because it contains important
information for you.
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.
the risk of water retention, especially if
your heart and
liver are not working properly
R blood-thinning tablets (coumarin derived
oral
anticoagulants) since this can increase the
risk of
bleeding. Your doctor will check the dose.
R 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.
Fertility
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.
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.
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 and
lipid profile.
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.
05.04.2016 07:35:57
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):
R abnormally high levels of red blood cells
R weight gain
R hot flushes
R acne
R enlarged prostate and associated problems
R various reactions where the injection was
given (e.g.
pain, bruising, or irritation)
Uncommon side effects (may affect up to 1 in
100 patients):
R allergic reaction
R increased appetite, changes in blood test
results (e.g.
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 (e.g.
itching,
reddening, or dry skin)
R joint pain, pain in limbs, muscle problems
(e.g. spasm,
pain or stiffness), or an increased creatine
phosphokinase in the blood
R urinary tract disorders (e.g. decreased flow
of urine,
urinary retention, urge to pass urine at night)
R 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
R tiredness, general feeling of weakness,
excessive
sweating, or night sweats
Rare side effects (may affect up to 1 in 1000
patients):
R 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
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).
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 or pharmacist.
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 this medicine out of the sight and reach
of children.
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.
6. Contents of the pack and other
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
(corresponding to 631.5 mg testosterone).
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 Croatia: Nebido 1000 mg/4 ml otopina za
injekciju
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 January 2016
&
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.
&
Notes on handling the OPC (One-PointCut)
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.
85065211_06.indd 2
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).
