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SUPREFACT 1MG/ML INJECTION

Active substance(s): BUSERELIN ACETATE

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528235

5. How to store Suprefact Injection

• Hair grows more than normal (including
body and facial hair)
• Hair loss (including body or facial hair)
• Splitting of nails
• Increase in breast size or breast tenderness
• Changes in the level of liver enzymes, fats
(lipids) and a substance called ‘bilirubin’ in
the blood shown up in blood tests
• Frequency not known: changes in ECG
(QT prolongation)
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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.

Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Suprefact Injection after the expiry
date which is stated on the label and carton.
The expiry date refers to the last day of that
month. Once opened use within 15 days.
Do not store above 25°C. Do not freeze.
Keep the vials in the outer carton in order to
protect from light.
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. Contents of the pack and other
information

What Suprefact Injection contains
• Each 1 ml contains 1 milligram of the active
substance, buserelin as buserelin acetate
• The other ingredients are, sodium chloride,
sodium dihydrogen phosphate, sodium
hydroxide, benzyl alcohol and water for
injections

Manufacturer
Sanofi-Aventis Deutschland GmbH,
Industriepark Höchst,
65926 Frankfurt am Main,
Germany
This leaflet does not contain all the
information about your medicine. If you have
any questions or are not sure about anything,
ask your doctor or pharmacist.
This leaflet was last revised in
November 2014.
© sanofi, 1986 – 2014
528235

SAP-Nr. (DMC): 528235

SRZ-Nr.: 508940

INFORMATION FOR THE USER

Suprefact® 1mg/ml
Injection
Buserelin acetate

Schriftgröße: 9 Punkt

Druckfarben: Pantone Reflex Blue

What is in this leaflet
1. What Suprefact Injection is and what it is
used for
2. What you need to know before you use
Suprefact Injection
3. How to use Suprefact Injection
4. Possible side effects
5. How to store Suprefact Injection
6. Contents of the pack and other information
1. What Suprefact Injection is and
what it is used for

What Suprefact Injection looks like and
contents of the pack
Suprefact Injection is available in boxes
containing two multidose vials. Each vial
contains 5.5 milligrams of solution.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

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PACKAGE LEAFLET:

Is this leaflet hard
to see or read?
Phone 0845 372 7101
for help
Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• 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.
• If any of the side effects gets serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

Format 420 x 148 mm

Suprefact Injection contains a medicine called
buserelin acetate. This belongs to a group of
medicines called gonadotropin releasing
hormone analogues. This is a synthetic
version of a hormone that occurs naturally in
the body. It works by lowering the production
of sex hormones.
It is used to treat prostate cancer by lowering
the amount of the hormone ‘testosterone’.
2. What you need to know before you
use Suprefact Injection

Before using Suprefact, your doctor should
assess your risk of developing diseases of
heart and blood vessels (cardiovascular
disease), diabetes mellitus and anaemia. If
you develop any of the above, you should be
monitored and treated accordingly.
Do not use this medicine and tell your
doctor if:
× You are allergic (hypersensitive) to:
– buserelin
– other similar medicines such as goserelin

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– any of the other ingredients of Suprefact
Injection (listed in Section 6 below)
• Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
× You have had an operation to remove your
testicles
× You have a tumour that is not affected
by changes in hormone levels
× This medicine is intended for men only.
Another presentation is available for
women. It is important that these medicines
are not used during pregnancy or breastfeeding.
Do not use if any of the above apply to you. If
you are not sure, talk to your doctor or
pharmacist before using Suprefact Injection.
Take special care with Suprefact
Injection
Check with your doctor or pharmacist
before using your medicine if:
s You have depression. There have been
reports of depression in patients using
Suprefact Injection which may be severe. If
you are using Suprefact Injection and
develop depressed mood, inform your
doctor
s You have high blood pressure. Your blood
pressure must be checked regularly
s You have diabetes. You should check your
blood glucose levels regularly

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s You have metabolic bone disease or have
additional risk factors for osteoporosis such
as chronic alcohol abuse, smoking, a family
history of osteoporosis or are on long term
therapy with anticonvulsants or
corticosteroids
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using Suprefact Injection.
Warnings and precautions
Please tell your doctor if you have any of the
following:
Any heart or blood vessel conditions,
including heart rhythm problems
(arrhythmia), or are being treated with
medicines for these conditions. The risk of
heart rhythm problems may be increased
when using Suprefact Injection.
Other medicines and Suprefact
Injection
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Suprefact Injection
can affect the way some other medicines
work. Also some medicines can affect the way
Suprefact Injection works.
In particular, tell your doctor or pharmacist if
you are taking the following:
• medicines for diabetes

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SAP-Nr. (DMC): 528235

Suprefact Injection might interfere with some
medicines used to treat heart rhythm
problems (e.g. quinidine, procainamide,
amiodarone and sotalol) or might increase the
risk of heart rhythm problems when used with
some other drugs(e.g. methadone (used for
pain relief and part of drug addiction
detoxification), moxifloxacin (an antibiotic),
antipsychotics used for serious mental
illnesses).
Pregnancy and breast-feeding
This medicine is intended for use in men.
However, there is another type of this
medicine which can be used in women.
Women should not use either type of this
medicine if they are pregnant or breast
feeding.

Driving and using machines
You may feel dizzy, drowsy or have blurred
eyesight while using this medicine. If this
happens, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Suprefact Injection
Suprefact injection contains:
• Benzyl alcohol. It must not be given to
premature or newborn babies. Benzyl
alcohol may cause toxic reactions and
allergic reactions in infants and children up
to 3 years old.

SRZ-Nr.: 508940

3. How to use Suprefact Injection

Suprefact Injection is normally given by a
doctor or nurse. This is because it needs to be
given as an injection underneath the skin
(subcutaneous injection).
How much Suprefact Injection is given
If you are not sure why you are being given
Suprefact Injection or have any questions
about how much Suprefact Injection is being
given to you, speak to your doctor or nurse.
• 0.5ml of Suprefact Injection will be given to
you every 8 hours for 7 days
• After 7 days of treatment, you will be given
the nasal spray
If you have more Suprefact Injection than
you should
It is unlikely that your doctor or nurse will
give you too much medicine. Your doctor and
nurse will monitor your progress by testing
your blood at regular intervals and check the
medicine you are given. Always ask if you are
not sure why you are getting a dose of
medicine.
The following effects may occur: feeling weak,
headache, feeling nervous, hot flushes, feeling
dizzy, feeling sick, stomach pain, swelling of
the legs and breast pain. You may also have
pain, bleeding or hardening of the skin at the
site of injection.
If you miss a dose of Suprefact Injection
Your doctor or nurse will have instructions on
when to give you this medicine. It is unlikely
that you will not be given the medicine as it
has been prescribed. However, if you do think
you have missed a dose, tell your doctor or
nurse.

Schriftgröße: 9 Punkt

Druckfarben: Pantone Reflex Blue

If you are injecting this medicine yourself and
you forget a dose, take it as soon as you
remember it. However, if it is nearly time for
the next dose, skip the missed dose. Do not
take a double dose to make up for a forgotten
dose.
If you stop having Suprefact Injection.
Keep using Suprefact Injection until your
doctor tells you to stop. This is important in
helping treat your tumour.
Blood Tests
Using Suprefact Injection may affect the
results of some blood tests. In particular,
Suprefact Injection can change the level of
liver enzymes and fats in the blood (lipids)
shown up in blood tests. If you are going to
have a blood test, it is important to tell
your doctor you are using Suprefact Injection.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
4. Possible side effects

Like all medicines, Suprefact can cause side
effects, although not everybody gets them.
Stop using Suprefact and see a doctor
or go to a hospital straight away if;
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue
• You have leg pain, difficulty breathing or
being short of breath and chest pain.
This could be because of blood clots in your
body and lungs

Format 420 x 148 mm

Tell your doctor straight away if you notice
any of the following serious side effects:
• You bruise more easily than usual. This
could be because of a blood problem called
‘thrombocytopenia’
• You get a lot of infections. Signs include
fever, sore throat or mouth ulcers. These
could be signs of a blood problem
called leucopenia
• You have severe headaches and eyesight
problems. This is very rare but if it happens
it could be due to tumours on the pituitary
gland. This gland is found at the base of the
brain
• Your blood pressure becomes higher. This is
very rare but if it happens you may get
symptoms such as crushing chest pain,
confusion, problems with your eyesight,
tiredness and an uneven heartbeat
• You have problems passing water (urine)
• You have sharp pain or aching in your side
in the area between the ribs and the hips.
These could be signs of a swollen kidney
• You feel tired and your body is swollen.
These could be signs of fluid build up in the
tissues called lymphostasis
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:
• Loss of sex drive (libido)
• Atrophy (shrinking) of the testes
• Bone or muscle discomfort such as shoulder
pain or stiffness or muscle weakness. If
Suprefact Injection is used for a long period
of time, it may increase the risk of you
getting a condition called ‘osteoporosis’. This
is when your bones are more likely to break

• Lowered tolerance to glucose which may
lead to worsening of existing diabetes
• Changes in body weight, changes in appetite
and increased thirst
• Mood changes such as feeling depressed or
worsening of depression and feeling
anxious.
Mood changes, depression
• Frequency: Long term use: common
Short term use: Uncommon
• Feeling nervous, dizzy, tired or drowsy
• Headache and disturbed sleep
• Problems with memory and concentration
• Pain or redness at the injection site
• Unusual skin sensations such as numbness,
tingling, pricking, burning or creeping on
the skin. This can feel like ‘pins and needles’
(usually in the arms and legs) and is called
paraesthesia
• Dry eyes (possibly leading to eye irritation in
people who wear contact lenses), blurred
eyesight, feeling of pressure behind the eyes
• Hearing problems such as ringing in the ears
(tinnitus)
• Very fast, uneven or forceful heartbeat
(palpitations)
• Facial swelling (puffiness) due to water
retention which may also cause swollen
arms or legs
• Feeling or being sick, stomach ache, pain
in the lower abdomen, diarrhoea or
constipation
• Dry skin or acne or hot flushes

Erstellt am: 10. Januar 2015 / Version: 2 / Mac

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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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