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SUPRECUR INJECTION

Active substance(s): BUSERELIN ACETATE

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528234

• Problems with memory and concentration
• 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
• Hair grows more than normal (including body
and facial hair)
• Hair loss (including body or facial hair)
• Splitting of nails
• Vaginal discharge, changes in breast size, breast
tenderness or milk production
• Changes in the level of liver enzymes, fats
(lipids) and a substance called ‘bilirubin’ in the
blood shown up in blood tests
• Worsening of your condition if you have uterine
fibroids
• 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.

5. How to store Suprecur Injection
This medicine should be kept in a safe place
where children cannot see or reach it.
Do not use Suprecur Injection after the expiry date
which is stated on the carton and label. 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.
Discoloured or cloudy solution should not be
used.
Each vial contains enough solution for ten doses.
After finishing a course of treatment the vial
should be disposed of and a new vial started for
the next treatment.
Medicines should not be disposed of via
wastewater or household waste. If you are using
this medicine at home you will be given a
container (a sharps bin) to use for disposal. Return
the sharps bin or any used or unused syringes to
your doctor or nurse or pharmacist for disposal.
These measures will help to protect the
environment.

6. Contents of the pack and other
information
What Suprecur Injection contains
• Each 1ml of solution 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

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Suprecur® 1mg/ml
Injection
Buserelin acetate

What Suprecur Injection looks like and
contents of the pack
Suprecur Injection is available in boxes
containing two multidose vials. Each vial contains
5.5 millilitres 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
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, 1997-2014

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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.

What is in this leaflet
1. What Suprecur Injection is and what it is
used for
2. What you need to know before you use
Suprecur Injection
3. How Suprecur Injection is given
4. Possible side effects
5. How to store Suprecur Injection
6. Contents of the pack and other information
1. What Suprecur Injection is
and what it is used for
The name of your medicine is Suprecur 1mg/ml
Injection (called Suprecur Injection throughout
this leaflet). It 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 can be used to treat infertility. It works by
stopping the natural production of hormones
that control ovulation. Synthetic hormones are
then used to artificially stimulate ovulation. Your
doctor should give you more information about
how your treatment works.

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2. What you need to know before you
use Suprecur Injection
Do not have this medicine and tell your
doctor if:
× You are allergic (hypersensitive) to buserelin or
other similar medicines such as goserelin, or
any of the other ingredients of Suprecur
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 abnormal menstrual bleeding
× You are pregnant or breast-feeding
× You have a tumour that is not affected by
changes in hormone levels
× This medicine is for use in women only.
However there is another form of this medicine
that can be used in men. Men should not use
either form of this medicine if they have had
their testicles removed
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or nurse before having Suprecur Injection.
Take special care with Suprecur
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 Suprecur
Injection which may be severe. If you are using
Suprecur Injection and develop depressed
mood, inform your doctor.

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SAP-Nr. (DMC): 528234

SRZ-Nr.: 508940

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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
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
s You have polycystic ovarian disease
If you are not sure if any of the above apply to
you, talk to your doctor, nurse or pharmacist
before having Suprecur 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 Suprecur Injection.
Other medicines and Suprecur 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 Suprecur Injection can affect the way
some other medicines work. Also some medicines
can affect the way Suprecur 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): 528234

Suprecur 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
Do not have this medicine if:
• You are pregnant, might become pregnant or
think you may be pregnant. This is because
Suprecur Injection may be harmful to the
developing baby. Women must have a
pregnancy test to make sure they are not
pregnant before being given this medicine.
Suprecur Injection will be stopped before you
are given the hormones used to stimulate
ovulation
• You are breast-feeding or planning to breastfeed. This is because small amounts may pass
into mothers’ milk
If you get pregnant during treatment, stop having
this medicine and tell your doctor immediately.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
You may feel dizzy, drowsy or have blurred
eyesight while having this medicine. If this
happens, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Suprecur Injection
Suprecur 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 Suprecur Injection is given
Suprecur is normally given by a doctor or nurse.
This is because it needs to be given as an injection
underneath the skin (subcutaneous injection).
Using this medicine
• The doctor or nurse will usually give you the
first injections
• You may then be trained how to give the
injections to yourself. Your doctor or nurse will
show you how to do this. Do not try to inject
yourself if you have not been trained how to
do so.
If you are not sure what to do, talk to your doctor
or nurse immediately.
How much Suprecur Injection is given
If you are not sure why you are being given
Suprecur Injection or have any questions about
how much Suprecur Injection is being given to
you, speak to your doctor or nurse.
Your doctor will start treatment on day 1 or day 21
of your menstrual cycle. Your daily dose will be:
• 200 to 500 micrograms given as a single daily
injection or 500 micrograms twice a day
• You will be given daily injections until blood
tests show that levels of sex hormones are
lowered. This usually takes one to three weeks
• You will then be given other hormones as well
as Suprecur Injection
• Your doctor will tell you how long you are to
continue having these medicines
If you are able to give Suprecur Injection to
yourself, your doctor or nurse will show you how
to do this. Do not try to inject yourself if you have
not been trained how to do so. If you are not sure
what to do, talk to your doctor or nurse
immediately.

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If you have more Suprecur 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, and check the
medicine you are given. Always ask if you are not
sure why you are getting a dose of medicine.
If you give yourself more Suprecur Injection than
you should, tell a doctor or go to a hospital
casualty department straight away. Take the
medicine pack with you. This is so the doctor
knows what you have taken.
Having too much Suprecur Injection may make
you feel weak, nervous, dizzy and sick. You may
also have a headache, hot flushes, 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 Suprecur 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.
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 Suprecur Injection.
Keep using Suprecur Injection until your doctor
tells you to stop. If you stop, your infertility
treatment may be affected.
Blood Tests
Using Suprecur Injection may affect the results of
some blood tests. In particular, Suprecur 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 having Suprecur Injection

Format 420 x 148 mm

If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Suprecur Injection can cause
side effects, although not everybody gets them.
Stop having Suprecur 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 may also have pain or a skin rash
in the area you were injected with Suprecur
• You have diarrhoea, pain, swelling or a feeling
of tension in your stomach, feel sick or are sick,
have gained weight, are having difficulty
breathing or are short of breath or are passing
less urine. These could be signs of a serious side
effect called ‘Ovarian Hyperstimulation
Syndrome’. This is more likely if you are taking
other hormones as well as Suprecur Injection
(buserelin) as part of a treatment for infertility
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

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:
• Menopausal-like symptoms and withdrawal
bleeding
• Some weeks after starting treatment you may
get signs such as hot flushes, increased
sweating, dry vagina, painful sexual intercourse
or loss of sex drive (libido). These may be severe
in some cases. Breakthrough bleeding or
spotting may also occur
• Pain, discomfort or swelling in the lower part of
the stomach, changes to your periods,
constipation, diarrhoea or needing the toilet
more often. These symptoms could be a sign of
ovarian cysts.
• Bone or muscle discomfort such as shoulder
pain or stiffness. Bones may become less dense
during long-term treatment, due to a lowering
in the amount of bone mineral. This effect is
reversible when treatment is stopped. If
Suprecur 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 (which may be like a migraine)
and disturbed sleep
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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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