SUPRECUR 150 MICROGRAMS NASAL SPRAY

Active substance: BUSERELIN ACETATE

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2. Before you use Suprecur Nasal Spray
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Suprecur®
150 micrograms
Nasal Spray Solution
Buserelin acetate

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for help
Read all of this leaflet carefully before you
start using this medicine
• 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.

1. What Suprecur Nasal Spray
is and what it is used for
The name of your medicine is Suprecur 150
micrograms Nasal Spray Solution (called Suprecur
Nasal Spray 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 for the following:
• Treatment of endometriosis – an illness where
some of the tissues that line the womb are
found elsewhere in the body
• As part of a treatment for 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

Do not use this medicine and tell your
doctor if:
× You are allergic (hypersensitive) to buserelin or
other similar medicines such as goserelin,
benzalkonium chloride or any of the other
ingredients of Suprecur Nasal Spray (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 where
the cause is not endometriosis
× You have a tumour that is not affected by
hormones
× You are pregnant or breast-feeding
× 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 use if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist
before using Suprecur Nasal Spray.
Take special care with Suprecur
Nasal Spray
Check with your doctor or pharmacist before
using your medicine if:
s You have depression. There have been reports
of depression in patients taking Suprecur Nasal
Spray which may be severe. If you are taking
Suprecur Nasal Spray and develop depressed
mood, inform your doctor.
s You have high blood pressure. Your blood
pressure must be checked regularly
s You have diabetes. Your blood glucose levels
must be checked regularly
s You have endometriosis and are taking oral
contraceptives (the Pill or mini Pill). Your
doctor will ask you to change to another
form of contraception

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 Nasal Spray.
Taking other medicines

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 Nasal Spray
can affect the way some other medicines work.
Also some medicines can affect the way
Suprecur Nasal Spray works.
In particular, tell your doctor or pharmacist if you
are taking the following:
• Medicines for diabetes
• Oral contraceptives (the Pill or mini Pill). If you
have endometriosis and are taking oral
contraceptives your doctor will ask you to
change to another form of contraception
Pregnancy and breast-feeding
Do not use this medicine if:
• You are pregnant, might become pregnant or
think you may be pregnant. This is because
Suprecur Nasal Spray may be harmful to the
developing baby. Women must have a
pregnancy test to make sure they are not
pregnant before starting this medicine.
Suprecur Nasal Spray 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

Women with endometriosis should use nonhormonal methods of contraception (such as
condoms). This is to prevent pregnancy during
treatment with this medicine. If treatment is
interrupted even for only a few days, ovulation
may occur and there is a risk of pregnancy.
If you get pregnant during treatment, stop using
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 using this medicine. If this
happens, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Suprecur Nasal Spray
Suprecur Nasal Spray contains benzalkonium
chloride. This may cause difficulty breathing,
wheezing or tightness in the chest
(bronchospasm).

3. How to use Suprecur Nasal Spray
Always use Suprecur Nasal Spray exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Using this medicine
• It is very important you use this medicine
regularly and space the doses out evenly
through the day
• This medicine can be used if you have a cold.
If you have a cold, blow your nose thoroughly
before using the spray. If you are using a nasal
decongestant wait at least 30 minutes after
using Suprecur Nasal Spray before using the
decongestant
• Do not use in children

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• Do not use in women who have gone through
the menopause (sometimes called ‘the change
of life’)
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
How to use Suprecur Nasal Spray:
1. Preparing the spray
• Remove the screw cap from bottle
• Remove the metered-dose nebulizer from
transparent plastic container and take off
both protective caps
• Screw the nebulizer on to the bottle
2. If you are using the spray for the first
time
• Hold the bottle upright
• Pump 5 to 8 times until an even spray is
produced. This initial pumping is for the
purpose of filling the system and testing
the spray. It should not be repeated after
the first use in order to avoid wasting the
medicine
3.




Using the spray
Keep the bottle upright
Bend your head slightly over the bottle
Spray the solution into the nose

4. After using the spray
• After use leave the nebulizer on the bottle
• After replacing the protective cap on the
nebulizer, the spray bottle is best stored in
its transparent container in an upright
position

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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 Nasal Spray
(buserelin) as part of a treatment for infertility

How much Suprecur Nasal Spray to use:
Treatment of endometriosis:
• The usual dose is one spray in each nostril
three times each day. This is to make a
total daily dose of 900 micrograms
• Use the spray in the morning, at mid-day
and in the evening
• Treatment will be for a maximum of 6 months
• Treatment should be started on the first or
second day of your menstrual period. This
is to lower the chances you may be
pregnant. Your doctor may perform a
pregnancy test if there is any doubt
• You may get a menstrual period after the
first few weeks of using this medicine. You
may also carry on getting breakthrough
bleeding or spotting
As part of treatment for infertility:
• The usual dose is one spray in one nostril
only, four times each day to make a total
daily dose of 600 micrograms
• Space the doses evenly throughout the day
• After you have been using this medicine for
two to three weeks, you may be given other
hormones to take as well as Suprecur Nasal
Spray
• Your doctor will tell you how long to
continue taking these medicines
Children
This medicine should not be used in children.
If you use more Suprecur Nasal Spray than you
should
If you use more Suprecur Nasal Spray 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

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 nose bleeds and a hoarse voice
• Changes in your sense of taste or smell
• 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

4. Possible side effects
Like all medicines, Suprecur Nasal Spray can cause
side effects, although not everybody gets them.
Stop using Suprecur Nasal Spray 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 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

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 Nasal Spray 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
• 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, hot flushes 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
Talk to your doctor or pharmacist if any of the
side effects gets serious or lasts longer than a few
days, or if you notice any side effects not listed in
this leaflet.

5. How to store Suprecur Nasal Spray
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Suprecur Nasal Spray after the expiry
date which is stated on the bottle. The expiry date
refers to the last day of that month.
Store between 2 °C and 25 °C. Do not freeze.
Once opened the product should be used within
5 weeks.
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 Suprecur Nasal Spray contains
• Each spray dose contains 150 micrograms of the
active substance, buserelin as buserelin acetate
• The other ingredients are citric acid, sodium
citrate, sodium chloride and benzalkonium
chloride in aqueous solution.
What Suprecur Nasal Spray looks like and
contents of the pack
Suprecur Nasal Spray is available in cartons
containing two bottles and two metered-dose
pumps (nebulisers). Each bottle contains 10 grams
of solution.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi,
One Onslow Street, Guildford,
Surrey,
GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi-Aventis Deutschland GmbH,
Industriepark Höchst,
65926 Frankfurt am Main,
Germany
This package contains a metered dose nebulizer
Manufacturer: Sanofi-Aventis Deutschland GmbH,
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 09/2012.
© sanofi, 1997 – 2012

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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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