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SYNAREL 2 MG/ML NASAL SPRAY SOLUTION

Active substance(s): NAFARELIN ACETATE

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PACKAGE LEAFLET: INFORMATION
FOR THE USER
Important things that you SHOULD know about
your medicine:
• SYNAREL is for the treatment of
endometriosis or as part of a supervised
fertility programme and is for use by women
only.
• 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.
• You should take SYNAREL regularly as
instructed by your doctor or nurse, in order
for it to be effective.
• Most people do not have serious problems
when taking SYNAREL but side effects can
occur – see Section 4 for details. 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.
• Taking other medicines may sometimes
cause problems. Check with your doctor or
pharmacist before taking this or any other
medicines.
Please read the rest of this leaflet. It includes
other important information on the safe and
effective use of this medicine that might be
especially important to you. If you have any
further questions, ask your doctor or pharmacist.
This leaflet was last updated in 06/2016.
What is in this leaflet
1. What Synarel is and what it is used for
2. What you need to know before you take
Synarel
3. How to take Synarel
4. Possible side effects
5. How to store Synarel
6. Contents of the pack and other information
1. What Synarel is and what it is used for
Synarel works by reducing the normal response
of your body to a hormone called GnRH
(gonadotrophin releasing hormone). As a result,
your ovaries produce less of another hormone
called oestrogen. You will notice the reduced
amount of oestrogen usually by your periods
either stopping or being reduced in amount after
about one month of taking Synarel.

2. Prime the pump by pressing the bottle
upwards several times firmly and quickly until
the air is expelled and a fine spray appears.
This usually requires about 5 – 7 presses. It is
not necessary to prime the pump again during
subsequent use.

Using the Spray Pump
1. Gently blow your nose to clear the nostrils.

2. Remove the safety clip and the plastic cap to
uncover the nasal piece. Hold the bottle as
shown previously.

FPO 128 - 10 mil

2mg/ml Nasal Spray
Nafarelin acetate

Do not take Synarel if you are breast-feeding.
Ì Driving and using machines
Synarel is not known to affect the ability to drive
or use machinery.
Ì Synarel contains benzalkonium chloride
Benzalkonium chloride (a type of preservative) is
an irritant and may cause skin reactions, swelling
and bronchospasm.
3. How to use Synarel
Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Ì How to use your medicine
For endometriosis: the usual dose is one spray
twice each day for six months. Spray into one
nostril in the morning, and the other nostril in the
evening (a total of 2 sprays per day). You should
use the spray for the first time between the
second and fourth day of your period.
For endometriosis, the longest time for which you
should be taking your medicine is 6 months.
For use in fertility programmes: if you are taking
this medicine as part of a fertility programme, the
dose is usually one spray to both nostrils in the
morning, and one spray to both nostrils in the
evening (4 sprays per day).
If you are taking this medicine as part of a fertility
programme, your doctor will tell you how long to
keep taking your medicine. This will usually be for
no longer than 8 weeks.
Take your spray as your doctor has told you
to. If you are still not sure, ask your doctor or
pharmacist.
It is important to keep taking your spray.
If you have any questions, don’t wait until your
nasal spray is finished before seeing your doctor.
Priming the Spray Pump: Before you use a
bottle of Synarel for the first time, you have to
prime the spray pump. This only needs to be
done once, before you take your first dose.
1. Remove the safety clip and the plastic dust
cap to uncover the nasal piece. Hold the
bottle with two fingers on the ‘shoulders’ and
your thumb on the bottom of the bottle.

Synarel ® 2mg/ml Nasal Spray
Nafarelin acetate

Synarel®

Synarel has to get into your blood stream before
it can work. This cannot happen if it is taken by
mouth, because your stomach acid will break
it down and it will be digested. Therefore, nasal
inhalation is a simple way to get this medicine
into your blood stream.
Synarel is used to treat endometriosis. It can
also be prescribed with other medicines for
women trying to become pregnant as part of a
supervised fertility programme.
2. What you need to know before you take
Synarel
Ì Do not use Synarel
• If you are allergic to Synarel, gonadotrophin
releasing hormone or any of the other
ingredients of this medicine (listed in section 6).
• If you are pregnant or may become pregnant
whilst taking Synarel. If you are taking
Synarel as part of a fertility programme, your
pregnancy will be planned to take place after
you stop taking this medicine.
• If you suffer from vaginal bleeding, for
which your doctor could not find the cause.
• If you are currently breast-feeding.
• If you are under 18 years of age.
Ì Warnings and precautions
Talk to your doctor or pharmacist before using
Synarel
• If you suffer from Polycystic Ovarian
Disease as there is a potential risk for
excessive follicular stimulation
• If you think you might be pregnant there
is a risk to the development of the foetus
and/or miscarriage.
• There have been reports of depression
in patients taking Synarel which may be
severe. If you are taking Synarel and develop
depressed mood, inform your doctor.
Your doctor will advise whether you can still take
Synarel.
Ì Other medicines and Synarel
Tell your doctor or pharmacist if you are using,
have recently used, or might use any other
medicines.
Nasal decongestants should not be used within
the 30 minute period before taking a dose
of Synarel as they can significantly reduce
absorption of the medicine in the nose. If your
nose is congested, Synarel will still be absorbed.
If you have been using an oral contraceptive to
prevent pregnancy, your doctor will ask you to
stop taking these and use a barrier method of
contraception (diaphragm, condom) to stop you
becoming pregnant.
Ì Synarel with food and drink
Synarel can be taken with or without food.
Ì Pregnancy, breast-feeding and fertility
Do not take Synarel if you are pregnant or trying
to become pregnant.

3. Clean the tip of pump. Hold the bottle in a
horizontal position and rinse the spray tip with
warm water, while wiping the tip with your
finger or a clean soft cloth.

Do not clean the spray tip with a pointed object.
This could cause an improper dose of the
spray to be delivered. Do not remove the pump
from the bottle, as this will release the priming
pressure.
Wipe the tip dry with a clean soft cloth or tissue.

Synarel ® 2mg/ml Nasal Spray
Nafarelin acetate
FPO 128 - 10 mil

4. Bend head forward slightly. Close one nostril
and put the spray tip into the other, aiming
towards the back and outer side of your nose.

5. Press the bottle firmly up between thumb and
fingers once only whilst gently breathing in
through the nostril. If your doctor has told you
to take 4 sprays every day, now spray into
your other nostril.

6. Remove the sprayer from the nostril. Bend
head backwards for a few seconds to let the
spray spread over back of the nose.

7. Clean the tip of pump. Hold the bottle in a
horizontal position and rinse the spray tip with
warm water, while wiping the tip with your
finger or a clean soft cloth.

Do not clean the spray tip with a pointed object.
This could cause an improper dose of the spray
to be delivered. Do not remove the pump from the
bottle, as this will release the priming pressure.
Wipe the tip dry with a clean soft cloth or tissue.

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12/4/17 11:07 AM

Cleaning the spray tip before and after use is
important to prevent clogging of the tip.
8. Replace the safety clip and the plastic dust
cap on the nasal piece.

If you use more Synarel than you should
• If you have taken too many sprays at once,
or in one day contact your doctor or go to
your nearest hospital casualty department
immediately.
If you forget to use Synarel
• If you forget to take your spray at the
proper time, take it as soon as you
remember and take the next spray at your
normal time. Do not take a double dose to
make up for a forgotten dose.
• If you miss one or more doses, vaginal
bleeding (often called breakthrough bleeding)
may occur. Also, release of an egg from
the ovary (ovulation) may occur. If you
have had sexual intercourse and not used
contraception, you could become pregnant. It
is then important that you stop taking Synarel
and see your doctor to make sure that you are
not pregnant. (This is why it is very important
to use a barrier method of contraception when
you are taking this medicine.).
• Take your spray as your doctor has told
you to.
• If you are still not sure, ask your doctor or
pharmacist.
• It is important to keep taking your spray.
• If you have any questions, don’t wait until
your nasal spray is finished before seeing
your doctor.
4. Possible side effects
Like all medicines, Synarel can cause side effects
although not everybody gets them.
Stop taking Synarel and tell your doctor straight
away if you have an allergy to this medicine. If
you are allergic to it, you may become short of
breath, have chest pain, or a rash which may or
may not be itchy.
Synarel may lead to enlargement of the ovaries
due to excess egg production (OHSS – Ovarian
Hyperstimulation Syndrome). This can lead to
pain in the pelvis, stomach or calf, swelling or
feeling bloated, passing less urine, difficulty
in breathing or an increase in weight. If you
experience any of these symptoms, tell your
doctor immediately.

Other side effects Synarel may cause are listed
below by frequency:
Very common side effects: may affect more than
1 in 10 people
• weight increase
• swings of emotion
• sex drive decrease
• headache
• hot flushes
• nasal irritation and/or inflammation
• acne
• oily appearance on the skin and the
formation of grease scales
• painful muscles
• breast size decrease
• vaginal dryness
• oedema
Common side effects: may affect up to 1 in 10 people
• allergic reaction which may include
shortness of breath, chest pain and a rash
which may or may not be itchy
• itching which may be accompanied by swelling
• skin rash including hives
• oestrogen deficiency
• weight decrease
• depression
• tingling sensation in parts of your body
• hypertension
• hypotension
• excessive hair growth
• artificial menopause
• abnormal bleeding from the vagina
• sex drive increase
• difficulty sleeping (insomnia)
• bone density decreases
Uncommon side effects: may affect up to 1 in
100 people
• hair loss
• joint pain
• breast size increase
• ovarian cyst formation
Not known side effects: the frequency cannot be
estimated from the available data
• migraine
• blurred vision
• palpitations
• liver enzyme increases
• short term increase in symptoms of
endometriosis
• enlargement of the ovaries due to excess
egg production
Tell your doctor if you are due to have any
medical tests as the results may be affected.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
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 Synarel
• You should always put the safety clip and
the plastic dust cap back on when you are
not using the medicine.
• Keep your spray out of the reach and sight
of children.
• Do not use Synarel after the expiry date which
is stated on the carton after EXP. The expiry
date refers to the last day of that month.
• Do not store above 25°C and protect from
freezing.
• Keep the bottle upright and store away
from light.
• Do not throw away any medicines via
household waste. Ask your pharmacist how
to throw away medicines you no longer
use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Synarel contains and its package:
The active substance is nafarelin acetate. The
Synarel spray liquid contains nafarelin acetate
equivalent to a concentration of 2 mg/ml nafarelin
in a bottle fitted with a metered spray pump.
Each actuation of the spray pump delivers
200 micrograms of nafarelin.
The other ingredients in the spray liquid are:
• Sorbitol, benzalkonium chloride, glacial
acetic acid, water; and
• Sodium hydroxide or hydrochloric acid to
adjust the acidity.
Synarel is available in white, high density
polyethylene bottles with a 0.1ml metered spray
pump, containing 6.5ml (30 sprays) or 10ml
(60 sprays). Synarel is also available in PVC-coated
glass bottles with an internal conical reservoir
in the base and a valois pump, with either an
aluminium crimp-on cap or a polypropylene
snap-on cap, containing 4ml (30 sprays) or 8ml
(60 sprays). These are designed to deliver 30 or
60 sprays respectively (as stated on the pack)
and should be disposed of once they have
been used for the appropriate number of spray
applications.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10
1930, Zaventem, Belgium
This leaflet was last revised in 12/2017.
Ref: SL 11_0
14470300

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