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IMIGRAN NASAL SPRAY 20MG

Active substance(s): SUMATRIPTAN

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10000000127106
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Package Leaflet: Information for the User

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

10 mg and 20 mg
sumatriptan

1 What Imigran nasal spray is
and what it is used for

Read all of this leaflet carefully before you
start taking 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
only. Do not pass it on to others - it may
harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

Each Imigran nasal spray contains a single dose of
sumatriptan, which belongs to a group of medicines
called triptans (also known as 5-HT1 receptor agonists).
Imigran nasal spray is used to treat migraine
headache.
Migraine symptoms may be caused by the temporary
widening of blood vessels in the head. Imigran nasal
spray is believed to reduce the widening of these
blood vessels. This in turn helps to take away the
headache and relieve other symptoms of a migraine
attack, such as feeling or being sick (nausea or
vomiting) and sensitivity to light and sound.

2 What you need to know before you use Imigran nasal spray
Don’t use Imigran:
• If you’re allergic to sumatriptan, or any of the other
ingredients of this medicine (listed in section 6).
• If you have a heart problem such as narrowing of
the arteries (Ischaemic heart disease) or chest pains
(angina), or have already had a heart attack.
• If you have circulation problems in your legs that
cause cramp-like pains when you walk (peripheral
vascular disease).
• If you have had a stroke or a mini-stroke (also called
a transient ischaemic attack or TIA).
• If you have high blood pressure. You may be able to
use Imigran if your high blood pressure is mild and is
being treated.
• If you have serious liver disease.
• With other migraine medicines, including those
which contain ergotamine, or similar medicines
such as methysergide or any triptan/5-HT1 receptor
agonist (medicines which are also used for treating
migraine).
• With anti-depressants called MAOIs (monoamine
oxidase inhibitors), or if you have taken these
medicines in the last 2 weeks.
If any of these apply to you:
Tell your doctor, and don’t use Imigran nasal spray.



Take special care with Imigran
Talk to your doctor or pharmacist before using Imigran.
If you have any extra risk factors
• If you are a heavy smoker, or are using nicotine
replacement therapy, and especially
• If you are a man aged over 40, or
• If you are a woman who has
been through the menopause.



If you have a history of fits (seizures)
Or if you have other conditions which might make it
more likely that you’ll have a fit - for example, a head
injury or alcoholism.
Tell your doctor so that you can be supervised
more closely.



If you have liver or kidney disease
Tell your doctor so that you can be supervised
more closely.



If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Imigran. If you know
you are allergic to an antibiotic but you are not sure
whether it is a sulphonamide:
Tell your doctor or pharmacist before using Imigran.



If you are taking anti-depressants called SSRIs
(Selective Serotonin Reuptake Inhibitors) or SNRIs
(Serotonin Noradrenaline Reuptake Inhibitors)
Tell your doctor or pharmacist before using Imigran.
Also see Other medicines and Imigran, below.



If you use Imigran frequently
Using Imigran too often may make your headaches
worse.
Tell your doctor if this applies to
you. He or she may recommend you
stop using Imigran.



3 How to use Imigran nasal spray (continued)
How to use the nasal spray

Don’t open a blister until you are ready to use a spray.
Each spray is sealed in a blister to keep it clean and
safe. If you carry a spray without a blister, or in an open
blister, it may not work properly when you need it.

1
2
3
4

Each spray contains just one dose of Imigran.
Don’t press the plunger too soon or you will lose the
dose.
Imigran nasal spray has three parts:
The nozzle

B

Remove the nasal spray from the blister packaging just before you want to use it.
Get into a comfortable position. You may prefer to sit down.
Blow your nose if it feels blocked, or if you have a cold.
Hold the nasal spray gently with your fingers and thumb, as shown in picture A.
Don’t press the blue plunger yet.

5 Block one nostril by pressing a finger firmly on the side of your nose. It doesn’t
matter which nostril you choose.

6 Put the nozzle of the nasal spray into the other nostril, as far as feels comfortable

The part that you put into your
nostril. The spray comes out of a
tiny hole in the top.

1/
2

- about 1 cm or inch (picture B).
Breathe out gently through your mouth.
Hold your head upright and close your mouth.

The finger-grip
Hold this when you
use the spray.

The blue plunger
Press this to spray the whole dose
into your nostril in one go.
This only works once - don’t press
the plunger until you have put the
nozzle into your nostril or you will
lose the dose.

Like all medicines, this medicine can cause
side effects, but not everybody gets them.
Some symptoms may be caused by the migraine itself.
Adverse events reported in adults have also been
observed in adolescents. These include very rare
reports of heart attacks.

Allergic reaction: get doctor’s help
straight away



Other medicines and Imigran
Tell your doctor or pharmacist if you’re taking, have
recently taken or might take any other medicines.
This includes any herbal products or medicines you’ve
bought without a prescription.
Some medicines must not be taken with Imigran and
others may cause adverse effects if they’re taken with
Imigran. You must tell your doctor if you are taking:
• ergotamine also used to treat migraine, or similar
medicines such as methysergide (see Section 2). Don’t
use Imigran at the same time as these medicines.
Stop taking these medicines at least 24 hours
before using Imigran. Don’t take any medicines
which contain ergotamine or compounds similar to
ergotamine again for at least 6 hours after using
Imigran.
• other triptans/5-HT1 receptor agonists (such as
naratriptan, rizatriptan, zolmitriptan), also used to
treat migraine, (see Section 2). Don’t use Imigran at
the same time as these medicines. Stop taking these
medicines at least 24 hours before using Imigran.
Don’t take another triptan/5-HT1 receptor agonist
again for at least 24 hours after using Imigran.
• SSRIs (Selective Serotonin Reuptake Inhibitors) or
SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)
used to treat depression. Using Imigran with these

medicines can cause serotonin
syndrome (a collection of
symptoms which can include restlessness, confusion,
sweating, hallucinations, increased reflexes, muscle
spasms, shivering, increased heartbeat and shaking).
Tell your doctor immediately if you are affected in
this way.
• MAOIs (monoamine oxidase inhibitors) used to treat
depression. Don’t use Imigran if you have taken
these in the last 2 weeks.
• St John’s Wort (Hypericum perforatum). Taking
herbal remedies that contain St John’s Wort while
you are using Imigran may make side effects more
likely.

Pregnancy and breast-feeding
• If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your doctor for
advice before taking this medicine. There is only
limited information about the safety of Imigran for
pregnant women, though up until now there is no
evidence of any increased risk of birth defects. Your
doctor will discuss with you whether or not you
should use Imigran while you are pregnant.
• Don’t breast-feed your baby for 12 hours after using
Imigran. If you express any breast milk during this
time, discard the milk and don’t give it to your baby.

Driving and using machines
Either the symptoms of migraine or your medicine may
make you drowsy. If you are affected, don’t drive or
operate machinery.



Very common side effects
(affect more than 1 in 10 people)
• Unpleasant taste.

7 Start to breathe in gently through your nose.
As you breathe in:
Press the blue plunger firmly with your thumb.
The plunger may feel a bit stiff and you may hear it click. Keep breathing in while
spraying (picture C).

8 Remove the spray and remove your finger from the side of your nose.
Keep your head upright for 10-20 seconds, breathing gently in through your nose
and out through your mouth. This helps the medicine stay in your nose.
Your nose may feel wet inside and you may notice a slight taste after using the
spray - this is normal and will soon pass.

9 Your nasal spray is now empty. Throw it away safely and hygienically.

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(affect up to 1 in 10 people)
• Heaviness, pressure, tightness or pain in the chest,
throat or other parts of the body, or feelings of
unusual sensations, including numbness, tingling
and warmth or cold. These effects may be intense
but generally pass quickly.
If these effects continue or become severe
(especially the chest pain):
Get medical help urgently. In a very small number
of people these symptoms can be caused by a
heart attack.



Other common side effects include:
• Irritation or burning sensation in the nose or throat;
nose bleeds.

Only use Imigran after your migraine
headache begins
Don’t use Imigran to try to prevent an attack.
Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
There’s a step-by-step guide to using the spray at the
end of this section.

How much to use
Adults aged 18 to 65
• The usual dose for adults aged 18 to 65 is one
Imigran 20 mg spray into just one nostril.
But one Imigran 10 mg spray into one nostril is
enough for some people.
Don’t use more than two sprays in 24 hours.
Adolescents aged 12 to 17
• The usual dose for adolescents aged 12 to 17 is one
Imigran 10 mg spray into one nostril.
Children under 12
• Imigran nasal spray is not recommended for
children under 12 years old.

When to use Imigran
• It’s best to use Imigran as soon as you feel a
migraine coming on, although it can be used at any
time during an attack.

If your symptoms start to come back
• You can use a second Imigran nasal spray after 2 hours,
but don’t use more than two sprays in 24 hours.

If the first spray has no effect
• Don’t use a second spray, or any other Imigran
preparation for the same attack.
If Imigran doesn’t give you any relief:
Ask your doctor or pharmacist for advice.



If you use more Imigran than you should
• Don’t use more than two Imigran nasal sprays in 24
hours.
Using too much Imigran could make you ill. If you
have used more than two sprays in 24 hours:
Contact your doctor for advice.



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

Older people (aged over 65)
• Imigran nasal spray is not recommended for people
aged over 65.
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turn over

6 Contents of the pack and other information
• Feeling sick (nausea) or being sick (vomiting),
although this may be due to the migraine itself.
• Tiredness or drowsiness.
• Dizziness, feeling weak, or getting hot flushes.
• Temporary increase in blood pressure.
• Shortness of breath.
• Aching muscles.

Very rare side effects

The following side effects have occurred but their
frequency is not known.
• The signs of allergy include rash, hives (itchy rash);
wheezing; swollen eyelids, face or lips; complete
collapse.
If you get any of these symptoms soon after using Imigran:
Don’t use any more. Contact a doctor straight away.

Common side effects

C

If you feel pain or tightness in your
chest after you use Imigran
These effects may be intense but they usually pass
quickly. If they don’t pass quickly, or they become
severe:
Get medical help immediately. Section 4 of this
leaflet has more information about these possible
side effects.

4 Possible side effects

Step-by-step guide to using your Imigran nasal spray
A

3 How to use Imigran nasal spray

In very rare cases, people have developed serious heart
conditions after using Imigran, even though they had
no signs of heart disease before. If any of the points
above applies to you it could mean you have a greater
risk of developing heart disease - so:
Tell your doctor so that your heart function can be
checked before Imigran is prescribed for you.

(affect up to 1 in 10,000 people)
• Liver function changes. If you have a blood test to
check your liver function, tell your doctor or nurse
that you are using Imigran.
Some patients may have the following side effects but
it is not known how often they occur
• Seizures/fits, tremors, muscle spasm, neck stiffness.
• Visual disturbances such as flickering, reduced vision,
double vision, loss of vision and in some cases even
permanent defects (although these may be due to
the migraine attack itself).
• Heart problems, where your heart beat may go
faster, slower or change rhythm, chest pains (angina)
or heart attack.
• Pale blue-tinged skin and/or pain in your fingers,
toes, ears, nose or jaw in response to cold or stress
(Raynaud’s phenomenon).
• Feeling faint (blood pressure may go down).
• Pain in the lower left side of the stomach and
bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• Pain in the joints.
• Feeling anxious.
• Excessive sweating.

Reporting of side effects

What Imigran nasal spray contains

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.

The active substance is sumatriptan (10 mg or 20 mg).

5 How to store Imigran nasal
spray

Keep this medicine out of the sight and reach of children.
Keep this medicine in the sealed blister in the box to
protect it from light.
Don’t store above 30°C and don’t freeze.
Don’t use this medicine after the expiry date shown
on the carton. The expiry date refers to the last day of
that month.
Don’t 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 protect the environment.

The other ingredients are potassium dihydrogen
phosphate, dibasic sodium phosphate anhydrous,
sulphuric acid, sodium hydroxide and purified water.

What Imigran nasal spray looks like and
contents of the pack
This medicine is provided in a pre-filled nasal spray
device and contains sumatriptan in 0.1 ml of a
yellow-coloured solution.
Imigran nasal spray is packed in a box containing the
nasal sprays individually sealed in blisters. They are
available in packs of 2 and 6 pre-filled nasal spray
devices. Each nasal spray contains one dose of Imigran.

Marketing authorisation holder and
manufacturer

Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name

Imigran Nasal Spray 10 mg
Imigran Nasal Spray 20 mg

Reference number
10949/0260
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: May 2014
IMIGRAN and the IMIGRAN logo are registered trade
marks of the GSK group of companies
© 2014 GSK group of companies. All rights reserved

Marketing Authorisation Holder: Glaxo Wellcome UK Ltd,
Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer: GlaxoSmithKline Manufacturing S.p.A.,
San Polo di Torrile, Parma, Italy

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10000000127106

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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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