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IMIGRAN 20 MG NASAL SPRAY

Active substance(s): SUMATRIPTAN

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PATIENT INFORMATION LEAFLET

2568
27.05.15[4]

Imigran™ 20 mg Nasal Spray
(sumatriptan)
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.
Your medicine is available using above name but will be referred to as
Imigran nasal spray throughout this leaflet.
Imigran nasal spray is also available in 10 mg strength.
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
1. What Imigran nasal spray is and what it is used for
Each Imigran nasal spray contains a single dose of sumatriptan,
which belongs to a group of medicines called triptans (also known as 5HT1 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/5HT1 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.
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.
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.
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.
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.
3. How to use Imigran nasal spray
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.
Older people (aged over 65)
 Imigran nasal spray is not recommended for people aged over 65.
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.
Step-by-step guide to using your Imigran 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.
Each spray contains just one dose of Imigran.
Don’t press the plunger too soon or you will lose the dose.

How to use the nasal spray
1. Remove the nasal
spray from the blister
packaging just before you
want to use it.
2. Get into a comfortable
position. You may prefer
to sit down.
3. Blow your nose if it
feels blocked, or if you
have a cold.
4. 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 - about
1 cm or 1/2 inch (picture
B).
Breathe out gently
through your mouth.
Hold your head upright
and close your mouth.
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.

Very common side effects
(affecting more than 1 in 10 people)
 Unpleasant taste.
Common side effects
(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.
 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
(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 heartbeat 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
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 Imigran Nasal Spray
Keep this medicine out of the sight and reach of children.
Store in the original container in order to protect from light.
Do not store above 30°C and do not freeze.

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

Don’t use this medicine after the expiry date shown on the carton. The
expiry date refers to the last day of that month.

4. Possible side effects
Like all medicines, Imigran can cause side effects, but not everybody gets
them.
Some symptoms may be caused by the migraine itself.

If your Imigran nasal spray fails to work properly or shows any signs of
deterioration, you should seek the advice of your pharmacist.

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
The following side effects have occurred but their exact 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.

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 Imigran nasal spray contains
Each pre-filled nasal spray device contains 20 mg sumatriptan in 0.1 ml of
aqueous solution.
The other ingredients are potassium dihydrogen phosphate, dibasic
sodium phosphate anhydrous, sulphuric acid, sodium hydroxide and
purified water
What Imigran looks like and content of the pack
Yellow to dark yellow liquid, in glass vial in a single dose nasal spray
device.
Nasal Spray device - Light grey colour nozzle and finger grip, blue colour
plunger, plastic single use nasal spray device is individually sealed in a
blister

They are available in packs of 1 and 2 pre-filled nasal spray devices.
Each nasal spray contains one dose of Imigran.
Manufacturer and Product Licence holder
Manufactured by GlaxoSmithKline Manufacturing S.p.A., Strada
Provinciale Asolana, 90, 43056 San Polo Di Torrile, Parma, Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2568

Leaflet revision and issue date (Ref.) 27.05.15[4]
Imigran is a trademark of the Glaxo Group Ltd.

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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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