IMIGRAN 10MG NASAL SPRAY

Active substance: SUMATRIPTAN

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Imigran® 10mg Nasal Spray
Sumatriptan 10mg Nasal Spray
(sumatriptan)
Your medicine is available using one of the above names but will be
referred to as Imigran Nasal Spray throughout this;
Patient Information Leaflet
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.
Imigran 20mg Nasal Spray is also available.
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 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 Nasal Spray:
 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.

 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 till 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 Imigran nasal spray 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

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 Nasal Spray
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.

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.
Imigran nasal spray has three parts:

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

How to use the nasal spray

5) How to store Imigran 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.
9. Your nasal spray is now empty.
Throw it away safely and hygienically.

4) Possible side effects
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
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.
Very common side effects (affect 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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.







Keep all medicines out of the sight and reach of children.
Always keep Imigran Nasal Spray in the sealed blister pack provided.
Keep Imigran Nasal Spray away from heat and out of light.
Do not store above 30°C. Store in the original container. Do not freeze.
Do not use Imigran nasal spray after the expiry date shown on the carton.
The expiry date refers to the last day of that month.
 If your doctor stops your treatment do not keep any leftover nasal spray
unless your doctor tells you to. Return any unused nasal spray to your
pharmacist for safe disposal.
 If Imigran Nasal Spray becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
 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 10mg of the active sumatriptan.
The spray also contains 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
Each pre-filled nasal spray device with a grey plastic body/nozzle and a
blue plunger contains 10mg of the active sumatriptan in 0.1ml of clear pale
yellow to dark yellow coloured aqueous solution.
Imigran 10mg Nasal Spray is available in packs containing 2 pre-filled nasal
spray devices wrapped individually in a blister pack. Each nasal spray
contains one dose of Imigran.
PL 10383/1682

POM

Who makes and repackages your medicine
Imigran 10mg Nasal Spray is manufactured by GlaxoSmithKline S.p.A.,
Officina Farmaceutica di S. Polo di Torrile, Parma, Italy. Procured from
within the EU and repackaged by Product Licence Holder Primecrown Ltd.,
4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 31.07.2013.
Imigran® is a registered trademark of GlaxoSmithKline group of companies.

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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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