IMIGRAN 10MG NASAL SPRAY

Active substance: SUMATRIPTAN

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PRE-PRESS NO.:

02-1808

PRODUCT:

Imigran 10mg Nasal spray

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/2253E

DATE OF PROOF:

09/07/13

DATE:

PROOF HISTORY:
v.1 - waymade - 09/07/13

CUSTOMER
APPROVED:
DATE:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MARCH 2013

Pg 4

Pg 1

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 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet.

5. How to store Imigran nasal spray
Keep out of the sight and reach of children.
Keep Imigran nasal spray in the sealed blister in the box to protect it from light.
Do not store above 30°C. Do not freeze. Store in the original container.
Don’t use Imigran nasal spray after the expiry date shown on the carton. The expiry date refers to the last day of
that month.
If the nasal spray shows any signs of deterioration, seek the advice of your pharmacist.
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
The active substance is sumatriptan. (10 mg).
The other ingredients are potassium dihydrogen phosphate, disodium hydrogen phosphate, 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 aqueous solution.
Imigran nasal spray is packed in a box containing the nasal sprays individually sealed in blisters.
They are available in packs of 2 pre-filled nasal spray devices. Each nasal spray contains one dose of Imigran.
Marketing Authorisation Holder and Manufacturer
POM

PL No: 6464/2253

This product is manufactured by GlaxoSmithKline S.p.A., Officina Farmaceutica di S. Polo di Torrile (Parma),
Italy and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon Essex SS14 3FR
Leaflet revision and issue date (Ref.) 08.07.2013
Imigran is a registered trademark of the Glaxo Wellcome Group

IMIGRAN®

10mg NASAL SPRAY
(sumatriptan)

Patient Information Leaflet

This product is known by the above name but will usually be referred to as Imigran nasal spray or Imigran
throughout this leaflet. Another strength (20mg) is also available.
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.
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:
• 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.
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,
overleaf.
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

PRE-PRESS NO.:

CODE:

DT

Q.A.
APPROVED:

09/07/13

DATE:

PROOF HISTORY:
v.1 - waymade - 09/07/13

CUSTOMER
APPROVED:

DATE OF PROOF:

6464/2253E

02-1808

ARTWORKER:

CUSTOMER: Waymade
Imigran 10mg Nasal spray
PRODUCT:

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MARCH 2013

Pg 3

Pg 2

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

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.

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
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.

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.

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.

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.

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 ½ 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.

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.

A

B

C

4. Possible side effects

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

Like all medicines, this medicine can cause side effects, but not everybody gets them.

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.

Adverse events reported in adults have also been observed in adolescents. These include very rare reports of
heart attacks.

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.

Some symptoms may be caused by the migraine itself.

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.

If Imigran doesn’t give you any relief:

Ask your doctor or pharmacist for advice.

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

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.

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.
Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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