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IMIGRAN SUBJECT

Active substance(s): SUMATRIPTAN / SUMATRIPTAN SUCCINATE

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2 What you need to know before you use Imigran Subject

7
Package Leaflet:
Information for the User

Take special care with Imigran Subject

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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 had high blood pressure Imigran may not be
suitable for you
Tell your doctor or pharmacist before using Imigran.
If you have liver or kidney disease
If either of these apply to you:
Tell your doctor or pharmacist before using Imigran.
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’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 maleate; or any triptan or 5-HT1 agonist
(such as naratriptan or zolmitriptan)
With any of the following anti-depressants:
MAOIs (monoamine oxidase inhibitors) or if you have
taken an MAOI in the last 2 weeks
SSRIs (selective serotonin reuptake inhibitors)
including citalopram, fluoxetine, fluvoxamine,
paroxetine and sertraline
SNRIs (serotonin noradrenaline reuptake inhibitors)
including venlafaxine or duloxetine.
For children under 18 years of age.
If any of these apply to you:
Tell your doctor, and don’t use Imigran Subject.

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sumatriptan solution for injection in pre-filled cartridges
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.

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What is in this leaflet
1 What Imigran Subject is and what it is used for
2 What you need to know before you use Imigran Subject
3 How to use Imigran Subject
4 Possible side effects
5 How to store Imigran Subject
6 Contents of the pack and other information
7 Step-by-step guide to using Imigran Subject

Don’t use Imigran Subject:

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

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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 (below) has
more information about these possible side effects.

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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 Subject). 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 Subject).
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 for at least 24 hours after using Imigran.
MAOIs used to treat depression. Don’t use Imigran if
you have taken these in the last 2 weeks.
SSRIs and SNRIs 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.
St John’s Wort (Hypericum perforatum). Taking herbal
remedies containing St John’s Wort while using Imigran
may make side effects more likely.

Pregnancy and breast-feeding

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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 Subject
Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Imigran Subject is usually injected into the thigh.
There’s a step-by-step guide to using the syringe at the end
of this leaflet (see section 7 overleaf).

If you use more Imigran than you should

Other common side effects include:

Using too much Imigran could make you ill. If you have
used more than two injections in 24 hours:
Contact your doctor for advice.
If you have further questions about the use of this
medicine, ask your doctor or pharmacist.

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When to use Imigran

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It’s best to use Imigran as soon as you feel a migraine or
a cluster headache coming on, although you can use it
at any time during an attack
Don’t use Imigran to try to prevent an attack - only use
it after your migraine symptoms start.

How much to use
Adults aged 18 to 65
The usual dose for adults aged 18 to 65 with migraine
or a cluster headache is one 6 mg injection.
Children under 18
Imigran is not recommended for children under
18 years old.
Older people (aged over 65)
Imigran is not recommended for people aged
over 65.

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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.
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.

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Very common side effects

If your symptoms start to come back

(affect more than 1 in 10 people)
Temporary pain at the site of injection
Stinging or burning, redness, swelling, bruising and
bleeding at the site of injection.

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Common side effects

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You can use a second Imigran injection if at least 1 hour
has passed since the first injection.

If the first injection has no effect

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Don’t use a new injection or any other Imigran
preparation for the same attack.
If Imigran doesn’t give you any relief:
Ask your doctor or pharmacist for advice.



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(affect up to 1 in 10 people)
Pain, heaviness, pressure or tightness in the chest,
throat or other parts of the body, or 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.

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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.

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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 Subject
Keep this medicine out of the sight and reach of children.
You may wish to carry Imigran Subject with you in case of a
migraine attack.
Always keep your injections in the case provided to protect
them from the light. Store below 30ºC.
Don’t use this medicine after the expiry date shown on the
carton. The expiry date refers to the last day of that month.
Do not throw away medicines via wastewater or household
waste. Ask your doctor, practice nurse or pharmacist how to
dispose of your empty Cartridge Packs safely. You may be
able to do this at your doctor’s surgery.

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Other formats

Product licence held by Glaxo Wellcome UK Ltd., Stockley
Park West, Uxbridge, Middlesex UB11 1BT
Manufactured by Glaxo Operations UK Ltd., Harmire Road,
Barnard Castle, County Durham DL12 8DT
The information provided applies only to Imigran Subject.

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 Subject
Reference number
10949/0113
This is a service provided by the Royal National Institute of
Blind People.
Leaflet date: May 2014
Imigran, Imigran Subject and the Imigran logo are
registered trademarks of the GSK group of companies
The Subject logo is a trade mark of the GSK group of
companies
© 2014 GSK group of companies. All rights reserved

6 Contents of the pack and other information

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Marketing authorisation holder and manufacturer

What Imigran Subject contains

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The active substance is sumatriptan (6 mg)
The other ingredient is 0.5 ml sterile sodium chloride
solution.

What Imigran Subject looks like and contents of
the pack
Each Imigran injection treatment pack comes complete
with an injection device (Pen) and a cartridge pack which
contains two pre-filled syringes.
Imigran injection is also available as refill packs, which
contain one cartridge of 2 pre-filled syringes.

10000000127730

7 Step-by-step guide to using your Imigran Subject injection system
This leaflet shows you how to load the Subject Pen and how to use it to give a
dose of Imigran medicine.
Please read this leaflet before using the injection system.
The GlaxoSmithKline Subject injection system is designed for use with a
medicine called Imigran.
Each Subject injection system comes complete with an Imigran Cartridge Pack.
The Cartridge pack contains two pre-filled cartridge syringes.
Subject refill packs containing one Imigran Subject Cartridge are also available.
Important: In the unlikely event that you have a problem with the Imigran
Subject injection mechanism, please:
Return it to your pharmacist who will replace it; or
Contact GlaxoSmithKline Customer Contact Centre on Freephone
0800 221441 and they will tell you how to return it.
Keep out of the sight and reach of children

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How to give an injection using the Subject Pen

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4

Read the leaflet fully and carefully before using the Subject Pen
Each Imigran Subject injection system comes complete with a Cartridge Pack
which contains two cartridge syringes pre-filled with Imigran
Use the photo on the left to help you identify the different parts of the
injection system
Do not load the Pen until you are ready to give the injection.

Push the Subject Pen firmly into the
opened Cartridge Pack and gently
screw it clockwise (about half a turn)
until it will twist no further.

1

Swing open the Lid of the Carrycase.

2

Tear off the red Seal from one of the
cartridges. Open the blue hinged lid
underneath the Seal.

5

Keeping your finger away from the
blue Release Button, pull the Subject
Pen out of the Cartridge Pack. You
may have to pull quite hard to do
this. A safety catch stops accidental
injection before you are ready.

3

Take out the Subject Pen from the
Carrycase. Check that the White Rod
is not sticking out beyond the end of
the Pen (see picture11). If it is sticking
out, place the Pen back inside the
Carrycase, push firmly and the Rod
should click into place. The Pen is now
ready for use.

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The loaded Pen is now ready for immediate use.

7

Press the Pen with the long blue Nose
End firmly against a clean area of
skin – usually the outside of the thigh
(as in picture) – so the grey part slides
down to cover part of the blue nose.
This releases the safety catch.

8

Hold the Pen firmly and press the
blue Release Button at the top of
the Subject Pen. Count slowly to 10
keeping the Subject Pen very still and
the Release Button depressed.
Do not take the Pen away from the
skin too soon or some of the
injection may be wasted.
Then lift the Pen away taking care not
to touch the needle point.

Description of parts

Lid

Cartridge
Button
Holes

Release
Button

Seal

Subject Pen
Carrycase
Nose End
White Rod
(inside
Nose End)

Cartridge
Pack
Locating
Buttons

Do not try to put the loaded Pen back into the Carrycase until after you
have used the injection, or the needle may be damaged and the Pen will
not inject correctly.

7 Step-by-step guide to using your Imigran Subject injection system (continued)
9

Return the used cartridge syringe to
the empty space in the Cartridge Pack
straight away.

10 Pushing the Pen down into the

Cartridge Pack as far as it will go,
unscrew the Pen by twisting it
anti-clockwise (about half a turn) until
it comes away.

11 Withdraw the Subject Pen from the

Cartridge Pack. Close the blue hinged
lid over the used syringe.

12 Put the Subject Pen back into the

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Carrycase and push it down until it
stays down. It will click into place. The
Subject Pen is then ready for use next
time.
Close the Lid of the Carrycase until
you need to use the next cartridge
syringe. When you have used both
cartridges, remove and replace the
Cartridge Pack. (See right.)

How to remove the used Cartridge Pack

1

When both syringes have been used,
you can remove the Cartridge Pack.

2

Hold the Carrycase and press the two
blue Locating Buttons with one hand.

3

Gently pull out the Cartridge Pack
with the other hand.

4

Be careful to dispose of your empty
Cartridge Packs safely. The Cartridge
Pack will hold the used Subject
cartridge syringes and needles until
you can safely dispose of them. You
should be able to do this at your
doctor’s surgery, so ask your doctor or
practice nurse.

How to put a new Cartridge Pack into the Carrycase
Each Subject Pen comes complete with an Imigran Cartridge Pack which
contains two pre-filled cartridge syringes.
1 Swing open the Lid of the Carrycase,
the Subject Pen is already in its place.

2

Push the Cartridge Pack into the
Carrycase, pressing the blue buttons
on either side so it slides in smoothly.

3

It does not matter which side of the
Cartridge Pack is closest to the Subject
Pen.

4

The Cartridge Pack is in the right
position when the blue Locating
Buttons show through the holes on
either side of the Carrycase.

5

Close the Carrycase by swinging back
the Lid and snapping it shut.

6

You can keep your Cartridge Pack
safely in the Carrycase until you need
to give yourself an injection.

7

Keep your Carrycase and any refill Cartridge Packs at a temperature
below 30˚C/86˚F. If they are kept warmer than this for more than
24 hours it could spoil them.

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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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