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IMIGRAN SUBJECT 6 MG/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE SYRINGES

Active substance(s): SUMATRIPTAN

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PACKAGE LEAFLET: Information for the User

IMIGRAN® SUBJECT®
6 mg/0.5 ml solution for injection in pre-filled
cartridge syringes

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.

(sumatriptan succinate)

Also see Other medicines and Imigran, below.

Your medicine is called IMIGRAN SUBJECT 6 mg/0.5 ml solution
for injection in pre-filled cartridge syringes but will be referred to
as Imigran Subject throughout this leaflet

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.

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.

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

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.

2. What you need to know before you use
Imigran Subject
Don’t use Imigran Subject:
• 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
Take special care with Imigran Subject
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 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.
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
• 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).
When to use Imigran
• 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.
If your symptoms start to come back
• 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
• 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.
If you use more Imigran than you should
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.

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.
Very common side effects
(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.
Common side effects
(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.
Other common side effects include:
• 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 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.
Do not store above 30°C.
Store in the original package. Protect from light.
Don’t use Imigran injection after the expiry date shown on the
carton.
The expiry date refers to the last day of that month.
Ask your doctor, practice nurse or pharmacist how to dispose of
medicines no longer required or empty Cartridge Packs safely.
You may be able to do this at your doctor’s surgery.

6. Contents of the pack and other information
What Imigran Subject contains
Each pre-filled 0.5 ml cartridge syringe contains 6 mg sumatriptan
(as the succinate) in saline.
Also contains: sodium chloride and water for injection.
What Imigran Subject looks like and contents of the pack
Each refill pack containing two pre-filled syringes.
Procured from within the EU by PL holder:
PilsCo Ltd, 10-16 Colvilles Place, East Kilbride, G75 0SN
IMIGRAN SUBJECT 6 mg/0.5 ml solution for injection in pre-filled
cartridge syringes PL 39467/0247
POM
Manufacturer
GlaxoSmithKline B.V.
Huis ter Heideweg 62
3705 LZ Zeist
The Netherlands
Leaflet last revised 07/01/2015
IMIGRAN® and IMIGRAN SUBJECT® are registered trademarks
of the GlaxoSmithKline group of companies.
The Subject logo is a trade mark of the GSK group of companies
© 2014 GSK group of companies.
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
Description of parts

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.

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.

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.

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.

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

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

How to give an injection using the Subject Pen
• 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 above to help you identify the different parts of
the injection system
• Do not load the Pen until you are ready to give the
injection.

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.

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.

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 Carrycase and push it
down until it stays down.
It will click into place.
The Subject Pen is then
ready for use next time.
13. 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.)

4. 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.

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.

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.

6. The loaded Pen is now ready for immediate use.

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.

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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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