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IMIGRAN INJECTION 12MG/ML

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PACKAGE LEAFLET: INFORMATION FOR THE USER

1671
27.05.15[10]

IMIGRAN™ SUBJECT™
IMIGRAN™ INJECTION 12 mg/ml

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.

(sumatriptan succinate)
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 called Imigran Injection/Imigran Subject but will be
referred to as Imigran Subject throughout this leaflet
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 (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 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.
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 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 30oC. Store in the original pack, away 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 cartridge syringe contains 8.4mg of sumatriptan
succinate equivalent to 6mg sumatriptan as the active ingredient in
0.5ml sterile sodium chloride solution. Also contains sodium chloride
and water for injection.
What Imigran Subject looks like and contents of the pack
Imigran Subject is available in grey & blue carry case, marked with ‘gsk
logo & GlaxoSmithKline’ on both sides with blue press release button
containing grey pen with blue top and bottom and blue cartridge Refill
pack.
Each Imigran Subject Treatment Pack comes complete with an injection
device (SUBJECT Pen) and a Cartridge Refill Pack which contains two
pre-filled syringes

Product Licence Holder and Manufacturer
Manufactured by Glaxo Operations UK, Harmire Road, Barnard Castle,
Co. Durham, UK. Procured from the EU by the Product Licence holder
Star Pharmaceutical Ltd., 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.

POM

PL 20636/1671

Leaflet revision and issue date (Ref :) 27.05.15[10]
IMIGRAN and IMIGRAN SUBJECT are registered trademarks of the
GlaxoSmithKline 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.

6. The loaded Pen is now ready for immediate use.
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. 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.
9. Return the used cartridge
syringe to the empty space in
the Cartridge Pack straight
away.

Description of parts

10. Pushing the Pen down into the
Cartridge Pack as far as it will
go, unscrew the Pen by twisting
it anticlockwise (about half a
turn) until it comes away.

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.

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.)
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.

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.

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.

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 not above 30°C / 86°F. If they are kept warmer than
this for more than 24 hours it could spoil them.

Keep out of the sight and reach of children

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.

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.

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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