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IMIGRAN SUBJECT INJECTION

Active substance(s): SUMATRIPTAN SUCCINATE

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Package Leaflet: Information for the User
®

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IMIGRAN SUBJECT

INJECTION

(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.
The name of your medicine is IMIGRAN SUBJECT INJECTION, but it will be referred as
Imigran Subject or Imigran throughout this leaflet.

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 your
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 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.

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 6mg
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
You may wish to carry Imigran Subject with
you in case of a migraine attack.
Keep your injections in the case provided.
Do not store above 30°C. Protect from light.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN. A child may be harmed by
medicine prescribed for someone else.
Read the Patient Instruction Leaflet (see
overleaf) on what to do with the cartridge
containing the used syringes and needles.
Take care to follow this advice.
If your doctor stops your treatment do not
keep any leftover injections unless your doctor
tells you to. Return any unused injections to
your pharmacist for safe disposal.
Do not use after the expiry date ‘Exp’printed
on the pack. The expiry date refers to the last
day of that month.

6 Contents of the pack and
other information
What Imigran Subject contains

Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit
4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.

Each 0.5ml syringe contains 6mg sumatriptan
(as the succinate) in saline. Also contains
sodium chloride and water for injection.

IMIGRAN SUBJECT INJECTION
PL No: 18799/1305

What Imigran Subject looks like and
contents of the pack

If you need more help or advice on migraine
please contact the following national
organisations:

Each Imigran Subject Treatment Pack comes
complete with an injection device (Subject Pen)
and a cartridge pack which contains two prefilled syringes.

Manufactured by: Glaxo Operations UK Ltd,
Barnard Castle, UK.

POM

Migraine Action Association
Unit 6, Oakley Hay Lodge Business Park, Great
Folds Road, Great Oakley, Northants NN18 9AS
Telephone: 01536 461333
The Migraine Trust
55-56 Russell Square, London WC1B 4HP
Telephone: 020 7463 1336
The following national organisation offers help
and advice on cluster headaches:
Organisation for the Understanding of Cluster
Headaches (OUCH UK)
Pyramid House, 956 High Road, London N12 9RX,
Telephone: 01646 651979
You may be able to find out more about prescribed
medicines from books in public libraries.
Leaflet date: 06.05.2015
IMIGRAN, IMIGRAN SUBJECT and the IMIGRAN
logo are registered trademarks of the
GlaxoSmithKline group of companies.
The SUBJECT logo is a trademark 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.

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 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.

The Cartridge pack contains two pre-filled cartridge syringes.

1 Swing open the lid of the Carrycase.

Subject refill packs containing one Imigran Subject Cartridge are also
available.

2 Tear off the red seal from one of

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.

the cartridges. Open the blue
hinged lid underneath the seal.

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.

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.

5 Keeping your finger away from

Do not take the pen away from the skin too soon or some of the
injection may be wasted.

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.

Keep out of the sight and reach of children
Description of parts

Then lift the pen away taking care not to touch the needle point.

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 step 11 picture). 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.

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 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.

11

12
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.

Withdraw the Subject Pen from the
Cartridge Pack. Close the blue
hinged lid over the used syringe.

How to remove the used Cartridge Pack

How to put a new Cartridge Pack into the Carrycase

1

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

Each Subject Pen comes complete with an Imigran Cartridge Pack
which contains two pre-filled cartridge syringes.

2

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

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.)

1

2

Swing open the lid of the
Carrycase, the Subject Pen is
already in its place.
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.

3
4

Gently pull out the Cartridge Pack
with the other hand.
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.

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.

Expand view ⇕

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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