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

Active substance(s): SUMATRIPTAN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

IMIGRAN® SUBJECT™ 6mg/0.5ml solution for
injection in pre-filled syringes
(sumatriptan succinate)
Your medicine is available using the above name, but will be referred to
as Imigran Subject throughout the remainder of this leaflet.
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)

• 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.

• 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.

If the first injection has no effect
• Don’t use a new injection or any other Imigran preparation for the
same attack.

Take special care with Imigran Subject

If you have further questions about the use of this medicine, ask
your doctor or pharmacist.

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.

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.

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)
S0487-2-CZ-PIL-17.11.2014

• Pain in the lower left side of the stomach and bloody diarrhoea
(ischaemic colitis)
• Diarrhoea
• Pain in the joints
• Feeling anxious
• Excessive sweating.

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.

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:
ww.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.
Do not store Imigran Subject above 30° C. Store in the original package
in order to protect from light.
Do not use Imigran Subject after the expiry date stated on the syringe
and carton. The expiry date refers to the last day of that month.
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 Subject contains
The active substance is sumatriptan (6 mg). Each pre-filled 0.5ml
Cartridge Syringe contains 6mg sumatriptan (as the succinate) in saline.
The other ingredients: sodium chloride and water for injection.

What Imigran Subject looks like and contents of the pack
An injection device (Pen) and a cartridge pack which contains two prefilled syringes comes in a grey case.

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.

Each Subject injection system comes complete with an Imigran Cartridge
Pack.
The Cartridge pack contains two pre-filled cartridge syringes and 1
SUBJECT pen injector.

Manufacturer:
Glaxo Wellcome Operations, Harmire road, Barnard castle,
Co Durham, DL12 8DT, United Kingdom
Procured from within the EU and repackaged by: Amimed Direct Ltd,
Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial
Estate, Irving Way, Hendon, London, NW9 6AQ.
POM
PL No: 33902/0487
This leaflet was last approved: 17/11/2014
IMIGRAN® SUBJECT™ is a registered trademark of the
GlaxoSmithKline group of companies.

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.

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 prefilled 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

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.

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

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

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

1 Swing open the Lid of 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 Tear off the red Seal from one of the
cartridges. Open the blue hinged lid
underneath the Seal.

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

• Do not load the Pen until you are ready to give the injection.

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

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

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 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.

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.

S0487-2-CZ-PIL-17.11.2014

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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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