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SUMATRIPTAN SUBJECT INJECTION

Active substance(s): SUMATRIPTAN SUCCINATE

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IMIGRAN

2

®

Package Leaflet:
Information for the User

SUBJECT injection
(sumatriptan succinate)
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.

1
What is in this leaflet
1

What Imigran Subject is and what it is used for

2
3

What you need to know before you use Imigran
Subject
How to use Imigran Subject

4

Possible side effects

5

How to store Imigran Subject

6

Content of the pack and other information

7

Step-by-step guide to using your Imigran Subject
injection system

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.

What you need to know before you use Imigran Subject

Don’t use Imigran Subject

Take special care with 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

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.

 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.

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 you use more Imigran than you should

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).

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

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.

Using too much Imigran could make you ill. If you have
used more than two injections in 24 hours:

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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.

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 Subject.
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)

5

Diarrhoea
Pain in the joints
Feeling anxious
Excessive sweating.

How to store Imigran

Keep 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. Do not store above 30°C
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 your empty Cartridge Packs safely. You may be
able to do this at your doctor’s surgery.

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.

• 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 Sumatriptan.
• 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 that contain St John’s Wort while using Imigran
may make side effects more likely.

6

Content of the pack and other information

What Imigran Subject contains
• The active substance is sumatriptan (6 mg)
• The other ingredient is 0.5ml 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.
Manufactured by: Glaxo Wellcome Operations, Harmire
Road- County Durham, DL12 8DT, Barnard Castle, UK.
Procured from within the EU & repackaged by product
License holder: Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, SL1 4NL, UK.
IMIGRAN SUBJECT injection, PL: 39352/0075
Leaflet date: 06.02.2015

POM

Imigran is a registered 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.
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.

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.

Lid

Seal

Subject Pen
Carrycase
Nose End

Cartridge
Pack

This releases the safety catch.

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.

Cartridge
Button
Holes

Release
Button

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.

1. Swing open the Lid of the Carrycase.

Keep out of the sight and reach of children

Description of parts

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.

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.

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.

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.

Locating
Buttons

White Rod
(inside Nose
End)

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

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.

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.

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.

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.)

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.

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.

SUMATRIPTAN

Package Leaflet:
Information for the User

SUBJECT Injection
(sumatriptan succinate)
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

1

What is in this leaflet
1

What Sumatriptan Subject is and what it is
used for

2

What you need to know before you use
Imigran Subject

3

How to use Sumatriptan Subject

4

Possible side effects

5

How to store Sumatriptan Subject

6

Content of the pack and other information

7

Step-by-step guide to using your Sumatriptan
Subject injection system

3

What Sumatriptan Subject is and what it is
used for

Each Sumatriptan 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).
Sumatriptan 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.
Sumatriptan 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 Sumatriptan Subject
3
Don’t use Sumatriptan Subject
Take special care with Sumatriptan 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 Sumatriptan 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)

Talk to your doctor or pharmacist before using Sumatriptan.
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 Sumatriptan, 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 Sumatriptan 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.

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
Sumatriptan. Also see Other medicines and
Sumatriptan, below.
If you use Sumatriptan frequently
Using Sumatriptan too often may make your headaches
worse.
→ Tell your doctor if this applies to you. He or she may
recommend you stop using Sumatriptan.
If you feel pain or tightness in your chest after you use
Sumatriptan.
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 Sumatriptan

Tell your doctor or pharmacist if you’re taking, have
recently taken or might take any other medicines. This
→ Tell your doctor so that you can be supervised more
includes any herbal products or medicines you’ve bought
closely.
without a prescription.
If you have had high blood pressure Sumatriptan may not Some medicines must not be taken with Sumatriptan and
be suitable for you
others may cause adverse effects if they’re taken with
 Tell your doctor or pharmacist before using
Sumatriptan. You must tell your doctor if you are taking:
Sumatriptan.
• ergotamine also used to treat migraine, or similar
If you have liver or kidney disease
medicines such as methysergide (see section 2 Don’t use
If either of these apply to you:
Imigran Subject). Don’t use Imigran at the same time as
→ Tell your doctor or pharmacist before using
these medicines. Stop taking these medicines at least 24
Sumatriptan.
hours before using Sumatriptan. Don’t take any medicines
which contain ergotamine or compounds similar to
If you are allergic to antibiotics called sulphonamides
ergotamine again for at least 6 hours after using
If so, you may also be allergic to Sumatriptan. If you know
Sumatriptan.
you are allergic to an antibiotic but you are not sure whether it
is a sulphonamide:
→ Tell your doctor or pharmacist before using
Sumatriptan.

 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 Sumatriptan Subject.

How to use Sumatriptan Subject

Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Sumatriptan 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 Sumatriptan than you should
Using too much Sumatriptan could make you ill. If you have
used more than two injections in 24 hours:
→ Contact your doctor for advice.
If you have any further questions about the use of this
medicine, ask your doctor or pharmacist.

When to use Sumatriptan
• It’s best to use Sumatriptan as soon as you feel a

4

migraine or a cluster headache coming on, although
you can use it at any time during an attack
• Don’t use Sumatriptan to try to prevent an attack – only
use it after your migraine symptoms start.

Like all medicines, this medicine Subject can cause side
effects, but not everybody gets them. Some symptoms may
be caused by the migraine itself.

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
 Sumatriptan is not recommended for children under
18 years old.
Older people (aged over 65)
• Sumatriptan is not recommended for people aged over
65.

If your symptoms start to come back
 You can use a second Sumatriptan injection if at least 1
hour has passed since the first injection, but don’t use
more than two injections in 24 hours.

If the first injection has no effect
 Don’t use a new injection or any other Sumatriptan
preparation for the same attack.
If Sumatriptan doesn’t give you any relief:
→ Ask your doctor or pharmacist for advice.

Possible side effects

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
Sumatriptan Subject:
→ 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 Sumatriptan Subject.
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 or pharmacist.
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

6

Content of the pack and other information

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What
Sumatriptan Subject contains
• The active substance is sumatriptan (6 mg)
• The other ingredient is 0.5ml sterile sodium chloride
solution.

What Sumatriptan Subject looks like and contents
of the pack
Each Sumatriptan injection treatment pack comes complete
with an injection device (Pen) and a Cartridge Pack which
contains two pre-filled syringes.

How to store Sumatriptan

Keep out of the sight and reach of children.
You may wish to carry Sumatriptan Subject with you in case
of a migraine attack
Always keep your injections in the case provided to protect
them from the light. Do not store above 30°C.
Don’t use Sumatriptan 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 your empty Cartridge Packs safely. You may be
able to do this at your doctor’s surgery.

Manufactured by: Glaxo Wellcome Operations, Harmire
Road- County Durham, DL12 8DT, Barnard Castle, UK.
Procured from within the EU & repackaged by product
License holder: Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, SL1 4NL, UK.
SUMATRIPTAN SUBJECT Injection, PL: 39352/0075
Leaflet date: 06.02.2015
POM

• other triptans/5-HT1 receptor agonists (such as
naratriptan, rizatriptan, zolmitriptan), also used to treat
migraine, (see section 2 Don’t use Sumatriptan
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 Sumatriptan.
• MAOIs used to treat depression. Don’t use
Sumatriptan if you have taken these in the last 2 weeks
• SSRIs and SNRIs used to treat depression.
Using Sumatriptan 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 that contain St John’s Wort while using
Sumatriptan 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 Sumatriptan 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 Sumatriptan while you are pregnant
• Don’t breast-feed your baby for 12 hours after
using Sumatriptan. 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.

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Step-by-step guide to using your Sumatriptan Subject injection system

This leaflet shows you how to load the Subject Pen and how to use it to give a
dose of Sumatriptan medicine.
Please read this leaflet before using the injection system.
The GlaxoSmithKline Subject injection system is designed for use with a
medicine called Sumatriptan.
Each Subject injection system comes complete with an Sumatriptan Cartridge
Pack.
The Cartridge pack contains two pre-filled cartridge syringes.
Subject refill packs containing one Sumatriptan Subject Cartridge are also
available.
Important: In the unlikely event that you have a problem with the Sumatriptan
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.

How to give an injection using the Subject Pen



Read the leaflet fully and carefully before using the Subject Pen
Each Sumatriptan Subject injection system comes complete with a
Cartridge Pack which contains two cartridge syringes pre-filled with
Sumatriptan
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.




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.

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.

Keep out of the sight and reach of children

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.

Description of parts

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.

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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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.

Step-by-step guide to using your Sumatriptan Subject injection system
9. Return the used cartridge syringe to
the empty space in the Cartridge Pack
straight away.

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

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.

How to put a new Cartridge Pack into the Carrycase
Each Subject Pen comes complete with an Sumatriptan 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.

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.

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.)

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.

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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