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SUMATRIPTAN 6MG/0.5ML INJECTION

Active substance(s): SUMATRIPTAN / SUMATRIPTAN SUCCINATE

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S1809 LEAFLET Imigran 20170505

How to remove the used Cartridge Pack

S1809 LEAFLET Imigran 20170505

Take special care with Imigran Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER
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. 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.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.

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.

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

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.)



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

How to put a new Cartridge Pack into the Carrycase

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.

®

Imigran Injection
(sumatriptan succinate)

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

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.

1

What Imigran Injection is and what it is used for

2

What you need to know before you use Imigran Injection

If you have had high blood pressure Imigran may not be
suitable for you

3

How to use Imigran Injection

 Tell your doctor or pharmacist before using Imigran.

4

Possible side effects

5

How to store Imigran Injection

6

Contents of the pack and other information

7

Step-by-step guide to using Imigran Injection

If either of these apply to you:
 Tell your doctor or pharmacist before using Imigran.

1

What Imigran Injection is and what it is used for

If you are allergic to antibiotics called sulphonamides

If you have liver or kidney disease

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

Each Imigran Injection 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).

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:

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

Imigran Injection is used to treat migraine headache and a rare
condition called cluster headache.

If you are taking anti-depressants called SSRIs

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

Imigran Injection 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.

5. Close the Carrycase by
swinging back the Lid and
snapping it shut.

2

Migraine and cluster headache symptoms may be caused by the
temporary widening of blood vessels in the head.

What you need to know before you use Imigran Injection

Don’t use Imigran Injection:

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.
S1809 LEAFLET Imigran 20170505



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)





 Tell your doctor or pharmacist before using Imigran.

(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
Injection). 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 Injection).
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.

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 Injection.



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.

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.

5

How to store Imigran Injection



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30° C.



Store in the original package to protect from light.



Do not use after the expiry date printed on the pack label.



Keep your injections in the case provided. You may wish to carry
Imigran Injection with you in case of a migraine attack.



If you get any of these symptoms soon after using Imigran:
 Don’t use any more. Contact a doctor straight away.

Take the used injection pen and empty cartridges back to the
pharmacist for disposal.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the medicine
if your doctor tells you to.

Very common side effects



If the medicine fails to work correctly or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.

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.

(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

How to use Imigran Injection

Always use this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.



Read the leaflet fully and carefully before using the Subject Pen



Each Imigran 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.

What Imigran Injection looks like and contents of the pack

1

The carton contains a grey carrycase containing 1 Auto-injector pen
(the injection device) and a blue Cartridge Pack containing two
cartridge syringes pre-filled with the injection.

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.

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.

6

The loaded Pen is now ready for immediate use.

6


(affect up to 1 in 10 people)


3

Contents of the pack and other information

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.

Each 0.5ml pre-filled cartridge syringe contains 6mg of the active
ingredient sumatriptan (as the succinate) in a solution of sodium
chloride and water for injection.

Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.

Imigran Injection is usually injected into the thigh.

Other common side effects include:

There’s a step-by-step guide to using the syringe at the end of this
leaflet (see section 7 overleaf).



Feeling sick (nausea) or being sick (vomiting), although this may
be due to the migraine itself



Tiredness or drowsiness

Manufacturer

When to use Imigran



Dizziness, feeling weak, or getting hot flushes





Temporary increase in blood pressure



This product is manufactured by Glaxo Operations UK Limited
(trading as Glaxo Wellcome Operations), Harmire Road, Barnard
Castle, Co. Durham, DL12 8DT, UK.

Shortness of breath



Aching muscles.



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.

Very rare side effects
How much to use

(affect up to 1 in 10,000 people)

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)


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

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.

PL: 19488/1809

Leaflet revision date: 05 May 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.

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

Imigran® is a registered trade mark of Glaxo Group Ltd, UK.



Pale, blue-tinged skin and/or pain in your fingers, toes, ears,
nose or jaw in response to cold or stress (Raynaud’s
phenomenon)

7

Imigran is not recommended for people aged over 65.

You can use a second Imigran injection if at least 1 hour has
passed since the first injection.

POM



If your symptoms start to come back


How to give an injection using the Subject Pen

What Imigran Injection contains

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.

Description of parts

Step-by-step guide to using your Imigran Injection

This leaflet shows you how to load the Subject Pen and how to use it
to give a dose of Imigran medicine.



Feeling faint (blood pressure may go down)



Pain in the lower left side of the stomach and bloody diarrhoea
(ischaemic colitis)

Please read this leaflet before using the injection system.



Diarrhoea



Pain in the joints

The GlaxoSmithKline Injection system is designed for use with a
medicine called Imigran.



Feeling anxious

Each Subject injection system comes complete with an Imigran
Cartridge Pack.



Excessive sweating.

The Cartridge pack contains two pre-filled cartridge syringes.

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.

Subject refill packs containing one Imigran Injection Cartridge are
also available.
Important: In the unlikely event that you have a problem with the
Imigran 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

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.

S1809 LEAFLET Imigran 20170505

S1809 LEAFLET Sumatriptan 20170505

How to remove the used Cartridge Pack

S1809 LEAFLET Sumatriptan 20170505

PACKAGE LEAFLET: INFORMATION FOR THE USER
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. 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.

The name of this product is Sumatriptan 6mg/0.5ml Injection but will
be referred to as Sumatriptan injection throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.

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.

How to put a new Cartridge Pack into the Carrycase

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.)



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.

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)

What is in this leaflet

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:

1

What Sumatriptan Injection is and what it is used for

 Tell your doctor so that you can be supervised more closely.

2

What you need to know before you use Sumatriptan
Injection

3

How to use Sumatriptan Injection

If you have had high blood pressure Sumatriptan may not be
suitable for you

4

Possible side effects

 Tell your doctor or pharmacist before using Sumatriptan.

5

How to store Sumatriptan Injection

6

Contents of the pack and other information

If you have liver or kidney disease

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

7

Step-by-step guide to using Sumatriptan Injection

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

If either of these apply to you:
 Tell your doctor or pharmacist before using Sumatriptan.

1

What Sumatriptan Injection is and what it is used for

Each Sumatriptan Injection 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).

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

Sumatriptan Injection is used to treat migraine headache and a
rare condition called cluster headache.

3. It does not matter which side of
the Cartridge Pack is closest to
the Subject Pen.
11. Withdraw the Subject Pen from
the Cartridge Pack. Close the
blue hinged lid over the used
syringe.

Sumatriptan 6mg/0.5ml Injection
(sumatriptan succinate)

Take special care with Sumatriptan Injection

If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Sumatriptan. 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 Sumatriptan.

Migraine and cluster headache symptoms may be caused by the
temporary widening of blood vessels in the head.

If you are taking anti-depressants called SSRIs

Sumatriptan Injection 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.

(Serotonin Noradrenaline Reuptake Inhibitors)

5. Close the Carrycase by
swinging back the Lid and
snapping it shut.

2

If you use Sumatriptan frequently

6. You can keep your Cartridge
Pack safely in the Carrycase
until you need to give yourself
an injection.



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

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.



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)

Some medicines must not be taken with Sumatriptan and others may
cause adverse effects if they’re taken with Sumatriptan.
You must tell your doctor if you are taking:

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

What you need to know before you use Sumatriptan
Injection

Don’t use Sumatriptan 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.
S1809 LEAFLET Sumatriptan 20170505





(Selective Serotonin Reuptake Inhibitors) or SNRIs
 Tell your doctor or pharmacist before using Sumatriptan.
Also see Other medicines and Sumatriptan, below.

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



ergotamine also used to treat migraine, or similar medicines
such as methysergide (see section 2 Don’t use Sumatriptan
Injection). Don’t use Sumatriptan at the same time as these
medicines. Stop taking these medicines at least 24 hours before
using Sumatriptan. Don’t take any medicines which contain
ergotamine or compounds similar to ergotamine again for at least
6 hours after using Sumatriptan.



other triptans/5-HT1 receptor agonists (such as naratriptan,
rizatriptan, zolmitriptan), also used to treat migraine, (see
section 2 Don’t use Sumatriptan Injection).
Don’t use Sumatriptan at the same time as these medicines.
Stop taking these medicines at least 24 hours before using
Sumatriptan. Don’t take another triptan/5-HT1 receptor agonist
for at least 24 hours after 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 Injection.



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 containing St John’s Wort while using Sumatriptan may
make side effects more likely.

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.

5

How to store Sumatriptan Injection



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30° C.



Store in the original package to protect from light.



Do not use after the expiry date printed on the pack label.



Keep your injections in the case provided. You may wish to carry
Sumatriptan Injection with you in case of a migraine attack.



If you get any of these symptoms soon after using Sumatriptan:
 Don’t use any more. Contact a doctor straight away.

Take the used injection pen and empty cartridges back to the
pharmacist for disposal.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the medicine
if your doctor tells you to.

Very common side effects



If the medicine fails to work correctly or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.

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.

(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

How to use Sumatriptan Injection

Always use this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.



(affect up to 1 in 10 people)

Driving and using machines

3

Contents of the pack and other information

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.

Sumatriptan Injection is usually injected into the thigh.

Other common side effects include:

There’s a step-by-step guide to using the syringe at the end of this
leaflet (see section 7 overleaf).



Feeling sick (nausea) or being sick (vomiting), although this may
be due to the migraine itself

Each 0.5ml pre-filled cartridge syringe contains 6mg of the active
ingredient sumatriptan (as the succinate) in a solution of sodium
chloride and water for injection.

The carton contains a grey carrycase containing 1 Auto-injector pen
(the injection device) and a blue Cartridge Pack containing two
cartridge syringes pre-filled with the injection.

Tiredness or drowsiness

Manufacturer



Dizziness, feeling weak, or getting hot flushes





Temporary increase in blood pressure



This product is manufactured by Glaxo Operations UK Limited
(trading as Glaxo Wellcome Operations), Harmire Road, Barnard
Castle, Co. Durham, DL12 8DT, UK.

Shortness of breath



Aching muscles.

Don’t use Sumatriptan to try to prevent an attack - only use it
after your migraine symptoms start.

Very rare side effects
How much to use

(affect up to 1 in 10,000 people)

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)


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

POM

Each Sumatriptan 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.

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.

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.

6

The loaded Pen is now ready for immediate use.

PL: 19488/1809

Leaflet revision date: 05 May 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD or
Braille.



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)

Please read this leaflet before using the injection system.



Pain in the lower left side of the stomach and bloody diarrhoea
(ischaemic colitis)

The GlaxoSmithKline Injection system is designed for use with a
medicine called Sumatriptan.



Diarrhoea



Pain in the joints

Each Subject injection system comes complete with an Sumatriptan
Cartridge Pack.



Feeling anxious



Excessive sweating.

Sumatriptan is not recommended for people aged over 65.

You can use a second Sumatriptan injection if at least 1 hour has
passed since the first injection.

Liver function changes. If you have a blood test to check your
liver function, tell your doctor or nurse that you are using
Sumatriptan.

Some patients may have the following side effects but it is not
known how often they occur

If your symptoms start to come back


Read the leaflet fully and carefully before using the Subject Pen



Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.







What Sumatriptan Injection looks like and contents of the pack

When to use Sumatriptan
It’s best to use Sumatriptan as soon as you feel a migraine or
a cluster headache coming on, although you can use it at any
time during an attack

How to give an injection using the Subject Pen

What Sumatriptan Injection contains


Either the symptoms of migraine or your medicine may make you
drowsy. If you are affected, don’t drive or operate machinery.

6

Description of parts

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.

7

Step-by-step guide to using your Sumatriptan Injection

This leaflet shows you how to load the Subject Pen and how to use it
to give a dose of Sumatriptan medicine.

The Cartridge pack contains two pre-filled cartridge syringes.
Subject refill packs containing one Sumatriptan Injection Cartridge
are also available.
Important: In the unlikely event that you have a problem with the
Sumatriptan 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.

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.

Keep out of the sight and reach of children
S1809 LEAFLET Sumatriptan 20170505

+ Expand Transcript

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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