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IMIGRAN INJECTIONS

Active substance(s): SUMATRIPTAN SUCCINATE

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Pg 4

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

08/01/14

DATE:

DATE:

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Imigran injection

ARTWORKER:

CODE:

6464/0680G

DATE OF PROOF:

MULTIPLE MANUFACTURERS

PROOF HISTORY:
v.1 - waymade - 08/01/14

\(ÃEè7
Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED JULY 2013
REPORTING SIDE EFFECTS

Pg 1

Pg 4

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 Imigran Pen. Count slowly to 10 keeping the Imigran 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.

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)
Patient Information 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.
What is in this leaflet
1. What Imigran Injection is and what it is used for
2. What you need to know before you use Imigran Injection
3. How to use Imigran Injection
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 your Imigran Injection system

1. What Imigran Injection is and what it is used for
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).
Imigran Injection 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 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.

2. What you need to know before you use Imigran Injection
11. Withdraw the Imigran Pen from the Cartridge Pack. Close the
blue hinged lid over the used syringe.

12. Put the Imigran Pen back into the Carrycase and push it down until
it stays down. It will click into place. The Imigran 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 sections ‘How to remove the used Cartridge).

1.

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

Don't use Imigran Injection:

If you're allergic to sumatriptan, or any of the other ingredients (listed in section 6)

If you have a heart problem such as narrowing of the arteries (ischaemic heart disease) or
chest pains (angina), or have already had a heart attack

If you have circulation problems in your legs that cause cramp-like pains when you walk
(peripheral vascular disease)

If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)

If you have high blood pressure. You may be able to use Imigran if your high blood pressure
is mild and is being treated

If you have serious liver disease

With other migraine medicines, including those which contain ergotamine, or similar
medicines such as methysergide maleate; or any triptan or 5-HT1 agonist (such as naratriptan
or zolmitriptan)

With any of the following anti-depressants:
• MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI in the last 2
weeks
• SSRIs (selective serotonin reuptake inhibitors) including citalopram, fluoxetine,
fluvoxamine, paroxetine and sertraline
• SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine or duloxetine.

For children under 18 years of age.
If any of these apply to you:

Tell your doctor, and don’t use Imigran Injection.
Take special care with Imigran Injection
Talk to your doctor or pharmacist before using Imigran.

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.

4. Be careful to dispose of your empty Cartridge Packs safely. The
Cartridge Pack will hold the used Imigran 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.

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 liver or kidney disease
If either of these apply to you:

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

How to put a new Cartridge Pack into the Carrycase
Each Imigran Pen comes complete with an Imigran Cartridge Pack which contains two pre-filled
cartridge syringes.

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.

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

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.

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

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

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 (overleaf) 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.

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.

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.
©[´ÐC

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.

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Pg 4

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

08/01/14

DATE:

DATE:

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Imigran injection

ARTWORKER:

CODE:

6464/0680G

DATE OF PROOF:

MULTIPLE MANUFACTURERS

PROOF HISTORY:
v.1 - waymade - 08/01/14

\(ÃEè7
Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED JULY 2013
REPORTING SIDE EFFECTS

Pg 2





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

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5. How to store Imigran Injection
Do not use after the expiry date printed on the carton label or cartridge label. The expiry date refers to the
last day of that month.
Imigran Injection should not be stored above 30°C. Protect from light.
Keep all medicines out of sight and reach of children.
If your doctor tells you to stop using this medicine, please take the syringe or any unused injections back
to the pharmacist for safe disposal. Only keep the syringe if your doctor tells you to. 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.
If the injections show any signs of deterioration, seek the advice of your pharmacist before using it.

6. Contents of the pack and other information
Your medicine is called Imigran Injection.
Each pre-filled 0.5ml cartridge syringe contains 6mg of the active ingredient sumatriptan, (as the succinate).
Imigran Injection also contains sodium chloride and water for injections.
Imigran Injection come complete with one auto-injector device (a Pen) and a cartridge pack, which contains
two pre-filled cartridge syringes.
POM

PL No: 6464/0680

This product is manufactured by Glaxo Operations UK Ltd, Barnard Castle, England, or, Vetter Pharma Fertigung & Co KG, Ravensburg, Germany, or, GlaxoSmithKline S.p.A., Officina Farmaceutica Di San Polo
Di Torrile, Parma, Italy and is procured from within the EU and repackaged by the Product Licence Holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 08.01.2014
Imigran is a registered trademark of Glaxo Group.

7. Step-by-step guide to using your Imigran Injection system

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.

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

Children under 18

Imigran is not recommended for children under 18 years old.

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

Older people (aged over 65)

Imigran is not recommended for people aged over 65.

Each injection system comes complete with an Imigran Cartridge Pack.

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, but
don’t use more than two injections in 24 hours.

The Cartridge pack contains two pre-filled cartridge syringes.
Imigran refill packs containing one Imigran 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
Keep out of the sight and reach of children

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:


Please read this leaflet before using the injection system.

Description of parts

Ask your doctor or pharmacist for advice.

If you use more Imigran than you should

Don’t use more than two Imigran injections in 24 hours

Lid

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

Release
Button


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

Injection Pen
Carrycase

4. Possible side effects

Nose End

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.

White Rod
(inside
Nose End)

Cartridge
Button
Holes
Seal
Cartridge
Pack
Locating
Buttons

How to give an injection using the Imigran Injection Pen
• Read the leaflet fully and carefully before using the Injection Pen
• Each Imigran injection system comes complete with a Cartridge Pack which contains two cartridge
syringes pre-filled with Imigran
• Use the photo above to help you identify the different parts of the injection system
• Do not load the Pen until you are ready to give the injection.

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.

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.

3. Take out the Imigran Pen from the Carrycase. Check that the
White Rod is not sticking out beyond the end of the Pen (see
picture 11). 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.

Very rare side effects
(affect up to 1 in 10,000 people)

Liver function changes. If you have a blood test to check your liver function, tell your doctor or
nurse that you are using Imigran.
Some patients may have the following side effects but it is not known how often they occur

Seizures/fits, tremors, muscle spasm, neck stiffness

Visual disturbances such as flickering, reduced vision, double vision, loss of vision, and in some
cases even permanent defects (although these may be due to the migraine attack itself)

Heart problems, where your heartbeat may go faster, slower or change rhythm, chest pains
(angina) or heart attack

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

Feeling faint (blood pressure may go down)

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

Diarrhoea

Pain in the joints

Feeling anxious

Excessive sweating.

4. Push the Imigran Pen firmly into the opened Cartridge Pack
and gently screw it clockwise (about half a turn) until it will twist no
further.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet.

6. The loaded Pen is now ready for immediate use.

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.

5. Keeping your finger away from the blue Release Button, pull the
Imigran Pen straight 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.

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.

By reporting side effects you can help provide more information on the safety of this medicine.
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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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