Patient leaflet - Imigran injection, Sumatriptan Succinate 6 mg / 0.5 ml injection
What Imigran is and what it is used for
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If either of these apply to you:
What you need to know before you use Imigran
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Tell your doctor or pharmacist before using Imigran. If you are allergic to antibiotics called sulphonamides
8 Hold the pen firmly and press the blue release button at the top of the pen. Count slowly to 10 keeping the 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.
How to use Imigran
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How to put a new cartridge pack into the carrycase
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:
Possible side effects
4
How to store Imigran
Each pen comes complete with an Imigran cartridge pack which contains two pre-filled cartridge syringes.
5
Tell your doctor or pharmacist before using Imigran. If you are taking anti-depressants called SSRIs
Contents of the pack and other information
6
(Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)
Step-by-step guide to using your Imigran injection system
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1 Swing open the lid of the carrycase, the pen is already in its place.
Tell your doctor or pharmacist before using Imigran.
Also see Other medicines and Imigran, below.
1
What Imigran is and what it is used for
9 Return the used cartridge syringe to the empty space in the cartridge pack straight away.
2 Push the cartridge pack into the carrycase, pressing the blue buttons on either side so it slides in smoothly.
Imigran syringe may contain latex
The syringe needle shield may contain latex.
Each Imigran 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).
Tell your doctor if you are allergic to latex.
If you use Imigran frequently
3 It does not matter which side of the cartridge pack is closest to the pen.
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.
Imigran is used to treat migraine headache and a rare condition called cluster headache.
If you feel pain or tightness in your chest after you use Imigran
10 Pushing the pen down into the cartridge
4 The cartridge pack is in the right position when the blue locating buttons show
These effects may be intense but they usually pass quickly. If they don’t pass quickly, or they become severe:
pack as far as it will go, unscrew the pen by twisting it anti-clockwise (about half a turn) until it comes away.
Migraine and cluster headache symptoms may be caused by the temporary
widening of blood vessels in the head. Imigran 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.
through the holes on either side of the
Get medical help immediately. Section 4 (below) has more information about these possible side effects.
carrycase.
5 Close the carrycase by swinging back the lid and snapping it shut.
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.
What you need to know before you use Imigran 
2
6 You can keep your cartridge pack safely in the carrycase until you need to give yourself an injection.
Don’t use Imigran:
Some medicines must not be taken with Imigran and others may cause adverse effects if they’re taken with Imigran.
11 Withdraw the pen from the cartridge pack.
- If you’re allergic to sumatriptan, or any of the other ingredients of this medicine (listed in section 6)
Close the blue hinged lid over the used syringe.
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:
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)
- ergotamine also used to treat migraine, or similar medicines such as methysergide (see section 2 Don’t use Imigran). 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 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
- 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.
12 Put the Pen back into the Carrycase and
push it down until it stays down. It will click into place. The Pen is then ready for use next time.
- 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:
13 Close the Lid of the Carrycase until you
- MAOIs used to treat depression. Don’t use Imigran if you have taken these in the last 2 weeks.
need to use the next cartridge syringe. When you have used both cartridges, remove and replace the Cartridge Pack. (See right.)
MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI 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.
- 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.
- St John’s Wort (Hypericum perforatum). Taking herbal remedies containing St John’s Wort while using Imigran may make side effects more likely.
If any of these apply to you:
Tell your doctor, and don’t use Imigran.
Take special care with Imigran
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using Imigran.
- 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
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
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Common side effects
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.
Contents of the pack and other information
Step-by-step guide to using your Imigran Injection System
(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.
What Imigran contains
This leaflet shows you how to load the pen and how to use it to give a dose of Imigran medicine.
Each pre-filled 0.5ml Cartridge Syringe contains 6mg of sumatriptan (as the succinate) in saline.
Driving and using machines
Please read this leaflet before using the injection system.
Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, don’t drive or operate machinery.
Also contains sodium chloride and water for injections.
The GlaxoSmithKline injection system is designed for use with a medicine called Imigran.
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.
What Imigran looks like and contents of the pack
Imigran contains
Each Imigran is available in 2 pre-filled syringes in cases plus an auto-injector, in a plastic tray within a carton.
Each injection system comes complete with an Imigran cartridge pack.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially ‘sodium-free’.
Other common side effects include:
Each injection pack contains 2 pre-filled syringes and auto injector in a cartridge.
The cartridge pack contains two pre-filled cartridge syringes.
Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself
Imigran injection is also available as refill packs, which contain 2 pre-filled cartridge syringes.
Subject refill packs containing one Imigran cartridge are also available.
- Tiredness or drowsiness
- Dizziness, feeling weak, or getting hot flushes
How to use Imigran
I Ref:1603/020221/1/B 3
Temporary increase in blood pressure
Manufacturer and Licence Holder
Important: In the unlikely event that you have a problem with the Imigran injection mechanism, please:
- Shortness of breath
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Manufactured by Glaxo Operations UK Ltd, Barnard Castle, UK and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Aching muscles.
- 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.
Very rare side effects
Imigran Subject is usually injected into the thigh.
(affect up to 1 in 10,000 people)
There’s a step-by-step guide to using the syringe at the end of this leaflet (see section 7 overleaf).
Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are using Imigran.
Keep out of the sight and reach of children
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
Description of parts
When to use Imigran
Some patients may have the following side effects but it is not known how often they occur
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
PL 15184/1603 - Imigran Injection
POM Cartridge
Seizures/fits, tremors, muscle spasm, neck stiffness
Button
Lid
- 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)
Don’t use Imigran to try to prevent an attack - only use it after your migraine symptoms start.
Imigran is a registered trademark of the GlaxoSmithKline Group of Companies.
Holes
Release
Button
Seal
- Heart problems, where your heartbeat may go faster, slower or change rhythm, chest pains (angina) or heart attack
How much to use
Leaflet revision date: 02/02/21
Pen
Adults aged 18 to 65
Pale, blue-tinged skin and/or pain in your fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud’s phenomenon)
Cartridge Pack
The usual dose for adults aged 18 to 65 with migraine or a cluster headache is one 6 mg injection.
Blind or partially sighted?
Carrycase
Feeling faint (blood pressure may go down)
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Nose End
Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis)
Locating Buttons White Rod
Children under 18
Imigran is not recommended for children under 18 years old.
- Diarrhoea
If you had a recent injury or if you have inflammation (like rheumatism or inflammation of the colon) you may experience pain or pain worsening at the site of injury or inflammation
(inside
Older people (aged over 65)
Tel: 01527 505414 to obtain the leaflet in a format suitable for you
Nose End)
Imigran is not recommended for people aged over 65.
Pain in the joints
How to give an injection using the pen
If your symptoms start to come back
Feeling anxious
- Read the leaflet fully and carefully before using the 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
- You can use a second Imigran injection if at least 1 hour has passed since the first injection.
- Difficulty swallowing
- Excessive sweating.
If the first injection has no effect
Reporting of side effects
Don’t use a new injection or any other Imigran preparation for the same attack.
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:
- Do not load the pen until you are ready to give the injection.
1 Swing open the lid of the carrycase.
If Imigran doesn’t give you any relief:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ask your doctor or pharmacist for advice.
2 Tear off the red seal from one of the
By reporting side effects you can help provide more information on the safety of this medicine
cartridges. Open the blue hinged lid
If you use more Imigran than you should
underneath the seal.
Using too much Imigran could make you ill. If you have used more than two injections in 24 hours:
Contact your doctor for advice.
How to store Imigran
5
If you have further questions about the use of this medicine, ask your doctor or pharmacist.
Storing your medicine
- Do not store above 30°C.
3 Take out the pen from the carrycase.
- Protect from light.
Check that the white rod is not
- KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Possible side effects
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sticking out beyond the end of the pen
- Do not take Imigran after the expiry date which is stated on the labels or carton. The expiry date refers to the last day of the month. • If your doctor tells you to stop using this medicine, return any unused injections to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.
(see picture11). If it is sticking out,
Like all medicines, this medicine can cause side effects, but not everybody gets them. Some symptoms may be caused by the migraine itself.
place the pen back inside the
carrycase, push firmly and the rod
should click into place. The pen is now
Allergic reaction: get doctor’s help straight away
ready for use.
- If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
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.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
4 Push the pen firmly into the
If you get any of these symptoms soon after using Imigran:
opened cartridge pack and gently
Don’t use any more. Contact a doctor straight away.
screw it clockwise (about half a turn)
until it will twist no further.
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.