IMIGRAN INJECTION, SUMATRIPTAN SUCCINATE 6 MG / 0.5ML INJECTION - patient leaflet, side effects, dosage

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. See section 4.

Your medicine is called Imigran Injection throughout the rest of this leaflet it will be referred to as Imigran.

What is in this leaflet

What Imigran is and what it is used for

What you need to know before you use Imigran

How to use Imigran

Possible side effects

How to store Imigran

Contents of the pack and other information

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

Q What Imigran is and what it is used for

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).

Imigran 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 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.

Q

What you need to know before you use Imigran

Don’t use Imigran:

• 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)
• 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.

Take special care with Imigran

Talk to your doctor or pharmacist before using Imigran.

If you have any extra risk factors

• If you are a heavy smoker or are using nicotine replacement therapy, and especially
• If you are a man aged over 40, or
• If you are a woman who has been through the menopause

In very rare cases, people have developed serious heart conditions after using Imigran, even though they had no signs of heart disease before. If any of the points above applies to you it could mean you have a greater risk of developing heart disease – so:

• - ► Tell your doctor so that your heart function can be checked before Imigran is prescribed for you.

If you have a history of fits (seizures)

Or if you have other conditions which might make it more likely that you’ll have a fit – for example, a head injury or alcoholism:

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

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

• — ► Tell your doctor or pharmacist before using Imigran.

If you have liver or kidney disease

If either of these apply to you:

• — ► Tell your doctor or pharmacist before using Imigran.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Imigran. If you know you are allergic to an antibiotic but you are not sure whether it is a sulphonamide:

• -► Tell your doctor or pharmacist before using Imigran. If you are taking anti-depressants called SSRIs

(Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)

• -► Tell your doctor or pharmacist before using Imigran.

Also see Other medicines and Imigran, below.

Imigran syringe may contain latex

The syringe needle shield may contain latex.

—►Tell your doctor if you are allergic to latex.

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). 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 Subject). Don’t use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Don’t take another triptan/5-HT1 receptor agonist for at least 24 hours after using Imigran.
• MAOIs used to treat depression. Don’t use Imigran if you have taken these in the last 2 weeks.
• SSRIs and SNRIs used to treat depression. Using Imigran with these medicinescan 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.
• 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.

Imigran contains

• Sodium: This medicine contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially ‘sodium-free’.

Q

How to use Imigran

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

Imigran Subject is usually injected into the thigh.

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

When to use Imigran

• It’s best to use Imigran as soon as you feel a migraine or a cluster headache coming on, although you can use it at any time during an attack
• Don’t use Imigran to try to prevent an attack – only use it after your migraine symptoms start.
• The usual dose for adults aged 18 to 65 with migraine or a cluster headache is one 6 mg injection.
• Imigran is not recommended for children under 18 years old.
• 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.
• 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.

Q

Possible side effects

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

Allergic reaction: get doctor’s help straight away

The following side effects have occurred but their exact frequency is not known.

• The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after using Imigran:

Don’t use any more. Contact a doctor straight away.

Very common side effects

(affect more than 1 in 10 people)

• Temporary pain at the site of injection
• Stinging or burning, redness, swelling, bruising and bleeding at the site of injection.

Common side effects

(affect up to 1 in 10 people)

• Pain, heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations, including numbness, tingling and warmth or cold. These effects may be intense but generally pass quickly.

If these effects continue or become severe (especially the chest pain):

-► Get medical help urgently. In a very small number of people these symptoms can be caused by a heart attack.

Other common side effects include:

• Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself
• Tiredness or drowsiness
• Dizziness, feeling weak, or getting hot flushes
• Temporary increase in blood pressure
• Shortness of breath
• Aching muscles.

Very rare side effects

(affect up to 1 in 10,000 people)

• Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are using Imigran.
• 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
• 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
• Pain in the joints
• Feeling anxious
• Difficulty swallowing
• Excessive sweating.

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

Q

How to store Imigran

Storing your medicine

• Do not store above 30°C.
• Protect from light.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• 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.
• 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.
• 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.

Q

Contents of the pack and other information

What Imigran contains

Each pre-filled 0.5ml Cartridge Syringe contains 6mg of sumatriptan (as the succinate) in saline.

Also contains sodium chloride and water for injections.

What Imigran looks like and contents of the pack

Each Imigran is available in 2 pre-filled syringes in cases plus an auto-injector, in a plastic tray within a carton.

Each injection pack contains 2 pre-filled syringes and auto injector in a cartridge.

Imigran injection is also available as refill packs, which contain 2 pre-filled cartridge syringes.

Manufacturer and Licence Holder

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 ORE.

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.

| pom | PL 15184/1603 – Imigran Injection

Imigran is a registered trademark of the GlaxoSmithKline Group of Companies.

Leaflet revision date: 02/02/21

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

Q Step-by-step guide to using your Imigran Injection System

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

Please read this leaflet before using the injection system.

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

Each injection system comes complete with an Imigran cartridge pack.

The cartridge pack contains two pre-filled cartridge syringes.

Subject 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; or
• Contact GlaxoSmithKline Customer Contact Centre on Freephone 0800 221441 and they will tell you how to return it.

Keep out of the sight and reach of children

Description of parts

Lid

Release Button

Pen

Carry case

Nose End

White Rod (inside Nose End)

How to give an injection using the pen

• 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
• 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 pen from the carrycase. Check that the white rod is not sticking out beyond the end of the pen (see picturel 1). 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 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 pen out of the cartridge pack. You may have to pull quite hard to do this. A safety catch stops accidental injection until you are ready.

  
  

  6 The loaded pen is now ready for immediate use.

  
  
  
  

  Do not try to put the loaded pen back into the carrycase until after you have used the injection, or the needle may be damaged and the pen will

  
  

  not inject correctly.

  • 7 Press the pen with the long blue nose end firmly against a clean area of skin – usually the outside of the thigh (as in picture) – so the grey part slides down to cover part of the blue nose. This releases the safety catch.

  • 8 Hold the pen firmly and press the blue release button at the top of the 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.

  • 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 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.

Sumatriptan Succinate 6mg/0.5ml 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. See section 4.

Your medicine is called Sumatriptan Succinate Succinate 6mg/0.5ml Injection throughout the rest of this leaflet it will be referred to as Sumatriptan Succinate.

What is in this leaflet

Q

What Sumatriptan Succinate is and what it is used for

Q

What you need to know before you use Sumatriptan Succinate

Q

How to use Sumatriptan Succinate

Q

Possible side effects

Q

How to store Sumatriptan Succinate

Q

Contents of the pack and other information

Q Step-by-step guide to using your Sumatriptan Succinate injection system

Q What Sumatriptan Succinate is and what it is used for

Each Sumatriptan Succinate 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 Succinate 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 Succinate 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.

Q

What you need to know before you use Sumatriptan Succinate

Don’t use Sumatriptan Succinate:

• 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 succinate 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 Sumatriptan Succinate.

Take special care with Sumatriptan Succinate

Talk to your doctor or pharmacist before using Sumatriptan succinate.

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 succinate, 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 succinate 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 Sumatriptan succinate may not be suitable for you

• - ►Tell your doctor or pharmacist before using Sumatriptan succinate. If you have liver or kidney disease

If either of these apply to you:

• - ►Tell your doctor or pharmacist before using Sumatriptan succinate. If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Sumatriptan succinate. 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 succinate.

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 succinate.

Also see Other medicines and Sumatriptan succinate, below.

Sumatriptan succinate syringe may contain latex

The syringe needle shield may contain latex.

• - ►Tell your doctor if you are allergic to latex.

If you use Sumatriptan succinate frequently

Using Sumatriptan succinate too often may make your headaches worse.

“► Tell your doctor if this applies to you. He or she may recommend you stop using Sumatriptan succinate.

If you feel pain or tightness in your chest after you use Sumatriptan succinate

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 succinate

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 Sumatriptan succinate and others may cause adverse effects if they’re taken with Sumatriptan succinate.

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 Sumatriptan succinate Subject). Don’t use Sumatriptan succinate at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan succinate. Don’t take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using Sumatriptan succinate.
• other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see section 2 Don’t use Sumatriptan succinate Subject). Don’t use Sumatriptan succinate at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan succinate. Don’t take another triptan/5-HT1 receptor agonist for at least 24 hours after using Sumatriptan succinate.
• MAOIs used to treat depression. Don’t use Sumatriptan succinate if you have taken these in the last 2 weeks.
• SSRIs and SNRIs used to treat depression. Using Sumatriptan succinate 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 succinate may make side effects more likely.
• 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 succinate 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 succinate while you are pregnant
• Don’t breast-feed your baby for 12 hours after using Sumatriptan succinate. 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.

Sumatriptan Succinate contains

• Sodium: This medicine contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially ‘sodium-free’.

Q

How to use Sumatriptan Succinate

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

Sumatriptan succinate 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 Sumatriptan succinate

• It’s best to use Sumatriptan succinate 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 Sumatriptan succinate to try to prevent an attack – only use it after your migraine symptoms start.
• The usual dose for adults aged 18 to 65 with migraine or a cluster headache is one 6 mg injection.
• Sumatriptan succinate is not recommended for children under 18 years old.
• Sumatriptan succinate is not recommended for people aged over 65.
• You can use a second Sumatriptan succinate injection if at least 1 hour has passed since the first injection.
• Don’t use a new injection or any other Sumatriptan succinate preparation for the same attack.

If Sumatriptan succinate doesn’t give you any relief:

• ->-Ask your doctor or pharmacist for advice.

If you use more Sumatriptan succinate than you should

Using too much Sumatriptan succinate 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.

Q

Possible side effects

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

Allergic reaction: get doctor’s help straight away

The following side effects have occurred but their exact frequency is not known.

• The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after using Imigran:

-► Don’t use any more. Contact a doctor straight away.

Very common side effects

(affect more than 1 in 10 people)

• Temporary pain at the site of injection
• Stinging or burning, redness, swelling, bruising and bleeding at the site of injection.

Common side effects

(affect up to 1 in 10 people)

• Pain, heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations, including numbness, tingling and warmth or cold. These effects may be intense but generally pass quickly.

If these effects continue or become severe (especially the chest pain): Get medical help urgently. In a very small number of people these symptoms can be caused by a heart attack.

Other common side effects include:

• Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself
• Tiredness or drowsiness
• Dizziness, feeling weak, or getting hot flushes
• Temporary increase in blood pressure
• Shortness of breath
• Aching muscles.

Very rare side effects

(affect up to 1 in 10,000 people)

• Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are using Imigran.
• 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
• 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
• Pain in the joints
• Feeling anxious
• Difficulty swallowing
• Excessive sweating.

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

Q

How to store Sumatriptan Succinate

Storing your medicine

• Do not store above 30°C.
• Protect from light.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use Sumatriptan Succinate 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.
• 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.
• 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.

Q

Contents of the pack and other information

What Sumatriptan Succinate Succinate contains

Each pre-filled 0.5ml Cartridge Syringe contains 6mg of sumatriptan (as the succinate) in saline.

Also contains sodium chloride and water for injections.

What Sumatriptan Succinate Succinate looks like and contents of the pack

Each Sumatriptan Succinate is available in 2 pre-filled syringes in cases plus an auto-injector, in a plastic tray within a carton.

Each injection pack contains 2 pre-filled syringes and auto injector in a cartridge.

Sumatriptan Succinate is also available as refill packs, which contain 2 pre-filled cartridge syringes.

Manufacturer and Licence Holder

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 ORE.

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.

| POM | PL 15184/1603 – Sumatriptan Succinate 6mg/0.5ml Injection

Leaflet revision date: 02/02/21

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

Q Step-by-step guide to using your Sumatriptan Succinate Injection System

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

Please read this leaflet before using the injection system.

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

Each injection system comes complete with an sumatriptan succinate 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 Sumatriptan Succinate injection mechanism, please:

• Return it to your pharmacist who will replace it; or
• Contact GlaxoSmithKline Customer Contact Centre on Freephone 0800 221441 and they will tell you how to return it.

Keep out of the sight and reach of children

Description of parts

Lid

Release Button

Pen

Carrycase

Nose End

White Rod (inside Nose End)

How to give an injection using the pen

• Read the leaflet fully and carefully before using the pen
• Each sumatriptan succinate injection system comes complete with a cartridge pack which contains two cartridge syringes pre-filled with sumatriptan succinate
• 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.

• 3 Take out the pen from the carrycase. Check that the white rod is not sticking out beyond the end of the pen (see picturel 1). 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 pen firmly into the opened cartridge pack and gently screw it clockwise (about half a turn) until it will twist no further.