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PACKAGE LEAFLET: INFORMATION FOR THE USER

Imigran® Injection

(Sumatriptan succinate)

Solution for Injection in pre-filled cartridges

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

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others - it may harm them, even if their signs of illness are the same as yours.

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

4.

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 Imigran® Injection

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-HT-i 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

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® Injection 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-HTi 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® Injection.

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® Injection, 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® Injection 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® Injection may not be suitable for you

->■ Tell your doctor or pharmacist before using Imigran® Injection If you have liver or kidney disease

If either of these apply to you:

->■ Tell your doctor or pharmacist before using Imigran® Injection.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Imigran® Injection. 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® Injection.

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® Injection.

Also see Other medicines and Imigran® Injection, below.

If you use Imigran® Injection frequently

Using Imigran® Injection too often may make your headaches worse.

->■ Tell your doctor if this applies to you. He or she may recommend you stop using Imigran® Injection.

If you feel pain or tightness in your chest after you use Imigran® Injection

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 has more information about these possible side effects.

Other medicines and Imigran® Injection

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® Injection and others may cause adverse effects if they’re taken with Imigran® Injection. 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® Injection at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran® Injection. Don’t take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using Imigran® Injection.

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

•    MAOIs used to treat depression. Don’t use Imigran® Injection if you have taken these in the last 2 weeks.

•    SSRIs and SNRIs used to treat depression. Using Imigran® Injection 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® Injection 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® Injection 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® Injection while you are pregnant

•    Don’t breast-feed your baby for 12 hours after using Imigran® Injection. 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)

When to use Imigran® Injection

•    It’s best to use Imigran® Injection 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® Injection to try to prevent an attack - only use it after your migraine symptoms start.

How much to use

Adults aged 18 to 65

•    The usual dose for adults aged 18 to 65 with migraine or a cluster headache is one 6 mg injection.

Children under 18

•    Imigran® Injection is not recommended for children under 18 years old.

Older people (aged over 65)

•    Imigran® Injection is not recommended for people aged over 65.

If your symptoms start to come back

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

If the first injection has no effect

•    Don’t use a new injection or any other Imigran® preparation for the same attack.

If Imigran® Injection doesn’t give you any relief:

-> Ask your doctor or pharmacist for advice.

If you use more Imigran® Injection than you should

Using too much Imigran® Injection 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.

4.    POSSIBLE SIDE EFFECTS

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

Allergic reaction: get doctor’s help straight away

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

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

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

-> 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® Injection.

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

•    Seizures/fits, tremors, muscle spasm, neck stiffness

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

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

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

•    Feeling faint (blood pressure may go down)

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

•    Diarrhoea

•    Pain in the joints

•    Feeling anxious

•    Excessive sweating.

Reporting of side effects:

If you get any side effects, talk to your doctor, 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.

5.    HOW TO STORE IMIGRAN® INJECTION

•    Keep out of the sight and reach of children.

•    Do not store above 30°C.Protect from light.

•    You may wish to keep your Imigran® Injection with you in case of a migraine attack.

•    Always keep your injections in the case provided.

•    Don’t use Imigran® Injection after the expiry date shown on the carton. This refers to the last day of that month.

•    Ask your doctor, nurse or pharmacist how to dispose of your empty Cartridge packs safely. You may be able to do this at your doctor’s surgery.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Imigran® Injection contains

Each pre-filled syringe contains 6mg of the active ingredient sumatriptan (as the succinate) in sodium chloride and water for injections.

What Imigran® Injection look like and the contents of the pack

Imigran® Injection contains 2 pre-filled cartridge syringes in a blue cartridge pack containing a clear, colourless to pale yellow liquid practically free from particles, plus auto-injector, in a grey and blue plastic case marked ‘IMIGRAN’ on both sides.

Who manufactured your medicine

Do not load the Pen until you are ready to give the injection.

Manufactured by Glaxo Wellcome Operations, Harmire Road, County Durham DL12 8DT UK and is procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 ORB.

PL 16378/0364    |POM|

Leaflet dated: 03.11.2014    Leaflet reference: I Ml J

Imigran® and the Imigran® logo are registered trademarks of the GlaxoSmithKline group of companies

The information provided applies only to Imigran⁰ Injection_

If you need more help or advice on migraine please contact the following national organisations:

Migraine Action Association

Unit 6

Oakley Hay Lodge Business Park Great Folds Road Great Oakley Northants NN18 9AS Telephone: 01536 461333 The Migraine Trust 55-56 Russell Square London WC1B4HP Telephone: 020 7463 1336

The following national organisation offers help and advice on cluster headaches:

Organisation for the Understanding of Cluster Headaches (OUCH UK)

Pyramid House 956 High Road London N12 9RX Telephone: 01646 651979

You may be able to find out more about prescribed medicines from books in public libraries.

7. STEP-BY-STEP GUIDE TO USING YOUR IMIGRAN® INJECTION

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 injection system is designed for use with a medicine called Imigran®. Each injection comes complete with an Imigran® Cartridge Pack.

The Cartridge pack contains two pre-filled cartridge syringes.

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

Description of parts

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 to help you identify the different parts of the injection system

1. Swing open the Lid of the Carrycase

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 before 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	X / /n i
of the thigh (as in picture) - so the	/X / ^T)/S/ ^
grey part slides down to cover part	/ X / ^
of the blue nose. This releases	N(\ ^ \///)
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.

(continued overleaf)

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