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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.

1 What Imigran Radis is and what it is used for

Each Imigran Radis tablet contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HTj receptor agonists).

Imigran Radis is used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Imigran Radis is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.

What is in this leaflet

1    What Imigran Radis is and what it is used for

2    What you need to know before you use Imigran Radis

3    How to use Imigran Radis

4    Possible side effects

5    How to store Imigran Radis

6    Contents of the pack and other information

2 What you need to know before you use Imigran Radis

Don't use Imigran Radis:

•    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 sertaline

•    SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine and duloxetine

•    For children under 18 years of age.

If any of these apply to you:

^ Tell your doctor, and don't use Imigran Radis.

Take special care with Imigran Radis

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.

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. 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 Radis). 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-HT, receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see section 2 Don't use Imigran Radis). 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-HT receptor agonist again 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 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 together with 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.

120150

Imigran Radis 100 mg tablets are white and printed with 'GS YE7' on one side and '100' on the other. They are available in a blister pack containing 6 tablets.

Marketing authorisation holder and manufacturer

Product Licence held by GlaxoSmithKline UK Ltd., Stockley Park West, Uxbridge, Middlesex UB11 1BT

Manufactured by GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznan, Poland The information provided applies only to Imigran Radis tablets.