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2511, 2512 If you have a history of fits (seizures)

22.08.13[2] 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.

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.

Your medicine will be referred to as Imigran Radis throughout this leaflet. Imigran Radis is also available in other strength.

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

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-HT₁ 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.

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 5HT₁ 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 liver or kidney disease

If either of these apply to you:

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

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-HT₁ 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-HT1 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.

3. HOW TO USE IMIGRAN RADIS

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

When to take Imigran Radis

-    It's best to take Imigran Radis as soon as you feel a migraine coming

on, although you can take it at any time during an attack

-    Don’t use Imigran Radis to try to prevent an attack - only use it after your migraine symptoms start.

How much to take Adults aged 18 to 65

-    The usual dose for adults aged 18 to 65 is one Imigran Radis 50 mg tablet swallowed whole with water (do not crush or chew it). Some patients may need a 100 mg dose - you should follow your doctor's advice.

-    If you have problems swallowing tablets, you can disperse a tablet in a small amount of water before you take it - although this may have a bitter taste.

Children under 18

-    Imigran Radis is not recommended for children under 18 years old.

Older people (aged over 65)

-    Imigran Radis is not recommended for people aged over 65.

If your symptoms start to come back

-    You can take a second Imigran Radis tablet if at least 2 hours have passed since the first tablet. Don’t take more than 300 mg in total in 24 hours.

If the first tablet has no effect

-    Don’t take a second tablet or any other Imigran preparation for the same attack. Imigran can still be used for your next attack.

If Imigran Radis doesn't give you any relief:

^ Ask your doctor or pharmacist for advice.

If you take more Imigran than you should

-    Don’t take more than six 50 mg tablets or three 100 mg tablets (that's 300 mg in total) in 24 hours.

Taking too much Imigran Radis could make you ill. If you have taken more than 300 mg in 24 hours:

^ Contact your doctor for advice.

If you have any 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:

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

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 taking Imigran Radis.

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.

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

5.    HOW TO STORE IMIGRAN RADIS

Keep your medicines out of the sight and reach of children.

Do not use Imigran Radis after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets become discoloured or show any other signs of deterioration please contact your doctor or pharmacist before taking this medicine.

6.    FURTHER INFORMATION What Imigran Radis contains

-    The active substance is sumatriptan (as the succinate)

Each film-coated dispersible tablet contains 50 mg or 100 mg sumatriptan (as the succinate).

-    The other ingredients in the tablets are calcium hydrogen phosphate anhydrous, sodium bicarbonate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171) and glycerol triacetate.

-    The 50 mg tablets also contain red iron oxide (E172).

What Imigran Radis looks like and contents of the pack

Imigran Radis 50 mg Tablets are pink film-coated, triangular shaped, biconvex tablets debossed with 'GS 1YM' on one face and '50' on the other.

Imigran Radis 100 mg Tablets are white film-coated, triangular shaped, biconvex tablets debossed with 'GS YE7' on one face and '100' on the other.

Imigran Radis Tablets are available in a pack size of 4 and 6 tablets.

Manufacturer and Product Licence holder

Manufactured by:

GlaxoSmithKline Pharmaceuticals S.A., Poznan, Poland.

Glaxo Operations UK Ltd., Ware, UK.

Procured from within in the EU by Product Licence holder

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.

Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 22.08.13[2] Imigran Radis is a trademark of the Glaxo Group Ltd.