IMIGRAN RADIS 50MG TABLETS
Active substance: SUMATRIPTAN SUCCINATE
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Package Leaflet: Information for the User
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again.
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. (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:
If you have had a stroke or a mini-stroke
Take special care with Imigran Radis
Your doctor needs to know certain information before you use 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:
If you have any further
questions, ask your doctor or pharmacist (chemist). prescribed for you. Do not pass it on to others - it may harm them, even if their symptoms are the same as yours. gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
This medicine has been
50 mg or 100 mg tablets
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)
Other medicines and Imigran
Tell your doctor if youre taking any other medicines or have recently taken any. This includes any herbal products, dietary supplements such as vitamins, iron or calcium or medicines youve bought without a prescription. Some medicines must not be taken with Imigran and others may cause adverse effects if theyre taken with Imigran. You must tell your doctor if you are taking: ergotamine also used to treat migraine, or similar medicines such as methysergide maleate; or any triptan or 5-HT1 agonist (such as naratriptan or zolmitriptan). Dont use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Dont take them again for at least 6 hours after using Imigran MAOIs used to treat depression. Dont 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 Johns Wort (Hypericum perforatum).
Pregnancy and breast-feeding
Taking herbal remedies containing St Johns Wort together with Imigran may make side effects more likely.
If you are pregnant or could be pregnant,
If any of the side effects
2 Before you use Imigran Radis
Dont use Imigran Radis:
Tell your doctor or pharmacist before using Imigran. Also see Other medicines and Imigran, below.
In this leaflet
1 What Imigran Radis is and what it is used for film-coated dispersible tablets 2 Before you use Imigran Radis 3 How to use Imigran Radis 4 Possible side effects 5 How to store Imigran Radis 6 Further information
If youre allergic (hypersensitive) to
Tell your doctor so that your heart function can be checked before Imigran is prescribed for you.
sumatriptan
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 a history of fits (seizures) Or if you have other conditions which might make it more likely that youll have a fit for example, a head injury or alcoholism. 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 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 dont pass quickly, or they become severe: Get medical help immediately. Section 4 (overleaf) has more information about these possible side effects.
talk to your doctor before you use Imigran. 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 Dont breast-feed your baby for 12 hours after using Imigran. If you express any breast milk during this time, discard the milk and dont 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, dont drive or operate machinery.
Tell your doctor, and dont use Imigran Radis.
3 How to use Imigran Radis
Always take Imigran Radis exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
5 How to store Imigran Radis
If the first tablet has no effect
Imigran preparation for the same attack. Imigran can still be used for your next attack. If Imigran Radis doesnt give you any relief:
Dont take a second tablet or any other
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.
When to take Imigran Radis
Its 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 Dont use Imigran Radis to try to prevent an attack only use it after your migraine symptoms start.
Ask your doctor or pharmacist for advice.
If you take more Imigran than you should
three 100 mg tablets (thats 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 product, ask your doctor or pharmacist.
Dont take more than six 50 mg tablets or
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 doctors 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.
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.
4 Possible side effects
Like all medicines, Imigran Radis tablets can cause side effects, but not everybody gets them. Allergic reaction: get doctors 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: Dont use any more. Contact a doctor straight away.
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 (Raynauds 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.
Keep out of the reach and sight 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 30C 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.
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 Pozna, Poland The information provided applies only to Imigran Radis tablets. There are two national organisations that offer both help and advice on migraine: 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 WC1B 4HP Telephone: 020 7436 1336 You may be able to find out more about prescribed medicines from books in public libraries.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
6 Further information
What Imigran Radis contains
or 100 mg)
The active substance is sumatriptan (50 mg The other ingredients in the tablets are
calcium hydrogen phosphate, sodium hydrogen carbonate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate. The 50 mg tablet also contains iron oxide, red (E172).
Please be ready to give the following information: Product name Imigran Radis 50 mg tablet Imigran Radis 100 mg tablet Reference number 19494/0013 This is a service provided by the Royal National Institute of Blind People. Leaflet date: January 2010 Imigran and Imigran Radis are registered trademarks of the GlaxoSmithKline group of companies Radis is a trademark of the GlaxoSmithKline group of companies 2010 GlaxoSmithKline group of companies
If you get side effects
If you notice any unwanted effects, even ones not listed in this leaflet, or if any of the side effects becomes troublesome: Tell your doctor or pharmacist.
What Imigran Radis looks like and contents of the pack
Imigran Radis 50 mg tablets are pink and printed with GS 1YM on one side and 50 on the other. They are available in a blister pack containing 6 tablets. 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.
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. Dont take more than 300 mg in total in 24 hours.
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again.
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. (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:
If you have had a stroke or a mini-stroke
Take special care with Imigran Radis
Your doctor needs to know certain information before you use 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:
If you have any further
questions, ask your doctor or pharmacist (chemist). prescribed for you. Do not pass it on to others - it may harm them, even if their symptoms are the same as yours. gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
This medicine has been
50 mg or 100 mg tablets
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)
Other medicines and Imigran
Tell your doctor if youre taking any other medicines or have recently taken any. This includes any herbal products, dietary supplements such as vitamins, iron or calcium or medicines youve bought without a prescription. Some medicines must not be taken with Imigran and others may cause adverse effects if theyre taken with Imigran. You must tell your doctor if you are taking: ergotamine also used to treat migraine, or similar medicines such as methysergide maleate; or any triptan or 5-HT1 agonist (such as naratriptan or zolmitriptan). Dont use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Dont take them again for at least 6 hours after using Imigran MAOIs used to treat depression. Dont 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 Johns Wort (Hypericum perforatum).
Pregnancy and breast-feeding
Taking herbal remedies containing St Johns Wort together with Imigran may make side effects more likely.
If you are pregnant or could be pregnant,
If any of the side effects
2 Before you use Imigran Radis
Dont use Imigran Radis:
Tell your doctor or pharmacist before using Imigran. Also see Other medicines and Imigran, below.
In this leaflet
1 What Imigran Radis is and what it is used for film-coated dispersible tablets 2 Before you use Imigran Radis 3 How to use Imigran Radis 4 Possible side effects 5 How to store Imigran Radis 6 Further information
If youre allergic (hypersensitive) to
Tell your doctor so that your heart function can be checked before Imigran is prescribed for you.
sumatriptan
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 a history of fits (seizures) Or if you have other conditions which might make it more likely that youll have a fit for example, a head injury or alcoholism. 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 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 dont pass quickly, or they become severe: Get medical help immediately. Section 4 (overleaf) has more information about these possible side effects.
talk to your doctor before you use Imigran. 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 Dont breast-feed your baby for 12 hours after using Imigran. If you express any breast milk during this time, discard the milk and dont 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, dont drive or operate machinery.
Tell your doctor, and dont use Imigran Radis.
3 How to use Imigran Radis
Always take Imigran Radis exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
5 How to store Imigran Radis
If the first tablet has no effect
Imigran preparation for the same attack. Imigran can still be used for your next attack. If Imigran Radis doesnt give you any relief:
Dont take a second tablet or any other
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.
When to take Imigran Radis
Its 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 Dont use Imigran Radis to try to prevent an attack only use it after your migraine symptoms start.
Ask your doctor or pharmacist for advice.
If you take more Imigran than you should
three 100 mg tablets (thats 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 product, ask your doctor or pharmacist.
Dont take more than six 50 mg tablets or
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 doctors 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.
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.
4 Possible side effects
Like all medicines, Imigran Radis tablets can cause side effects, but not everybody gets them. Allergic reaction: get doctors 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: Dont use any more. Contact a doctor straight away.
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 (Raynauds 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.
Keep out of the reach and sight 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 30C 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.
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 Pozna, Poland The information provided applies only to Imigran Radis tablets. There are two national organisations that offer both help and advice on migraine: 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 WC1B 4HP Telephone: 020 7436 1336 You may be able to find out more about prescribed medicines from books in public libraries.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
6 Further information
What Imigran Radis contains
or 100 mg)
The active substance is sumatriptan (50 mg The other ingredients in the tablets are
calcium hydrogen phosphate, sodium hydrogen carbonate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate. The 50 mg tablet also contains iron oxide, red (E172).
Please be ready to give the following information: Product name Imigran Radis 50 mg tablet Imigran Radis 100 mg tablet Reference number 19494/0013 This is a service provided by the Royal National Institute of Blind People. Leaflet date: January 2010 Imigran and Imigran Radis are registered trademarks of the GlaxoSmithKline group of companies Radis is a trademark of the GlaxoSmithKline group of companies 2010 GlaxoSmithKline group of companies
If you get side effects
If you notice any unwanted effects, even ones not listed in this leaflet, or if any of the side effects becomes troublesome: Tell your doctor or pharmacist.
What Imigran Radis looks like and contents of the pack
Imigran Radis 50 mg tablets are pink and printed with GS 1YM on one side and 50 on the other. They are available in a blister pack containing 6 tablets. 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.
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. Dont take more than 300 mg in total in 24 hours.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
