Sumatriptan 50mg Tablets
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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.
The name of your medicine is Imigran ® 50 mg tablets, but will be referred to as Imigran throughout the rest of the leaflet.
What is in this leaflet
1 What Imigran is and what it is used for
2 What you need to know before you use Imigran
3 How to use Imigran
4 Possible side effects
5 How to store Imigran
6 Contents of the pack and other information
1 What Imigran is and what it is used for
Each Imigran capsule-shaped tablet contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HTi receptor agonists).
Imigran is used to treat migraine headache.
Migraine 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 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
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 ministroke (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; oranytriptan or 5-HTi agonist (such as naratriptan or zolmitriptan)
• With any of the following antidepressants:
• 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 and duloxetine
• For children under 18 years of age.
If any of these apply to you:
—> Tell your doctor, and don’t use Imigran tablets.
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 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 liver or kidney disease
If you have an intolerance to some sugars
If any 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). 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). 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 that contain 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.
Always take Imigran exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
When to take Imigran
• It’s best to take Imigran as soon as you feel a migraine coming on, although you can take 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.
How much to take
Adults aged 18 to 65
• The usual dose for adults aged 18 to
65 is one Imigran 50 mg tablet, swallowed whole with water. Some patients may need a 100 mg dose - you should follow your doctor’s advice.
Children under 18
• Imigran is not recommended for children under 18 years old.
Older people (aged over 65)
• Imigran is not recommended for people aged over 65.
If your symptoms start to come back
• You can take a second Imigran 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 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 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.
Some patients may get 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.aov.uk/vellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5 How to store Imigran
Keep out of the sight and reach of children.
Do not use Imigran after the expiry date shown on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment
6 Contents of the pack and other information
What Imigran contains
• The active substance is sumatriptan (50 mg)
• The other ingredients in the tablets are lactose monohydrate, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, methylhydroxypropylcellulose (E464) and titanium dioxide (E171), triacetin and iron oxide (E172).
What Imigran looks like and contents of the pack
Imigran 50 mg tablets are pink, film-coated, capsule-shaped, biconvex tablet, engraved “GX ES3” on one face and plain on the other face or “50” on one face and plain on the other face.
They are available in a blister pack containing 4 tablets and 12 tablets.
Manufacturer:
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland.
Or
Glaxo Operations UK Ltd, Ware, Hertfordshire, UK
Procured from within the EU & repackaged by product License holder:
Kosei Pharma UK Ltd.,
956 Buckingham Avenue,
Slough Trading Estate,
SL1 4NL, UK.
IMIGRAN® 50 mg Tablets, „„„„
M POM
PLPI: 39352/0019
Leaflet date: 10.07.2014
Imigran and the Imigran logo are registered trademarks of the GlaxoSmithKline group of companies.
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Sumatriptan 50 mg tablets
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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.
The name of your medicine is Sumatriptan 50 mg tablets, but will be referred as Sumatriptan throught rest of the leaflet.
What is in this leaflet
1 What Sumatriptan is and what it is used for
2 What you need to know before you use Sumatriptan
3 How to use Sumatriptan
4 Possible side effects
5 How to store Sumatriptan
6 Contents of the pack and other information
1 What Sumatriptan is and what it is used for
Each Sumatriptan capsule-shaped tablet contains a single dose of
sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HTi receptor agonists).
Sumatriptan is used to treat migraine headache.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan 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 Don’t use Sumatriptan
• 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 ministroke (also called a transient ischaemic attack or TIA)
• If you have high blood pressure. You
may be able to use sumatriptan 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; oranytriptan or 5-HTi agonist (such as naratriptan or zolmitriptan)
• With any of the following antidepressants:
• 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 and duloxetine
• For children under 18 years of age.
If any of these apply to you:
—> Tell your doctor, and don’t use Sumatriptan tablets.
Take special care with Sumatriptan
Talk to your doctor or pharmacist before using Sumatriptan:
If you have any extra risk factors
• If you are a heavy smoker, or 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, 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 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 liver or kidney disease
If you have an intolerance to some sugars
If any 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 sumatriptan. 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.
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. Also see Other medicines and Sumatriptan, below.
If you use Sumatriptan frequently
Using Sumatriptan too often may make your headaches worse.
—> Tell your doctor if this applies to you. He or she may recommend you stop using Sumatriptan.
If you feel pain or tightness in your chest after you use Sumatriptan
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 Sumatriptan
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 and others may cause adverse effects if they’re taken with Sumatriptan. 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). Don’t use Sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan. Don’t take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using Sumatriptan.
• other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see section 2 Don’t use Sumatriptan). Don’t use Sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan. Don’t take another triptan/5-HT 1 receptor agonist again for at least 24 hours after using Sumatriptan.
• MAOIs used to treat depression. Don’t use Sumatriptan if you have taken these in the last 2 weeks
• SSRIs and SNRIs used to treat depression. Using Sumatriptan 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 that contain St John’s Wort together with Sumatriptan 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 Sumatriptan ty 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 Sumatriptan while you are pregnant
• Don’t breast-feed your baby for 12 hours after using Sumatriptan 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.
Always take Sumatriptan exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
When to take Sumatriptan
• It’s best to take Sumatriptan as soon as you feel a migraine coming on,
although you can take it at any time during an attack
• Don’t use Sumatriptan 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 Sumatriptan 50 mg tablet, swallowed whole with water. Some patients may need a 100 mg dose - you should follow your doctor’s advice.
Children under 18
• Sumatriptan is not recommended for children under 18 years old.
Older people (aged over 65)
• Sumatriptan is not recommended for people aged over 65.
If your symptoms start to come back
• You can take a second Sumatriptan 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 Sumatriptan preparation for the same attack. Sumatriptan can still be used for your next attack.
If Sumatriptan doesn’t give you any relief: —> Ask your doctor or pharmacist for advice.
If you take more Sumatriptan 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 Sumatriptan 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 Sumatriptan:
—> 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.
5 How to store Sumatriptan
• 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 Sumatriptan.
Some patients may get 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.aov.uk/vellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use Sumatriptan after the expiry date shown on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.
6 Contents of the pack and other information
What Sumatriptan contains
• The active substance is sumatriptan (50 mg)
• The other ingredients in the tablets are lactose monohydrate, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, methylhydroxypropylcellulose (E464) and titanium dioxide (E171), triacetin and iron oxide (E172).
What Sumatriptan looks like and contents of the pack
Sumatriptan 50 mg tablets are pink, film-coated, capsule-shaped, biconvex tablet, engraved “GX ES3” on one face and plain on the other face or “50” on one face and plain on the other face.
They are available in a blister pack containing 4 tablets and 12 tablets.
Manufacturer: GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland Or
Glaxo Operations UK Ltd, Ware, Hertfordshire, UK
Procured from within the EU & repackaged by product License holder:
Kosei Pharma UK Ltd.,
956 Buckingham Avenue,
Slough Trading Estate,
SL1 4NL, UK
SUMITRIPTAN 50 mg Tablets,
PLPI: 39352/0019
Leaflet date: 10.07.2014
POM