Imigran Radis 50mg
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Imigran® Radis® 50mg Tablets
(sumatriptan succinate)
Revision Date: 04 November 2013 Leaflet Reference: IMI R50
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.
What is in this leaflet
1. What Imigran® Radis® 50mg Tablets are and what they are used for
2. What you need to know before you use Imigran® Radis® 50mg Tablets
3. Howto use Imigran® Radis® 50mg Tablets
4. Possible side effects
5. Howto store Imigran® Radis® 50mg Tablets
6. Contents of the pack and other information
1. WHAT IMIGRAN® RADIS® 50MG TABLETS ARE AND WHAT THEY ARE USED FOR
Each Imigran® Radis® 50mg tablet contains a single dose of
sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT-i receptor agonists).
Imigran® Radis® 50mg Tablets are used to treat migraine headache.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Imigran® Radis®50mg Tablets are 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® 50MG TABLETS
Don’t use Imigran® Radis® 50mg Tablets:
• 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® Radis® 50mg Tablets 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 5HT! 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® 50mg Tablets.
Take special care with Imigran® Radis® 50mg Tablets
Talk to your doctor or pharmacist before using Imigran® Radis® 50mg Tablets.
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® Radis® 50mg Tablets, 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® Radis® 50mg Tablets are 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 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® Radis® 50mg Tablets. 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® Radis® 50mg Tablets.
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 Radis 50mg Tablets. Also see Other medicines and Imigran® Radis® 50mg Tablets, below.
If you use Imigran® Radis® 50mg Tablets frequently
Using Imigran® Radis® 50mg Tablets too often may make your headaches worse.
—► Tell your doctor if this applies to you. He or she may recommend you stop using Imigran® Radis® 50mg Tablets.
If you feel pain or tightness in your chest after you use Imigran® Radis® 50mg Tablets
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® Radis® 50mg Tablets
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® Radis® 50mg Tablets and others may cause adverse effects if they’re taken with Imigran® Radis® 50mg Tablets. 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® 50mg Tablets). Don’t use Imigran® Radis® 50mg Tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran® Radis® 50mg Tablets. Don’t take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using Imigran® Radis® 50mg Tablets.
• other triptans/5-HTi receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see section 2 Don’t use Imigran® Radis® 50mg Tablets). Don’t use Imigran® Radis® 50mg Tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran® Radis® 50mg Tablets. Don’t take another triptan/5-HT! receptor agonist again for at least 24 hours after using Imigran® Radis® 50mg Tablets.
(Continued overleaf)
• MAOIs used to treat depression. Don’t use Imigran® Radis® 50mg Tablets if you have taken these in the last 2 weeks.
• SSRIs and SNRIs used to treat depression. Using Imigran® Radis® 50mg Tablets 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® Radis® 50mg Tablets 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® Radis® 50mg Tablets 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® Radis® 50mg Tablets while you are pregnant
• Don’t breast-feed your baby for 12 hours after using Imigran® Radis® 50mg Tablets. 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® 50MG TABLETS
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® 50mg Tablets
• It’s best to take Imigran® Radis® 50mg Tablets 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® 50mg Tablets 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®
50mg tablet swallowed whole with water (do not crush or chew it).
Some patients may need a 100mg 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® 50mg Tablets are not recommended for children under 18 years old.
Older people (aged over 65)
• Imigran® Radis® 50mg Tablets are not recommended for people aged over 65.
If your symptoms start to come back
• You can take a second Imigran® Radis® 50mg tablet if at least 2 hours have passed since the first tablet. Don’t take more than 300mg 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® Radis® 50mg Tablets can still be used for your next attack.
If Imigran® Radis® 50mg doesn’t give you any relief:
—► Ask your doctor or pharmacist for advice.
If you take more Imigran® Radis® 50mg Tablets than you should
• Don’t take more than six 50mg tablets or three 100 mg tablets
(that’s 300 mg in total) in 24 hours.
Taking too many Imigran® Radis® 50mg Tablets could make you ill. If you have taken more than 300mg 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® Radis® 50mg Tablets:
> 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® 50mg Tablets.
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® RADIS® 50MG TABLETS
• Do not store above 30°C.
• Keep out of the sight and reach of children.
• Do not use Imigran® Radis® 50mg Tablets after the expiry date shown on the carton. The expiry date refers to the last day of that month.
• If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do. 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.
6. FURTHER INFORMATION
Your medicine is called Imigran® Radis® 50mg Tablets.
Each pink, film-coated triangular shaped, biconvex tablet is marked ‘GS 1YM’ on one side and ‘50’ on the reverse.
Imigran® Radis® 50mg Tablets are available in blister packs of 4 tablets. What is in your medicine
Each film-coated tablet contains 50mg of the active ingredient sumatriptan (as the succinate).
Each tablet also contains calcium hydrogen phosphate, microcrystalline cellulose, sodium hydrogen carbonate, magnesium stearate, croscarmellose sodium, hypromellose (E464), titanium dioxide (E171), red iron oxide (E172) and glycerol triacetate.
Who manufactured your medicine
Imigran® Radis® 50mg Tablets are manufactured by GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 6-322 Poznan, Poland and are procured from within the EU and repackaged by Product Licence Holder Beachcourse Limited., 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0452 |POM|
Revision Date: 04 November 2013 Leaflet Reference: IMI R50
Imigran and the Imigran Radis logo are registered trademarks of the GlaxoSmithKline group of companies. Radis is a trademark of the GlaxoSmithKline group of companies.
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