Sumatriptan 50mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIGRAN 50mg TABLETS SUMATRIPTAN 50mg TABLETS (sumatriptan succinate)
Your medicine is known as the above names but will be referred to as Imigran throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist (chemist).
• This medicine has been prescribed for you. Do not pass it on to others- it may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1 What Imigran is and what it is used for
2 Before you use Imigran
3 How to use Imigran
4 Possible side effects
5 How to store Imigran
6 Further 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-HT1 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. BEFORE YOU TAKE IMIGRAN
Don't use Imigran:
• If you’re allergic (hypersensitive) 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 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 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
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:
^ 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.
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 if you’re taking any other medicines or have recently taken any. This includes any herbal products, dietary supplements such as vitamins, iron or calcium 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 maleate; or any triptan or 5-HT1 agonist (such as naratriptan or zolmitriptan). 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 them again for at least 6 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 or could be pregnant, 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
• 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 TAKE IMIGRAN
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Imigran tablets can cause side effects, but not everybody gets them.
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.
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.
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
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use Imigran after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Imigran contains
• Each film-coated tablet contains 50mg of the active ingredient sumatriptan (as the succinate)
• Imigran also contain the following inactive ingredients: lactose monohydrate, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium type A, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), red iron oxide (E172) and triacetin.
What Imigran looks like and contents of the pack
• IMIGRAN are pink and capsule-shaped and marked ‘GXES3' on one side and plain on the other.
• Imigran are available as blister packs of 4 or 12 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1 DX.
Manufacturer
Imigran are manufactured by
• Glaxo Operations UK Limited, Ware Hertfordshire, UK.
• GlaxoSmithkline Pharmaceuticals SA, Poznan, Poland.
| POM| PL No. 08747/0267
Leaflet revision date: 25 November 2013
Imigran is a registered trade mark of Glaxo Group Ltd, UK.
267 LEAFLET Imigran 20131125