MigraKind 50 mg Film-Coated Tablets

• Never give the tablets to someone else, because it may harm them, even if their symptoms seem to be the same as yours.
• Keep this leaflet - you may need to read it again. It contains important information.
• You must tell your doctor if your pharmacist has confirmed you have migraine and if you take MigraKind.
• If you have any further questions or there is anything you do not understand, ask your doctor or pharmacist.
• Throughout this leaflet, MigraKind 50 mg Film-Coated Tablets are referred to as MigraKind.

1. What MigraKind is and what it is used for
2. What you need to know before you take MigraKind
3. How to take MigraKind
4. Possible side effects
5. How to store MigraKind
6. More about the MigraKind

• 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 MigraKind 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 medicine 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

For children under 18 years of age.

If any of these apply to you:

Tell your doctor, and don’t use MigraKind tablets.

Talk to your doctor or pharmacist before using MigraKind.

• If you are a heavy smoker, or using nicotine replacement therapy, and especially
• If you are a man aged over 40, or
• you are very overweight
• you have diabetes
• you have high cholesterol
• you have a close relative who developed early heart disease - either your father or brother developed heart
• disease before the age of 55, or your mother or sister developed heart disease before the age of 65.

If three or more of the points above apply to you, you may be at higher risk of heart disease- see your doctor without taking

In very rare cases, people have developed serious heart conditions after using MigraKind, 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 MigraKind. 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 had high blood pressure MigraKind may not be suitable for you
• Tell your doctor or pharmacist before using MigraKind,
  If you have liver or kidney disease
  If either of these apply to you:
• Tell your doctor or pharmacist before using MigraKind,
  If you have an intolerance to some sugars
• 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 MigraKind, 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 MigraKind.
  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 MigraKind. Also see Other medicines and MigraKind, below.

Using MigraKind too often may make your headaches worse.

• Tell your doctor if this applies to you. He or she may recommend you stop using MigraKind.

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.

If three or more of the points above apply to you, you may be at higher risk of heart disease – see your doctor without taking MigraKind. If you are not sure, your pharmacist or doctor can help.

• if your headaches usually last longer than 24 hours, or become more frequent
• if you generally have four or more migraine attacks each month
• if you do not recover completely in between your migraine attacks
• if you are over 50 and this is your first headache of this type
• if your migraine attacks get worse or become more frequent, or your symptoms change
• if your migraine includes symptoms such as
• weakness on one side of your body
  • clumsy and un-coordinated movements
  • reduced level of consciousness
  • a recent rash with a headache
  • double vision
  • tinnitus (ringing in the ears)
  • seizure (fit)- like movements

The use of buprenorphine together with MigraKind can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and MigraKind”).

If any of the points in this list apply to you, and you haven’t already talked to a pharmacist or doctor about these, get their advice before taking MigraKind.

Tell your doctor or pharmacist if you are 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 MigraKind and others may cause adverse effects if they are taken with MigraKind.

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 MigraKind).Don’t use MigraKind at the same time as these medicines. Stop taking these medicines at least 24 hours before using MigraKind. Don’t take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using MigraKind.
• other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see section 2 Don’t use MigraKind). Don’t use MigraKind at the same time as these medicines. Stop taking these medicines at least 24 hours before using MigraKind. Don’t take another triptan/5-HT1 receptor agonist again for at least 24 hours after using MigraKind.
• MAOIs used to treat depression. Don’t use MigraKind if you have taken these in the last 2 weeks.
• SSRIs and SNRIs used to treat depression. Using MigraKind 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 MigraKind may make side effects more likely.
• Buprenorphine, naloxone: These medicines may interact with MigraKind and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C.Contact your doctor when experiencing such symptoms.

• 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 this medicine 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 this medicine while you are pregnant
• Don’t breast-feed your baby for 12 hours after using this medicine. If you express any breast milk during this time, discard the milk and don’t give it to your baby.

Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, do not drive or operate machinery.

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product

• Take one tablet as soon as possible at the first signs of a migraine headache.
• If your symptoms start to come back, you can take a second tablet after 2 hours. You must leave at least 2 hours after the first tablet.

Swallow each tablet whole with water.

Don’t take more than two tablets in 24 hours.

Don’t take more than two tablets for the same attack.

If the first tablet does not provide any relief:

Don’t take a second tablet.

If you use MigraKind too often, it may make your headaches worse. If this happens you should consult your doctor or pharmacist, who may tell you to stop taking MigraKind.

You should wait at least 24 hours before taking a medicine containing a triptan (including other sumatriptan-containing products, zolmitriptan, rizatriptan, naratriptan) or at least 6 hours before taking a medicine containing ergotamine or methysergide.

Talk to your doctor before you take any more MigraKind tablets. Getting no relief at all from MigraKind may mean that you do not have migraine.

MigraKind is only to relieve migraine symptoms.

Don’t take it to try to prevent an attack. Don’t take it until you are sure it’s a migraine and not just a headache.

Taking too much could make you ill. Keep to the dose and follow the instructions.

If you take too many tablets, tell a doctor straight away. Take the box and this leaflet with you.

Do not take a double dose to make up for a forgotten dose.

Do not take this medicine if you are under 18 or over 65 and have migraine symptoms. Talk to your doctor.

The following side effects have occurred but their exact frequency is not known.

Some people may be allergic to these tablets.

Signs of allergy include rash; hives (itchy rash); wheezing; breathlessness; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after taking MigraKind, don’t take any more.

Tell a doctor straight away. Take the packaging and this leaflet with you.

Very rare side effects: tell doctor as soon as possible

(affect less than 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 MigraKind.

Common side effects: tell doctor if long or severe

(affect less than 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.

• Feeling sick (nauseous) or being sick (vomiting) – although this is often part of the migraine attack itself.
• Tiredness or drowsiness.
• Dizziness, feeling weak, or getting hot flushes.
• Feeling faint (blood pressure may go up or down).
• Shortness of breath.
• Temporary increase in blood pressure
• Aching muscles
• Short-lived/temporary muscle spasms of the jaw affecting jaw movement.

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 (Raynaudâ•™s phenomenon)
• Feeling faint (blood pressure may go down)
• Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis)
• Diarrhoea
• If you had a recent injury or if you have inflammation (like rheumatism or inflammation of the colon) you may experience pain or pain worsening at the site of injury or inflammation.
• Pain in the joints
• Feeling anxious
• Difficulty swallowing
• Excessive sweating

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.

• The active substance is sumatriptan.
  Each film coated tablet contains 50 mg sumatriptan (as the succinate).
• The other ingredients are: Core: lactose monohydrate, lactose, crosscarmellose sodium, microcrystalline cellulose, magnesium stearate. Coating: Lactose monohydrate, mannitol (E421), titanium dioxide (E171), triacetin and talc.

Round white film coated tablets marked ‘RDY’ on one face and ‘292’ on the other.

Pack sizes:

2, 6 tablets

Not all pack sizes may be marketed.

Other formats of this leaflet

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