Sumatriptan 100mg film-coated Tablets

• 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. See section 4.

1. What Sumatriptan is and what it is used for
2. What you need to know before you take Sumatriptan
3. How to take Sumatriptan
4. Possible side effects
5. How to store Sumatriptan
6. Contents of the pack and other information

• If you are 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 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; 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
  • 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 do not take Sumatriptan Film-Coated Tablets.

Talk to your doctor or pharmacist before taking Sumatriptan.

• 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 an intolerance to some sugars

If any of these apply to you:

• Tell your doctor so that you can be supervised more closely

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.

(Selective Serotonin Reuptake Inhibitors) or SNRIs (Seratonin 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.

These effects may be intense but they usually pass quickly. If they do not pass quickly, or they become severe:

• Get medical help immediately. Section 4 has more information about these possible side effects.

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

Some medicines must not be taken with Sumatriptan and others may cause adverse effects if they are taken with Sumatriptan.

• ergotamine also used to treat migraine, or similar medicines such as methysergide (see section 2 Do not take Sumatriptan). Do not use Sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan. Do not 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 Do not use Sumatriptan). Do not use Sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan. Do not take another triptan/5-HT₁ receptor agonist again for at least 24 hours after using Sumatriptan.
• MAOIs used to treat depression. Do not 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.

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is only limited information about the safety of Sumatriptan for pregnant women, though up until 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
• Do not breastfeed your baby for 12 hours after using Sumatriptan. If you express any breast milk during this time, discard the milk and do not 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 an intolerance to some sugars, contact your doctor before taking this medicinal product.

• 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
• Do not use Sumatriptan to try to prevent an attack - only use it after your migraine symptoms start.

Adults aged 18 to 65

• The usual dose for adults aged 18 to 65 is one Sumatriptan 50 mg film-coated 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 film-coated tablet if at least 2 hours have passed since the first tablet. Do not take more than 300 mg in total in 24 hours.

If the first tablet has no effect

• Do not take a second tablet or any other Sumatriptan preparation for the same attack. Sumatriptan can still be used for your next attack.

If Sumatriptan does not give you any relief:

• Ask your doctor or pharmacist for advice.

• Do not 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.

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.

• 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
• Short-lived/temporary muscle spasms of the jaw affecting jaw movement.

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 that you are taking Sumatriptan.

• 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
• Difficulty swallowing
• Pain in the joints
• Feeling anxious
• Excessive sweating
• 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.

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 effects you can help provide more information on the safety of this medicine.

• The active substance is sumatriptan.
  Sumatriptan 50 mg: Each film coated tablet contains 50 mg sumatriptan (as the succinate).
  Sumatriptan 100 mg: Each film coated tablet contains 100 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.

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

100 mg: Capsule shaped white film coated tablets marked ‘RDY’ on one face and ‘293’ on the other.

2, 3, 4, 6, 12 and 18 tablets

Not all pack sizes may be marketed.