Gramegran 50 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Gramegran is and what it is used for

Each Gramegran 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).

Gramegran is used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Gramegran 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 take Gramegran

Do not take Gramegran:

• 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 TIA or a transient ischaemic attack).
• if you have high blood pressure. You may be able to take Gramegran 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 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 do not take Gramegran.

Warnings and Precautions

Take special care with Gramegran if you have any extra risk factors. If three or more of the points below apply to you, you may be at higher risk of heart disease – see your doctor without taking Gramegran:

• 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 of sister developed heart disease before the age of 65
• if you have been through the menopause.

In very rare cases, people have developed serious heart conditions after taking Gramegran, even though they had no sign of heart disease before. If any of the points above apply 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 Gramegran is prescribed for you.

Talk to your doctor or pharmacist if:

• you have a history of fits (seizures), or if you have other conditions which might make it more likely that you will have a fit – for example, a head injury or alcoholism, tell your doctor so that you can be supervised more closely.

• you have had high blood pressure
• you have liver or kidney disease
• you are allergic to antibiotics called sulfonamides, you may also be allergic to Gramegran. If you know you are allergic to an antibiotic but you are not sure whether it is a sulfonamide, tell your doctor or pharmacist before taking Gramegran.
• you are taking anti-depressants called SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors) (see “Other medicines and Gramegran” below)
• you take Gramegran frequently. Taking Gramegran too often may make your headaches worse. Your doctor may recommend you stop taking Gramegran.
• you feel pain or tightness in your chest after you take Gramegran, as these effects may be intense but they usually pass quickly. If they do not pass quickly, or they become severe, get medical help immediately. See section 4.
• your headaches usually last longer than 24 hours, or become more frequent
• you generally have four or more migraine attacks each month
• you do not recover completely in between your migraine attacks
• you are over 50 and this is your first headache of this type

• your migraine attacks get worse or become more frequent, or your symptoms change

  • your migraine includes symptoms such as

    o weakness on one side of your body

    o clumsy and un-coordinated movements

    o reduced level of consciousness

    o a recent rash with a headache

    o double vision

    o tinnitus (ringing in the ears)

    o seizure (fit)-like movements.

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

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before taking Gramegran.

Other medicines and Gramegran

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any herbal products you have bought without a prescription.

Some medicines must not be taken with Gramegran and others may cause adverse effects if they are taken with Gramegran. You must tell your doctor if you are taking:

• ergotamine (also used to treat migraine), or similar medicines such as methysergide (see section 2 “Do not take Gramegran”). Do not take Gramegran at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Gramegran. Do not take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after taking Gramegran.
• other triptans/5-HT₁ receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see section 2 “Do not take Gramegran”). Do not take Gramegran at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Gramegran. Do not take another triptan/5-HT₁ receptor agonist again for at least 24 hours after taking Gramegran.
• MAOIs used to treat depression. Do not take Gramegran if you have taken these in the last 2 weeks.
• SSRIs and SNRIs used to treat depression. Taking Gramegran 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 with Gramegran may make side effects more likely.

• Buprenorphine, naloxone: These medicines may interact with Gramegran and you may experience symptoms such as involuntary, rhythmic contractions of the muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of the reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such

  symptoms.

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 Gramegran in pregnancy, although there is no evidence of any increased risk of birth defects. Your doctor will discuss with you whether or not you should take Gramegran while you are pregnant.
• Do not breast-feed your baby for 12 hours after taking Gramegran. If you express any breast milk during this time, discard the milk and do not give it to your baby.
• Some breast-feeding women report breast and/or nipple pain after use of sumatriptan. The pain is usually temporary and disappears in 3 to 12 hours.

Driving and using machines

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

Gramegran contains lactose

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

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Gramegran

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults aged 18 to 65 years

• 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.

Do not take more than two tablets in 24 hours and do not take more than two tablets for the same attack. If the first tablet does not provide any relief, do not take a second tablet.

If you take Gramegran 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 Gramegran.

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.

Package Leaflet: Information for the patient Gramegran 50 mg film-coated tablets

sumatriptan

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(8619269) Date : 04/05/2024, (R) 22.08.2025, 29.08.2025

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

Gramegran is only to relieve migraine symptoms.

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

Children under 18 and adults over 65

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

If you take too much Gramegran

If you (or someone else) have taken too many tablets, or if you think a child might have swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. Take the medicine carton and this leaflet with you.

If you forget to take Gramegran

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

If you have any further questions on 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 attack 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 taking Gramegran, do not take 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
• Feeling faint (blood pressure may go down)
• Temporary increase in blood pressure
• Shortness of breath
• Aching muscles.

Rare side effects

(may affect up to 1 in 1,000 people)

• Breast pain.

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 Gramegran.

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)
• 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.

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 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.

5. How to store Gramegran

• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any particular storage conditions.
• Do not take this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Gramegran tablets contain

Active ingredient - Each tablet contains 70 mg sumatriptan succinate equivalent to 50 mg of sumatriptan.

Other ingredients of the tablets are lactose monohydrate, hypromellose, microcrystalline cellulose,

croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Gramegran looks like and contents of the pack

Gramegran 50 mg film-coated tablets are pink, capsule shaped, biconvex, film-coated tablet, plain on both sides.

Gramegran 50 mg film-coated tablets are available in blister packs containing 2 tablets in a carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Accord, Barnstaple, EX32 8NS, UK

Manufacturer:

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF

Accord-UK Ltd

Whiddon Valley

Barnstaple

Devon, EX32 8NS

This leaflet was last revised in August 2025.

The PIL is available in formats suitable for the blind and partially sighted on request from the Marketing Authorisation Holder.

If you would like a leaflet with larger text, please contact

01271 385257

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INP113 80 6645 2 8619269

(8619269) Date : 04/05/2024, (R) 22.08.2025, 29.08.2025