Zomig Rapimelt Migraine Control 2.5 mg tablets – patient leaflet, side effects, dosage

1. What Zomig is and what it is used for

Zomig contains zolmitriptan and belongs to a group of medicines called triptans (also called serotonin receptor agonists).

Zomig is used to treat migraine headache in adults aged 18 to 65 years.

• Migraine symptoms may be caused by swollen blood vessels in the head. Zomig is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound.
• Zomig works only when a migraine attack has started. It will not stop you from getting an attack.

2. What you need to know before you take Zomig

Do not take Zomig:

• If you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in Section 6).
• If you have high blood pressure.

• If you have ever had heart problems, including a heart attack, angina (chest pain caused by exercise or effort), Prinzmetal’s angina (chest pain which happens at rest), heart failure or

  • related symptoms such as shortness of breath or pressure over the chest.
• If you have had a stroke or short-lasting symptoms similar to stroke which wears off after a day or two (also called ‘transient ischaemic attack’ or TIA).
• If you have ever had epilepsy or other seizures (fits).
• If you have a rare type of migraine called hemiplegic or basilar migraine.
• If you have ever had poor circulation in your legs, with pain on walking (also called ‘peripheral vascular disease’).
• If you have phenylketonuria (see Zomig contains Aspartame (E951) for further information).
• You have ever had liver or kidney problems.
• If you are at the same time taking some other medicines for migraine (e.g. ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine. See ‘Other medicines and Zomig’ for further information.

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

Warnings and precautions

Your pharmacist should have asked you questions to make sure this medicine is suitable for you. If any of the following apply to you, make sure you have told your pharmacist or doctor:

• If you have ever been told that you may have an increased risk of heart disease. You might be at risk if 3 or more of the following apply to you:

  • you have diabetes
  • you regularly smoke 10 or more cigarettes a day
  • you are very overweight
  • you are a man over 40 or a woman who has reached the menopause
  • you have high cholesterol
  • you have a father, son or brother who had heart disease before aged 55
  • you have a mother, daughter or sister who had heart disease before aged 65.
• If you have had fewer than 5 migraine attacks in the past.
• If you had your first ever migraine attack within the last year.
• If you start to get migraines more often, or your usual migraine symptoms change.
• If you are over 50 and this is the first time you have had this type of headache.
• If your headaches usually last longer than 24 hours.
• If you do not recover completely in between your migraine attacks.
• If you have ever had liver problems.
• If you are taking any medicine for treatment of depression (see ‘Other medicines and Zomig’ for further information).

Zomig is not recommended for people aged over 65.

Children and adolescents

Zomig is not recommended in children and adolescents under 18 years.

Other medicines and Zomig

Tell your pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines you buy without prescription.

If you go into hospital tell the medical staff you are taking Zomig.

In particular, tell your pharmacist if you are taking any of the following medicines:

Medicines for migraine

• If you take a triptan other than Zomig (such as sumatriptan or naratriptan) leave 24 hours before taking Zomig.
• After taking Zomig leave 24 hours before taking any another triptan.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking Zomig.
• After taking Zomig leave 6 hours before taking ergotamine or ergot-type medicines.

Do not take Zomig with other migraine medicines, to treat the same migraine attack.

Medicines for depression

Ask your doctor or pharmacist if you are not sure about the type of medicine you take for depression.

• Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobemide). A maximum intake of 5 mg of Zomig in 24 hrs is advised if you are also taking a MAO-A inhibitor.
• SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine or citalopram, paroxetine, fluvoxamine or sertraline or a SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine or duloxetine. Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who took Zomig in combination with so called serotoninergic medicines (e.g. certain medicines for the treatment of depression). Signs of serotonin syndrome may be for example agitation, restlessness, fever, excessive sweating, tremor, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, twitching and muscle rigidity. Your doctor may advise you on this.
• The herbal medicine St John’s wort (Hypericum perforatum). Do not take St John’s wort at the same time as Zomig. If you already take a St John’s wort preparation, do not take Zomig until you have spoken to your doctor.

Other medicines

• Cimetidine (for indigestion or stomach ulcers).
• A quinolone antibiotic (such as ciprofloxacin).

Zomig with food and drink

You can take this medicine with or without food. It does not affect the way that this medicine works.

Women taking a combined oral contraceptive pill

If you are taking a combined oral contraceptive pill, contact your doctor:

• If you have only recently started to have migraines (in the last 3 months).
• If your migraine symptoms have got worse.

This is because you may have a greater chance of having a stroke. Your doctor may want to change your contraceptive to reduce this chance.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Zomig is unlikely to affect driving or using machines. However, it may make you drowsy.

• Wait to see how it affects you before you try these activities
• If you do feel drowsy, do not drive or try to use machines

Zomig contains Aspartame (E951)

Zomig contains 5 mg Aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Zomig Rapimelt contains sodium

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

Zomig Rapimelt contains benzyl alcohol

Zomig Rapimelt 2.5 mg contains 0.0000032 mg of benzyl alcohol in each orodispersible tablet.

Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (called “metabolic acidosis”).

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (called “metabolic acidosis”).

3. How to take Zomig

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

Adults aged 18-65 years of age

• The recommended dose is one tablet (2.5 mg).
• Take a tablet as soon as you feel your migraine start.
• Peel the blister pack open as shown on the foil (do not push the tablet through the foil).
• Put the tablet on your tongue, let it dissolve and then swallow – you do not need any water.
• You can take Zomig at any time during an attack, but try and take it as soon as possible after your migraine starts.
• If your migraine has not gone after 2 hours, or if it comes back within 24 hours, you can take another tablet.
• Make sure you leave at least 2 hours between tablets.
• Do not take more than two Zomig tablets in 24 hours.
• The maximum daily does is 5 mg.

If your Zomig tablets do not work, tell your doctor or pharmacist.

Do not take Zomig to stop you from getting a migraine. Only take it when you are sure your migraine has started.

If you are under 18 years of age or over 65 years of age and experience a migraine talk to your doctor or pharmacist and do not take Zomig.

See your doctor if:

• You have 4 or more migraine headaches a month
• You need to take 4 or more packs of Zomig (8 or more tablets) a month

If you do, your doctor may wish to change your treatment.

You must see a doctor if your symptoms get worse or do not improve at all after taking 2 tablets of Zomig.

If you take more Zomig than you should

If you take more tablets than your pharmacist told you to take, talk to your doctor or pharmacist straight away or go to the nearest hospital. Remember to take this medicine with you.

If you forget to take Zomig Rapimelt

• 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, although not everybody gets them. These are usually mild and go away after a short time. Some of the symptoms below could be part of the migraine attack itself.

If you notice any of the following serious side effects, stop taking Zomig and contact a doctor straight away:

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

• Allergic reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat or severe allergic reactions (anaphylaxis).

Very rare (may affect up to 1 in 10,000 people):

• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart. The signs include chest pain and shortness of breath.
• Spasm of the blood vessels of the gut, which can cause damage to your gut. The signs include stomach pain or bloody diarrhoea.
• Bleeding in the brain (cerebral bleeding) or stroke.

Other possible side effects include:

Common (may affect up to 1 in 10 people):

These side effects are usually mild and go away after a short time.

• Abnormal sensations such as tingling in your fingers and toes or skin that is sensitive to touch.
• Feeling sleepy, dizzy or warm.
• Headache.
• Uneven heart beat.
• Feeling sick (nausea) or being sick (vomiting).
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain or pressure in the throat, neck, arms and legs, or chest.
• Problems swallowing.

Uncommon (may affect up to 1 in 100 people):

• Very fast heart beat.
• Slightly higher blood pressure.
• Increase in the amount of water you pass (urine) or in how often you need to pass water.

Very rare (may affect up to 1 in 10,000 people:

People who have migraines may be at risk of certain problems in the blood circulation of the brain, for example, cerebral bleeding (bleeding in the brain) or strokes.

If you get any of these side effects, do not take any more Zomig until you have talked with your doctor or pharmacist.

Reporting of side effects

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 at: 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 Zomig

• Keep this medicine out of the sight and reach of children.
• Keep your medicine in the container it came in.
• Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• 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 Zomig tablet contains

The active ingredient is zolmitriptan. Each tablet contains 2.5 mg of zolmitriptan.

The other ingredients are: aspartame (E951), citric acid anhydrous, silica colloidal anhydrous, crospovidone, magnesium stearate, mannitol (E421), microcrystalline cellulose, orange flavour (contains benzyl alcohol) and sodium hydrogen carbonate.

What Zomig tablets look like and contents of the pack

• Zomig tablets are white, flat-faced, round and marked with the letter ‘Z’ on one side.
• Zomig tablets come in peelable aluminium laminate blister packs containing 2 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Zomig tablets is held by Grünenthal Ltd, TOR Building,

Saint Cloud Way, Maidenhead, Berkshire, SL6 8BN, United Kingdom.

Zomig tablets are manufactured by Farmaceutici Formenti S.p.A. Via Di Vittorio 2, 21040 Origgio (VA) Italy or Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Zomig Rapimelt Migraine Control 2.5 mg

Reference number PL 21727/0087

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in May 2024

You can also get support and information about migraine from the Migraine Action Association (UK), 4^th Floor, 27 East Street, Leicester, LE1 6NB

www.migraine.org.uk