Patient leaflet - Zolmitriptan 5 mg orodispersible tablets
1. WHAT ZOLMITRIPTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Zolmitriptan orodispersible tablets contain zolmitriptan and belong to a group of medicines called triptans. Zolmitriptan is used to treat migraine headache.
- Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan 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.
- Zolmitriptan works only when a migraine attack has started. It will not stop you from getting an attack.
2. BEFORE YOU TAKE ZOLMITRIPTAN TABLETS
Do not take Zolmitriptan
- if you are allergic (hypersensitive) 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) or have experienced heart 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 (transient ischaemic attack or TIA)
- 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 section below: ‘Other medicines and Zolmitriptan’ for further information.
Do not take Zolmitriptan tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zolmitriptan tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zolmitriptan tablets:
- If you are at risk of getting ischaemic heart disease (poor blood flow in the arteries of the heart). Your risk is greater if you smoke, have high blood pressure, high levels of cholesterol, diabetes or if anyone in your family has ischaemic heart disease.
- If you have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat).
- If you have ever had liver problems.
- If you have headaches which are not like your usual migraine headache
- The use of Buprenorphine together with Zolmitriptan can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Zolmitriptan”).
If you go into hospital tell the medical staff you are taking Zolmitriptan tablets.
Zolmitriptan is not recommended for people aged over 65.
As with other migraine treatments, using too much Zolmitriptan can cause daily headaches or can make your migraine headaches worse. Ask your doctor if you think that this is the case for you. You may need to stop using Zolmitriptan to correct the problem.
Children and adolescents
Zolmitriptan tablets are not recommended in children and adolescents under 18years.
Other medicines and Zolmitriptan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines you buy without prescription.
In particular, tell your doctor if you are taking any of the following medicines:
Medicines for migraine
- If you take a triptan other than Zolmitriptan tablets (such as sumatriptan or naratriptan) leave 24 hours before taking Zolmitriptan.
- After taking Zolmitripan tablets leave 24 hours before taking another triptan.
- If you take medicines containing ergotamine or ergot type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmitriptan tablets.
- After taking Zolmitriptan tablets leave 6 hours before taking ergotamine or ergot-type medicines Medicines for depression
- Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobemide).
- SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine or sertraline.
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 Zolmitriptan 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. Other medicines
- Cimetidine (for indigestion or stomach ulcers).
- A quinolone antibiotic (such as ciprofloxacin).
You should not take the herbal remedy St John’s wort (Hypericum perforatum) at the same time as this medicine. If you already take a St John’s wort preparation, stop taking it and mention this to your doctor at your next visit. Taking Zolmitriptan orodispersible tablets with food and drink
You can take Zolmitriptan with or without food. It does not affect the way that Zolmitriptan works. Pregnancy,breast-feeding and fertility
It is not known if taking Zolmitriptan during pregnancy is harmful. If you are pregnant or breast feeding, think you may be pregnant are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
During a migraine attack your reactions may be slower than usual. Bear this in mind when you drive or use any tools or machines. Zolmitriptan is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zolmitriptan affects you before you try these activities.
Important information about some of the ingredients of Zolmitriptan
Zolmitriptan orodispersible tablets contain 4mg of aspartame per 2.5 mg tablet or 8mg aspartame per 5mg 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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. This medicine contains mannitol and may have a mild laxative effect.
3. HOW TO TAKE ZOLMITRIPTAN TABLETS
Always take Zolmitriptan tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You can take Zolmitriptan as soon as a migraine headache starts. You can also take it once an attack is underway.
- The recommended dose is one tablet (either 2.5 mg or 5 mg).
- Peel the blister pack open as shown on the foil. Do not push the tablet through the foil.
- Place the tablet on your tongue, where it will dissolve and be swallowed with the saliva. You do not have to take a drink of water to swallow your tablet.
- You can take another tablet if the migraine is still present after two hours or if it returns within 24 hours. If the tablets did not give you enough help with your migraine, tell your doctor. Your doctor may change your treatment. Do not use more than the dose prescribed for you.
- Do not use more than two doses in one day unless prescribed by your doctor. If you have been prescribed the 2.5 mg tablet, the maximum daily dose is 5 mg. If you have been prescribed the 5mg tablet, the maximum daily dose is 10 mg. If you take more Zolmitriptan than you should
If you have taken more Zolmitriptan than prescribed by your doctor, tell your doctor or pharmacist or go to the nearest hospital straight away. Take the Zolmitriptan medicine with you.
If you forget to take Zolmitriptan
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zolmitriptan can cause side effects, although not everybody gets them. 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 Zolmitriptan and contact a doctor straight away:
Rare (may affect up to 1 in 1000 people):
- Allergic/hypersensitivity reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat. 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 side effects (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 throat, neck, arms and legs, or chest
- Problems swallowing
Uncommon side effects (may affect 1to 10 users in 1,000):
- 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 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, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in 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 ZOLMITRIPTAN TABLETS
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zolmitriptan tablet contains
- The active substance is zolmitriptan. Zolmitriptan orodispersible tablets contain either 2.5 mg or 5 mg of zolmitriptan.
- The other ingredients are mannitol (E421), calcium silicate, microcrystalline cellulose, aspartame (E951), sodium starch glycolate type A, crospovidone, colloidal anhydrous silica, magnesium stearate and orange cream flavour (containing e.g. maltodextrin (maize), acacia (E414), ascorbic acid (E300), butylhydroxyanisole (E320)). What Zolmitriptan looks like and contents of the pack
Zolmitriptan 2.5 mg orodispersible tablets are white and round flat tablets with the diameter 7.0 mm. Zolmitriptan 5 mg orodispersible tablets are white and round flat tablets with the diameter 8.0 mm. Zolmitriptan orodispersible tablets 2.5 mg and 5 mg come in peelable aluminium laminate blister packs containing 2, 3, 6 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd., 3rd Floor, Nexus Building, 4 Gatwick Road, Crawley, West Sussex, RH10 9BG, United Kingdom Manufacturer Torrent Pharma (UK) Ltd. or Kleva Pharmaceuticals S.A. 3rd Floor, Nexus Building, 4 Gatwick Road, Crawley, 189 Parnithos Ave., Acharnai Attiki, 13675, Greece West Sussex, RH10 9BG, United Kingdom
This leaflet was last updated in March 2025
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