Patient Leaflet Updated 24-Aug-2021 | Grunenthal Ltd
Zomig Rapimelt 5 mg Orodispersible Tablets
Package leaflet: Information for the user
Zomig Rapimelt 5 mg orodispersible tablets
zolmitriptan
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Zomig Rapimelt is and what it is used for
2. What you need to know before you take Zomig Rapimelt
3. How to take Zomig Rapimelt
4. Possible side effects
5. How to store Zomig Rapimelt
6. Contents of the pack and other information
1. What Zomig Rapimelt is and what it is used for
Zomig Rapimelt contains zolmitriptan and belongs to a group of medicines called triptans.
Zomig Rapimelt is used to treat migraine headache.
2. What you need to know before you take Zomig Rapimelt
Do not take Zomig Rapimelt:
Do not take Zomig Rapimelt if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zomig Rapimelt.
Warnings and precautions
Talk to your doctor of pharmacist before taking Zomig Rapimelt:
If you go into hospital tell the medical staff you are taking Zomig Rapimelt.
Zomig Rapimelt is not recommended for people aged over 65.
As with other migraine treatments, using too much Zomig Rapimelt 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 taking Zomig Rapimelt to correct the problem.
Children and adolescents
Zomig Rapimelt is not recommended in children and adolescents under 18 years.
Other medicines and Zomig Rapimelt
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
Medicines for depression
Other medicines
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.
Zomig Rapimelt with food and drink
You can take Zomig Rapimelt with or without food. It does not affect the way that Zomig Rapimelt works.
Pregnancy breast-feeding and fertility
It is not known if taking Zomig Rapimelt during pregnancy is harmful. 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
During a migraine attack your reactions may be slower than usual. Bear this in mind when you drive or use any tools or machines.
Zomig Rapimelt is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how Zomig Rapimelt affects you before you try these activities.
Zomig Rapimelt contains Aspartame (E951)
Zomig Rapimelt 5 mg orodispersible tablets contains 10 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.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’
3. How to take Zomig Rapimelt
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You can take this medicine as soon as a migraine headache starts. You can also take it once an attack is underway.
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.
If you take more Zomig Rapimelt than you should
If you have taken more Zomig Rapimelt than prescribed by your doctor, talk to your doctor or pharmacist straight away or go to the nearest hospital straight away. 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. 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 Rapimelt and contact a doctor straight away:
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
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.
Uncommon (may affect up to 1 in 100 people):
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 Rapimelt
6. Contents of the pack and other information
What Zomig Rapimelt 5 mg orodispersible tablet contains
The active ingredient is zolmitriptan. Each tablet contains 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 (SN027512) and sodium hydrogen carbonate.
What Zomig Rapimelt 5 mg orodispersible tablets look like and contents of the pack
Zomig may also be available as orodispersible 2.5 mg tablets, nasal spray 5 mg/dose and film-coated tablets 2.5 mg.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Zomig Rapimelt 5 mg orodispersible tablets is held by
Zomig Rapimelt 5 mg orodispersible tablets are manufactured by
or
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 5 mg
Reference number PL21727/0084
This is a service provided by the Royal National Institute of Blind People.
July 2021
PIL Zomig Rapimelt 5 mg UK CNS 16 0019 (based on CNS 14 0020) 08/11/2016 KV
Unit 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
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