Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Zomig Rapimelt contains zolmitriptan and belongs to a group of medicines called triptans.
Zomig Rapimelt is used to treat migraine headache.
Zomig Rapimelt works only when a migraine attack has started. It will not stop you from getting an attack.
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 or pharmacist before you take Zomig Rapimelt:
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.
If you are treated with both Zomig and certain types of antidepressants, then your doctor will need to carefully monitor you.
If you use any type of painkiller whilst taking Zomig Rapimelt, then your headache could get worse. If this happens, speak to your doctor as soon as possible.
If you go into hospital tell the medical staff you are taking Zomig Rapimelt.
Zomig Rapimelt is not recommended for people aged over 65.
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
Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who took Zomig Rapimelt 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, tremor, restlessness, fever, excessive sweating, twitching, muscle rigidity uncoordinated movement of limbs or eyes and uncontrollable jerking of muscles. Your doctor may advise you on this.
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
Zomig Rapimelt contains Aspartame (E951)
Zomig Rapimelt 2.5 mg contains 5 mg aspartame in each orodispersible 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’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor of pharmacist if you are not sure.
You can take this medicines 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.
If you take more Zomig Rapimelt than you should
If you have taken more Zomig Rapimelt than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take the Zomig Rapimelt medicine with you.
If you forget to take Zomig Rapimelt
Do not use more than the dose prescribed for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 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 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):
Do not be concerned by this list of possible side effects. You may not get them.
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:
HPRA Pharmacovigilance
Website: www.hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
What Zomig Rapimelt contains
The active ingredient is zolmitriptan. Each tablet contains 2.5 mg of zolmitriptan.
The other ingredients are: aspartame (E951) (see section 2), citric acid anhydrous, silica colloidal anhydrous, crospovidone, magnesium stearate, mannitol (E421), microcrystalline cellulose, orange flavour (SN027512) and sodium hydrogen carbonate.
What Zomig Rapimelt 2.5 mg orodispersible tablets look like and contents of the pack
Zomig may also be available as film-coated tablets 2.5 mg.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Zomig Rapimelt 2.5 mg orodispersible tablets is held by Grünenthal Pharma Ltd., 4045 Kingswood Road, Citywest Business Park, Citywest, Co. Dublin,
Ireland
Zomig Rapimelt 2.5 mg orodispersible 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.
This leaflet was last revised in September 2020.