Patient leaflet - Zolmitriptan Rapimelt 2.5 mg orodispersible tablets, Zomig Rapimelt 2.5 mg orodispersible tablets
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.
Migraine symptoms may be
caused by swollen blood vessels in the head. Zomig Rapimelt 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 Rapimelt 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 Rapimelt
Do not take Zomig Rapimelt:
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) 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 ‘Other medicines and Zomig Rapimelt’ for further information.
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 taking Zomig Rapimelt:
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.
If you are taking any medicine for
treatment of depression (see ‘Other medicines and Zomig Rapimelt’ for further information).
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
If you take a triptan other than
Zomig Rapimelt (such as sumatriptan or naratriptan) leave 24 hours before taking Zomig Rapimelt.
After taking Zomig Rapimelt
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 Zomig Rapimelt.
After taking Zomig Rapimelt
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 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, 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.
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 2.5mg
orodispersible tablets contains 5mg 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 1mmol sodium (23mg) 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.
- The recommended dose is one tablet (2.5mg).
POM
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 in order 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.
The maximum daily dose is
10mg.
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):
Allergic 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 (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.
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
- Do not store tablets above 30°C.
- Keep your tablets in the container they came in.
- If your doctor tells you to stop taking your tablets, take any tablets you have left back to the pharmacy for safe disposal. Only keep your tablets if your doctor tells you to.
- Do not take your tablets after the expiry date on the container. Take any tablets that are out of date back to the pharmacy.
- Keep your Zomig Rapimelt in a safe place, where children cannot see or reach them. Your tablets could harm them.
If the tablets become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.
6. Contents of the pack and other information
What Zomig Rapimelt 2.5mg orodispersible tablets contain
Each orodispersible tablet contains 2.5mg of Zomig as the active ingredient.
Your tablet also contains the following inactive ingredients: aspartame, citric acid anhydrous, silica colloidal anhydrous,
crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, orange flavour SN027512 and sodium hydrogen carbonate.
What Zomig Rapimelt 2.5mg orodispersible tablets look like and contents of the pack
Each Zomig tablet is a white, round, bevelled edge,
orodipsersible tablet marked with a ‘Z’ on one side and plain on the reverse.
Zomig comes in packs of
2 orodispersible tablets
Manufacturered by: AstraZeneca U.K. Limited, Macclesfield, Cheshire, UK.
OR
Grünenthal GmbH, Zieglerstrasse 6- D- 52078 Aachen, Germany.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Zomig® Rapimelt® 2.5mg orodispersible tablets
PL 18799/1272
Leaflet date: 25.08.2020.
Zomig Rapimelt is a registered trademark of Grünenthal GmbH.
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