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ZOMIG RAPIMELT MIGRAINE CONTROL 2.5MG TABLETS

Active substance(s): ZOLMITRIPTAN / ZOLMITRIPTAN / ZOLMITRIPTAN

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Package leaflet: Information for the user
Zomig Rapimelt Migraine Control™ 2.5 mg Tablets
zolmitriptan
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you.
 Keep this leaflet. You may need to read it again.
 Ask pharmacist if you need more information or advice.
 Make sure you tell your doctor that you have been given Zomig Rapimelt Migraine Control. This
helps to make sure your medical records are kept up to date.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See Section 4.
 You must talk to a doctor if you do not feel better or if you feel worse.
In this leaflet Zomig Rapimelt Migraine Control tablets are called Zomig.
What is in this leaflet:
1.
What Zomig is and what it is used for
2.
What you need to know before you take Zomig
3.
How to take Zomig
4.
Possible side effects
5.
How to store Zomig
6.
Contents of the pack and other information

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
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uneven heart beat (including Wolff Parkinson White syndrome) 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 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 ergottype 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:
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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. Talk to your doctor if you get weakness and/or a lack of coordination,
confusion or other behavior changes after taking Zomig at the same time as a SSRI or a SNRI.
 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 Aspartame, a source of phenylalanine and may be harmful for people with
phenylketonuria.

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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):
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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,
Wesbite: www.mhra.gov.uk/yellowcard. 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.

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6.

Do not store above 30°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.

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
(SN027512) 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 AstraZeneca UK Limited, 600 Capability
Green, Luton, LU1 3LU, UK.
Zomig tablets are manufactured by AstraZeneca UK Limited, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.

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
17901/0238
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in October 2016
© AstraZeneca 2016
Zomig Rapimelt Migraine Control is a trade mark of the AstraZeneca group of companies.

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

CNS 16 0018

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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