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ZOMIG RAPIMELT 2.5MG ORODISPERSIBLE TABLETS

Active substance(s): ZOLMITRIPTAN / ZOLMITRIPTAN / ZOLMITRIPTAN

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Assessed against UK PIL dated November 2014

By Tammy Karikari at

Package Leaflet: Information for the User

Zomig Rapimelt® 2.5mg Orodispersible Tablets
(zolmitriptan)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• 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.
• The name of this medicine is Zomig Rapimelt 2.5mg Orodispersible
Tablets but it will be referred to as Zomig Rapimelt throughout the
remainder of this leaflet.
• This medicine is also available in another strength.
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.
• 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.
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 contain aspartame, a
source of phenylalanine, which may be harmful for people with
phenylketonuria.

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).
• 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:

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 Yellow Card Scheme, Website:
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 Rapimelt
• Keep out of the sight and reach of children.
• Do not store above 30oC.
• Do not use Zomig Rapimelt after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. This will help to protect the environment.
6. Contents of the pack and other information
What Zomig Rapimelt contains
Each tablet contains 2.5mg zolmitriptan.
Other ingredients: aspartame (E951), citric acid anhydrous, silica
colloidal anhydrous, crospovidone, magnesium stearate, mannitol,
microcrystalline cellulose, orange flavour and sodium hydrogen
carbonate.
What Zomig Rapimelt looks like and contents of the pack
Zomig Rapimelt are white, flat-faced, round tablets marked with the letter
‘Z’ on one side and plain on the reverse.
Zomig Rapimelt comes in peelable aluminium laminate blister packs
containing 6 orodispersible tablets and a grey plastic wallet.
Manufactured by
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.

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.

Repackaged by MPT Pharma Ltd.

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.

Leaflet dated 14th November 2016
Leaflet coded xxxxxxxxxxxx

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.

PL: 33532/0414
POM

Zomig Rapimelt® is a registered trademark of IPR Pharmaceuticals, Inc.
You can also get support and information about migraine from the
Migraine Action Association (UK), Unit 6, Oakley Hay Lodge Business
Park, Great Folds Road, Great Oakley, Northants NN18 9AS.

Expand Transcript

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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