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ZOMIG RAPIMELT 2.5MG ORODISPERSIBLE TABLETS

Active substance(s): ZOLMITRIPTAN

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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 your medicine is Zomig
Rapimelt 2.5mg Orodispersible
Tablets but will be referred to as
Zomig Rapimelt.
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 shortlasting 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:
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 side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
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.
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.
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

POM

Leaflet date: 16.11.2015
Zomig Rapimelt 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),
Unit 6, Oakley Hay Lodge Business
Park, Great Folds Road, Great
Oakley, Northants NN18 9AS.

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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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