ZOMIG RAPIMELT 2.5 MG ORODISPERSIBLE TABLETS

Active substance: ZOLMITRIPTAN

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P034548

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zomig Rapimelt
2.5 mg
orodispersible
tablets
zolmitriptan

Read all of this leaflet carefully
before you start taking this
medicine.
• 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. Do not pass
it on to others. It may harm them,
even if their symptoms are the
same as yours.
• If any of the side effects get
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Zomig Rapimelt is and
what it is used for
2. Before you take Zomig Rapimelt
3. How to take Zomig Rapimelt
4. Possible side effects
5. How to store Zomig Rapimelt
6. Further 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. Before you take
Zomig Rapimelt
Do not take Zomig Rapimelt if:
• You are allergic (hypersensitive)
to zolmitriptan or any of the other
ingredients of this medicine (see
Section 6: Further information).
• You have high blood pressure.
• 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.
• You have had a stroke or
short-lasting symptoms similar
to stroke (transient ischaemic
attack or TIA).
• 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 section below: ‘Taking other
medicines’ 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.
Take special care with
Zomig Rapimelt
Before you take Zomig Rapimelt,
tell your doctor 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.
• You have been told that you have
Wolff-Parkinson-White Syndrome
(a type of abnormal heart beat).
• You have ever had liver problems.
• You have headaches which are
not like your usual migraine
headache.
• You are taking any medicine for
treatment of depression (see
section below: ‘Taking other
medicines’ 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 under 18 years or
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.
Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken 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.
Taking 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 and breast-feeding
• It is not known if taking
Zomig Rapimelt during pregnancy
is harmful. Before taking Zomig
Rapimelt, tell your doctor if you
are pregnant or trying to become
pregnant.
• Before taking Zomig Rapimelt
tell your doctor if you are
breast-feeding.

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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.
Important information about
some of the ingredients of
Zomig Rapimelt
Zomig Rapimelt 2.5 mg
orodispersible tablets contain
aspartame, a source of
phenylalanine, which may be harmful
for people with phenylketonuria.

3. How to take
Zomig Rapimelt
Always take Zomig Rapimelt exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.

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You can take Zomig Rapimelt as
soon as a migraine headache starts.
You can also take it once an attack
is underway.
• The usual dose is one tablet
(2.5 mg).
• 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 to
by your doctor.
• The maximum daily dose is
10 mg.
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.

4. Possible side effects
Like all medicines, Zomig Rapimelt
can cause side effects, although not
everybody gets them. Some of the
symptoms below could be part of the
migraine attack itself.
Stop taking Zomig Rapimelt and
contact your doctor straight away
if you notice any of the following:
Rare (affects less than 1 in
1,000 people)
• Allergic reactions including itchy
rash (urticaria) and swelling of
the face, lips, mouth, tongue and
throat.
Very rare (affects less than
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:
Common (affects less than
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 (affects less than
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.
Do not be concerned by this list of
possible side effects. You may not
get any of them. If any of the side
effects get serious, or if you notice
any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

5. How to store
Zomig Rapimelt
• Keep out of the reach and sight
of children.
• Keep your medicine in the
container it came in.
• Do not use Zomig Rapimelt after
the expiry date stated on the
carton. The expiry date refers to
the last day of that month.
• Do not store above 30°C.
• Medicines should not be disposed
of via wastewater or household
waste. Ask your pharmacist how
to dispose of medicines no longer
required. These measures will
help to protect the environment.

6. Further information
What Zomig Rapimelt 2.5 mg
orodispersible tablets contain
The active ingredient is zolmitriptan.
Zomig Rapimelt 2.5 mg
orodispersible tablets contain
2.5 mg of zolmitriptan.
The other ingredients are:
aspartame, citric acid anhydrous,
silica colloidal anhydrous,
crospovidone, magnesium stearate,
mannitol, 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 Rapimelt 2.5 mg
orodispersible tablets are white,
flat-faced, round and marked
with the letter ‘Z’ on one side.
• Zomig Rapimelt 2.5 mg
orodispersible tablets come in
peelable aluminium laminate
blister packs containing 6 tablets.
Zomig may also be available as
orodispersible 5 mg tablets, nasal
spray 5 mg/dose and film-coated
tablets 2.5 mg and 5 mg.
Marketing Authorisation Holder
and Manufacturer
The Marketing Authorisation
for Zomig Rapimelt 2.5 mg
orodispersible tablets is held
by AstraZeneca UK Limited,
600 Capability Green, Luton,
LU1 3LU, UK.
Zomig Rapimelt 2.5 mg
orodispersible 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
2.5 mg
Reference number
17901/0076
This is a service
provided by the
Royal National
Institute of Blind
People.
Leaflet updated: June 2012
© AstraZeneca 2012
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.
CNS 12 0037

P034548

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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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