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ZOMIG RAPIMELT 5MG ORODISPERSIBLE TABLETS

Active substance(s): ZOLMITRIPTAN

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Package leaflet: Information for the user

P039700

Zomig Rapimelt 5 mg 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.
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 of 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 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 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 (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.

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12-12-14
P039700

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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.
• 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, 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
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.

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 Rapimelt 5 mg
orodispersible tablets look like and
contents of the pack
• Zomig Rapimelt 5 mg
orodispersible tablets are white,
flat-faced, round and marked with
‘Z 5’ on one side.
• Zomig Rapimelt 5 mg
orodispersible tablets come in
peelable aluminium laminate blister
packs containing 6 tablets.
Zomig may also be available as
orodispersible 2.5 mg tablets, nasal
spray 5 mg/dose and film‑coated
tablets 2.5 mg.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation
for Zomig Rapimelt 5 mg
orodispersible tablets is held
by AstraZeneca UK Limited,
600 Capability Green, Luton,
LU1 3LU, UK.
Zomig Rapimelt 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 5 mg
Reference number
17901/0230
This is a service
provided by the
Royal National
Institute of Blind
People.
This leaflet was last revised in
November 2014
© AstraZeneca 2014
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 14 0020

5. How to store Zomig Rapimelt
• 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.
• 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.
6. Contents of the pack and other
information
What Zomig Rapimelt 5 mg
orodispersible tablet contains
The active ingredient is zolmitriptan.
Zomig Rapimelt 5 mg orodispersible
tablets contain 5 mg of zolmitriptan.

P039700

453935-A01
12-12-14
P039700

Black

Technical Info

530140L1
2117

Profile

Zomig Rapimelt 5mg Leaflet:
Patient GB
RY

Body text size

Smallest text size

9.5 pt

6.0 pt

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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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