ZOMIG RAPIMELT 2.5MG ORODISPERSIBLE TABLETS

Active substance: 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.
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.
The name of your medicine is Zomig
Rapimelt 2.5mg Orodispersible
Tablets but will be referred to as
Zomig Rapimelt.
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 shortlasting 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.
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 2.5mg
orodispersible tablets contain
aspartame, a source of
phenylalanine, which may be
harmful for people with
phenylketonuria.

3. How to take
Zomig Rapimelt
Always take Zomig Rapimelt exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.
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.
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 any 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. Further Information
What Zomig Rapimelt 2.5mg
orodispersible tablets contain
Each orodispersible tablet contains
2.5mg of Zomigas 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: CIMA Labs Inc,
Eden Prairie, MN 55344, USA.
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 No: 18799/1272

POM

Leaflet date: 18.09.2014
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.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Zolmitriptan Rapimelt 2.5mg orodispersible tablets
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.
The name of your medicine is
Zolmitriptan Rapimelt 2.5mg
Orodispersible Tablets but will be
referred to as Zolmitriptan Rapimelt.
In this leaflet:
1. What Zolmitriptan Rapimelt is
and what it is used for
2. Before you take Zolmitriptan
Rapimelt
3. How to take Zolmitriptan
Rapimelt
4. Possible side effects
5. How to store Zolmitriptan
Rapimelt
6. Further information

1. What Zolmitriptan Rapimelt
is and what it is used for
Zolmitriptan Rapimelt contains
zolmitriptan
and belongs to a group of medicines
called triptans.
Zolmitriptan Rapimelt is used to
treat migraine headache.
Migraine symptoms may be
caused by swollen blood vessels
in the head. Zolmitriptan 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.
Zolmitriptan Rapimelt works only
when a migraine attack has
started. It will not stop you from
getting an attack.

2. Before you take
Zolmitriptan Rapimelt
Do not take Zolmitriptan 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 shortlasting 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 Zolmitriptan Rapimelt if
any of the above apply to you.
If you are not sure, talk to your doctor
or pharmacist before taking
Zolmitriptan Rapimelt.
Take special care with Zolmitriptan
Rapimelt
Before you take Zolmitriptan
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 Zolmitriptan
Rapimelt.
Zolmitriptan Rapimelt is not
recommended for people aged under
18 years or over 65.
As with other migraine treatments,
using too much Zolmitriptan 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 Zolmitriptan
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
Zolmitriptan Rapimelt (such as
sumatriptan or naratriptan)
leave 24 hours before taking
Zolmitriptan Rapimelt.
After taking Zolmitriptan 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 Zolmitriptan
Rapimelt.
After taking Zolmitriptan 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 Zolmitriptan Rapimelt with
food and drink
You can take Zolmitriptan Rapimelt
with or without food. It does not
affect the way that Zolmitriptan
Rapimelt works.
Pregnancy and breast-feeding
It is not known if taking
Zolmitriptan Rapimelt during
pregnancy is harmful. Before
taking Zolmitriptan Rapimelt, tell
your doctor if you are pregnant or
trying to become pregnant.
Before taking Zolmitriptan
Rapimelt tell your doctor if you
are breast-feeding.
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.
Zolmitriptan Rapimelt is unlikely
to affect driving or using tools
or machines. However, it may
make you feel sleepy. Wait
to see how Zolmitriptan Rapimelt
affects you before you try these
activities.
Important information about some
of the ingredients of Zolmitriptan
Rapimelt
Zolmitriptan Rapimelt 2.5mg
orodispersible tablets contain
aspartame, a source of
phenylalanine, which may be
harmful for people with
phenylketonuria.

3. How to take
Zolmitriptan Rapimelt
Always take Zolmitriptan Rapimelt
exactly as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.
You can take Zolmitriptan 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 Zolmitriptan
Rapimelt than you should
If you have taken more Zolmitriptan
Rapimelt than prescribed by your
doctor, tell your doctor or go to the
nearest hospital straight away. Take
the Zolmitriptan Rapimelt medicine
with you.

4. Possible side effects
Like all medicines, Zolmitriptan
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 Zolmitriptan 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.
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 any 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
Zolmitriptan 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 Zolmitriptan 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. Further Information
What Zolmitriptan Rapimelt 2.5mg
orodispersible tablets contain
Each orodispersible tablet contains
2.5mg of Zomigas 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 Zolmitriptan Rapimelt 2.5mg
orodispersible tablets look like
and contents of the pack
Each Zolmitriptan tablet is a
white, round, bevelled edge,
orodipsersible tablet marked with
a ‘Z’ on one side and plain on the
reverse.
Zolmitriptan comes in packs of 2
orodispersible tablets
Manufacturered by: CIMA Labs Inc,
Eden Prairie, MN 55344, USA.
Procured from within the EU and
repackaged by the Product
Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Zolmitriptan Rapimelt 2.5mg
Orodispersible Tablets
PL No: 18799/1272
POM
Leaflet date: 18.09.2014
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 view ⇕

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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