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SUMATRIPTAN 100MG TABLETS

Active substance: SUMATRIPTAN SUCCINATE

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Package Leaflet:
Information for the User
100mg tablets
(sumatriptan succinate)

Imigran®

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 (chemist).
• 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
gets serious, or if you notice
any side effect not listed in
this leaflet, please tell your
doctor or pharmacist.
The name of your medicine is
Imigran 100mg tablets, but will
be referred to as Imigran
throughout this leaflet. Please
note that the leaflet also
contains information about other
strength Imigran 50mg tablets.

1 What Imigran is and what it
is used for
Each Imigran capsule-shaped tablet
contains a single dose of sumatriptan,
which belongs to a group of medicines
called triptans (also known as 5-HT1
receptor agonists).
Imigran is used to treat migraine
headache.
Migraine symptoms may be caused by
the temporary widening of blood vessels
in the head. Imigran is believed to
reduce the widening of these blood
vessels. This in turn helps to take away
the headache and relieve other
symptoms of a migraine attack, such as
feeling or being sick (nausea or vomiting)
and sensitivity to light and sound.

2 Before you use Imigran

Don’t use Imigran:
• If you’re allergic (hypersensitive) to

In this leaflet
1 What Imigran is and what it
is used for
2 Before you use Imigran
3 How to use Imigran
4 Possible side effects
5 How to store Imigran
6 Further information








sumatriptan, or any of the other
ingredients (listed in Section 6)
If you have a heart problem such as
narrowing of the arteries (ischaemic
heart disease) or chest pains (angina),
or have already had a heart attack
If you have circulation problems in
your legs that cause cramp-like pains
when you walk (peripheral vascular
disease)
If you have had a stroke or a ministroke (also called a transient
ischaemic attack or TIA)
If you have high blood pressure.
You may be able to use Imigran if your
high blood pressure is mild and is
being treated

• If you have serious liver disease
• With other migraine medicines,
including those which contain
ergotamine, or similar medicines such
as methysergide maleate; or any
triptan or 5HT1 agonist (such as
naratriptan or zolmitriptan)
• With any of the following antidepressants:
• MAOIs (monoamine oxidase
inhibitors) or if you have taken an
MAOI in the last 2 weeks
• SSRIs (selective serotonin
reuptake inhibitors) including
citalopram, fluoxetine,
fluvoxamine, paroxetine and
sertraline
• SNRIs (serotonin noradrenaline
reuptake inhibitors) including
venlafaxine and duloxetine
• For children under 18 years of age.
If any of these apply to you:
Tell your doctor, and don’t use
Imigran tablets.

Take special care with Imigran
Your doctor needs to know certain
information before you use Imigran:
If you have any extra risk factors

• If you are a heavy smoker or are
using nicotine replacement therapy,
and especially
• If you are a man aged over 40, or
• If you are a woman who has been
through the menopause.

In very rare cases, people have
developed serious heart conditions after
using Imigran, even though they had no
signs of heart disease before. If any of
the points above applies to you it could
mean you have a greater risk of
developing heart disease - so:
Tell your doctor so that your heart
function can be checked before
Imigran is prescribed for you.
If you have a history of fits (seizures)
Or if you have other conditions which
might make it more likely that you’ll have
a fit – for example, a head injury or
alcoholism.
If you have liver or kidney disease
If you have an intolerance to some
sugars
If any of these apply to you:
Tell your doctor so that you can be
supervised more closely.
If you are allergic to antibiotics called
sulphonamides
If so, you may also be allergic to Imigran.
If you know you are allergic to an
antibiotic but you are not sure whether it
is a sulphonamide:
Tell your doctor or pharmacist
before using Imigran.
If you are taking anti- depressants
called SSRIs
(Selective Serotonin Reuptake Inhibitors)
or SNRIs (Serotonin Noradrenaline
Reuptake Inhibitors)
Tell your doctor or pharmacist
before using Imigran. Also see Other
medicines and Imigran, below.

If you use Imigran frequently
Using Imigran too often may make your
headaches worse.
Tell your doctor if this applies to
you. He or she may recommend you
stop using Imigran.
If you feel pain or tightness in your
chest after you use Imigran
These effects may be intense but they
usually pass quickly. If they don’t pass
quickly, or they become severe:
Get medical help immediately.
Section 4 (overleaf) has more
information about these possible side
effects.

Other medicines and Imigran
Tell your doctor if you’re taking any
other medicines or have recently taken
any. This includes any herbal products,
dietary supplements such as vitamins,
iron or calcium or medicines you’ve
bought without a prescription.
Some medicines must not be taken with
Imigran and others may cause adverse
effects if they’re taken with Imigran. You
must tell your doctor if you are taking:

• ergotamine also used to treat
migraine, or similar medicines such
as methysergide maleate; or any
triptan or 5-HT1 agonist (such as
naratriptan or zolmitriptan). Don’t use
Imigran at the same time as these
medicines. Stop taking these
medicines at least 24 hours before
using Imigran. Don’t take them again
for at least 6 hours after using Imigran
• MAOIs used to treat depression.
Don’t use Imigran if you have taken
these in the last 2 weeks

• SSRIs and SNRIs used to treat
depression. Using Imigran with these
medicines can cause serotonin
syndrome (a collection of symptoms
which can include restlessness,
confusion, sweating, hallucinations,
increased reflexes, muscle spasms,
shivering, increased heartbeat and
shaking). Tell your doctor immediately
if you are affected in this way.
• St John’s Wort (Hypericum
perforatum). Taking herbal remedies
containing St John’s Wort together
with Imigran may make side effects
more likely.

Pregnancy and breast-feeding
• If you are pregnant or could be
pregnant, talk to your doctor before
you use Imigran. There is only limited
information about the safety of Imigran
for pregnant women, though up till
now there is no evidence of any
increased risk of birth defects.
Your doctor will discuss with you
whether or not you should use Imigran
while you are pregnant
• Don’t breast-feed your baby for 12
hours after using Imigran. If you
express any breast milk during this
time, discard the milk and don’t give it
to your baby.

Driving and using machines
Either the symptoms of migraine or your
medicine may make you drowsy. If you
are affected, don’t drive or operate
machinery.

3 How to use Imigran
Always take Imigran exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.

When to take Imigran
• It’s best to take Imigran as soon as
you feel a migraine coming on,
although you can take it at any time
during an attack
• Don’t use Imigran to try to prevent an
attack – only use it after your migraine
symptoms start.

How much to take
Adults aged 18 to 65

• The usual dose for adults aged 18
to 65 is one Imigran 50mg tablet,
swallowed whole with water. Some
patients may need a 100mg dose –
you should follow your doctor’s advice
Children under 18

• Imigran is not recommended for
children under 18 years old.

4 Possible side effects
If your symptoms start to come
back
• You can take a second Imigran tablet
if at least 2 hours have passed since
the first tablet. Don’t take more than
300mg in total in 24 hours.

people aged over 65.

Allergic reaction: get doctor’s help
straight away

If the first tablet has no effect
• Don’t take a second tablet or any

• The signs of allergy include rash,

Very rare side effects
(affect up to 1 in 10,000 people)

• Liver function changes. If you have a
blood test to check your liver function,
tell your doctor or nurse that you are
taking Imigran.

The following side effects have occurred
but their exact frequency is not known.

other Imigran preparation for the same
attack.
Imigran can still be used for your next
attack.
If Imigran doesn’t give you any relief:

hives (itchy rash); wheezing;
swollen eyelids, face or lips;
complete collapse.
If you get any of these symptoms soon
after using Imigran:

If you take more Imigran than you
should
• Don’t take more than six 50mg

Contact your doctor for advice.

• Seizures/fits, tremors, muscle spasm,
neck stiffness

• Visual disturbances such as flickering,
reduced vision, double vision, loss of
vision, and in some cases even
permanent defects (although these
may be due to the migraine attack
itself)

Common side effects
(affect up to 1 in 10 people)

• Pain, heaviness, pressure or tightness
in the chest, throat or other parts of
the body, or unusual sensations,
including numbness, tingling and
warmth or cold. These effects may be
intense but generally pass quickly.

tablets or three 100mg tablets (that’s
300mg in total) in 24 hours.
Taking too much Imigran could make
you ill. If you have taken more than
300mg in 24 hours:

Some patients may get the following
side effects but it is not known how
often they occur

Don’t use any more. Contact a
doctor straight away.

Ask your doctor or pharmacist for
advice.

Older people (aged over 65)

• Imigran is not recommended for

Like all medicines, Imigran tablets can
cause side effects, but not everybody
gets them.

5 How to store Imigran

If these effects continue or become
severe (especially the chest pain):
Get medical help urgently. In a very
small number of people these
symptoms can be caused by a heart
attack.

If you have any further questions about
the use of this product, ask your doctor
or pharmacist.

Other common side effects include:
• Feeling sick (nausea) or being sick






(vomiting), although this may be due
to the migraine itself
Tiredness or drowsiness
Dizziness, feeling weak, or getting hot
flushes
Temporary increase in blood pressure.
Shortness of breath
Aching muscles.

• Heart problems, where your heartbeat
may go faster, slower or change rhythm,
chest pains (angina) or heart attack

• Pale, blue-tinged skin and/or pain in
your fingers, toes, ears, nose or jaw in
response to cold or stress (Raynaud’s
phenomenon)

• Feeling faint (blood pressure may go






down)
Pain in the lower left side of the
stomach and bloody diarrhoea
(ischaemic colitis)
Diarrhoea
Pain in the joints
Feeling anxious
Excessive sweating.

If you get side effects
If you notice any unwanted effects,
even ones not listed in this leaflet, or if
any of the side effects becomes
troublesome:
Tell your doctor or pharmacist.

Keep out of the sight and reach of
children.
Do not use Imigran after the expiry date
shown on the carton. The expiry date
refers to the last day of that month.
Do not store above 30ºC
Medicines should not be disposed of via
waste water 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 Imigran contains
• The active substance is sumatriptan

(100mg)
• The other ingredients in the tablets are

lactose, microcrystalline cellulose,
croscarmellose sodium, magnesium
stearate, hypromellose and titanium
dioxide (E171).
Warnings: Lactose – If you have been
told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicinal
product.

What Imigran looks like and
contents of the pack
The tablets are white or off-white, filmcoated, capsule-shaped, biconvex
tablets marked ‘GX ET2’ on one side and
plain on the reverse.
The tablets are available in a blister pack
of 2 tablets.

Manufactured by: Glaxo Operations
UK Limited, 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

Imigran® 100mg tablets
PLPI: 18799/0682

POM

There are two national
organisations that offer both
help and advice on migraine:
Migraine Action Association
Unit 6
Oakley Hay Lodge Business Park
Great Folds Road
Great Oakley
Northants
NN18 9AS
Telephone: 01536 461333
The Migraine Trust
55-56 Russell Square,
London WC1B 4HP
Telephone: 0207 436 1336
You may be able to find out more
about prescribed medicines from
books in public libraries.
Leaflet date: 27.08.2013
Imigran is a registered trademark of the
GlaxoSmithKline group of companies

Package Leaflet:
Information for the User

• Keep this leaflet. You may
need to read it again.
• If you have any further
questions, ask your doctor or
pharmacist (chemist).
• 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
gets serious, or if you notice
any side effect not listed in
this leaflet, please tell your
doctor or pharmacist.
The name of your medicine is
Sumatriptan 100mg tablets, but
will be referred to as
Sumatriptan throughout this
leaflet. Please note that the
leaflet also contains information
about other strength
Sumatriptan 50mg tablets.

In this leaflet

(sumatriptan succinate)

Sumatriptan 100mg tablets

Read all of this leaflet
carefully before you start
taking this medicine.

1 What Sumatriptan is and
what it is used for
2 Before you use
Sumatriptan
3 How to use Sumatriptan
4 Possible side effects
5 How to store Sumatriptan
6 Further information

1 What Sumatriptan is and
what it is used for
Each Sumatriptan capsule-shaped
tablet contains a single dose of
sumatriptan, which belongs to a group of
medicines called triptans (also known as
5-HT1 receptor agonists).
Sumatriptan is used to treat migraine
headache.
Migraine symptoms may be caused by
the temporary widening of blood vessels
in the head. Sumatriptan is believed to
reduce the widening of these blood
vessels. This in turn helps to take away
the headache and relieve other
symptoms of a migraine attack, such as
feeling or being sick (nausea or vomiting)
and sensitivity to light and sound.

2 Before you use Sumatriptan

Don’t use Sumatriptan:
• If you’re allergic (hypersensitive) to







sumatriptan, or any of the other
ingredients (listed in Section 6)
If you have a heart problem such as
narrowing of the arteries (ischaemic
heart disease) or chest pains (angina),
or have already had a heart attack
If you have circulation problems in
your legs that cause cramp-like pains
when you walk (peripheral vascular
disease)
If you have had a stroke or a ministroke (also called a transient
ischaemic attack or TIA)
If you have high blood pressure.
You may be able to use Sumatriptan if
your high blood pressure is mild and is
being treated

• If you have serious liver disease
• With other migraine medicines,
including those which contain
ergotamine, or similar medicines such
as methysergide maleate; or any
triptan or 5HT1 agonist (such as
naratriptan or zolmitriptan)
• With any of the following antidepressants:
• MAOIs (monoamine oxidase
inhibitors) or if you have taken an
MAOI in the last 2 weeks
• SSRIs (selective serotonin
reuptake inhibitors) including
citalopram, fluoxetine,
fluvoxamine, paroxetine and
sertraline
• SNRIs (serotonin noradrenaline
reuptake inhibitors) including
venlafaxine and duloxetine
• For children under 18 years of age.
If any of these apply to you:
Tell your doctor, and don’t use
Sumatriptan tablets.

Take special care with Sumatriptan
Your doctor needs to know certain
information before you use Sumatriptan:
If you have any extra risk factors

• If you are a heavy smoker or are
using nicotine replacement therapy,
and especially
• If you are a man aged over 40, or
• If you are a woman who has been
through the menopause.

In very rare cases, people have
developed serious heart conditions after
using Sumatriptan, even though they had
no signs of heart disease before. If any
of the points above applies to you it
could mean you have a greater risk of
developing heart disease - so:
Tell your doctor so that your heart
function can be checked before
Sumatriptan is prescribed for you.
If you have a history of fits (seizures)
Or if you have other conditions which
might make it more likely that you’ll have
a fit – for example, a head injury or
alcoholism.
If you have liver or kidney disease
If you have an intolerance to some
sugars
If any of these apply to you:
Tell your doctor so that you can be
supervised more closely.
If you are allergic to antibiotics called
sulphonamides
If so, you may also be allergic to
Sumatriptan. If you know you are allergic
to an antibiotic but you are not sure
whether it is a sulphonamide:
Tell your doctor or pharmacist
before using Sumatriptan.
If you are taking anti- depressants
called SSRIs
(Selective Serotonin Reuptake Inhibitors)
or SNRIs (Serotonin Noradrenaline
Reuptake Inhibitors)
Tell your doctor or pharmacist
before using Sumatriptan. Also see
Other medicines and Imigran, below.

If you use Sumatriptan frequently
Using Sumatriptan too often may make
your headaches worse.
Tell your doctor if this applies to
you. He or she may recommend you
stop using Sumatriptan.
If you feel pain or tightness in your
chest after you use Sumatriptan
These effects may be intense but they
usually pass quickly. If they don’t pass
quickly, or they become severe:
Get medical help immediately.
Section 4 (overleaf) has more
information about these possible side
effects.

• MAOIs used to treat depression.
Don’t use Sumatriptan if you have
taken these in the last 2 weeks
• SSRIs and SNRIs used to treat
depression. Using Sumatriptan with
these medicines can cause serotonin
syndrome (a collection of symptoms
which can include restlessness,
confusion, sweating, hallucinations,
increased reflexes, muscle spasms,
shivering, increased heartbeat and
shaking). Tell your doctor immediately
if you are affected in this way.
• St John’s Wort (Hypericum
perforatum). Taking herbal remedies
containing St John’s Wort together
with Sumatriptan may make side
effects more likely.

Other medicines and Sumatriptan

Pregnancy and breast-feeding

Tell your doctor if you’re taking any
other medicines or have recently taken
any. This includes any herbal products,
dietary supplements such as vitamins,
iron or calcium or medicines you’ve
bought without a prescription.

• If you are pregnant or could be

Some medicines must not be taken with
Sumatriptan and others may cause
adverse effects if they’re taken with
Sumatriptan. You must tell your doctor
if you are taking:

• ergotamine also used to treat
migraine, or similar medicines such
as methysergide maleate; or any
triptan or 5-HT1 agonist (such as
naratriptan or zolmitriptan). Don’t use
Sumatriptan at the same time as these
medicines. Stop taking these
medicines at least 24 hours before
using Sumatriptan. Don’t take them
again for at least 6 hours after using
Sumatriptan

pregnant, talk to your doctor before
you use Sumatriptan. There is only
limited information about the safety of
Sumatriptan for pregnant women,
though up till now there is no evidence
of any increased risk of birth defects.
Your doctor will discuss with you
whether or not you should use
Sumatriptan while you are pregnant
• Don’t breast-feed your baby for 12
hours after using Sumatriptan. If
you express any breast milk during
this time, discard the milk and don’t
give it to your baby.

Driving and using machines
Either the symptoms of migraine or your
medicine may make you drowsy. If you
are affected, don’t drive or operate
machinery.

3 How to use Sumatriptan
Always take Sumatriptan exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.

When to take Sumatriptan
• It’s best to take Sumatriptan as soon
as you feel a migraine coming on,
although you can take it at any time
during an attack
• Don’t use Sumatriptan to try to
prevent an attack – only use it after
your migraine symptoms start.

How much to take
Adults aged 18 to 65

• The usual dose for adults aged 18
to 65 is one Sumatriptan50mg tablet,
swallowed whole with water. Some
patients may need a 100mg dose –
you should follow your doctor’s advice
Children under 18

• Sumatriptan is not recommended for
children under 18 years old.
Older people (aged over 65)

• Sumatriptan is not recommended for
people aged over 65.

4 Possible side effects
If your symptoms start to come
back
• You can take a second Sumatriptan
tablet if at least 2 hours have passed
since the first tablet. Don’t take more
than 300mg in total in 24 hours.

Like all medicines, Sumatriptan tablets
can cause side effects, but not
everybody gets them.
Allergic reaction: get doctor’s help
straight away

If the first tablet has no effect

• The signs of allergy include rash,

Very rare side effects
(affect up to 1 in 10,000 people)

• Liver function changes. If you have a
blood test to check your liver function,
tell your doctor or nurse that you are
taking Sumatriptan.

The following side effects have occurred
but their exact frequency is not known.

• Don’t take a second tablet or any

5 How to store Sumatriptan

other Sumatriptan preparation for the
same attack.
Sumatriptan can still be used for your
next attack.
If Sumatriptan doesn’t give you any
relief:
Ask your doctor or pharmacist for
advice.

If you take more Sumatriptan than
you should

hives (itchy rash); wheezing;
swollen eyelids, face or lips;
complete collapse.
If you get any of these symptoms soon
after using Sumatriptan:

• Seizures/fits, tremors, muscle spasm,
neck stiffness

• Visual disturbances such as flickering,
reduced vision, double vision, loss of
vision, and in some cases even
permanent defects (although these
may be due to the migraine attack
itself)

Don’t use any more. Contact a
doctor straight away.

Common side effects
(affect up to 1 in 10 people)

• Pain, heaviness, pressure or tightness
in the chest, throat or other parts of
the body, or unusual sensations,
including numbness, tingling and
warmth or cold. These effects may be
intense but generally pass quickly.

• Don’t take more than six 50mg
tablets or three 100mg tablets (that’s
300mg in total) in 24 hours.
Taking too much Sumatriptan could
make you ill. If you have taken more than
300mg in 24 hours:

Some patients may get the following
side effects but it is not known how
often they occur

If these effects continue or become
severe (especially the chest pain):
Get medical help urgently. In a very
small number of people these
symptoms can be caused by a heart
attack.

Contact your doctor for advice.
If you have any further questions about
the use of this product, ask your doctor
or pharmacist.

Other common side effects include:
• Feeling sick (nausea) or being sick






(vomiting), although this may be due
to the migraine itself
Tiredness or drowsiness
Dizziness, feeling weak, or getting hot
flushes
Temporary increase in blood pressure.
Shortness of breath
Aching muscles.

• Heart problems, where your heartbeat
may go faster, slower or change rhythm,
chest pains (angina) or heart attack

• Pale, blue-tinged skin and/or pain in
your fingers, toes, ears, nose or jaw in
response to cold or stress (Raynaud’s
phenomenon)

• Feeling faint (blood pressure may go






down)
Pain in the lower left side of the
stomach and bloody diarrhoea
(ischaemic colitis)
Diarrhoea
Pain in the joints
Feeling anxious
Excessive sweating.

If you get side effects
If you notice any unwanted effects,
even ones not listed in this leaflet, or if
any of the side effects becomes
troublesome:
Tell your doctor or pharmacist.

Keep out of the sight and reach of
children.
Do not use Sumatriptan after the expiry
date shown on the carton. The expiry
date refers to the last day of that month.
Do not store above 30ºC
Medicines should not be disposed of via
waste water 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 Sumatriptan contains
• The active substance is sumatriptan

(100mg)
• The other ingredients in the tablets

are lactose, microcrystalline cellulose,
croscarmellose sodium, magnesium
stearate, hypromellose and titanium
dioxide (E171).
Warnings: Lactose – If you have been
told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicinal
product.

What Sumatriptan looks like and
contents of the pack
The tablets are white or off-white, filmcoated, capsule-shaped, biconvex
tablets marked ‘GX ET2’ on one side and
plain on the reverse.
The tablets are available in a blister pack
of 2 tablets.

Manufactured by: Glaxo Operations
UK Limited, 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

Sumatriptan 100mg tablets
PLPI: 18799/0682

POM

There are two national
organisations that offer both
help and advice on migraine:
Migraine Action Association
Unit 6
Oakley Hay Lodge Business Park
Great Folds Road
Great Oakley
Northants
NN18 9AS
Telephone: 01536 461333
The Migraine Trust
55-56 Russell Square,
London WC1B 4HP
Telephone: 0207 436 1336
You may be able to find out more
about prescribed medicines from
books in public libraries.
Leaflet date: 27.08.2013

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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