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IMIGRAN 50MG TABLETS

Active substance(s): SUMATRIPTAN / SUMATRIPTAN SUCCINATE

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Package Leaflet:
Information for the User
50mg tablets
(sumatriptan succinate)

Imigran®

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.
The name of your medicine is
Imigran 50mg tablets, but will
be referred to as Imigran
throughout this leaflet. Please
note that the leaflet also
contains information about other
strength Imigran 100mg tablets.

What is in this leaflet
1
2
3
4
5
6

What Imigran is and what
it is used for
What you need to know
before you use Imigran
How to use Imigran
Possible side effects
How to store Imigran
Contents of the pack and
other information

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 What you need to know
before you use Imigran
Don’t use Imigran:
If you’re allergic to sumatriptan, or
any of the other ingredients of this
medicine (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
mini-stroke (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
Talk to your doctor or pharmacist before
using Imigran.
If you have any extra risk factors
If you are a heavy smoker, or
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:
Tell your doctor so that you can be
supervised more closely.
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 or pharmacist if
you’re taking, have recently taken or
might take any other medicines. This
includes any herbal products 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 (see section 2 Don’t
use Imigran). 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 any medicines which contain
ergotamine or compounds similar to
ergotamine again for at least 6 hours
after using Imigran.
other triptans/5-HT1 receptor
agonists (such as naratriptan,
rizatriptan, zolmitriptan), also used to
treat migraine, (see section 2 Don’t
use Imigran). 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 another triptan/5-HT1 receptor
agonist again for at least 24 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
that contain St John’s Wort together
with Imigran may make side effects
more likely.

Pregnancy and breast-feeding
If you are pregnant, think you may
be pregnant or are planning to
have a baby, ask your doctor for
advice before taking this medicine.
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 this medicine 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.

5 How to store Imigran
If you take more Imigran than you
should

If these effects continue or become
severe (especially the chest pain):

Don’t take more than six 50mg
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:
Contact your doctor for advice.
If you have any further questions about
the use of this medicine, ask your doctor
or pharmacist.

 Get medical help urgently. In a very
small number of people these
symptoms can be caused by a heart
attack.

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.
Older people (aged over 65)
Imigran is not recommended for
people aged over 65.

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.

If the first tablet has no effect
Don’t take a second tablet or any
other Imigran preparation for the
same attack. Imigran can still be
used for your next attack.
If Imigran doesn’t give you any relief:
Ask your doctor or pharmacist for
advice.

4 Possible side effects
Like all medicines, this medicine can
cause side effects, but not everybody
gets them. Some symptoms may be
caused by the migraine itself.
Allergic reaction: get doctor’s help
straight away
The following side effects have occurred
but their exact frequency is not known.
The signs of allergy include rash,
hives (itchy rash); wheezing;
swollen eyelids, face or lips;
complete collapse.
If you get any of these symptoms soon
after using Imigran:
 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.

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.

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

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 Contents of the pack and
other information
What Imigran contains
The active substance is sumatriptan
(50mg)
The other ingredients in the tablets
are lactose anhydrous, lactose
monohydrate, microcrystalline
cellulose, sodium croscarmellose,
magnesium stearate, hypromellose,
titanium dioxide (E171), red iron
oxide (E172) and triacetin.

What Imigran looks like and
contents of the pack
Imigran 50mg Tablets are pink, filmcoated, capsule shaped tablets, plain on
one face and engraved ‘50’ on the other
face. IMIGRAN is available in pack sizes
of 4 tablets in a blister strip.

Manufactured by: Glaxo Wellcome
S.A., Avda.de Extramadura, 3, 09400
Aranda de Duero, Burgos, Spain
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® 50mg tablets
PLPI: 18799/0240

POM

Leaflet date: 09.07.2014
Imigran is a registered trademark of the
GlaxoSmithKline group of companies

Package Leaflet:
Information for the User

The name of your medicine is
Sumatriptan 50mg tablets, but
will be referred to as
Sumatriptan throughout this
leaflet. Please note that the
leaflet also contains information
about other strength
Sumatriptan 100mg tablets.

(Sumatriptan succinate)

Sumatriptan ® 50mg tablets

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.

What is in this leaflet
1
2
3
4
5
6

What Imigran is and what
it is used for
What you need to know
before you use Imigran
How to use Imigran
Possible side effects
How to store Imigran
Contents of the pack and
other information

1

agonist again for at least 24 hours
after using Sumatriptan .

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 What you need to know
before you use Sumatriptan
Don’t use Sumatriptan:
If you’re allergic to Sumatriptan, or
any of the other ingredients of this
medicine (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
mini-stroke (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
Talk to your doctor or pharmacist before
using Sumatriptan.
If you have any extra risk factors
If you are a heavy smoker, or
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:
Tell your doctor so that you can be
supervised more closely.
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 Sumatriptan,
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.

Other medicines and Sumatriptan
Tell your doctor or pharmacist if
you’re taking, have recently taken or
might take any other medicines. This
includes any herbal products or
medicines you’ve bought without a
prescription.
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 (see section 2 Don’t
use Sumatriptan). 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 any
medicines which contain ergotamine
or compounds similar to ergotamine
again for at least 6 hours after using
Sumatriptan.
other triptans/5-HT1 receptor
agonists (such as naratriptan,
rizatriptan, zolmitriptan), also used to
treat migraine, (see section 2 Don’t
use Sumatriptan ). 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
another triptan/5-HT1 receptor

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
that contain St John’s Wort together
with Sumatriptan may make side
effects more likely.

Pregnancy and breast-feeding
If you are pregnant, think you may
be pregnant or are planning to
have a baby, ask your doctor for
advice before taking this medicine.
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 this medicine 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.

5 How to store Sumatriptan
If you take more Sumatriptan than
you should

If these effects continue or become
severe (especially the chest pain):

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

 Get medical help urgently. In a very
small number of people these
symptoms can be caused by a heart
attack.

How much to take
Adults aged 18 to 65
The usual dose for adults aged 18
to 65 is one Sumatriptan 50mg
tablet, swallowed whole with water.
Some patients may need a 100mg
dose – you should follow your
doctor’s advice.
Children under 1
Sumatriptan is not recommended
for children under 18 years old.
Older people (aged over 65)
Sumatriptan is not recommended
for people aged over 65.

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.

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

4 Possible side effects
Like all medicines, this medicine can
cause side effects, but not everybody
gets them. Some symptoms may be
caused by the migraine itself.
Allergic reaction: get doctor’s help
straight away
The following side effects have occurred
but their exact frequency is not known.
The signs of allergy include rash,
hives (itchy rash); wheezing;
swollen eyelids, face or lips;
complete collapse.
If you get any of these symptoms soon
after using Sumatriptan:
 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.

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.

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

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 Contents of the pack and
other information
What Sumatriptan contains
The active substance is Sumatriptan
(50mg)
The other ingredients in the tablets
are lactose anhydrous, lactose
monohydrate, microcrystalline
cellulose, sodium croscarmellose,
magnesium stearate, hypromellose,
titanium dioxide (E171), red iron
oxide (E172) and triacetin.

What Sumatriptan looks like and
contents of the pack
Sumatriptan 50mg Tablets are pink, filmcoated, capsule shaped tablets, plain on
one face and engraved ‘50’ on the other
face. Sumatriptan is available in pack
sizes of 4 tablets in a blister strip.

Manufactured by: Glaxo Wellcome
S.A., Avda.de Extramadura, 3, 09400
Aranda de Duero, Burgos, Spain
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 50mg tablets
PLPI: 18799/0240
Leaflet date: 09.07.2014

POM

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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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