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PIZOTIFEN 0.5MG TABLETS

Active substance(s): PIZOTIFEN HYDROGEN MALATE

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Sanomigran® 0.5mg Tablets
(pizotifen hydrogen malate)
Patient Information Leaflet
This medicine will usually be referred to just as
Sanomigran in this leaflet.

What you need to know about
Sanomigran
Your doctor has decided that you need this
medicine to help treat your condition.

Please read this leaflet carefully before
you start to take your medicine. It
contains important information.
Keep the leaflet in a safe place because you may
want to read it again.
If you have any other questions, or if there is
something you don’t understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never
give it to someone else. It may not be the right
medicine for them even if their symptoms seem to
be the same as yours.
If any of the side effects gets 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 Sanomigran 0.5mg
Tablets but will be referred to as Sanomigran
throughout this leaflet. Please note that this leaflet
also contains information about the other strength:
Sanomigran 1.5mg tablets.

In this leaflet:
1. What Sanomigran is and what it is used for
2. Things to consider before you start to take
Sanomigran
3. How to take Sanomigran
4. Possible side effects
5. How to store Sanomigran
6. Further information

1. What Sanomigran is and what it is
used for
Sanomigran is available in two different strengths
containing either 0.5mg or 1.5mg of the active
ingredient, pizotifen hydrogen malate.
Sanomigran is a migraine treatment.
They may help to stop the effects of certain
naturally occurring substances in your body called
‘serotonin’, ‘histamine’ and ‘tryptamine’ which is
involved in causing some kinds of headache,
including migraine.

Sanomigran has been prescribed for you by your
doctor to help your migraine type headaches. If it
is taken regularly it can help to prevent headaches
or reduce the pain of cluster headaches, common
and classical migraine. Sanomigran can stop
some migraine attacks starting and help make
other attacks less severe.
They will not stop migraine attacks once they have
started.

2. Things to consider before you
start to take Sanomigran
Some people MUST NOT take
Sanomigran.
Talk to your doctor if:

Are you taking other medicines?
Remind your doctor if you are taking drugs
called alpha-or beta-blockers because
Sanomigran may affect the way they work.
Anything that makes you sleepy may make
you even sleepier if you are taking
Sanomigran as well. This includes sleeping
pills, sedatives and antihistamines such as
cold and hayfever medicines. It also includes
alcohol. It is best not to drink alcohol while you
are taking Sanomigran.
Always tell your doctor about all the medicines you
are taking. This means medicines you have
bought yourself as well as medicines on
prescription from your doctor.

you think you may be allergic to pizotifen
hydrogen malate or to any of the other
ingredients of Sanomigran. (These are listed
at the end of the leaflet).
you are breast-feeding.
Sanomigran should not be given to children aged
under 2.

Will there be any problems with driving or
using machinery?

You should also ask yourself these
questions before taking Sanomigran:

3. How to take Sanomigran

Do you have glaucoma (raised pressure in
your eyes)?
Do you ever have problems passing urine?
Do you have kidney problems, especially
kidney failure? (The medical term for this is
renal failure.)
Do you have liver problems? Sanomigran has
been associated with abnormal results of liver
function tests and possibly liver problems in a
few patients. You may not notice any
symptoms but if you notice yellowing of your
skin or the whites of your eyes, abnormal
darkening of the urine or unexplained nausea,
vomiting and tiredness, tell your doctor
straightaway. Your doctor may request blood
tests to check and to monitor your liver
function and may request that you stop the
treatment if your liver problem is serious.
Do you have epilepsy?
Are you pregnant?
Do you have an intolerance to some sugars?
(The tablets contain a small amount of lactose
and sucrose.)
If the answer to any of these questions is YES, tell
your doctor or pharmacist because Sanomigran
might not be the right medicine for you.

Some people may feel drowsy and/or dizzy while
they are taking Sanomigran. If this happens, you
should not drive or do anything that requires you
to be alert (such as operate tools or machinery)
until such problems clear.

The doctor will decide what dose of Sanomigran
you should take. Always take the tablets exactly
as your doctor has told you to. The dose will be on
the pharmacist’s label. Check the label carefully. It
should tell you how many tablets to take, and how
often. If you are not sure, ask your doctor or
pharmacist. Keep taking the tablets for as long as
you have been told unless you have any
problems. In that case, check with your doctor.
With Sanomigran, you do not wait for a migraine
and then treat the pain. You take it regularly to
stop your migraines even beginning or to make
them less severe.

Adults
The usual dose is 1.5mg of pizotifen each day.
This is one 1.5mg tablet or three 0.5mg
tablets. You may have been told to take your
tablets once a day or as three smaller doses.
Do not take more than 3mg in a single dose
(two 1.5mg tablets or six 0.5mg tablets). Do
not take more than 4.5mg (three 1.5mg tablets
or nine 0.5mg tablets) in a day.

Children (aged over 2 years)
Children can take up to 1.5mg of pizotifen
each day. This is three 0.5mg tablets. This is
usually best given in two or three smaller
doses.

Do not use the 1.5mg tablets for children. Do
not give them more than 1mg in a single dose.
This is two 0.5mg tablets.
For children over 2 who find it difficult to take
tablets Sanomigran is also available as an elixir
(syrup).

Sanomigran and Elixir should not be
given to children under 2 years of age.
Taking Sanomigran
Swallow the tablets whole. Have a drink with
them if this helps you to swallow.
If you take Sanomigran once a day, take them
in the evening a few hours before you go to
bed as any drowsiness will help you to sleep.
If you take your tablets in two or three doses,
spread them evenly through the day.
Carry on taking your Sanomigran even when you
feel well. Your headaches may come back if you
stop taking them. Do not stop taking them
suddenly, or you may experience withdrawal
symptoms, such as feeling anxious, shaking,
insomnia, feeling sick and blackouts. Talk to your
doctor if you want to stop taking your tablets.

What if you forget to take a dose?
If you forget to take your tablets, do not worry. If
you normally take Sanomigran several times a day
you should take the last dose you missed as soon
as you remember. Do not take it if there is less
than 4 hours before your next dose, but go back to
your regular dosing schedule. Do not double
doses or take more than your maximum daily
dose.
If you normally take one tablet each day take the
dose as soon as you remember. Take your next
dose as usual. Do not take more than your
maximum daily dose.
Tell your doctor if you keep forgetting to take your
tablets.

What if you take too many tablets?
All tablets can be risky if you take too many. If you
take too many Sanomigran at once, tell your
doctor or hospital casualty department as soon as
possible. Take your medicine pack with you so
that people can see what you have taken.

If you stop taking Sanomigran

Frequency: not known:

Manufactured by:

Do not change or stop the treatment without first
asking your doctor. Your doctor may want you to
reduce the dosage gradually before stopping
completely. This is to prevent any worsening of
your condition and reduce the risk of withdrawal
symptoms such as depression, trembling, nausea,
anxiety, generally feeling unwell, dizziness, sleep
disorder and weight loss.

If you have signs of yellowing of your skin or the
whites of your eyes, abnormal darkening of the
urine or unexplained nausea, vomiting and
tiredness (signs of jaundice or hepatitis).
Muscle cramps.

Novartis Pharmaceuticals UK Limited Wimblehurst
Road, Horsham, West Sussex, RH12 5AB,
England

4. Possible side effects
Sanomigran is suitable for most people, but, like
all medicines, they can sometimes cause side
effects.

Some side effects can be serious
Stop taking the tablets and tell your
doctor immediately if you notice any of
the following rare symptoms:
Symptoms of allergy such as a rash, itching or
hives on the skin or swelling of the face.

The side effects listed below have also
been reported:
More than 1 in 10 people have
experienced:
Increase in appetite and weight gain. An increase
in appetite may lead to an increase in bodyweight.
If you feel hungrier than usual, try to fill up on
fresh low calorie foods. These are much healthier
than processed high calorie foods. Your doctor
can give you advice about diet as some kinds of
foods are known to trigger migraine.

If any of the symptoms become troublesome,
or if you notice anything else not mentioned
here, please go and see your doctor. He/she
may want to give you a different medicine.

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 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 Sanomigran
Keep out of the sight and reach of children.
Do not use after the expiry date which is
stated on the carton after ‘Exp’. The expiry
date refers to the last day of that month.
Keep the blister strips in the outer carton in
order to protect from light. Only remove them
when it is time to take your medicine.
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.

Up to 1 in 10 people have experienced:

6. Further information

Drowsiness, tiredness, dizziness, dry mouth,
nausea. Feeling drowsy is not usually a problem
as you can take the tablets in the evening. The
effect of making you drowsy will help you to sleep.
You are less likely to feel drowsy after a few
weeks, as you get used to the tablets.

What Sanomigran contains

Up to 1 in 100 people have experienced:
Constipation.

Up to 1 in 1,000 people have experienced:
Depression, excitability or restlessness,
hallucinations (seeing, hearing or feeling things
that are not there), sleep disturbances, insomnia,
anxiety, tingling or numbness of the hands or feet,
muscle or joint pain.

Very rarely (less than 1 in 10,000) people
have experienced:
Convulsions (fits). Tell your doctor immediately if
you have a fit.

Each tablet contains 0.725mg pizotifen
hydrogen malate equivalent to 0.5mg
pizotifen.
The other ingredients are:
tablet core - lactose monohydrate,
maize starch, povidone, magnesium
stearate, talc
tablet coating - acacia gum, talc,
sucrose, colloidal anhydrous silica,
carnauba wax, printing ink and colouring
agents titanium dioxide (E171) and
yellow iron oxide (E172).

What Sanomigran looks like and contents
of the pack
Sanomigran is small ivory to yellow tablets
marked ‘SMG’ on one face.
Sanomigran comes in blister packs containing
60 tablets.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
®

Sanomigran 0.5mg Tablets
PL No: 18799/2390

POM

Leaflet date: 26.06.2015
Sanomigran is a registered trademark of Novartis.

Pizotifen 0.5mg Tablets
(pizotifen hydrogen malate)
Patient Information Leaflet
This medicine will usually be referred to just as
Pizotifen in this leaflet.

If it is taken regularly it can help to prevent
headaches or reduce the pain of cluster
headaches, common and classical migraine.
Pizotifen can stop some migraine attacks starting
and help make other attacks less severe.
They will not stop migraine attacks once they have
started.

What you need to know about Pizotifen
Your doctor has decided that you need this
medicine to help treat your condition.

2. Things to consider before you
start to take Pizotifen

Please read this leaflet carefully before
you start to take your medicine. It
contains important information.

Some people MUST NOT take Pizotifen.
Talk to your doctor if:

Keep the leaflet in a safe place because you may
want to read it again.
If you have any other questions, or if there is
something you don’t understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never
give it to someone else. It may not be the right
medicine for them even if their symptoms seem to
be the same as yours.
If any of the side effects gets 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 Pizotifen 0.5mg
Tablets but will be referred to as Pizotifen
throughout this leaflet. Please note that this leaflet
also contains information about the other strength:
Pizotifen 1.5mg tablets.

In this leaflet:
1. What Pizotifen is and what it is used for
2. Things to consider before you start to take
Pizotifen
3. How to take Pizotifen
4. Possible side effects
5. How to store Pizotifen
6. Further information

1. What Pizotifen is and what it is
used for
Pizotifen is available in two different strengths
containing either 0.5mg or 1.5mg of the active
ingredient, Pizotifen hydrogen malate.
Pizotifen is a migraine treatment.
They may help to stop the effects of certain
naturally occurring substances in your body called
‘serotonin’, ‘histamine’ and ‘tryptamine’ which is
involved in causing some kinds of headache,
including migraine.
Pizotifen have been prescribed for you by your
doctor to help your migraine type headaches.

you think you may be allergic to Pizotifen
hydrogen malate or to any of the other
ingredients of Pizotifen. (These are listed at
the end of the leaflet).
you are breast-feeding.
Pizotifen should not be given to children aged
under 2.

You should also ask yourself these
questions before taking Pizotifen:
Do you have glaucoma (raised pressure in
your eyes)?
Do you ever have problems passing urine?
Do you have kidney problems, especially
kidney failure? (The medical term for this is
renal failure.)
Do you have liver problems? Pizotifen has
been associated with abnormal results of liver
function tests and possibly liver problems in a
few patients. You may not notice any
symptoms but if you notice yellowing of your
skin or the whites of your eyes, abnormal
darkening of the urine or unexplained nausea,
vomiting and tiredness, tell your doctor
straightaway. Your doctor may request blood
tests to check and to monitor your liver
function and may request that you stop the
treatment if your liver problem is serious.
Do you have epilepsy?
Are you pregnant?
Do you have an intolerance to some sugars?
(The tablets contain a small amount of lactose
and sucrose.)
If the answer to any of these questions is YES, tell
your doctor or pharmacist because Pizotifen might
not be the right medicine for you.

Are you taking other medicines?
Remind your doctor if you are taking drugs
called alpha-or beta-blockers because
Pizotifen may affect the way they work.
Anything that makes you sleepy may make
you even sleepier if you are taking Pizotifen as
well. This includes sleeping pills, sedatives
and antihistamines such as cold and hayfever
medicines. It also includes alcohol. It is best
not to drink alcohol while you are taking
Pizotifen.
Always tell your doctor about all the medicines you
are taking. This means medicines you have
bought yourself as well as medicines on
prescription from your doctor.

Will there be any problems with driving or
using machinery?
Some people may feel drowsy and/or dizzy while
they are taking Pizotifen. If this happens, you
should not drive or do anything that requires you
to be alert (such as operate tools or machinery)
until such problems clear.

3. How to take Pizotifen
The doctor will decide what dose of Pizotifen you
should take. Always take the tablets exactly as
your doctor has told you to. The dose will be on
the pharmacist’s label. Check the label carefully. It
should tell you how many tablets to take, and how
often. If you are not sure, ask your doctor or
pharmacist. Keep taking the tablets for as long as
you have been told unless you have any
problems. In that case, check with your doctor.
With Pizotifen, you do not wait for a migraine and
then treat the pain. You take it regularly to stop
your migraines even beginning or to make them
less severe.

Adults
The usual dose is 1.5mg of Pizotifen each
day. This is one 1.5mg tablet or three 0.5mg
tablets. You may have been told to take your
tablets once a day or as three smaller doses.
Do not take more than 3mg in a single dose
(two 1.5mg tablets or six 0.5mg tablets). Do
not take more than 4.5mg (three 1.5mg tablets
or nine 0.5mg tablets) in a day.

Children (aged over 2 years)
Children can take up to 1.5mg of Pizotifen
each day. This is three 0.5mg tablets. This is
usually best given in two or three smaller
doses.

Do not use the 1.5mg tablets for children. Do
not give them more than 1mg in a single dose.
This is two 0.5mg tablets.
For children over 2 who find it difficult to take
tablets Pizotifen is also available as an elixir
(syrup).

Pizotifen and Elixir should not be given to
children under 2 years of age.
Taking Pizotifen
Swallow the tablets whole. Have a drink with
them if this helps you to swallow.
If you take Pizotifen once a day, take them in
the evening a few hours before you go to bed
as any drowsiness will help you to sleep.
If you take your tablets in two or three doses,
spread them evenly through the day.
Carry on taking your Pizotifen even when you feel
well. Your headaches may come back if you stop
taking them. Do not stop taking them suddenly, or
you may experience withdrawal symptoms, such
as feeling anxious, shaking, insomnia, feeling sick
and blackouts. Talk to your doctor if you want to
stop taking your tablets.

What if you forget to take a dose?
If you forget to take your tablets, do not worry. If
you normally take Pizotifen several times a day
you should take the last dose you missed as soon
as you remember. Do not take it if there is less
than 4 hours before your next dose, but go back to
your regular dosing schedule. Do not double
doses or take more than your maximum daily
dose.
If you normally take one tablet each day take the
dose as soon as you remember. Take your next
dose as usual. Do not take more than your
maximum daily dose.
Tell your doctor if you keep forgetting to take your
tablets.

What if you take too many tablets?
All tablets can be risky if you take too many. If you
take too many Pizotifen at once, tell your doctor or
hospital casualty department as soon as possible.
Take your medicine pack with you so that people
can see what you have taken.

If you stop taking Pizotifen

Frequency: not known:

Manufactured by:

Do not change or stop the treatment without first
asking your doctor. Your doctor may want you to
reduce the dosage gradually before stopping
completely. This is to prevent any worsening of
your condition and reduce the risk of withdrawal
symptoms such as depression, trembling, nausea,
anxiety, generally feeling unwell, dizziness, sleep
disorder and weight loss.

If you have signs of yellowing of your skin or the
whites of your eyes, abnormal darkening of the
urine or unexplained nausea, vomiting and
tiredness (signs of jaundice or hepatitis).
Muscle cramps.

Novartis Pharmaceuticals UK Limited Wimblehurst
Road, Horsham, West Sussex, RH12 5AB,
England.

4. Possible side effects
Pizotifen are suitable for most people, but, like all
medicines, they can sometimes cause side
effects.

Some side effects can be serious
Stop taking the tablets and tell your
doctor immediately if you notice any of
the following rare symptoms:
Symptoms of allergy such as a rash, itching
or hives on the skin or swelling of the face.

The side effects listed below have also
been reported:
More than 1 in 10 people have
experienced:
Increase in appetite and weight gain. An increase
in appetite may lead to an increase in bodyweight.
If you feel hungrier than usual, try to fill up on
fresh low calorie foods. These are much healthier
than processed high calorie foods. Your doctor
can give you advice about diet as some kinds of
foods are known to trigger migraine.

If any of the symptoms become troublesome,
or if you notice anything else not mentioned
here, please go and see your doctor. He/she
may want to give you a different medicine.

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 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 Pizotifen
Keep out of the sight and reach of children.
Do not use after the expiry date which is
stated on the carton after ‘Exp’. The expiry
date refers to the last day of that month.
Keep the blister strips in the outer carton in
order to protect from light. Only remove them
when it is time to take your medicine.
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.

Up to 1 in 10 people have experienced:

6. Further information

Drowsiness, tiredness, dizziness, dry mouth,
nausea. Feeling drowsy is not usually a problem
as you can take the tablets in the evening. The
effect of making you drowsy will help you to sleep.
You are less likely to feel drowsy after a few
weeks, as you get used to the tablets.

What Pizotifen contains

Up to 1 in 100 people have experienced:
Constipation.

Up to 1 in 1,000 people have experienced:
Depression, excitability or restlessness,
hallucinations (seeing, hearing or feeling things
that are not there), sleep disturbances, insomnia,
anxiety, tingling or numbness of the hands or feet,
muscle or joint pain.

Very rarely (less than 1 in 10,000) people
have experienced:
Convulsions (fits). Tell your doctor immediately if
you have a fit.

Each tablet contains 0.725mg Pizotifen
hydrogen malate equivalent to 0.5mg
Pizotifen.
The other ingredients are:
tablet core - lactose monohydrate,
maize starch, povidone, magnesium
stearate, talc
tablet coating - acacia gum, talc,
sucrose, colloidal anhydrous silica,
carnauba wax, printing ink and colouring
agents titanium dioxide (E171) and
yellow iron oxide (E172).

What Pizotifen looks like and contents of
the pack
Pizotifen is small ivory to yellow tablets
marked ‘SMG’ on one face.
Pizotifen comes in blister packs containing
60 tablets

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK

Pizotifen 0.5mg Tablets
PL No: 18799/2390
Leaflet date: 26.06.2015

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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