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SANOMIGRAN 1.5MG TABLETS

Active substance(s): PIZOTIFEN HYDROGEN MALATE

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Ref: 1481/270515/1/F

Sanomigran 1.5mg Tablets
®

(pizotifen hydrogen malate)
Patient Information Leaflet
What you need to know about Sanomigran Tablets
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 under
stand, 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.
Your medicine is called Sanomigran 1.5mg Tablets, but will be referred to as
Sanomigran Tablets throughout the leaflet. Please note that the leaflet also
contains information about other strengths of the medicine, Sanomigran
0.5mg Tablets
In this leaflet:
1

What Sanomigran Tablets are and what they are used for

2

Things to consider before you start to take Sanomigran Tablets

3

How to take Sanomigran Tablets

4

Possible side effects

5

How to store Sanomigran Tablets

6

Further information

1

What Sanomigran Tablets are and what they are
used for

Sanomigran Tablets are available in two different strengths containing either
0.5 mg or 1.5 mg of the active ingredient, pizotifen.
Sanomigran Tablets are a migraine treatment. They may help to stop the
effects of certain naturally occuring substances in your body called
“serotonin”, “histamine” and “tryptamine” which are involved in causing some
kinds of headache, including migraine.
Sanomigran Tablets have been prescribed for you by your doctor to help
your migraine type headaches. If they are taken regularly they can help to
prevent headaches or reduce the pain of cluster headaches, common and
classical migraine. Sanomigran Tablets can stop some migraine attacks
starting and help make other attacks less severe. They will not stop migraine
attacks once they have started.

* 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 Tablets 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 Sanomigran Tablets may affect the way they work.
Anything that makes you sleepy may make you even sleepier if you are
taking Sanomigran Tablets 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
Tablets.

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
Sanomigran Tablets. 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 Sanomigran Tablets

The doctor will decide what dose of Sanomigran Tablets 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 Tablets, 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 1.5 mg of pizotifen each day. This is one 1.5 mg tablet
or three 0.5 mg tablets. You may have been told to take your tablets once
a day or as three smaller doses.
* Do not take more than 3 mg in a single dose (two 1.5 mg tablets or six
0.5mg tablets). Do not take more than 4.5 mg (three 1.5 mg tablets or
nine 0.5 mg tablets) in a day.
Children (aged over 2 years)

* Children can take up to 1.5 mg of pizotifen each day. This is three 0.5 mg
2

Things to consider before you start to take
Sanomigran Tablets

Some people MUST NOT take Sanomigran Tablets.
Talk to your doctor if:
* you think you may be allergic to pizotifen or to any of the other ingredients
of Sanomigran Tablets. (These are listed at the end of the leaflet).
* you are breast-feeding.
Sanomigran Tablets should not be given to children aged under 2.
You should also ask yourself these questions before taking
Sanomigran Tablets:
* 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 straight
away. 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.

tablets. This is usually best given in two or three smaller doses.

* Do not use the 1.5 mg tablets for children. Do not give them more than
1 mg in a single dose. This is two 0.5 mg tablets.

For children over 2 who find it difficult to take tablets Sanomigran is also
available as an elixir (syrup).
Sanomigran Tablets and Elixir should not be given to children under 2
years of age.
Taking Sanomigran Tablets

* Swallow the tablets whole. Have a drink with them if this helps you to
swallow.

* If you take Sanomigran Tablets 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 Tablets 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.

Ref: 1481/270515/1/B

Sanomigran 1.5mg Tablets
®

(pizotifen hydrogen malate)
Patient Information Leaflet (continued)
What if you forget to take a dose?
If you forget to take your tablets, do not worry. If you normally take
Sanomigran Tablets 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 Tablets 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 Tablets
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.

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

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Keep the blister strips in the outer carton to protect from light.
* Do not take Sanomigran Tablets after the expiry date shown on the blister,

*
*

carton or carton label. If your doctor tells you to stop using this medicine,
take any remaining medicine back to the pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
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.

6
4

Possible side effects

Sanomigran Tablets 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.
Up to 1 in 10 people have experienced:
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.
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.
Frequency: not known:
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.
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.

How to store Sanomigran Tablets

Further information

What this medicine contains:
Each tablet contains 2.175mg of pizotifen hydrogen malate.
The other ingredients: lactose monohydrate, maize starch, povidone,
magnesium stearate, talc, acacia gum, sucrose, colloidal anhydrous silica,
carnauba wax, titanium dioxide (E171) ,yellow iron oxide (E172) and printing
ink.
What this medicine looks like and contents of the pack
Sanomigran are ivory coloured tablets printed SMG 1.5 on one side and
plain on the reverse.
They come in blister calendar packs of 28.
Manufacturer and Licence Holder
This medicine is manufactured by Novartis Pharmaceuticals UK Limited,
Wimblehurst Road, Horsham, West Sussex, RH12 5AB and is procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1481

Sanomigram 1.5mg Tablets

Sanomigran is a registered trademark of Novartis AG.
Revision date: 27/05/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1481/270515/2/F

Pizotifen 1.5mg Tablets
(pizotifen hydrogen malate)
Patient Information Leaflet
What you need to know about Pizotifen Tablets
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 under
stand, 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.
Your medicine is called Pizotifen 1.5mg Tablets, but will be referred to as
Pizotifen Tablets throughout the leaflet. Please note that the leaflet also
contains information about other strengths of the medicine,
Pizotifen 0.5mg Tablets
In this leaflet:
1

What Pizotifen Tablets are and what they are used for

2

Things to consider before you start to take Pizotifen Tablets

3

How to take Pizotifen Tablets

4

Possible side effects

5

How to store Pizotifen Tablets

6

Further information

1

What Pizotifen Tablets are and what they are
used for

Pizotifen Tablets are available in two different strengths containing either
0.5 mg or 1.5 mg of the active ingredient, pizotifen.
Pizotifen Tablets are a migraine treatment. They may help to stop the effects
of certain naturally occuring substances in your body called “serotonin”,
“histamine” and “tryptamine” which are involved in causing some kinds of
headache, including migraine.
Pizotifen Tablets have been prescribed for you by your doctor to help your
migraine type headaches. If they are taken regularly they can help to prevent headaches or reduce the pain of cluster headaches, common and classical migraine. Pizotifen Tablets can stop some migraine attacks starting and
help make other attacks less severe. They will not stop migraine attacks
once they have started.

* 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 Tablets 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 Tablets may affect the way they work.
Anything that makes you sleepy may make you even sleepier if you are
taking Pizotifen Tablets 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
Tablets.

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
Tablets. 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 Tablets

The doctor will decide what dose of Pizotifen Tablets 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 Tablets, 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 1.5 mg of pizotifen each day. This is one 1.5 mg tablet
or three 0.5 mg tablets. You may have been told to take your tablets once
a day or as three smaller doses.
* Do not take more than 3 mg in a single dose (two 1.5 mg tablets or six
0.5mg tablets). Do not take more than 4.5 mg (three 1.5 mg tablets or
nine 0.5 mg tablets) in a day.
Children (aged over 2 years)

* Children can take up to 1.5 mg of pizotifen each day. This is three 0.5 mg
2

Things to consider before you start to take
Pizotifen Tablets

Some people MUST NOT take Pizotifen Tablets.
Talk to your doctor if:
* you think you may be allergic to pizotifen or to any of the other ingredients
of Pizotifen Tablets. (These are listed at the end of the leaflet).
* you are breast-feeding.
Pizotifen Tablets should not be given to children aged under 2.
You should also ask yourself these questions before taking Pizotifen
Tablets:
* 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 straight
away. 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.

tablets. This is usually best given in two or three smaller doses.

* Do not use the 1.5 mg tablets for children. Do not give them more than
1 mg in a single dose. This is two 0.5 mg tablets.

For children over 2 who find it difficult to take tablets Sanomigran is also
available as an elixir (syrup).
Pizotifen Tablets and Elixir should not be given to children under 2
years of age.
Taking Pizotifen Tablets

* Swallow the tablets whole. Have a drink with them if this helps you to
swallow.

* If you take Pizotifen Tablets 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 Tablets 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.

Ref: 1481/270515/2/B

Pizotifen 1.5mg Tablets
(pizotifen hydrogen malate)
Patient Information Leaflet (continued)
What if you forget to take a dose?
If you forget to take your tablets, do not worry. If you normally take Pizotifen
Tablets 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
Tablets 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 Tablets
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.

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

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Keep the blister strips in the outer carton to protect from light.
* Do not take Pizotifen Tablets after the expiry date shown on the blister,

*
*

carton or carton label. If your doctor tells you to stop using this medicine,
take any remaining medicine back to the pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
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.

6
4

Possible side effects

Pizotifen Tablets 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.
Up to 1 in 10 people have experienced:
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.
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.
Frequency: not known:
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.
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.

How to store Pizotifen Tablets

Further information

What this medicine contains:
Each tablet contains 2.175mg of pizotifen hydrogen malate.
The other ingredients: lactose monohydrate, maize starch, povidone,
magnesium stearate, talc, acacia gum, sucrose, colloidal anhydrous silica,
carnauba wax, titanium dioxide (E171), yellow iron oxide (E172) and printing
ink.
What this medicine looks like and contents of the pack
Pizotifen are ivory coloured tablets printed SMG 1.5 on one side and plain
on the reverse.
They come in blister calendar packs of 28.
Manufacturer and Licence Holder
This medicine is manufactured by Novartis Pharmaceuticals UK Limited,
Wimblehurst Road, Horsham, West Sussex, RH12 5AB and is procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1481

Pizotifen 1.5mg Tablets

Revision date: 27/05/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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