SANOMIGRAN ELIXIR 0.25MG/5ML

Active substance: PIZOTIFEN MALATE

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SANOMIGRAN® Elixir

classical migraine. Sanomigran Elixir can
stop some migraine attacks starting and
help make other attacks less severe. It will
not stop migraine attacks once they have
started.

(pizotifen)
Patient Information Leaflet
What you need to know about Sanomigran
Elixir
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.
In this leaflet:
1. 
What Sanomigran Elixir is and what it’s
used for
2. 
Things to consider before you start to
take Sanomigran Elixir
3. 
How to take Sanomigran Elixir
4. 
Possible side effects
5. 
How to store Sanomigran Elixir
6. Further information
1. 
What Sanomigran Elixir is and what it’s
used for
Sanomigran Elixir is a syrup containing
0.25 mg of the active ingredient, pizotifen,
in each 5 ml.
Sanomigran Elixir is a migraine treatment.
It may help to stop the effects of certain
naturally occurring substances in your body
called “serotonin”, “histamine” and
“tryptamine” which are involved in causing
some kinds of headache, including
migraine.
Sanomigran Elixir 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

2. 
Things to consider before you start to
take Sanomigran Elixir
Some people MUST NOT take Sanomigran
Elixir. Talk to your doctor if:
▯▯ you think you may be allergic to pizotifen
or to any of the other ingredients of the
elixir. (These are listed at the end of the
leaflet.)
▯▯ you are breast-feeding.
Sanomigran Elixir should not be given to
children aged under 2.
You should also ask yourself these
questions before taking Sanomigran Elixir:
▯▯ 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 such as fructose? (The elixir
contains maltitol (hydrogenated
glucose syrup).)
▯▯ Are you an alcoholic?
If the answer to any of these questions is
YES, tell your doctor or pharmacist because
Sanomigran Elixir might not be the right
medicine for you.
Continued on next page

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Are you taking other medicines?
Remind your doctor if you are taking
drugs called alpha- or beta-blockers
because Sanomigran Elixir may affect the
way they work.
▯▯ Anything that makes you sleepy
may make you even sleepier if you
are taking Sanomigran Elixir 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 Elixir.
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 Elixir. 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.
Sanomigran Elixir contains ethanol
(alcohol). 5 ml of the elixir contains nearly
0.1 g of ethanol. The usual daily dose of
30 ml (1.5 mg pizotifen), will contain nearly
0.6 g of ethanol. This is less than a glass of
wine or a pint of beer, but will affect your
blood alcohol levels so you should take care
not to go over the limit if you are driving.
Other special warnings
▯▯ Sanomigran Elixir contains small amounts
of the preservatives methyl and propyl
hydroxybenzoate. These can sometimes
cause allergic reactions which might
appear some time after first taking the
elixir.
3. 
How to take Sanomigran Elixir
The doctor will decide what dose of
Sanomigran Elixir you should take. Always
take the medicine 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 much to
take, and how often. If you are not sure, ask
your doctor or pharmacist. Keep taking
Sanomigran Elixir for as long as you have
been told unless you have any problems. In
that case, check with your doctor.

With Sanomigran Elixir, 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 for adults is 1.5 mg of
pizotifen each day. This is six 5ml
spoonfuls.
▯▯ You may have been told to take your
medicine once a day, or you may have
it split into three smaller doses.
▯▯ Do not take more than 3 mg (twelve 5ml
spoonfuls) in a single dose. Do not take
more than 4.5 mg (eighteen 5ml
spoonfuls) in a day.
Children (aged over 2 years)
▯▯ Children can take up to 1.5 mg of pizotifen
each day. This is six 5ml spoonfuls.
▯▯ This is usually best given in two or three
smaller doses.
▯▯ Do not give them more than 1 mg in a
single dose. This is four 5ml spoonfuls.
Sanomigran Elixir should not be given to
children under 2 years of age.
Taking Sanomigran Elixir
▯▯ Have a drink with your elixir if this helps
you to swallow.
▯▯ If you take Sanomigran Elixir once a day,
take it in the evening a few hours before
you go to bed as any drowsiness will help
you to sleep.
▯▯ If you take your elixir in two or three doses,
spread them evenly through the day.
Carry on taking your Sanomigran Elixir even
when you feel well. Your headaches may
come back if you stop taking it. Do not stop
taking it 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 the medicine.
What if you forget to take a dose?
If you forget to take your medicine, do not
worry. If you normally take Sanomigran
Elixir 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.
Continued on next page

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If you normally take Sanomigran Elixir once
a 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 medicine.
What if you take too much?
All medicines can be risky if you take too
much. If you take too much Sanomigran
Elixir at one go, 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
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.
4. 
Possible side effects
Sanomigran Elixir is suitable for most
people, but, like all medicines, it can
sometimes cause side effects.
Some side effects can be serious
Stop taking the medicine 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 medicine 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 medicine.
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:
Seizures (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.
5. 
How to store Sanomigran Elixir
Keep all medicines out of the reach and
sight of children.
Do not take the elixir after the expiry date
which is printed on the outside of the pack.
If your doctor tells you to stop taking
Sanomigran Elixir, please take any which is
left back to your pharmacist to be
destroyed. Only keep it if the doctor tells
you to. Do not throw it away with your
normal household water or waste. This will
help to protect the environment.
6. Further information
Sanomigran Elixir is a clear, colourless
liquid with a pleasant fruity flavour
Continued on next page

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containing 0.25 mg of the active ingredient
pizotifen (as 0.365 mg of pizotifen hydrogen
malate) in each 5 ml of syrup. It comes in a
bottle containing 300 ml.
The syrup also contains the inactive
ingredients citric acid anhydrous, methyl
and propyl hydroxybenzoate, raspberry
flavour, maraschino flavour, disodium
phosphate anhydrous, ethanol 96% w/v,
maltitol liquid and purified water. It does
not contain tartrazine.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley
Business Park, Frimley, Camberley, Surrey
GU16 7SR, England.
Manufacturer
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West Sussex,
RH12 5AB, England,
United Kingdom and Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR,
England, United Kingdom.
This leaflet was revised in September
2013.
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at
Novartis Pharmaceuticals UK Ltd, telephone
number 01276 698370.
SANOMIGRAN is a registered trade mark
Copyright Novartis Pharmaceuticals UK
Limited

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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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