SANOMIGRAN TABLETS 1.5MG

Active substance: PIZOTIFEN HYDROGEN MALATE

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SANOMIGRAN® Tablets
0.5 and 1.5 mg

1.  hat Sanomigran Tablets are and what
W
they are used for

Patient Information Leaflet
This medicine will usually be referred to just as
Sanomigran Tablets in this leaflet.

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.

(pizotifen)

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 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.  hat Sanomigran Tablets are and what they are
W
used for
2.  hings to consider before you start to take
T
Sanomigran Tablets
3. How to take Sanomigran Tablets
4. Possible side effects
5. How to store Sanomigran Tablets

Sanomigran Tablets are available in two different
strengths containing either 0.5 mg or 1.5 mg of the
active ingredient, pizotifen.

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.

2.  hings to consider before you start to take
T
Sanomigran Tablets
Some people MUST NOT take Sanomigran Tablets.
Talk to your doctor if:
•  ou think you may be allergic to pizotifen or
y
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:
•  o you have glaucoma (raised pressure in
D
your eyes)?
• Do you ever have problems passing urine?

6. Further information

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.

•  o you have kidney problems, especially kidney
D
failure? (The medical term for this is renal failure.)

• Do you have epilepsy?
• Are you pregnant?
•  o you have an intolerance to some sugars?
D
(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?
•  emind your doctor if you are taking drugs called
R
alpha- or beta-blockers because Sanomigran
Tablets may affect the way they work.
•  nything that makes you sleepy may make
A
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
•  he usual dose is 1.5 mg of pizotifen each day.
T
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.
•  o not take more than 3 mg in a single dose
D
(two 1.5 mg tablets or six 0.5 mg 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)
•  hildren can take up to 1.5 mg of pizotifen each
C
day. This is three 0.5 mg tablets. This is usually
best given in two or three smaller doses.
•  o not use the 1.5 mg tablets for children. Do
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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
•  wallow the tablets whole. Have a drink with
S
them if this helps you to swallow.

•  o you have liver problems? Sanomigran has
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been associated with abnormal results of liver
function tests and possibly liver problems in a few

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• f you take Sanomigran Tablets once a day, take
I
them in the evening a few hours before you go to
bed as any drowsiness will help you to sleep.
• f you take your tablets in two or three doses,
I
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.
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
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 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:
•  ymptoms of allergy such as a rash, itching or
S
hives on the skin or swelling of the face.

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 Tablets
Keep your tablets in the pack they came in. Keep
your tablets in a safe place, away from strong light.

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:
Seizures (fits). Tell your doctor immediately if you
have a fit.

Keep all medicines out of the reach and sight
of  children.
Do not take the tablets after their expiry date which
is printed on the outside of the pack.
If your doctor tells you to stop taking Sanomigran
Tablets, please take any unused tablets back to your
pharmacist to be destroyed. Only keep the tablets
if the doctor tells you to. Do not throw them away
with your normal household water or waste. This will
help to protect the environment.

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 May 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

6. Further information
There are two strengths of Sanomigran Tablets.
Sanomigran Tablets 0.5 mg are ivory coloured
printed SMG on one side, and they contain 0.5 mg
of the active ingredient pizotifen (as 0.725 mg of
pizotifen hydrogen malate). They come in blister
packs of 60.
Sanomigran Tablets 1.5 mg are ivory coloured
printed SMG 1.5 on one side, and they contain
1.5 mg of the active ingredient pizotifen (as
2.175 mg of pizotifen hydrogen malate). They come
in calendar packs of 28.
The tablets also contain the inactive ingredients
lactose, starch, polyvinylpyrrolidone, magnesium
stearate, talc, gum acacia, carnauba wax, sugar,
printing wax, anhydrous colloidal silica and the
colouring agents E171 (titanium dioxide) and E172
(iron oxide).

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Bottom

dummy code read direction

The Maltings

775742/ Andersen, Claire

PANTONE 541 C

775742_GB_LFT
1406321
Leaflet_SANDOMIGRAN_SCT_0.5/1.5MG_3X20
+ 2X14_GB
GB
Same as previous
artwork (Dummy)

Cutting

Laetuscode

N/A
N/A

300 x 180 mm

PharmOps, Horsham

N/A

28/05/2013
News Gothic MT Regular, News Gothic MT Bold, News Gothic MT Italic, News Gothic MT Condensed Bold

1. Proof

K.Jerrum

7 pt - Copyright info / 8 pt Body text
Smallest code font size: 6 pt
N/A

SGS Number: 441579_1

Page 2/2

28/05/2013 11:31

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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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