SANDOMIGRAN®

0.5mg tablet

Pizotifen malate

What is in this leaflet

This leaflet answers some common questions about Sandomigran.

It does not contain all the available information. It does not take the place
of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you taking Sandomigran against the benefits this medicine is expected to have
for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Sandomigran is used for

Sandomigran contains the active ingredient pizotifen. It is used to prevent
attacks of migraine (severe periodic headache).

Migraine attacks are thought to be caused by temporary changes in the size of
small blood vessels in the brain. These changes to the blood vessels cause the
pain and problems with vision that often happen during a migraine. Sandomigran
prevents migraine attacks by stopping the blood vessels from changing in size.

Sandomigran can only be used to prevent migraine. It does not work during a
migraine attack.

Ask your doctor if you have any questions about why Sandomigran has been
prescribed for you.

Your doctor may have prescribed it for another reason.

Sandomigran is only available with a doctor's prescription. It is not
addictive.

Before you take Sandomigran

When you must not take it

Do not take Sandomigran if you have an allergy to:

• pizotifen (the active ingredient in Sandomigran)
• any of the other ingredients listed at the end of this leaflet

You may get hives or an itchy skin rash, swelling of the face, lips or
tongue, wheezing or troubled breathing, faintness or other symptoms if you take
it.

Do not take Sandomigran if the packaging is torn or shows signs of
tampering.

In that case, return it to your pharmacist.

Do not take Sandomigran after the use by (expiry) date printed on the
pack.

If you take it after the expiry date has passed, it may not work as well as it
should.

Do not give this medicine to a child.

Sandomigran is not recommended for use in children under 2 years of age as there
is not enough information on its use in people of that age.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, dyes
or preservatives.

Your doctor will want to know if you are prone to allergies.

If you have been told by your doctor that you have an intolerance to some
sugars (lactose), contact your doctor before taking Sandomigran.

Tell your doctor if you have any of the following medical conditions:

• a condition which makes passing urine difficult (eg. prostate trouble)
• glaucoma
• convulsions or fits

Your doctor may want to take special precautions if you have any of these
conditions. Sandomigran could make these conditions worse.

Tell your doctor if you are pregnant or intend to become pregnant.

Experience with Sandomigran in pregnancy is very limited. If it is necessary for
you to take this medicine, your doctor will discuss with you the benefits and
risks of taking it during pregnancy.

Tell your doctor if you are breast-feeding or intend to breast-feed.

Small amounts of Sandomigran pass into breast milk. Although such small amounts
are unlikely to harm the baby, breastfeeding while taking this medicine is not
recommended. Your doctor will discuss the benefits and risks of taking it when
breast-feeding.

If you have not told your doctor about any of these things, tell them
before you take Sandomigran.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that
you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Sandomigran may interfere with each other. These include:

• medicines to calm you down or help you sleep
• antihistamines, found in cough, cold and allergy medicines

These medicines may worsen the drowsiness that sometimes happens when you
take Sandomigran. You may need to take different amounts of your medicines or
you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking Sandomigran.

How to take Sandomigran

Follow all directions given to you by your doctor and pharmacist
carefully.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or
pharmacist for help.

How much to take

Adults and Children

Your doctor will usually start you on one tablet of Sandomigran each day. To
avoid making you drowsy, the dose is gradually increased, usually to three
tablets each day.

If your migraine attacks are still not controlled, your doctor may gradually
increase the dose up to a maximum of nine tablets each day, divided into two or
three doses.

When to take it

The tablets can be taken all at once (usually at night) or they can be
divided throughout the day (eg. 1 tablet in the morning and 2 tablets at night).

How to take it

Take the tablets with water or other liquid. They can be taken with or
without food.

For the best effect, take the tablets at about the same times each day.

Taking them at the same times each day will help you to remember to take them.

How long to take it

Continue taking Sandomigran every day for as long as your doctor
prescribes.

This medicine helps to prevent migraine. It must be taken every day, even if you
feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take
the next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it
as you would normally.

Do not take a double dose to make up for the one that you missed.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.

If you take too much (Overdose)

Immediately telephone your doctor or the National Poisons and Hazardous
Information Centre (telephone number 0800 POISON OR 0800 764 766), or go to the
Accident and Emergency Department at your nearest hospital if you think that you
or anyone else may have taken too much Sandomigran. Do this even if there are no
signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

Some of the symptoms of an overdose may include drowsiness, nausea (feeling
sick), low blood pressure, dizziness, difficulty breathing, coma, and
convulsions (particularly in children). Children may also become hyperactive.

While you are taking Sandomigran

Things you must do

If you become pregnant while taking Sandomigran, tell your doctor.

Your doctor can discuss with you the risks of taking it while you are pregnant.

If you are about to be started on any new medicine, remind your doctor and
pharmacist that you are taking Sandomigran.

Tell any other doctor, dentist or pharmacist who treats you that you are
taking Sandomigran.

Things you must not do

Do not give this medicine to anyone else even if their symptoms seem to be
the same as yours.

Do not use Sandomigran to treat any other complaints unless your doctor
tells you to.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to
be alert until you know how Sandomigran affects you.

This medicine may make you feel drowsy, especially when you first start to take
it. If that happens, do not drive or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking Sandomigran.

The combination could make you more drowsy than usual.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking Sandomigran.

All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• drowsiness
• tiredness
• dry mouth
• nausea (feeling sick)
• constipation
• headache
• aching muscles
• increased appetite, weight gain
• problems with sexual function

Tell your doctor as soon as possible if you notice any of the following:

• swollen ankles or other signs of fluid buildup
• faintness, dizziness or lightheadedness
• numbness or tingling feeling in arms or legs
• skin rash
• seeing, feeling or hearing things that are not there (hallucinations)

You may need medical attention if you get these side effects.

Tell your doctor if you notice anything else that is making you unwell.

Some people may get other side effects when taking Sandomigran.

After using Sandomigran

Storage

• Keep your tablets in the original container until it is time to take them.
• Store the tablets in a cool dry place where the temperature stays below
  30°C.
• Do not store Sandomigran or any other medicine in the bathroom or near a
  sink.
• Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines. Sandomigran will keep well if
it is cool and dry.

Keep the medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.

Disposal

If your doctor tells you to stop taking Sandomigran or you find that it
has passed the expiry date, ask your pharmacist what to do with any medicine you
have left over.

Product description

What it looks like

Sandomigran is an off-white- pale yellow sugar-coated tablet; packed in
blisters packs of 100 tablets.

Ingredients

Sandomigran tablets contain 0.5 mg pizotifen (as the malate salt) as the
active ingredient. They also contain:

• silica colloidal anhydrous
• lactose
• magnesium stearate
• starch-maize
• talc-purified
• povidone
• acacia
• sucrose
• titanium dioxide
• cetyl palmitate