INFORMATION FOR CONSUMERS
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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.
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.
Do not take Sandomigran if you have an allergy to:
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.
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:
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.
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:
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.
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.
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.
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).
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.
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 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.
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.
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.
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.
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.
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:
Tell your doctor as soon as possible if you notice any of the following:
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.
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.
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.
Sandomigran is an off-white- pale yellow sugar-coated tablet; packed in blisters packs of 100 tablets.
Sandomigran tablets contain 0.5 mg pizotifen (as the malate salt) as the active ingredient. They also contain:
Sandomigran is supplied in New Zealand by:
NOVARTIS New Zealand Limited
Private Bag 65904
Mairangi Bay
Auckland
Building G, 5 Orbit Drive
Rosedale
Auckland 0632
Telephone: 0800 652 422
This leaflet was prepared on 23 June 2009 based on the currently approved data sheet for this product.
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