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Sandomigran 0.5mg Tablets 100

IMPORTANT NOTE – A VALID AUSTRALIAN PRESCRIPTION IS REQUIRED BEFORE THIS ITEM CAN BE SHIPPED

Drug Name: pizotifen
Our Price $17.99
PBS $24.10
Concession $5.20
Safety Net $0.00

S8 Note - This prescription item is Schedule 8 and can only be supplied on a script from a registered doctor in Queensland. Any prescriptions from any other state cannot be filled and will be returned in the mail

Note: Private, PBS and our prices are available to the general public. Concession and Safety Net prices are only available to people with the appropriate concession or Safety Net cards. See Prescriptions for more details.

GOVERNMENT AUTHORITY SCRIPT

This prescription item requires a pre approved authority from the Government in order to get this item at the quoted price. Authority prescriptions need to be applied for by the doctor writing the script and can include reasons such as increased quantities due to dosage, increased repeats, use for a pre determined specified use, or the nature of the medication itself requiring specialist interaction. In the event that an authority is not granted on the script, the price will revert to the private price quoted for that item

WARNING - MULTIPLE PACK PRESCRIPTION - PLEASE READ CAREFULLY

This item contains more than one pack of a prescription product. Before this can be dispensed the doctor has to give approval. The prescription must be written for the total quantity or the prescription must be endorsed by your doctor "Regulation 24" otherwise we will be unable to dispense the increased amount. If you proceed with the order without approval, we will only send out one pack at the single pack price and refund the difference. Eg If your prescription is written out for 30 Tablets with 5 repeats and it does not have “Regulation 24 “ written on the script, the ONLY quantity we can dispense is 30 at one time. Further dispensing of this product could only occur after an appropriate length of time - usually 21 days but depends on dosage. In this example if you would like to obtain 180 Tablets then the doctor must endorse the prescription “Regulation 24” or the quantity must be written out for 180 and not 30. NB Conditions apply on the writing of a Regulation 24 prescription. Ask your doctor or pharmacist for details.

We can no longer accept signed authority forms from your doctor as permission to dispense more than one pack. Please contact our pharmacist for more information.

If you order this item as Private, NO PBS stickers will be issued. Once any prescription order has been sent the product cannot be returned for a refund even if your doctor changes your medication or you have an adverse reaction.

Sandomigran 0.5mg Tablets 100

Sandomigran 0.5mg Tablets 100

Product ID: 7516
$17.99

Pharmacist Only Medicine

This product is a Pharmacist Only Medicine and requires pharmacist advice before we can dispatch this product. You must first place the order and then contact our pharmacists within 48 hours on 1300 367 283. The pharmacist will determine if this product is appropriate for you and if so, approve the order. In the event that you do not do this, the product will be deleted from your order and the balance of your order will be dispatched. This is not required if you have a doctor's prescription.

 

General Information

Sandomigran®
Pizotifen malate
Consumer Medicine Information

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 provide.

If you have any concerns about 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 is used to prevent "vascular" headaches, including migraine, cluster headaches and vasomotor headaches.

Vascular headaches are thought to be caused by temporary changes in the size of small blood vessels in the brain. These changes cause the pain and problems with vision that often happen during a severe headache. Sandomigran prevents an attack by stopping the blood vessels from changing in size.

Sandomigran is only used to prevent severe headaches from happening. It will not stop an attack once it has started.

Ask your doctor if you have any questions about why this medicine 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.

There is not enough information to recommend this medicine for children.

Before you take Sandomigran
When you must not take it
Do not take Sandomigran if you have an allergy to pizotifen (the active ingredient) or to any of the other ingredients of Sandomigran listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take Sandomigran after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist.

Before you start to take it
Tell your doctor if you have any of the following medical conditions:

increased pressure in the eye due to glaucoma
difficulty in passing urine (water), due to prostate trouble or any other cause
Your doctor may want to take special precautions if you have one of the above conditions.

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 during pregnancy, your doctor will discuss with you the benefits and risks involved.

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 your baby, breast-feeding while taking this medicine is not recommended. Your doctor will discuss with you the benefits and risks involved.

Tell your doctor if you are lactose intolerant. This medicine contains lactose.

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.

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
Monoamine oxidase inhibitors (MAOI) which belong to a group of medicines called antidepressants
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.

If you have not told your doctor about any of these things, tell him/her before you start taking this medicine.

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
The usual starting dose is one tablet of Sandomigran each day. To avoid making you drowsy, the dose is gradually increased, usually to three tablets each day.

If your headaches 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
Your doctor may tell you to take all of the tablets at one time (usually at night) or he/she may tell you to divide the tablets over the day (for example, 1 tablet in the morning and 2 tablets at night).

How to take it
Take the tablets with a full glass of water. They can be taken with or without food.

Try to 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.

To prevent severe headaches, you must take this medicine 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 Poisons Information Centre (telephone number 13 11 26), or go to Accident and Emergency 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), dizziness or lightheadedness, slow breathing, coma, and convulsions (particularly in children). Children may also become overexcited.

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 take Sandomigran to treat a severe headache once it has started. This medicine is only used to prevent severe headaches. It will not stop an attack once it has started.

Do not give this medicine to anyone else, even if their condition seems similar to yours.

Do not take it to treat any other complaints unless your doctor tells you to. This medicine is not appropriate for common 'tension' headaches.

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 feel drowsier 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 these lists 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 as soon as possible if you notice any of the following:

signs of fluid buildup such as swelling of the ankles, feet or lower legs
faintness, dizziness or lightheadedness
numbness or tingling feeling in arms or legs
skin rash
seeing, feeling or hearing things that are not there (hallucinations)
signs of an allergic reaction such as swelling of the face or itchy skin
Tell your doctor if you notice any of the following and they worry you:

drowsiness
fatigue
dry mouth
nausea (feeling sick)
constipation
aching muscles
increased appetite, weight gain
problems with sexual function
problems sleeping
a feeling of deep sadness, anxiety or sudden mood changes
Tell your doctor if you notice anything else that is making you feel unwell. Some people may have other side effects not yet known or mentioned in this leaflet.

After taking Sandomigran
Storage
Keep your medicine in the original container until it is time to take it.
Store it in a cool dry place.
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.
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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description
What it looks like
Sandomigran is an off-white, sugar-coated tablet supplied in packs of 100 tablets.

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

colloidal anhydrous silica
lactose
magnesium stearate
maize starch
purified talc
povidone
acacia
sucrose
titanium dioxide
cetyl palmitate
Sponsor
Sandomigran is supplied in Australia by:

NOVARTIS Pharmaceuticals Australia Pty Limited
ACN 004 244 160
54 Waterloo Road
North Ryde NSW 2113

Telephone 1 800 671 203

®= Registered Trademark

This leaflet was prepared in
June 2005

(smg030605c.doc) based on PI (smg030605i.doc)

Australian Registration Number:

0.5 mg tablet AUST R 69608

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