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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

SEROQUEL

quetiapine fumarate, 25 mg, 100 mg, 200 mg and 300 mg tablets

What is in this leaflet

This leaflet answers some of the common questions people ask about Seroquel. It does not contain all the information that is known about Seroquel.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Seroquel against the benefits they expect it will 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 Seroquel is used for

Seroquel is used to treat schizophrenia and bipolar disorder. Schizophrenia and bipolar disorder are mental illnesses with disturbances in thinking, feelings and behaviour.

How Seroquel works

Seroquel belongs to a group of medicines called anti-psychotics, which improve the symptoms of certain types of mental illness.

Your doctor will help you understand the benefits of taking Seroquel and why you are taking it. Ask your doctor for further information if you have any questions

Before you use Seroquel

You must tell your doctor if:

You have any of the following medical conditions:

Tell your doctor if you know that you had a low white blood cell count in the past.

If you have any of these it may not be correct for you to take Seroquel, or you may have to take a lower dose.

If you drink alcohol, please mention this to your doctor before you start to take Seroquel.

Tell your doctor if you are pregnant, think you might be pregnant or are breast feeding The safety of Seroquel use during pregnancy is not yet known. It is not yet known how much Seroquel will pass through into breast milk.

If you have not told your doctor any of the things above, please tell him/her before you start taking any Seroquel.

When you must not use it

Do not use Seroquel if you have an allergy to Seroquel or to any ingredients listed at the end of this leaflet. If you have an allergic reaction, you may get a skin rash, hayfever, difficulty breathing or feel faint.

Do not give Seroquel to children. There is no information about its use in children.

Do not use Seroquel after the use by (expiry date) printed on the pack. It may have no effect at all, or an unexpected effect if you take it after the expiry date.

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

Do not give this medicine to anyone else.

Taking other medicines

You need to take special care if you take other medicines at the same time as Seroquel.

Tell your doctor if you are taking or about to stop taking any other medicines, including:

These medicines may affect the way Seroquel works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

Using Seroquel

Follow your doctor's instructions about when and how to take Seroquel. Please read the label on the container carefully. Ask your doctor or pharmacist if you are not sure about anything.

How to take it

Your doctor will decide what dose of Seroquel you should take.

Seroquel is taken once or twice a day. Your doctor may adjust your total daily dose between 150mg and 800mg a day depending on your individual treatment and needs. Some people may need more or less than this. Your dose will depend on your response.

If you are elderly, or have liver problems, your doctor will adjust your dose to suit you.

Swallow your Seroquel tablets whole with a full glass of water. You can take them before or after food.

Seroquel tablets come in different sizes, and each size is a different colour. Therefore don't be surprised if the colour of your tablet differs from time to time.

If you forget to take it

If it is almost time for your next dose (within 6 hours), skip the dose you missed and take your next dose when you are meant to.

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

Do not double the dose to make up for the dose you have missed. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

Overdose

Telephone your doctor or the National Poisons and Hazardous Chemicals Information Centre Ph: 0800 POISON (0800 764 766) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much Seroquel, even if there are no signs of discomfort or poisoning.

While you are using Seroquel

If you go into hospital, please let the medical staff know that you are taking Seroquel.

Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.

Be careful driving or operating machinery until you know how Seroquel affects you. Seroquel may cause dizziness or sleepiness in some people. Make sure you know how you react to Seroquel before you do anything else that could be dangerous if you are dizzy or sleepy. If you drink alcohol, dizziness or sleepiness may be worse.

If you are unsure about any of these points or have further questions, please ask your doctor or pharmacist.

Side effects

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

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 described below.

If any of the following happen, stop taking Seroquel and tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

These are rare but very serious side effects. If you have them, you may have had a serious reaction to Seroquel. You may need urgent medical attention or hospitalisation.

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

These things usually happen when you first take Seroquel and usually go away after a while.

Other side effects can include

These are all mild side effects of Seroquel.

Occasionally, Seroquel may be associated with changes in your liver or blood which may require your doctor to do certain blood tests.

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

Tell your doctor or pharmacist if you have any side effects or if you notice anything else that is making you feel unwell. Your doctor may wish to alter your treatment.

Important. This leaflet alerts you to some of the situations when you should call your doctor. Other situations which cannot be predicted, may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about using Seroquel.

After using it

Storage

Keep your Seroquel tablets in the foil pack until it is time to take them. If you take the tablets out of the box or foil pack they may not keep well.

Keep your tablets in a cool, dry place where the temperature stays below 30°C.

Do not store Seroquel tablets or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep your tablets in a safe place where children cannot see or reach them. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Do not leave Seroquel tablets in the car on hot days.

Disposal

Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.

Product description

Seroquel comes in four strengths, containing 25 mg, 100 mg, 200 mg or 300 mg of quetiapine fumarate. Each tablet strength is a different colour or shape:

Each strength comes in a blister pack containing 60 tablets.

Ingredients

Each tablet contains the active ingredient quetiapine fumarate. Each tablet also contains:

in addition

Seroquel 25 mg contains
iron oxide yellow CI77492 (E 172) and iron oxide red CI77491 (E 172)

Seroquel 100 mg contains
iron oxide yellow CI77492 (E 172)

Marketed by:

AstraZeneca Limited
PO Box 1301, Auckland.
Ph: (09) 623 6300 or 0800 363 200.

Trademarks herein are the property of the AstraZeneca Group.

This leaflet was prepared 20 September 2007.