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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

SEROQUEL XR

quetiapine fumarate, 50 mg, 200 mg, 300 mg and 400 mg tablets

What is in this leaflet

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

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 XR 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 XR is used for

Seroquel XR is used to treat schizophrenia, an illness with disturbances in thinking, feelings and behaviour.

How Seroquel XR works

Seroquel XR 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 XR and why you are taking it. Ask your doctor for further information if you have any questions.

Before you use Seroquel XR

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 XR, 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 XR.

Tell your doctor if you are pregnant, think you might be pregnant or are breast feeding

The safety of Seroquel XR use during pregnancy is not yet known. It is not yet known how much Seroquel XR 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 XR.

When you must not use it

Do not use Seroquel XR if you have an allergy to Seroquel XR 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 XR to children. There is no information about its use in children.

Do not use Seroquel XR 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 XR 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 XR.

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

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

Using Seroquel XR

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

How to take it

Seroquel XR is taken once daily without food. Swallow your Seroquel XR tablets whole with a full glass of water. Do not split, chew or crush the tablets.

How much to take

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

Seroquel XR is usually started at 300 mg for the first day. Following this, the dose will be adjusted by your doctor. The usual dose of Seroquel XR is 400 to 800 mg per 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 generally start you on 50 mg on the first day, then increase this to a higher dose depending on your response.

Your doctor may have switched your treatment from Seroquel tablets to Seroquel XR tablets. Your doctor will generally prescribe you a once daily dose of Seroquel XR, which is equivalent to your total daily dose of Seroquel tablets. Your doctor will tell you how many tablets you will need to take each day.

Seroquel XR 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.

When to take it

Seroquel XR should be taken once a day, at approximately the same time each day.
Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets. Seroquel XR tablets should be taken without food.

How long to take it

Continue taking the tablets for as long as your doctor tells you.

Seroquel XR helps control your condition, but does not cure it. Therefore you must take Seroquel XR every day.

Do not stop taking Seroquel XR unless your doctor tells you to - even if you feel better.

If you forget to take it

If it is almost time for your next dose, 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 are not sure what to do, ask your doctor or pharmacist. 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 XR, even if there are no signs of discomfort or poisoning.

While you are using Seroquel XR

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

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 XR affects you. Seroquel XR may cause dizziness or sleepiness in some people. Make sure you know how you react to Seroquel XR 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 XR.

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 XR 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 XR. 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 XR and usually go away after a while.

Other side effects can include

These are all mild side effects of Seroquel XR.

Occasionally, Seroquel XR 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 XR.

After using it

Storage

Keep your Seroquel XR 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 XR 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 XR 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 XR tablets are capsule shaped and are embossed with "XR" and the strength on one side, and plain on the other. Each tablet strength is a different colour:

Each strength comes in a blister pack containing 60 tablets.

Ingredients

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

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 29 May 2009.