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Read all of this leaflet carefully before you

start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    I f you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    I f any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Seroquel XL is and what it is used for

2.    Before you take Seroquel XL

3.    How to take Seroquel XL

4.    Possible side effects

5.    How to store Seroquel XL

6.    Further information

1. What Seroquel XL is and what it is used for

Seroquel XL contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Seroquel XL can be used to treat several illnesses, such as:

•    Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

•    Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.

•    Bipolar depression and major depressive episodes in major depressive disorder: where you may feel sad all the time or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.

When Seroquel XL is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness.

Your doctor may continue to prescribe Seroquel XL even when you are feeling better.

2. Before you take Seroquel XL

Do not take Seroquel XL if:

•    you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel XL (see section 6: Further information)

•    you are taking any of the following medicines:

-    protease inhibitors, such as nelfinavir (for HIV infection)

-    azole medicines (for fungal infections)

-    medicines for an infection (like erythromycin or clarithromycin)

-    nefazodone (for depression).

Do not take Seroquel XL if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Seroquel XL.

Take special care with Seroquel XL

Before you take your medicine, tell your doctor if:

•    You, or someone in your family, have or have had any heart problems such as a very fast heart beat or prolonged QT on an ECG (heart tracing), or if you are taking any medicines that may have an impact on the way your heart beats.

•    You have low blood pressure.

•    You have had a stroke, especially if you are elderly.

•    You have problems with your liver.

•    You have ever had a fit (seizure).

•    You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).

•    You have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Seroquel XL.

•    You are an elderly person with dementia (loss of brain function). If you are, Seroquel XL should not be taken because the group of medicines that Seroquel XL belongs to may increase

the risk of stroke, or in some cases the risk of death, in elderly people with dementia.

•    You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.

Tell your doctor immediately if you experience any of the following after taking Seroquel XL:

•    A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.

•    Uncontrollable movements, mainly of your face or tongue.

•    Dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall) in elderly patients.

•    Fits (seizures).

•    A long-lasting and painful erection (Priapism).

These conditions can be caused by this type of medicine.

Thoughts of suicide and worsening of your depression

If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer. These thoughts may also be increased if you suddenly stop taking your medication. You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.

You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Weight gain has been seen in patients taking Seroquel XL. You and your doctor should check your weight regularly.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines because it may affect the way the medicines work. This includes medicines obtained without a prescription and herbal medicines.

Do not take Seroquel XL if you are taking any of the following medicines:

•    Some medicines for HIV.

•    Azole medicines (for fungal infections).

•    Erythromycin or clarithromycin (for infections).

•    Nefazodone (for depression).

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Tell your doctor or pharmacist if you are taking any of the following medicines:

•    Epilepsy medicines (like phenytoin or carbamazepine).

•    High blood pressure medicines.

•    Rifampicin (for tuberculosis).

•    Barbiturates (for difficulty sleeping).

•    Thioridazine or Lithium (other anti-psychotic medicines).

•    Medicines that have an impact on the way your heart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections).

Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.

Taking Seroquel XL with food and drink

•    Seroquel XL should be taken without food, at least one hour before a meal or at bedtime.

•    Be careful how much alcohol you drink. This is because the combined effect of Seroquel XL and alcohol can make you sleepy.

•    Do not drink grapefruit juice while you are taking Seroquel XL. It can affect the way the medicine works.

Pregnancy and breast-feeding

If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor or pharmacist before taking Seroquel XL. You should not take Seroquel XL during pregnancy unless this has been discussed with your doctor. Seroquel should not be taken if you are breast-feeding.

The following symptoms may occur in newborn babies of mothers that have used Seroquel XL in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/ or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

Your tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how the tablets affect you.

Hospital - If you go into hospital, tell the medical staff that you are taking Seroquel XL.

Important information about some of the ingredients of Seroquel XL

Seroquel XL contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Effect on Urine Drug Screens If you are having a urine drug screen, taking Seroquel XL may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

If you have been on other medication for this condition, and that medication has stopped your periods, changing to Seroquel XL may allow them to return.

3. How to take Seroquel XL

Always take Seroquel XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose and may gradually increase it. When you are on your regular dose you will usually be taking between 150 mg and 800 mg each day. It will depend on your illness and needs.

•    You will take your tablets once a day.

•    Swallow your tablets whole with a drink of water.

•    Do not split, chew or crush the tablets.

•    Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when).

•    Do not drink grapefruit juice while you are taking Seroquel XL. It can affect the way the medicine works.

•    Do not stop taking your tablets even if you feel better, unless your doctor tells you.

Seroquel XL tablets are available in 5 different strengths.

•    Even though the dose might stay the same, it might be supplied as different strength tablets. For example one 400 mg tablet (white) or two 200 mg tablets (yellow).

•    So don’t be surprised if the colour of your tablets changes from time to time.

Liver problems

If you have liver problems your doctor may give you a lower dose.

Elderly people

If you are elderly your doctor may give you a lower dose.

Children and adolescents under 18 years

Seroquel XL should not be used by children and adolescents aged under 18 years.

If you take more Seroquel XL than you should

If you take more Seroquel XL than prescribed by your doctor, you may feel sleepy, feel faint or dizzy and experience abnormal heart beats. Contact your doctor or nearest hospital straight away. Take the Seroquel XL tablets with you.

If you forget to take a dose of Seroquel XL

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Seroquel XL

If you suddenly stop taking Seroquel XL, you may be unable to sleep (insomnia), or you may feel sick (nausea) or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability. Your doctor may suggest you reduce the dose gradually before stopping treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Seroquel XL can cause side effects, although not everybody gets them. If any of the following side effects get serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.

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