2. BEFORE YOU TAKE QUZAL:

A. Do not take QUZAL if:

• If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of QUZAL (see Section 6).

• 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).

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

B. Take special care with QUZAL:

Talk to your doctor or pharmacist before taking QUZAL if:

• You, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart 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 have diabetes or have a risk of getting diabetes. If you do, your doctor may check

your blood sugar levels while you are taking QUZAL.

• 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 are an elderly person with dementia (loss of brain function). If you are, QUZAL

should not be taken because the group of medicines that QUZAL 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.

• You have or have had a condition where you stop breathing for short periods during

your normal nightly sleep (called “sleep apnoea”) and are taking medicines that slow

down the normal activity of the brain (“depressants”).

• You have or have had a condition where you can’t completely empty your bladder

(urinary retention), have an enlarged prostate, a blockage in your intestines, or

increased pressure inside your eye. These conditions are sometimes caused by

medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to

treat certain medical conditions.

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

• 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.

Tell your doctor as soon as possible if you have:

• A fever, flu-like symptoms, sore throat, or any other infection, as this could be a result

of a very low white blood cell count, which may require QUZAL to be stopped and/or

treatment to be given.

• Constipation along with persistent abdominal pain, or constipation which has not

responded to treatment, as this may lead to a more serious blockage of the bowel.

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

Weight gain has been seen in patients taking QUZAL. You and your doctor should check

your weight regularly.

Children and Adolescents

QUZAL is not for use in children and adolescents below 18 years of age.

C. Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other

medicines.

Do not take QUZAL 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).

Please tell your doctor if you are taking any of the following medicines:

• Epilepsy medicines (like phenytoin or carbamazepine).

• High blood pressure medicines.

• 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).

• Medicines that can cause constipation.

• Medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to

treat certain medical conditions.

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

D. Taking QUZAL with food , drink and alcohol:

• QUZAL can be taken with or without food.

• Be careful how much alcohol you drink. This is because the combined effect of QUZAL

and alcohol can make you sleepy.

• Do not drink grapefruit juice while you are taking QUZAL. It can affect the way the

medicine works

E. Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a

baby ask your doctor for advice before taking QUZAL. You should not take QUZAL

during pregnancy unless this has been discussed with your doctor. QUZAL should not

be taken if you are breast-feeding.

The following symptoms which can represent withdrawal may occur in newborn babies

of mothers that have used QUZAL 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.

Ask your doctor or pharmacist for advice before taking any medicine.

F. 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.

G. Important information about some of the ingredients of QUZAL:

QUZAL 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.

H. Effect on Urine Drug Screens:

If you are having a urine drug screen, taking QUZAL 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.

3. HOW TO TAKE QUZAL:

Always take QUZAL exactly as your doctor or pharmacist has told you. You should

check with your doctor or pharmacist if you are not sure.

Taking this medicine:

Your doctor will decide on your starting dose. The maintenance dose (daily dose) will

depend on your illness and needs but will usually be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime or twice a day, depending on your

illness.

• Swallow your tablets whole with a drink of water.

• You can take your tablets with or without food.

• Do not drink grapefruit juice while you are taking QUZAL. It can affect the way the

medicine works.

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

Liver problems:

If you have liver problems your doctor may change your dose.

Elderly people:

If you are elderly your doctor may change your dose.

Use in children and adolescents

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

a. If you take more QUZAL than you should:

If you take more QUZAL than prescribed by your doctor, you may feel sleepy, feel dizzy

and experience abnormal heart beats. Contact your doctor or nearest hospital straight

away. Keep the QUZAL tablets with you.

b. If you forget to take a dose of QUZAL:

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.

c. If you stop taking QUZAL:

If you suddenly stop taking QUZAL, 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, QUZAL can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth.

• Feeling sleepy (this may go away with time, as you keep taking QUZAL) (may lead to

falls).

• Discontinuation symptoms (symptoms which occur when you stop taking QUZAL)

include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea,

being sick (vomiting), dizziness and irritability. Gradual withdrawal over a period of at

least 1 to 2 weeks is advisable.

• Putting on weight.

• Abnormal muscle movements. These include difficulty starting muscle movements,

shaking, feeling restless or muscle stiffness without pain.

• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common side effects (may affect up to 1 in 10 people):

• Rapid heartbeat.

• Feeling like your heart is pounding, racing or has skipped beats.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Low blood pressure when standing up. This may make you feel dizzy or faint (may lead

to falls).

• Increased levels of sugar in the blood.

• Blurred vision.

• Abnormal dreams and nightmares.

• Feeling more hungry.

• Feeling irritated.

• Disturbance in speech and language.

• Thoughts of suicide and worsening of your depression.

• Shortness of breath.

• Vomiting (mainly in the elderly).

• Fever.

• Changes in the amount of thyroid hormones in your blood.

• Decreases in the number of certain types of blood cells.

• Increases in the amount of liver enzymes measured in the blood.

• Increases in the amount of the hormone prolactin in the blood. Increases in the

hormone prolactin could in rare cases lead to the following:

Men and women to have swelling breasts and unexpectedly produce breast milk.

Women to have no monthly periods or irregular periods.

Uncommon side effects (may affect up to 1 in 100 people):

• Fits or seizures.

• Allergic reactions that may include raised lumps (weals), swelling of the skin and

swelling around the mouth.

• Unpleasant sensations in the legs (also called restless legs syndrome).

• Difficulty swallowing.

• Uncontrollable movements, mainly of your face and tongue.

• Sexual dysfunction.

• Diabetes.

• Change in electrical activity of the heart seen on ECG (QT prolongation).

• A slower than normal heart rate which may occur when starting treatment and which

may be associated with low blood pressure and fainting.

• Difficulty in passing urine.

• Fainting (may lead to falls).

• Stuffy nose.

• Decrease in the amount of red blood cells.

• Decrease in the amount of sodium in the blood.

• Worsening of pre-existing diabetes.

Rare side effects (may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy

or faint (a disorder called “neuroleptic malignant syndrome”).

• Yellowing of the skin and eyes (jaundice).

• Inflammation of the liver (hepatitis).

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

• Swelling of breasts and unexpected production of breast milk (galactorrhoea).

• Menstrual disorder.

• Blood clots in the veins especially in the legs (symptoms include swelling, pain and

redness in the leg), which may travel through blood vessels to the lungs causing chest

pain and difficulty in breathing. If you notice any of these symptoms seek medical advice

immediately.

• Walking, talking, eating or other activities while you are asleep.

• Body temperature decreased (hypothermia).

• Inflammation of the pancreas.

• A condition (called “metabolic syndrome”) where you have a combination of 3 or more

of the following: an increase in fat around your abdomen, a decrease in “good

cholesterol” (HDL-C), an increase in a type of fat in your blood called triglycerides, high

blood pressure and an increase in your blood sugar.

• Combination of fever, flu-like symptoms, sore throat, or any other infection with very low

white blood cell count, a condition called agranulocytosis.

• Bowel obstruction.

• Increased blood creatine phosphokinase (a substance from the muscles).

Very rare side effects (may affect up to 1 in 10,000 people):

• Severe rash, blisters, or red patches on the skin.

• A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing

or shock.

• Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).

• A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson

syndrome).

• Inappropriate secretion of a hormone that controls urine volume.

• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).

Not known (frequency cannot be estimated from the available data):

• Skin rash with irregular red spots (erythema multiforme).

• Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin

and peeling of the skin (toxic epidermal necrolysis).

• Symptoms of withdrawal may occur in newborn babies of mothers that have used

QUZAL during their pregnancy.

The class of medicines to which QUZAL belongs can cause heart rhythm problems,

which can be serious and in severe cases may be fatal.

Some side effects are only seen when a blood test is taken. These include changes in

the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood,

changes in the amount of thyroid hormones in your blood, increased liver enzymes,

decreases in the number of certain types of blood cells, decrease in the amount of red

blood cells, increased blood creatine phosphokinase (a substance in the muscles),

decrease in the amount of sodium in the blood and increases in the amount of the

hormone prolactin in the blood. Increases in the hormone prolactin could in rare cases

lead to the following:

• Men and women to have swelling of the breasts and unexpectedly produce breast milk.

• Women to have no monthly period or irregular periods.

Your doctor may ask you to have blood tests from time to time.

Side effects in children and adolescents

The same side effects that may occur in adults may also occur in children and

adolescents.

The following side effects have been seen more often in children and adolescents or

have not been seen in adults:

Very Common side effects (may affect more than 1 in 10 people):

• Increase in the amount of a hormone called prolactin, in the blood. Increases in the

hormone prolactin could in rare cases lead to the following:

boys and girls to have swelling of breasts and unexpectedly produce breast milk

girls to have no monthly period or irregular periods.

• Increased appetite.

• Vomiting.

• Abnormal muscle movements. These include difficulty starting muscle movements,

shaking, feeling restless or muscle stiffness without pain.

• Increase in blood pressure.

Common side effects (may affect up to 1 in 10 people):

• Feeling weak, fainting (may lead to falls).

• Stuffy nose.

• Feeling irritated.

If any of the side effects gets serious, or if you notice any side effects not listed in this

leaflet, please tell your doctor or pharmacist.