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Children and adolescents

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

The following side effect has been seen only in children and adolescents:

Very common (may affect up to1 in 10 people):

•    Increase in blood pressure.

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

Very common (may affect up to1 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

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

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

•    Stuffy nose.

•    Feeling irritated.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme atwww.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine

What Seroquel looks like and contents of the pack

Seroquel 25mg Tablets are round, peach, biconvex, film-coated, and are marked with ‘Seroquel 25’ on one side and are plain on the reverse.

They come in packs of 6 tablets or 30 tablets.

Manufactured by: AstraZeneca Ltd,

Macclesfield, Cheshire, UKOrCorden Pharma GmbH, Plankstadt, Germany Or, AstraZeneca Pharma, Reims, France.

Procured from within the EU and repackaged by the Product Licence holder: B&S

Healthcare,

Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 ONU, UK

Seroquel 25mg Tablets

Leaflet Date: 15.12.2014

Seroquel is a trade mark of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel 25mg Tablets

(quetiapine fumarate)

Read all of this leaflet carefully before you start taking this medicine.

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

•    If 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.

•    If 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.

The name of your medicine is Seroquel 25mg Tablets but will be referred to as Seroquel throughout this leaflet. Please note that the leaflet also contains information about other strengths: Seroquel 100mg, 150mg, 200mg and 300mg film-coated Tablets.

In this leaflet:

1.    What Seroquel is and what it is used for

2.    Before you take Seroquel

3.    Howto take Seroquel

4.    Possible side effects

5.    Howto store Seroquel

6.    Further information

1. What Seroquel is and what it is used for

Seroquel contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Seroquel 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: 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.

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

2. Before you take Seroquel

Do not take Seroquel if:

•    You are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel (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 if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Seroquel.

Take special care with Seroquel

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.

•    You are an elderly person with dementia, (loss of brain function) If you are, Seroquel should not be taken because the group of medicines that Seroquel 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:

•    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. You and your doctor should check your weight regularly.

Taking other medicines

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

Do not take Seroquel 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).

Tell your doctor 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 medicine).

•    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 first.

Taking Seroquel with food and drink

•    Seroquel can be taken with or without food.

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

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

Pregnancy and breast-feeding

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

The following symptoms may occur in newborn babies of mothers that have used Seroquel 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.

Important information about some of the ingredients of Seroquel

Seroquel 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 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 may allow them to return.

3. How to take Seroquel

Always take Seroquel 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 a regular dose you will usually be taking between 150mg and 800mg each day. It will depend on your illness and needs.

•    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 Seroquel. 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 tablets come in 5 different strengths and each strength is a different colour or shape.

•    Even though the dose might stay the same, it might be supplied as different strength tablets. For example, one 300 mg tablet (white) or two 150 mg tablets (pale 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 should not be used by children and adolescents aged under 18 years.

If you take more Seroquel than you should

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

If you forget to take a dose of Seroquel

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

If you suddenly stop taking Seroquel, you may be unable to sleep (insomnia), 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 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.

If any of the following happen, stop taking Seroquel and contact a doctor or go to the nearest hospital straight away, as you may need urgent medical attention:

Uncommon (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.

•    Uncontrollable movements, mainly of your face or tongue (Tardive dyskinesia).

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

•    A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint, large increase in blood pressure or heartbeat (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).

•    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.

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

•    Severe allergic reaction (called anaphylaxis) that may include difficulty in breathing, dizziness, shock and collapse.

•    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).

Other possible side effects:

Very Common (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 Seroquel) (may lead to falls).

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

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

•    Rapid heartbeat.

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

•    Upset stomach (Indigestion) or constipation.

•    Swelling of arms or legs.

•    Increased levels of sugar in the blood.

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

•    Blurred vision.

•    Abnormal dreams and nightmares.

•    Feeling more hungry.

•    Feeling irritated.

•    Disturbance in speech or language.

•    Thoughts of suicide and worsening of your depression

•    Shortness of breath.

•    Vomiting (mainly in the elderly).

•    Fever.

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

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

•    Difficulty swallowing.

•    Sexual dysfunction.

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

•    Stuffy nose.

•    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.

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

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

•    Menstrual disorder.

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

•    Body temperature decreased (hypothermia).

•    Inflammation of the pancreas, which causes severe pain in the abdomen and back.

•    A condition (called “metabolic syndrome”) where you may 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.

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

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

•    Worsening of pre-existing diabetes.

•    Inappropriate secretion of a hormone that controls urine volume.

•    Breakdown of muscle fibres 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)

The class of medicines to which Seroquel 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.