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SEROQUEL 300MG TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Seroquel 25mg Tablets / Quetiapine 25mg Tablets
Seroquel® 200mg Tablets / Quetiapine 200mg Tablets
Seroquel® 300mg Tablets / Quetiapine 300mg Tablets
(quetiapine fumarate)
This product is available as any of the above names but will be referred to as
Seroquel throughout the following leaflet. Please note that the leaflet also contains
information about other strengths (Seroquel 100mg and 150mg Tablets).
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 you get any side effects talk to your doctor or pharmacist. This includes any side
effects not listed in this leaflet. See Section 4.
In this leaflet:
1. What Seroquel is and what it is used for
2. What you need to know before you take Seroquel
3. How to take Seroquel
4. Possible side effects
5. How to store Seroquel
6. Contents of the pack and other 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:
 Bipolar depression: where you feel sad. You may find that you feel depressed,
feel guilty, lack energy, lose your appetite or can’t sleep.
 Mania: where you may feel very excited, elated, agitated, enthusiastic or
hyperactive or have poor judgment including being aggressive or disruptive.
 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.
Your doctor may continue to prescribe Seroquel even when you are feeling better.
2. What you need to know 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).
 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 Seroquel if the above applies to you. If you are not sure, talk to your
doctor or pharmacist before taking Seroquel.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Seroquel 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 Seroquel.
 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,
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.
 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
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.
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 Seroquel 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 Seroquel. You and your doctor
should check your weight regularly.
Children and Adolescents
Seroquel is not for use in children and adolescents below 18 years of age.
Other medicines and Seroquel
Tell your doctor if you are taking or have recently taken any other 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.
 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.
Seroquel with food, drink and alcohol
 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 or breast-feeding, think you may be pregnant or planning to
have a baby ask your doctor for advice 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 breast-feeding.
The following symptoms which can represent withdrawal 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.
Seroquel contains lactose
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.
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. 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 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.
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
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 dizzy and experience abnormal heart beats. Contact your doctor or nearest
hospital straight away. Keep 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), 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 medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Seroquel 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 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.
 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 (StevensJohnson 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 Seroquel during their pregnancy.
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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Seroquel
 Do not store above 30°C. Store in their original package.
 Keep all medicines out of the sight and reach of children.
 Do not use after the expiry date printed on the carton label or blister strip. The
expiry date refers to the last day of that month.
 If the tablets become discoloured or show any other signs of deterioration, you
should ask your doctor or pharmacist for advice.
 Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Seroquel contains
Your medicine is called Seroquel. Each film-coated tablet contains quetiapine
fumarate equivalent to 25mg, 200mg and 300mg quetiapine.
Seroquel also contains the following inactive ingredients:
lactose monohydrate, hypromellose, povidone, calcium hydrogen phosphate,
sodium starch glycollate, macrogol, microcrystalline cellulose, magnesium
stearate, titanium dioxide (E171).
Seroquel 25mg tablets also contain red iron oxide (E172) and yellow iron oxide
(E172).
What Seroquel looks like and contents of the pack
Seroquel 25mg Tablets are round, peach coloured, film-coated tablets marked
‘SEROQUEL 25’ on one side and a plain reverse. They are supplied as blister
packs of 30 and 6 tablets.
Seroquel 200mg Tablets are round, white, film-coated tablets marked
‘SEROQUEL 200’ on one side and plain on the reverse. They are supplied as
blister packs of 60 tablets.
Seroquel 300mg Tablets are oblong, white, film-coated tablets marked
‘SEROQUEL’ on one side and ‘300’ on the reverse. They are supplied as blister
packs of 60 tablets.
Manufacturer
Manufacturer by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield,
Cheshire and procured from within the EU and repackaged by the PL holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
POM
25mg
PL No: 15814/0727
200mg
PL No: 15814/0763
300mg
PL No: 15814/0769
Leaflet revision and issue date (Ref.): 19.01.2016.
Seroquel is a registered trade mark of AstraZeneca group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923
332 796.
You can also get information on mental health from the following national
organisations:
 MIND (National Association for Mental Health). MindinfoLine: 0845 766 0163.
 RETHINK (Formerly the National Schizophrenia Fellowship). Advice Service:
0208 974 6814.
 National Schizophrenia Fellowship (Scotland): 0131 662 4359.
 SANELINE Helpline: 0845 767 8000.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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