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SEROQUEL 100MG FILM-COATED TABLETS

Active substance(s): QUETIAPINE FUMARATE

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Package Leaflet: Information for the User

Seroquel® 100mg film-coated 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 you get any side effects talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet. See Section 4.
• The name of this medicine is Seroquel 100mg film-coated tablets but
will be referred to as Seroquel throughout the remainder of this leaflet.
• Seroquel film-coated tablets are also available in other strengths.
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: Contents of the pack and other
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 “anticholinergics”) 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 150mg and
800mg.
• 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.

• 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 fibres and pain in muscles (rhabdomyolysis).

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.

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.

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

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.

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).

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 30oC. Store in the original package.
• Keep your Seroquel tablets in a safe place, where children cannot see
or reach them.
• If your doctor stops your treatment, take any leftover tablets back to
the pharmacy.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Do not take your tablets after the expiry date on the container. The
expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are no
longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Seroquel contains:
Each tablet contains quetiapine fumarate equivalent to 100mg
quetiapine. Quetiapine is the active medicine.
They also contain other ingredients: povidone, calcium hydrogen
phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate
type A, lactose monohydrate, magnesium stearate, hypromellose,
macrogol, titanium dioxide (E171) and yellow ferric oxide (E172).
What Seroquel looks like and contents of the pack
Seroquel 100mg film-coated tablets are round, yellow, bi-convex tablets,
marked ‘SEROQUEL 100’ on one side and plain on the other.
Seroquel 100mg film-coated tablets are available as blister packs of 60
tablets.
Manufactured by
AstraZeneca UK Ltd, Macclesfield, Cheshire UK.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL: 33532/0377

POM

Leaflet dated 11th February 2016
Leaflet coded xxxxxxxxxxxx
Seroquel® is a registered trademark of the AstraZeneca group of
companies.
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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