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SEROQUEL 100 MG FILM-COATED TABLETS

Active substance(s): QUETIAPINE FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

P040960

Seroquel 25 mg, 100 mg, 150 mg, 200 mg and 300 mg
film-coated tablets
quetiapine
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.

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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 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.

6. Contents of the pack and other information
What Seroquel contains
• The active substance is quetiapine. Seroquel
tablets contain 25 mg, 100 mg, 150 mg,
200 mg or 300 mg of quetiapine (as quetiapine
fumarate).
The other ingredients are:
Tablet core: povidone, calcium hydrogen
phosphate dihydrate, microcrystalline cellulose,
sodium starch glycollate Type A, lactose
monohydrate, magnesium stearate.
Tablet coating: hypromellose, macrogol, titanium
dioxide (E171). The 25 mg, 100 mg and 150 mg
tablet also contain iron oxide yellow (E172) and
the 25 mg contain iron oxide red (E172).
What Seroquel looks like and contents of
the pack
Seroquel 25 mg film-coated tablets are peach
coloured, round biconvex and engraved with
SEROQUEL 25 on one side
Seroquel 100 mg film-coated tablets are
yellow, round biconvex and engraved with
SEROQUEL 100 on one side
Seroquel 150 mg film-coated tablets are pale
yellow, round biconvex and engraved with
SEROQUEL 150 on one side
Seroquel 200 mg film-coated tablets are
white, round biconvex and engraved with
SEROQUEL 200 on one side
Seroquel 300 mg film-coated tablets are white,
capsule-shaped and engraved with SEROQUEL
on one side and 300 on the other side
Pack sizes of 20, 30, 50, 60 and 100 tablets are
registered for all strengths. In addition, for 25 mg
tablets pack size of 6 tablets is registered. For
100 mg, 150 mg, 200 mg and 300 mg tablets
pack sizes of 10, 90 are registered. For 150 mg
and 300 mg tablets pack sizes of 120, 180 and
240 tablets are registered. For 3-Day Starterpack
pack size of 8 tablets is registered and for 4-Day
Starterpack pack size of 10 tablets is registered.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
• The Marketing Authorisations for Seroquel
are held by AstraZeneca UK Limited,
600 Capability Green, Luton, LU1 3LU,
United Kingdom.
• The tablets are made by AstraZeneca UK Limited,
Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, United Kingdom,
or AstraZeneca Pharmaceuticals LP,
587 Old Baltimore Pike, Newark,
Delaware 19702, USA.
This medicinal product is authorised in the
Member states of the EEA under the following
names:
Country
Trade name
Austria
Seroquel
Belgium
Seroquel
Croatia
Seroquel
Cyprus
Seroquel
Denmark
Seroquel
Estonia
Seroquel
Finland
Seroquel
Germany
Seroquel® 25 mg Filmtabletten,
Seroquel® 100 mg Filmtabletten,
Seroquel® 200 mg Filmtabletten,
Seroquel® 300 mg Filmtabletten
Greece
Seroquel
Iceland
Seroquel
Ireland
Seroquel
Italy
Seroquel
Latvia
Seroquel
Lithuania
Seroquel
Luxembourg
Seroquel
Malta
Seroquel
Netherlands
Seroquel
Norway
Seroquel
Portugal
Seroquel
Romania
Seroquel
Slovenia
Seroquel
Spain
Seroquel
Sweden
Seroquel
United Kingdom Seroquel

To listen to, or request
a copy of this leaflet in
Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the
following information:
Product name Reference
number
Seroquel 25 mg PL
film-coated
17901/0038
tablets
Seroquel 100 mg PL
film-coated
17901/0039
tablets
Seroquel 150 mg PL
film-coated
17901/0041
tablets
Seroquel 200 mg PL
film-coated
17901/0040
tablets
Seroquel 300 mg PL
film-coated
17901/0088
tablets
This leaflet was last revised in August 2015.
CNS 15 0027
Seroquel is a trade mark of the AstraZeneca
group of companies.
© AstraZeneca 2015
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.

5. How to store Seroquel
• Keep this medicine out of the reach and sight
of children.
• Do not use Seroquel after the expiry date
which is stated on the container after EXP. The
expiry date refers to the last day of that month.
• Do not store above 30°C.
• 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.

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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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