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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® 100 mg Film-Coated Tablets
(quetiapine fumarate)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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 only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Seroquel 100mg film-coated tablets
but will be referred to as Seroquel throughout the remainder of the
leaflet.
Your medicine is also available in strengths of 25mg, 200mg and
300mg.
What is 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 to quetiapine or any of the other ingredients
of this medicine (listed in 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).
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.
• if you have low blood pressure.
• if you have had a stroke, especially if you are elderly.
• if you have problems with your liver.
• if you have ever had a fit (seizure).
• if 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.
• if 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).









if 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.
if 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.
if 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”).
if 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.
if you have a history of alcohol or drug abuse.

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, have recently taken or might
take 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 this medicine. 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 this medicine exactly as your doctor has told you.
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 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, this medicine can cause side effects, although
not everybody gets them.
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.
• Changes in the amount of certain fats (triglycerides and total
cholesterol).
Common: 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: 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: 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: 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.
Additional 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: 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: 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 at:
(Website: www.mhra.gov.uk/yellowcard) or search for MHRA
Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Seroquel
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use Seroquel after the expiry date, which is stated on the
carton after the letters ‘EXP’. The expiry date refers to the last day
of that month.
If the tablets show any signs of discolouration or deterioration
consult your pharmacist for advice.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Seroquel contains
Each film-coated tablet contains 100 mg quetiapine (as quetiapine
fumarate).
The other ingredients are:
Tablet core: povidone, calcium hydrogen phosphate,
microcrystalline cellulose, sodium starch glycollate Type A,
lactose monohydrate, magnesium stearate.
Tablet coating: hypromellose, macrogol, titanium dioxide (E171),
iron oxide yellow (E172).
What Seroquel looks like and contents of the pack
Seroquel 100 mg film-coated tablets are yellow, round biconvex
and engraved with SEROQUEL 100 on one side and plain on the
reverse.
Seroquel 100 mg film-coated tablets are available in pack size 60.
Manufactured by: AstraZeneca UK Ltd, Macclesfield, Cheshire,
United Kingdom. Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock
Way, Lostock, Bolton BL6 4SA. Repackaged by: Maxearn Ltd,
Bolton, BL6 4SA.
Seroquel 100 mg Film-Coated Tablets PL20774/1539
Seroquel is a registered trademark

POM

th
Date of Preparation 13 November 2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant
Pharmaceuticals Ltd,
Tel: 01204 473081
You can also get information on mental health from the following
national organisation:






MIND (National Association for Mental Health).
MindinfoLine: 0845 766 0163
RETHINK (Formerly the National Scizophrenia Fellowship).
Advice Service: 020 8974 8614
National Schizophrenia Fellowship (Scotland): 0131 662
4359
SANELINE Helpline: 0845 767 8000.

PP1/1539/V3

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