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QUETIAPINE 100MG FILM-COATED TABLETS

Active substance(s): QUETIAPINE FUMARATE / QUETIAPINE FUMARATE / QUETIAPINE FUMARATE

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Patient Information Leaflet

Seroquel® 100mg 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 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.
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

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).

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.

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.

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

Before you stop taking any of your medicines, please talk to your doctor
first.

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.

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 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 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.

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, 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).

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:

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.

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.

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.

 Keep out of the sight and reach of children.
 Do not store above 30oC.
 Do not use this medicine after the expiry date which is stated on the
carton and the blister. The expiry date refers to the last day of that
month.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 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.

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 fibres and pain in muscles (rhabdomyolysis).

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
(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

6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Seroquel contains
The active substance is quetiapine. Each tablet contains 100mg
quetiapine (as fumarate).
The other ingredients are:
Core: povidone, calcium hydrogen phosphate dihydrate, microcrystalline
cellulose, sodium starch glycolate Type A, lactose monohydrate and
magnesium stearate.
Coating: hypromellose, macrogol, titanium dioxide (E171) and iron oxide
yellow (E172).
What Seroquel looks like and contents of the pack
Seroquel 100mg film-coated tablets are yellow, round, biconvex tablets
engraved with 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 MPT Pharma Ltd.
Leaflet dated 17th March 2017
Leaflet coded xxxxxxxx

POM

PL 33532/0788
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: 020 8974 6814.
 National Schizophrenia Fellowship (Scotland): 0131 662 4359.
 SANELINE Helpline: 0845 767 8000.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Patient Information Leaflet

Quetiapine 100mg 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 this medicine is Quetiapine 100mg film-coated tablets but
will be referred to as Quetiapine throughout the remainder of this
leaflet.
 Quetiapine film-coated tablets are also available in other strengths.
What is in this leaflet
1) What Quetiapine is and what it is used for
2) What you need to know before you take Quetiapine
3) How to take Quetiapine
4) Possible side effects
5) How to store Quetiapine
6) Contents of the pack and other information
1) WHAT QUETIAPINE IS AND WHAT IT IS USED FOR
Quetiapine contains a substance called quetiapine.
This belongs to a group of medicines called anti-psychotics. Quetiapine
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 Quetiapine even when you are
feeling better.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE
Do not take Quetiapine:
 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
Quetiapine.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Quetiapine:
 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
Quetiapine.
 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, Quetiapine should not be taken because the group of
medicines that Quetiapine 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 Quetiapine:
 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 Quetiapine 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 Quetiapine. You and your
doctor should check your weight regularly.
Children and adolescents
Quetiapine is not for use in children and adolescents below 18 years of
age.
Other medicines and Quetiapine
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Do not take Quetiapine 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.
Quetiapine with food, drink and alcohol
 Quetiapine can be taken with or without food.
 Be careful how much alcohol you drink. This is because the combined
effect of Quetiapine and alcohol can make you sleepy.
 Do not drink grapefruit juice while you are taking Quetiapine. 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 Quetiapine during pregnancy unless this
has been discussed with your doctor. Quetiapine 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 Quetiapine 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.
Quetiapine contains lactose
Quetiapine 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 Quetiapine 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 QUETIAPINE
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 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 Quetiapine. 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
Quetiapine should not be used by children and adolescents aged under
18 years.
If you take more Quetiapine than you should
If you take more Quetiapine 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 Quetiapine tablets with
you.
If you forget to take Quetiapine
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 Quetiapine
If you suddenly stop taking Quetiapine, 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 Quetiapine 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 Quetiapine 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, 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
Quetiapine) (may lead to falls).
 Discontinuation symptoms (symptoms which occur when you stop
taking Quetiapine) 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).

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:

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.

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.

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.

 Keep out of the sight and reach of children.
 Do not store above 30oC.
 Do not use this medicine after the expiry date which is stated on the
carton and the blister. The expiry date refers to the last day of that
month.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 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.

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 fibres and pain in muscles (rhabdomyolysis).

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
(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 QUETIAPINE

6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Quetiapine contains
The active substance is quetiapine. Each tablet contains 100mg
quetiapine (as fumarate).
The other ingredients are:
Core: povidone, calcium hydrogen phosphate dihydrate, microcrystalline
cellulose, sodium starch glycolate Type A, lactose monohydrate and
magnesium stearate.
Coating: hypromellose, macrogol, titanium dioxide (E171) and iron oxide
yellow (E172).
What Quetiapine looks like and contents of the pack
Quetiapine 100mg film-coated tablets are yellow, round, biconvex tablets
engraved with SEROQUEL 100 on one side and plain on the other.
Quetiapine 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 MPT Pharma Ltd.
Leaflet dated 17th March 2017
Leaflet coded xxxxxxxx

POM

PL 33532/0788
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: 020 8974 6814.
 National Schizophrenia Fellowship (Scotland): 0131 662 4359.
 SANELINE Helpline: 0845 767 8000.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Expand Transcript

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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