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SEROQUEL 200MG TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE

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Seroquel™ 200mg Tablets
(quetiapine fumarate)

Package Leaflet: Information for the User
Seroquel is available in the following strengths: 25mg, 100mg,
150mg, 200mg and 300mg. This leaflet only applies to Seroquel
200mg Tablets which will be referred to as Seroquel throughout
this leaflet.
Read all of this leaflet carefully before you start taking
this medicine.
ƒ Keep this leaflet. You may need to read it again.
ƒ If you have any further questions, ask your doctor or
pharmacist.
ƒ 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.
ƒ If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Seroquel is and what it is used for
Before you take Seroquel
How to take Seroquel
Possible side effects
How to store Seroquel
Further information

1. What Seroquel is and what it is used for
Seroquel contains a medicine called quetiapine. This belongs to a
group of medicines called anti-psychotics. Seroquel can be used
to treat several illnesses, such as:
ƒ 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.
ƒ Mania: where you may feel very excited, elated, agitated,
enthusiastic or hyperactive or have poor judgement including
being aggressive or disruptive.
ƒ Bipolar depression: where you may feel sad all the time or
you may find that you feel depressed, feel guilty, lack
energy, lose your appetite or can’t sleep.
Your doctor may continue to prescribe Seroquel even when you
are feeling better.

2. Before you take Seroquel
Do not take Seroquel if:
ƒ
ƒ

you are allergic (hypersensitive) to quetiapine or any of the
other ingredients of Seroquel (see Section 6 Further
information).
you are taking any of the following medicines:
ƒ protease inhibitors, such as nelfinavir (for HIV infection)
ƒ azole medicines (for fungal infections)
ƒ medicines for an infection (like erythromycin or
clarithromycin)
ƒ nefazodone (for depression).

Tell your doctor immediately if you experience:
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.
ƒ Uncontrollable movements, mainly of your face or tongue.
ƒ Dizziness or feeling very drowsy. This could increase the risk
of accidental injury (fall) in elderly patients.
ƒ Fits (seizures).
ƒ A long-lasting and painful erection (Priapism).

ƒ

Seroquel contains lactose monohydrate which is a type of sugar.
If you have been told by your doctor or pharmacist that you
cannot tolerate or digest some sugars, talk to your doctor before
taking this medicine.
If you have been on other medication for this condition, and that
medication has stopped your periods, changing to Seroquel may
allow them to return.

These conditions can be caused by this type of medicine.

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 has been seen in patients taking Seroquel. You and
your doctor should check your weight regularly.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines because it may affect the
way the medicines work. This includes medicines that you buy
without a prescription and herbal medicines.
In particular, tell your doctor if you are taking any of the
following medicines:
ƒ Epilepsy medicines (like phenytoin or carbamazepine).
ƒ High blood pressure medicines.
ƒ Rifampicin (for tuberculosis).
ƒ Barbiturates (for difficulty sleeping).
ƒ Thioridazine (another anti-psychotic medicine).
ƒ Medicines that affect the heart, for example, drugs that can
cause an imbalance in some of the chemicals in your blood
such as diuretics (water pills) or certain antibiotics.
Before you stop taking any of your medicines, please talk to your
doctor first.
If you have a urine drug screen, taking Seroquel could cause
positive results for methadone or drugs for depression called
tricyclic antidepressants (TCAs), even though you may not be
taking methadone or TCAs. The result will need to be confirmed
by a more specific test.

Taking Seroquel with food and drink
ƒ
ƒ

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 feel
sleepy.
Do not drink grapefruit juice while you are taking Seroquel.
It can affect the way the medicine works.

Do not take Seroquel if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Seroquel.

ƒ

Take special care with Seroquel

Pregnancy and breast-feeding

Before you take your medicine, tell your doctor if:
ƒ You, or someone in your family, have or have had any heart
problems such as a very fast heartbeat or prolonged QT on
an ECG (heart tracing), or if you are taking any medicines
that may have an impact on the way your heart beats.
ƒ You have low blood pressure.
ƒ You have had a stroke, especially if you are elderly.
ƒ You have problems with your liver.
ƒ You have ever had a fit (seizure).
ƒ 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).
ƒ 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.
ƒ You are an elderly person with dementia. 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.
ƒ 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.

Important information about some of the
ingredients of Seroquel

If you are pregnant, trying to get pregnant, or breast-feeding,
talk to your doctor before taking Seroquel.
The following symptoms 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.

Hospital - If you go into hospital, tell the medical staff that

you are taking Seroquel.

Page 1 of 2

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 and may gradually
increase it. When you are on your regular dose you will usually
be taking between 150mg and 800mg each day. It will depend
on your illness and needs.
ƒ You will take your tablets once a day, at bedtime or twice a
day, depending on your illness.
ƒ Swallow your tablets whole with a drink of water.
ƒ Do not stop taking your tablets even if you feel better, unless
your doctor tells you.
Seroquel tablets come in 5 different strengths and each strength
is a different colour or shape.
ƒ Even though the dose might stay the same, it might be
supplied as different strength tablets. For example, one
300mg tablet (white) or two 150mg tablets (pale yellow).
ƒ So don’t be surprised if the colour of your tablets changes
from time to time.

Liver problems

If you have liver problems your doctor may give you a lower
dose.

Elderly people

If you are elderly your doctor may give you a lower dose.

Children and adolescents under 18 years

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 faint or dizzy and have palpitations (a
pounding heartbeat). Contact your doctor or nearest hospital
straight away. Take 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 dose.

If you stop taking Seroquel

If you suddenly stop taking Seroquel, you may be unable to
sleep (insomnia), 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 product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Seroquel can cause side effects, although not
everybody gets them.

If any of the following happen, stop taking
Seroquel and contact a doctor or go to the nearest
hospital straight away, as you may need urgent
medical attention:
Uncommon (affects less than 1 in 100 people):
ƒ
ƒ
ƒ

Fits or seizures.
Allergic reactions that may include raised lumps (weals),
swelling of the skin and swelling around the mouth.
Uncontrollable movements, mainly of your face or tongue
(Tardive dyskinesia).

Rare (affects less than 1 in 1,000 people):
ƒ

ƒ
ƒ
ƒ
ƒ

A combination of high temperature (fever), sweating, stiff
muscles, feeling very drowsy or faint, large increase in blood
pressure or heartbeat (a disorder called “neuroleptic
malignant syndrome”).
Jaundice (yellowing of the skin and eyes).
Hepatitis (inflammation of the liver).
Priapism (a long-lasting and painful erection).
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.

Very rare (affects less than 1 in 10,000 people):
ƒ
ƒ
ƒ

Severe allergic reaction (called anaphylaxis) that may include
difficulty in breathing, dizziness and collapse.
Rapid swelling of the skin, usually around the eyes, lips and
throat (angioedema).
A severe rash, which may develop quickly. Symptoms may
include redness, blistering or peeling of the skin, with
possible blisters in the mouth or nose.

Other possible side effects:
Very common (affects more than 1 in 10 people):
ƒ
ƒ
ƒ

ƒ

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.

Common (affects less than 1 in 10 people):
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Rapid heartbeat.
Feeling like your heart is pounding, racing or has skipped
beats.
Indigestion or constipation.
Feeling weak.
Swelling of arms or legs.
High blood sugar.
Low blood pressure when standing. This may make you feel
dizzy or faint (may lead to falls).
Blurred vision.
Abnormal muscle movements. These include difficulty
starting muscle movements, shaking, feeling restless or
muscle stiffness without pain.
Abnormal dreams and nightmares.
Feeling more hungry.
Feeling irritated.
Disturbance in speech or language.
Thoughts of suicide and worsening of your depression.
Shortness of breath.
Vomiting (mainly in the elderly).
Fever.

The class of medicines to which Seroquel belongs can cause
heart rhythm problems, which can be serious and in severe cases
may be fatal.

Manufacturer

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
(including red blood cells), increased blood creatine
phosphokinase (a substance in the muscles), decreases 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:
ƒ Men and women to have swelling of the breasts and
unexpectedly produce breast milk.
ƒ Women to have no monthly period or irregular periods.

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Your doctor may ask you to have blood tests from time to time.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Children and adolescents

The same side effects that may occur in adults may also occur in
children and adolescents.
The following side effect has been seen only in children and
adolescents:

Very Common (affects more than 1 in 10 people):
ƒ

The following side effects have been seen more often in children
and adolescents:

Very Common (affects more than 1 in 10 people):
ƒ

ƒ
ƒ

ƒ

Restless legs.
Difficulty swallowing.
Sexual dysfunction.
Fainting (may lead to falls).
Stuffy nose.
Development of 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.

Rare (affects less than 1 in 1,000 people):
ƒ
ƒ
ƒ
ƒ
ƒ

Swelling of breasts and unexpected production of breast milk
(galactorrhoea).
Menstrual disorder.
Walking, talking, eating or other activities while you are
asleep.
Body temperature decreased (hypothermia).
Inflammation of the pancreas, which causes severe pain in
the abdomen and back.

Very rare (affects less than 1 in 10,000 people):
ƒ
ƒ
ƒ

Worsening of pre-existing diabetes.
Inappropriate secretion of a hormone that controls urine
volume.
Breakdown of muscle fibres and pain in muscles
(rhabdomyolysis).

Not known (can not be estimated from the available
data):
ƒ

Skin rash with irregular red spots (erythema multiforme).

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:
ƒ boys and girls to have swelling of breasts and
unexpectedly produce breast milk.
ƒ girls to have no monthly period or irregular periods.
Increased appetite.
Abnormal muscle movements. These include difficulty
starting muscle movements, shaking, feeling restless or
muscle stiffness without pain.

5. How to store Seroquel
ƒ
ƒ
ƒ
ƒ

Uncommon (affects less than 1 in 100 people):
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Increase in blood pressure.

ƒ
ƒ
ƒ

Do not store above 30ºC.
Store in the original package.
Keep out of the sight and reach of children.
Do not take your tablets after the expiry date printed on the
carton and blister strip label. The expiry date refers to the
last day of that month. Take any tablets which are out of
date back to the pharmacy.
If your doctor decides to stop your treatment, take any
tablets you have left back to the pharmacy.
If your tablets appear to be discoloured or show any other
signs of deterioration, take them back to your pharmacist
who will advise you what to do.
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. Further information
What Seroquel contains

Each film-coated tablet contains 200mg of the active ingredient
quetiapine (as fumarate).
Each film-coated tablet also contains several inactive ingredients
which allow it to be made. These are: povidone, calcium
hydrogen phosphate, microcrystalline cellulose, sodium starch
glycollate, lactose monohydrate, magnesium stearate,
hypromellose, macrogol and titanium dioxide.

What Seroquel looks like and contents of the pack
Seroquel are white, round, bi-convex film-coated tablets
engraved with ‘Seroquel 200’ on one side and plain on the
reverse.

They are available in blister packs containing 60 film-coated
tablets.

Page 2 of 2

Manufactured by: AstraZeneca UK Limited, Macclesfield,
Cheshire, England.

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0300

POM

You can also get information on mental health from the following
national organisations:
ƒ MIND (National Association for Mental Health).
MindinfoLine: 0845 766 0163.
ƒ RETHINK (Formerly the National Schizophrenia Fellowship).
Advice Service: 0208 974 6814.
ƒ National Schizophrenia Fellowship (Scotland):
0131 662 4359.
ƒ SANELINE Helpline: 0845 767 8000.
If you wish to receive this leaflet in Braille, large font or audio
format please contact 01302 552940 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product Name:
Seroquel 200mg Tablets
Reference Number:
08929/0300
Leaflet revision & issue date (Ref): 12.02.13
Seroquel™ is a trademark of the AstraZeneca group of
companies.

Quetiapine 200mg Tablets
(quetiapine fumarate)

Package Leaflet: Information for the User
Quetiapine is available in the following strengths: 25mg, 100mg,
150mg, 200mg and 300mg. This leaflet only applies to
Quetiapine 200mg Tablets which will be referred to as Quetiapine
throughout this leaflet.
Read all of this leaflet carefully before you start taking
this medicine.
ƒ Keep this leaflet. You may need to read it again.
ƒ If you have any further questions, ask your doctor or
pharmacist.
ƒ 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.
ƒ If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Quetiapine is and what it is used for
Before you take Quetiapine
How to take Quetiapine
Possible side effects
How to store Quetiapine
Further information

1. What Quetiapine is and what it is used for
Quetiapine contains a medicine called quetiapine. This belongs to
a group of medicines called anti-psychotics. Quetiapine can be
used to treat several illnesses, such as:
ƒ 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.
ƒ Mania: where you may feel very excited, elated, agitated,
enthusiastic or hyperactive or have poor judgement including
being aggressive or disruptive.
ƒ Bipolar depression: where you may feel sad all the time or
you may find that you feel depressed, feel guilty, lack
energy, lose your appetite or can’t sleep.
Your doctor may continue to prescribe Quetiapine even when you
are feeling better.

2. Before you take Quetiapine
Do not take Quetiapine if:
ƒ
ƒ

you are allergic (hypersensitive) to quetiapine or any of the
other ingredients of Quetiapine (see Section 6 Further
information).
you are taking any of the following medicines:
ƒ protease inhibitors, such as nelfinavir (for HIV infection)
ƒ azole medicines (for fungal infections)
ƒ medicines for an infection (like erythromycin or
clarithromycin)
ƒ nefazodone (for depression).

Tell your doctor immediately if you experience:
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.
ƒ Uncontrollable movements, mainly of your face or tongue.
ƒ Dizziness or feeling very drowsy. This could increase the risk
of accidental injury (fall) in elderly patients.
ƒ Fits (seizures).
ƒ A long-lasting and painful erection (Priapism).

ƒ

Quetiapine contains lactose monohydrate which is a type of
sugar. If you have been told by your doctor or pharmacist that
you cannot tolerate or digest some sugars, talk to your doctor
before taking this medicine.
If you have been on other medication for this condition, and that
medication has stopped your periods, changing to Quetiapine
may allow them to return.

These conditions can be caused by this type of medicine.

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 has been seen in patients taking Quetiapine. You
and your doctor should check your weight regularly.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines because it may affect the
way the medicines work. This includes medicines that you buy
without a prescription and herbal medicines.
In particular, tell your doctor if you are taking any of the
following medicines:
ƒ Epilepsy medicines (like phenytoin or carbamazepine).
ƒ High blood pressure medicines.
ƒ Rifampicin (for tuberculosis).
ƒ Barbiturates (for difficulty sleeping).
ƒ Thioridazine (another anti-psychotic medicine).
ƒ Medicines that affect the heart, for example, drugs that can
cause an imbalance in some of the chemicals in your blood
such as diuretics (water pills) or certain antibiotics.
Before you stop taking any of your medicines, please talk to your
doctor first.
If you have a urine drug screen, taking Quetiapine could cause
positive results for methadone or drugs for depression called
tricyclic antidepressants (TCAs), even though you may not be
taking methadone or TCAs. The result will need to be confirmed
by a more specific test.

Taking Quetiapine with food and drink
ƒ
ƒ

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 feel
sleepy.
Do not drink grapefruit juice while you are taking Quetiapine.
It can affect the way the medicine works.

Do not take Quetiapine if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Quetiapine.

ƒ

Take special care with Quetiapine

Pregnancy and breast-feeding

Before you take your medicine, tell your doctor if:
ƒ You, or someone in your family, have or have had any heart
problems such as a very fast heartbeat or prolonged QT on
an ECG (heart tracing), or if you are taking any medicines
that may have an impact on the way your heart beats.
ƒ You have low blood pressure.
ƒ You have had a stroke, especially if you are elderly.
ƒ You have problems with your liver.
ƒ You have ever had a fit (seizure).
ƒ 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).
ƒ 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.
ƒ You are an elderly person with dementia. 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.
ƒ 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.

Important information about some of the
ingredients of Quetiapine

If you are pregnant, trying to get pregnant, or breast-feeding,
talk to your doctor before taking Quetiapine.
The following symptoms 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.

Hospital - If you go into hospital, tell the medical staff that

you are taking Quetiapine.

Page 1 of 2

3. How to take Quetiapine
Always take Quetiapine 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 and may gradually
increase it. When you are on your regular dose you will usually
be taking between 150mg and 800mg each day. It will depend
on your illness and needs.
ƒ You will take your tablets once a day, at bedtime or twice a
day, depending on your illness.
ƒ Swallow your tablets whole with a drink of water.
ƒ Do not stop taking your tablets even if you feel better, unless
your doctor tells you.
Quetiapine tablets come in 5 different strengths and each
strength is a different colour or shape.
ƒ Even though the dose might stay the same, it might be
supplied as different strength tablets. For example, one
300mg tablet (white) or two 150mg tablets (pale yellow).
ƒ So don’t be surprised if the colour of your tablets changes
from time to time.

Liver problems

If you have liver problems your doctor may give you a lower
dose.

Elderly people

If you are elderly your doctor may give you a lower dose.

Children and adolescents under 18 years

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 faint or dizzy and have palpitations (a
pounding heartbeat). Contact your doctor or nearest hospital
straight away. Take the Quetiapine tablets with you.

If you forget to take a dose of 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 dose.

If you stop taking Quetiapine

If you suddenly stop taking Quetiapine, you may be unable to
sleep (insomnia), 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 product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Quetiapine can cause side effects, although
not everybody gets them.

If any of the following happen, stop taking
Quetiapine and contact a doctor or go to the
nearest hospital straight away, as you may need
urgent medical attention:
Uncommon (affects less than 1 in 100 people):
ƒ
ƒ
ƒ

Fits or seizures.
Allergic reactions that may include raised lumps (weals),
swelling of the skin and swelling around the mouth.
Uncontrollable movements, mainly of your face or tongue
(Tardive dyskinesia).

Rare (affects less than 1 in 1,000 people):
ƒ

ƒ
ƒ
ƒ
ƒ

A combination of high temperature (fever), sweating, stiff
muscles, feeling very drowsy or faint, large increase in blood
pressure or heartbeat (a disorder called “neuroleptic
malignant syndrome”).
Jaundice (yellowing of the skin and eyes).
Hepatitis (inflammation of the liver).
Priapism (a long-lasting and painful erection).
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.

Very rare (affects less than 1 in 10,000 people):
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Severe allergic reaction (called anaphylaxis) that may include
difficulty in breathing, dizziness and collapse.
Rapid swelling of the skin, usually around the eyes, lips and
throat (angioedema).
A severe rash, which may develop quickly. Symptoms may
include redness, blistering or peeling of the skin, with
possible blisters in the mouth or nose.

Other possible side effects:
Very common (affects more than 1 in 10 people):
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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.

Common (affects less than 1 in 10 people):
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Rapid heartbeat.
Feeling like your heart is pounding, racing or has skipped
beats.
Indigestion or constipation.
Feeling weak.
Swelling of arms or legs.
High blood sugar.
Low blood pressure when standing. This may make you feel
dizzy or faint (may lead to falls).
Blurred vision.
Abnormal muscle movements. These include difficulty
starting muscle movements, shaking, feeling restless or
muscle stiffness without pain.
Abnormal dreams and nightmares.
Feeling more hungry.
Feeling irritated.
Disturbance in speech or language.
Thoughts of suicide and worsening of your depression.
Shortness of breath.
Vomiting (mainly in the elderly).
Fever.

The class of medicines to which Quetiapine belongs can cause
heart rhythm problems, which can be serious and in severe cases
may be fatal.

Manufacturer

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
(including red blood cells), increased blood creatine
phosphokinase (a substance in the muscles), decreases 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:
ƒ Men and women to have swelling of the breasts and
unexpectedly produce breast milk.
ƒ Women to have no monthly period or irregular periods.

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Your doctor may ask you to have blood tests from time to time.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Children and adolescents

The same side effects that may occur in adults may also occur in
children and adolescents.
The following side effect has been seen only in children and
adolescents:

Very Common (affects more than 1 in 10 people):
ƒ

The following side effects have been seen more often in children
and adolescents:

Very Common (affects more than 1 in 10 people):
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Restless legs.
Difficulty swallowing.
Sexual dysfunction.
Fainting (may lead to falls).
Stuffy nose.
Development of 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.

Rare (affects less than 1 in 1,000 people):
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Swelling of breasts and unexpected production of breast milk
(galactorrhoea).
Menstrual disorder.
Walking, talking, eating or other activities while you are
asleep.
Body temperature decreased (hypothermia).
Inflammation of the pancreas, which causes severe pain in
the abdomen and back.

Very rare (affects less than 1 in 10,000 people):
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Worsening of pre-existing diabetes.
Inappropriate secretion of a hormone that controls urine
volume.
Breakdown of muscle fibres and pain in muscles
(rhabdomyolysis).

Not known (can not be estimated from the available
data):
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Skin rash with irregular red spots (erythema multiforme).

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:
ƒ boys and girls to have swelling of breasts and
unexpectedly produce breast milk.
ƒ girls to have no monthly period or irregular periods.
Increased appetite.
Abnormal muscle movements. These include difficulty
starting muscle movements, shaking, feeling restless or
muscle stiffness without pain.

5. How to store Quetiapine
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Uncommon (affects less than 1 in 100 people):
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Increase in blood pressure.

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Do not store above 30ºC.
Store in the original package.
Keep out of the sight and reach of children.
Do not take your tablets after the expiry date printed on the
carton and blister strip label. The expiry date refers to the
last day of that month. Take any tablets which are out of
date back to the pharmacy.
If your doctor decides to stop your treatment, take any
tablets you have left back to the pharmacy.
If your tablets appear to be discoloured or show any other
signs of deterioration, take them back to your pharmacist
who will advise you what to do.
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. Further information
What Quetiapine contains

Each film-coated tablet contains 200mg of the active ingredient
quetiapine (as fumarate).
Each film-coated tablet also contains several inactive ingredients
which allow it to be made. These are: povidone, calcium
hydrogen phosphate, microcrystalline cellulose, sodium starch
glycollate, lactose monohydrate, magnesium stearate,
hypromellose, macrogol and titanium dioxide.

What Quetiapine looks like and contents of the
pack

Quetiapine are white, round, bi-convex film-coated tablets
engraved with ‘Quetiapine 200’ on one side and plain on the
reverse.
They are available in blister packs containing 60 film-coated
tablets.

Page 2 of 2

Manufactured by: AstraZeneca UK Limited, Macclesfield,
Cheshire, England.

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0300

POM

You can also get information on mental health from the following
national organisations:
ƒ MIND (National Association for Mental Health).
MindinfoLine: 0845 766 0163.
ƒ RETHINK (Formerly the National Schizophrenia Fellowship).
Advice Service: 0208 974 6814.
ƒ National Schizophrenia Fellowship (Scotland):
0131 662 4359.
ƒ SANELINE Helpline: 0845 767 8000.
If you wish to receive this leaflet in Braille, large font or audio
format please contact 01302 552940 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product Name:
Quetiapine 200mg Tablets
Reference Number:
08929/0300
Leaflet revision & issue date (Ref): 12.02.13

Expand view ⇕

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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