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SEROQUEL 100MG TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel™ 100mg Tablets
(quetiapine fumarate)

Seroquel is available in the following strengths: 25mg,
100mg, 150mg, 200mg and 300mg. This leaflet only applies
to Seroquel 100mg Tablets which will be referred to as
Seroquel throughout this leaflet.

Read all of this leaflet carefully before you
start taking this medicine.







Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
If you get any side effects talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet. See Section 4.

In this leaflet:

1.
2.
3.
4.
5.
6.

What Seroquel is and what it is used for
What you need to know before you take Seroquel
How to take Seroquel
Possible side effects
How to store Seroquel
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
judgement including being aggressive or disruptive.

Schizophrenia: where you may hear or feel things that
are not there, believe things that are not true or feel
unusually suspicious, anxious, confused, guilty, tense or
depressed.
Your doctor may continue to prescribe Seroquel even when
you are feeling better.

2. What you need to know before you take
Seroquel
Do not take Seroquel:




If you are allergic (hypersensitive) to quetiapine or any
of the other ingredients of Seroquel (see Section 6:
Contents of the pack and other information).
If you are taking any of the following medicines:

some medicines for HIV

azole medicines (for fungal infections)

erythromycin or clarithromycin (for infections)

nefazodone (for depression).

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

Warnings and Precautions
Talk to your doctor or pharmacist before taking Seroquel
if:


















You, or someone in your family, have or have had any
heart problems, for example heart rhythm problems,
weakening of the heart muscle or inflammation of the
heart or if you are taking any medicines that may have
an impact on the way your heart beats.
You have low blood pressure.
You have had a stroke, especially if you are elderly.
You have problems with your liver.
You have ever had a fit (seizure).
You have diabetes or have a risk of getting diabetes. If
you do, your doctor may check your blood sugar levels
while you are taking Seroquel.
You know that you have had low levels of white blood
cells in the past (which may or may not have been
caused by other medicines).
You are an elderly person with dementia (loss of brain
function). If you are, Seroquel should not be taken
because the group of medicines that Seroquel belongs to
may increase the risk of stroke, or in some cases the
risk of death, in elderly people with dementia.
You or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots.
You have or have had a condition where you stop
breathing for short periods during your normal nightly
sleep (called “sleep apnoea”) and are taking medicines
that slow down the normal activity of the brain
(“depressants”).
You have or have had a condition where you can’t
completely empty your bladder (urinary retention), have
an enlarged prostate, a blockage in your intestines, or
increased pressure inside your eye. These conditions are
sometimes caused by medicines (called
“anti-cholinergics”) that affect the way nerve cells
function in order to treat certain medical conditions.

Tell your doctor immediately if you experience any of the
following after taking Seroquel:








A combination of fever, severe muscle stiffness,
sweating or a lowered level of consciousness (a disorder
called “neuroleptic malignant syndrome”). Immediate
medical treatment may be needed.
Uncontrollable movements, mainly of your face or
tongue.
Dizziness or a severe sense of feeling sleepy. This could
increase the risk of accidental injury (fall) in elderly
patients.
Fits (seizures).
A long-lasting and painful erection (Priapism).

These conditions can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

A fever, flu-like symptoms, sore throat, or any other
infection, as this could be a result of a very low white
blood cell count, which may require Seroquel to be
stopped and/or treatment to be given.

Constipation along with persistent abdominal pain, or
constipation which has not responded to treatment, as
this may lead to a more serious blockage of the bowel.



Thoughts of suicide and worsening of your
depression

Elderly people

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



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.
If you are elderly your doctor may change your dose.

Use in children and adolescents

Seroquel should not be used by children and adolescents
aged under 18 years.

If you take more Seroquel than you should

If you take more Seroquel than prescribed by your doctor,
you may feel sleepy, feel dizzy and experience abnormal
heart beats. Contact your doctor or nearest hospital straight
away. Keep the Seroquel tablets with you.

If you forget to take a dose of Seroquel

If you forget to take a dose, take it as soon as you
remember. If it is almost time to take the next dose, wait
until then. Do not take a double dose to make up for a
forgotten tablet.

If you stop taking Seroquel

If you suddenly stop taking Seroquel, you may be unable to
sleep (insomnia), or you may feel sick (nausea), or you may
experience headache, diarrhoea, being sick (vomiting),
dizziness or irritability. Your doctor may suggest you reduce
the dose gradually before stopping treatment.

Seroquel is not for use in children and adolescents below 18
years of age.

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

Other medicines and Seroquel

4. Possible side effects

Tell your doctor if you are taking or have recently taken any
other medicines.
Do not take Seroquel if you are taking any of the following
medicines:

Some medicines for HIV.

Azole medicines (for fungal infections).

Erythromycin or clarithromycin (for infections).

Nefazodone (for depression).
Tell your doctor if you are taking any of the following
medicines:

Epilepsy medicines (like phenytoin or carbamazepine).

High blood pressure medicines.

Barbiturates (for difficulty sleeping).

Thioridazine or Lithium (other anti-psychotic medicines).

Medicines that have an impact on the way your heart
beats, for example, drugs that can cause an imbalance
in electrolytes (low levels of potassium or magnesium)
such as diuretics (water pills) or certain antibiotics
(drugs to treat infections).

Medicines that can cause constipation.

Medicines (called “anti-cholinergics”) that affect the way
nerve cells function in order to treat certain medical
conditions.
Before you stop taking any of your medicines, please talk to
your doctor first.

Seroquel with food, drink and alcohol





Seroquel can be taken with or without food.
Be careful how much alcohol you drink. This is because
the combined effect of Seroquel and alcohol can make
you sleepy.
Do not drink grapefruit juice while you are taking
Seroquel. It can affect the way the medicine works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby ask your doctor for
advice before taking Seroquel. You should not take Seroquel
during pregnancy unless this has been discussed with your
doctor. Seroquel should not be taken if you are
breast-feeding.
The following symptoms which can represent withdrawal may
occur in newborn babies of mothers that have used Seroquel
in the last trimester (last three months of their pregnancy):
shaking, muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems, and difficulty in feeding. If
your baby develops any of these symptoms you may need to
contact your doctor.

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

Very common side effects (may affect more than 1
in 10 people):









Common side effects (may affect up to 1 in 10
people):





















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 monohydrate

Seroquel contains lactose monohydrate which is a type of
sugar. If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before taking
this medicine.

Effect on Urine Drug Screens

If you are having a urine drug screen, taking Seroquel may
cause positive results for methadone or certain drugs for
depression called tricyclic antidepressants (TCAs) when some
test methods are used, even though you may not be taking
methadone or TCAs. If this happens, a more specific test can
be performed.

3. How to take Seroquel
Always take Seroquel exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure. Your doctor will decide on your starting dose. The
maintenance dose (daily dose) will depend on your illness and
needs but will usually be between 150mg and 800mg.

You will take your tablets once a day, at bedtime or
twice a day, depending on your illness.

Swallow your tablets whole with a drink of water.

You can take your tablets with or without food.
Page 1 of 2

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).

Rapid heartbeat.
Feeling like your heart is pounding, racing or has
skipped beats.
Constipation, upset stomach (indigestion).
Feeling weak.
Swelling of arms or legs.
Low blood pressure when standing up. This may make
you feel dizzy or faint (may lead to falls).
Increased levels of sugar in the blood.
Blurred vision.
Abnormal dreams and nightmares.
Feeling more hungry.
Feeling irritated.
Disturbance in speech and language.
Thoughts of suicide and worsening of your depression.
Shortness of breath.
Vomiting (mainly in the elderly).
Fever.
Changes in the amount of thyroid hormones in your
blood.
Decreases in the number of certain types of blood cells.
Increases in the amount of liver enzymes measured in
the blood.
Increases in the amount of the hormone prolactin in the
blood. Increases in the hormone prolactin could in rare
cases lead to the following:

Men and women to have swelling breasts and
unexpectedly produce breast milk.

Women to have no monthly periods or irregular
periods.

Uncommon side effects (may affect up to 1 in 100
people):

















Fits or seizures.
Allergic reactions that may include raised lumps (weals),
swelling of the skin and swelling around the mouth.
Unpleasant sensations in the legs (also called restless
legs syndrome).
Difficulty swallowing.
Uncontrollable movements, mainly of your face and
tongue.
Sexual dysfunction.
Diabetes.
Change in electrical activity of the heart seen on ECG
(QT prolongation).
A slower than normal heart rate which may occur when
starting treatment and which may be associated with
low blood pressure and fainting.
Difficulty in passing urine.
Fainting (may lead to falls).
Stuffy nose.
Decrease in the amount of red blood cells.
Decrease in the amount of sodium in the blood.
Worsening of pre-existing diabetes.

Rare side effects (may affect up to 1 in 1,000
people):



















A combination of high temperature (fever), sweating,
stiff muscles, feeling very drowsy or faint (a disorder
called “neuroleptic malignant syndrome”).
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
A long-lasting and painful erection (priapism).
Swelling of breasts and unexpected production of breast
milk (galactorrhoea).
Menstrual disorder.
Blood clots in the veins especially in the legs (symptoms
include swelling, pain and redness in the leg), which
may travel through blood vessels to the lungs causing
chest pain and difficulty in breathing. If you notice any
of these symptoms seek medical advice immediately.
Walking, talking, eating or other activities while you are
asleep.
Body temperature decreased (hypothermia).
Inflammation of the pancreas.
A condition (called “metabolic syndrome”) where you
have a combination of 3 or more of the following: an
increase in fat around your abdomen, a decrease in
“good cholesterol” (HDL-C), an increase in a type of fat
in your blood called triglycerides, high blood pressure
and an increase in your blood sugar.
Combination of fever, flu-like symptoms, sore throat, or
any other infection with very low white blood cell count,
a condition called agranulocytosis.
Bowel obstruction.
Increased blood creatine phosphokinase (a substance
from the muscles).

Very rare side effects (may affect up to
1 in 10,000 people):







Severe rash, blisters, or red patches on the skin.
A severe allergic reaction (called anaphylaxis) which
may cause difficulty in breathing or shock.
Rapid swelling of the skin, usually around the eyes, lips
and throat (angioedema).
A serious blistering condition of the skin, mouth, eyes
and genitals (Stevens-Johnson syndrome).
Inappropriate secretion of a hormone that controls urine
volume.
Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis).

Not known (frequency cannot be estimated from
the available data):





Skin rash with irregular red spots (erythema
multiforme).
Serious, sudden allergic reaction with symptoms such as
fever and blisters on the skin and peeling of the skin
(toxic epidermal necrolysis).
Symptoms of withdrawal may occur in newborn babies
of mothers that have used Seroquel during their
pregnancy.

The class of medicines to which Seroquel belongs can cause
heart rhythm problems, which can be serious and in severe
cases may be fatal. Some side effects are only seen when a
blood test is taken. These include changes in the amount of
certain fats (triglycerides and total cholesterol) or sugar in
the blood, changes in the amount of thyroid hormones in your
blood, increased liver enzymes, decreases in the number of
certain types of blood cells, decrease in the amount of red
blood cells, increased blood creatine phosphokinase (a
substance in the muscles), decrease in the amount of sodium
in the blood and increases in the amount of the hormone
prolactin in the blood. Increases in the hormone prolactin
could in rare cases lead to the following:

Men and women to have swelling of the breasts and
unexpectedly produce breast milk.

Women to have no monthly period or irregular periods.
Your doctor may ask you to have blood tests from time to
time.

Side effects in children and adolescents

5. How to store Seroquel










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. Contents of the pack and other
information
What Seroquel contains

Each film-coated tablet contains 100mg 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 type A, lactose monohydrate,
magnesium stearate, hypromellose, macrogol 400,
titanium dioxide (E171) and yellow iron oxide (E172).

What Seroquel looks like and contents of the pack

Seroquel are yellow, round, bi-convex film-coated tablets
engraved with ‘Seroquel 100’ on one side and plain on the
reverse.

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

Manufacturer

Manufactured by:
AstraZeneca UK Limited, Macclesfield, Cheshire, England.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster,
DN3 1QR.
PL No: 08929/0299

POM

You can also get information on mental health from the
following national organisations:

MIND (National Association for Mental Health).
MindinfoLine: 0845 766 0163.

RETHINK (Formerly the National Schizophrenia
Fellowship). Advice Service: 0208 974 6814.

National Schizophrenia Fellowship (Scotland):
0131 662 4359.

SANELINE Helpline: 0845 767 8000.
If you wish to receive this leaflet in Braille, large font or audio
format please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product Name
Seroquel 100mg Tablets
Reference Number
08929/0299
Leaflet revision & issue date (Ref): 05.07.16
Seroquel™ is a trademark of the AstraZeneca group of
companies.

The same side effects that may occur in adults may also
occur in children and adolescents. The following side effects
have been seen more often in children and adolescents or
have not been seen in adults:

Very Common side effects (may affect more than 1
in 10 people):








Increase in the amount of a hormone called prolactin, in
the blood. Increases in the hormone prolactin could in
rare cases lead to the following:

boys and girls to have swelling of breasts and
unexpectedly produce breast milk

girls to have no monthly period or irregular
periods.
Increased appetite.
Vomiting.
Abnormal muscle movements. These include difficulty
starting muscle movements, shaking, feeling restless or
muscle stiffness without pain.
Increase in blood pressure.

Common side effects (may affect up to 1 in 10
people):




Feeling weak, fainting (may lead to falls).
Stuffy nose.
Feeling irritated.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme (Website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine 100mg Tablets
(quetiapine fumarate)

Quetiapine is available in the following strengths: 25mg,
100mg, 150mg, 200mg and 300mg. This leaflet only applies
to Quetiapine 100mg Tablets which will be referred to as
Quetiapine throughout this leaflet.

Read all of this leaflet carefully before you
start taking this medicine.







Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
If you get any side effects talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet. See Section 4.

In this leaflet:

1.
2.
3.
4.
5.
6.

What Quetiapine is and what it is used for
What you need to know before you take Quetiapine
How to take Quetiapine
Possible side effects
How to store Quetiapine
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
judgement 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 (hypersensitive) to quetiapine or any
of the other ingredients of Quetiapine (see Section 6:
Contents of the pack and other information).
If you are taking any of the following medicines:

some medicines for HIV

azole medicines (for fungal infections)

erythromycin or clarithromycin (for infections)

nefazodone (for depression).

Do not take Quetiapine if the above applies to you. 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.
You have low blood pressure.
You have had a stroke, especially if you are elderly.
You have problems with your liver.
You have ever had a fit (seizure).
You have diabetes or have a risk of getting diabetes. If
you do, your doctor may check your blood sugar levels
while you are taking Quetiapine.
You know that you have had low levels of white blood
cells in the past (which may or may not have been
caused by other medicines).
You are an elderly person with dementia (loss of brain
function). If you are, 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.
You or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots.
You have or have had a condition where you stop
breathing for short periods during your normal nightly
sleep (called “sleep apnoea”) and are taking medicines
that slow down the normal activity of the brain
(“depressants”).
You have or have had a condition where you can’t
completely empty your bladder (urinary retention), have
an enlarged prostate, a blockage in your intestines, or
increased pressure inside your eye. These conditions are
sometimes caused by medicines (called
“anti-cholinergics”) that affect the way nerve cells
function in order to treat certain medical conditions.

Tell your doctor immediately if you experience any of the
following after taking 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

Elderly people

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



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.
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 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 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.

Quetiapine is not for use in children and adolescents below 18
years of age.

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

Other medicines and Quetiapine

4. Possible side effects

Tell your doctor if you are taking or have recently taken 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 Quetiapine. 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.

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

Very common side effects (may affect more than 1
in 10 people):









Common side effects (may affect up to 1 in 10
people):





















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 monohydrate

Quetiapine contains lactose monohydrate 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 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. 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.
Page 1 of 2

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).

Rapid heartbeat.
Feeling like your heart is pounding, racing or has
skipped beats.
Constipation, upset stomach (indigestion).
Feeling weak.
Swelling of arms or legs.
Low blood pressure when standing up. This may make
you feel dizzy or faint (may lead to falls).
Increased levels of sugar in the blood.
Blurred vision.
Abnormal dreams and nightmares.
Feeling more hungry.
Feeling irritated.
Disturbance in speech and language.
Thoughts of suicide and worsening of your depression.
Shortness of breath.
Vomiting (mainly in the elderly).
Fever.
Changes in the amount of thyroid hormones in your
blood.
Decreases in the number of certain types of blood cells.
Increases in the amount of liver enzymes measured in
the blood.
Increases in the amount of the hormone prolactin in the
blood. Increases in the hormone prolactin could in rare
cases lead to the following:

Men and women to have swelling breasts and
unexpectedly produce breast milk.

Women to have no monthly periods or irregular
periods.

Uncommon side effects (may affect up to 1 in 100
people):

















Fits or seizures.
Allergic reactions that may include raised lumps (weals),
swelling of the skin and swelling around the mouth.
Unpleasant sensations in the legs (also called restless
legs syndrome).
Difficulty swallowing.
Uncontrollable movements, mainly of your face and
tongue.
Sexual dysfunction.
Diabetes.
Change in electrical activity of the heart seen on ECG
(QT prolongation).
A slower than normal heart rate which may occur when
starting treatment and which may be associated with
low blood pressure and fainting.
Difficulty in passing urine.
Fainting (may lead to falls).
Stuffy nose.
Decrease in the amount of red blood cells.
Decrease in the amount of sodium in the blood.
Worsening of pre-existing diabetes.

Rare side effects (may affect up to 1 in 1,000
people):



















A combination of high temperature (fever), sweating,
stiff muscles, feeling very drowsy or faint (a disorder
called “neuroleptic malignant syndrome”).
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
A long-lasting and painful erection (priapism).
Swelling of breasts and unexpected production of breast
milk (galactorrhoea).
Menstrual disorder.
Blood clots in the veins especially in the legs (symptoms
include swelling, pain and redness in the leg), which
may travel through blood vessels to the lungs causing
chest pain and difficulty in breathing. If you notice any
of these symptoms seek medical advice immediately.
Walking, talking, eating or other activities while you are
asleep.
Body temperature decreased (hypothermia).
Inflammation of the pancreas.
A condition (called “metabolic syndrome”) where you
have a combination of 3 or more of the following: an
increase in fat around your abdomen, a decrease in
“good cholesterol” (HDL-C), an increase in a type of fat
in your blood called triglycerides, high blood pressure
and an increase in your blood sugar.
Combination of fever, flu-like symptoms, sore throat, or
any other infection with very low white blood cell count,
a condition called agranulocytosis.
Bowel obstruction.
Increased blood creatine phosphokinase (a substance
from the muscles).

Very rare side effects (may affect up to
1 in 10,000 people):








Severe rash, blisters, or red patches on the skin.
A severe allergic reaction (called anaphylaxis) which
may cause difficulty in breathing or shock.
Rapid swelling of the skin, usually around the eyes, lips
and throat (angioedema).
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 Quetiapine during their
pregnancy.

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.
Your doctor may ask you to have blood tests from time to
time.

5. How to store Quetiapine










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. Contents of the pack and other
information
What Quetiapine contains

Each film-coated tablet contains 100mg 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 type A, lactose monohydrate,
magnesium stearate, hypromellose, macrogol 400,
titanium dioxide (E171) and yellow iron oxide (E172).

What Quetiapine looks like and contents of the pack

Quetiapine are yellow, round, bi-convex film-coated tablets
engraved with ‘Quetiapine 100’ on one side and plain on the
reverse.
They are available in blister packs containing 60 film-coated
tablets.

Manufacturer

Manufactured by:
AstraZeneca UK Limited, Macclesfield, Cheshire, England.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster,
DN3 1QR.
PL No: 08929/0299

POM

You can also get information on mental health from the
following national organisations:

MIND (National Association for Mental Health).
MindinfoLine: 0845 766 0163.

RETHINK (Formerly the National Schizophrenia
Fellowship).
Advice Service: 0208 974 6814.

National Schizophrenia Fellowship (Scotland):
0131 662 4359.

SANELINE Helpline: 0845 767 8000.
If you wish to receive this leaflet in Braille, large font or audio
format please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product Name
Quetiapine 100mg Tablets
Reference Number
08929/0299
Leaflet revision & issue date (Ref): 05.07.16

Side effects in children and adolescents

The same side effects that may occur in adults may also
occur in children and adolescents. The following side effects
have been seen more often in children and adolescents or
have not been seen in adults:

Very Common side effects (may affect more than 1
in 10 people):








Increase in the amount of a hormone called prolactin, in
the blood. Increases in the hormone prolactin could in
rare cases lead to the following:

boys and girls to have swelling of breasts and
unexpectedly produce breast milk

girls to have no monthly period or irregular
periods.
Increased appetite.
Vomiting.
Abnormal muscle movements. These include difficulty
starting muscle movements, shaking, feeling restless or
muscle stiffness without pain.
Increase in blood pressure.

Common side effects (may affect up to 1 in 10
people):




Feeling weak, fainting (may lead to falls).
Stuffy nose.
Feeling irritated.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme (Website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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