Skip to Content

UK Edition. Click here for US version.

SEROQUEL 300MG TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Revision date: 03.01.2017
Leaflet reference: SER300 /UT

SEROQUEL® 300MG TABLETS
(quetiapine fumarate)
medicines that Seroquel belongs to may increase the risk of stroke, or
Your medicine is known by the above names, but will be referred to as
in some cases the risk of death, in elderly people with dementia.
Seroquel® Tablets throughout this leaflet. Please note that other strengths
 if you or someone else in your family has a history of blood clots, as
of this product (25mg, 150mg, and 300mg tablets) are available and the
medicines like these have been associated with formation of blood
information is covered in this leaflet.
clots.
Read all of this leaflet carefully before you start taking this medicine
 if you have or have had a condition where you stop breathing for short
because it contains important information for you.
periods during your normal nightly sleep (called “sleep apnoea”) and
 Keep this leaflet. You may need to read it again.
are taking medicines that slow down the normal activity of the brain
 If you have any further questions, ask your doctor or pharmacist.
(“depressants”).
 if you have or have had a condition where you can’t completely empty
 This medicine has been prescribed for you only.
your bladder (urinary retention), have an enlarged prostate, a blockage
Do not pass it on to others. It may harm them, even if their signs of illness
in your intestines, or increased pressure inside your eye. These
are the same as yours.
conditions are sometimes caused by medicines (called “anti If you get any side effects talk to your doctor or pharmacist. This
cholinergics”) that affect the way nerve cells function in order to treat
includes any possible side effects not listed in this leaflet. See section
certain medical conditions.
4.
 if you have a history of alcohol or drug abuse.
What is in this leaflet
Tell your doctor immediately if you experience any of the following after
taking Seroquel® Tablets:
1. What Seroquel® Tablets is and what it is used for
®
 A combination of fever, severe muscle stiffness, sweating or a lowered
2. What you need to know before you take Seroquel Tablets
level of consciousness (a disorder called “neuroleptic malignant
3. How to take Seroquel® Tablets
syndrome”). Immediate medical treatment may be needed.
4. Possible side effects
 Uncontrollable movements, mainly of your face or tongue.
5. How to store Seroquel® Tablets
6. Contents of the pack and other information
 Dizziness or a severe sense of feeling sleepy. This could increase the
risk of accidental injury (fall) in elderly patients.
 Fits (seizures).
1. WHAT SEROQUEL® TABLETS ARE AND WHAT THEY ARE USED
 A long-lasting and painful erection (Priapism).
FOR
These conditions can be caused by this type of medicine.
Tell your doctor as soon as possible if you have:
Seroquel® Tablets contain a substance called quetiapine. This belongs to
a group of medicines called anti-psychotics. Seroquel® Tablets can be
 A fever, flu-like symptoms, sore throat, or any other infection, as this
used to treat several illnesses, such as:
could be a result of a very low white blood cell count, which may
require Seroquel® Tablets to be stopped and/or treatment to be given.
 Bipolar depression: where you feel sad. You may find that you feel

Constipation along with persistent abdominal pain, or constipation
depressed, feel guilty, lack energy, lose your appetite or can’t sleep.
which has not responded to treatment, as this may lead to a more
 Mania: where you may feel very excited, elated, agitated, enthusiastic
serious blockage of the bowel.
or hyperactive or have poor judgment including being aggressive or
disruptive.
 Thoughts of suicide and worsening of your depression
 Schizophrenia: where you may hear or feel things that are not there,
If you are depressed you may sometimes have thoughts of harming or
believe things that are not true or feel unusually suspicious, anxious,
killing yourself. These may be increased when first starting treatment,
confused, guilty, tense or depressed.
since these medicines all take time to work, usually about two weeks but
sometimes longer. These thoughts may also be increased if you suddenly
Your doctor may continue to prescribe Seroquel® Tablets even when you
stop taking your medication. You may be more likely to think like this if
are feeling better.
you are a young adult. Information from clinical trials has shown an
increased risk of suicidal thoughts and/or suicidal behaviour in young
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SEROQUEL ®
adults aged less than 25 years with depression.
TABLETS
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
®
Do not take Seroquel Tablets:
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
 if you are allergic to quetiapine or any of the other ingredients of this
getting worse, or if they are worried about changes in your behaviour.
medicine (listed in section 6).
 if you are taking any of the following medicines:
Weight gain

Some medicines for HIV
Weight gain has been seen in patients taking Seroquel® Tablets. You and

Azole medicines (for fungal infections)
your doctor should check your weight regularly.

Erythromycin or clarithromycin (for infections)

Nefazodone (for depression).
Do not take Seroquel® Tablets if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Seroquel® Tablets.

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

Warnings and Precautions

Other medicines and Seroquel® Tablets

Talk to your doctor or pharmacist before taking Seroquel® Tablets:
 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® Tablets.
 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® Tablets should not be taken because the group of

4

Tell your doctor if you are taking, have recently taken or might take any
other medicines. Do not take Seroquel® Tablets 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

1

If you forget to take Seroquel® Tablets

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.

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® Tablets
If you suddenly stop taking Seroquel® Tablets, you may be unable to
sleep (insomnia), or you may feel sick (nausea), or you may experience
headache, diarrhoea, being sick (vomiting), dizziness or irritability. Your
doctor may suggest you reduce the dose gradually before stopping
treatment.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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

4. POSSIBLE SIDE EFFECTS

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® Tablets during pregnancy
unless this has been discussed with your doctor. Seroquel® Tablets
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® Tablets 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, 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® Tablets) (may lead to falls).
 Discontinuation symptoms (symptoms which occur when you stop
taking Seroquel® Tablets) 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).

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® Tablets contains lactose
Seroquel® Tablets contain 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.

Common: may affect up to 1 in 10 people







Effect on Urine Drug Screens
If you are having a urine drug screen, taking Seroquel® Tablets 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® TABLETS
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. Your doctor will decide on
your starting dose. The maintenance dose (daily dose) will depend on
your illness and needs but will usually be between 150 mg and 800 mg.
 You will take your tablets once a day, at bedtime or twice a day,
depending on your illness.
 Swallow your tablets whole with a drink of water.
 You can take your tablets with or without food.
 Do not drink grapefruit juice while you are taking Seroquel® Tablets. 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

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

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

Women to have no monthly periods or irregular periods.

Uncommon: may affect up to 1 in 100 people
If you are elderly your doctor may change your dose.
 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.

Use in children and adolescents
Seroquel® Tablets should not be used by children and adolescents aged
under 18 years.
If you take more Seroquel® Tablets than you should
If you take more Seroquel® Tablets 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.

2








Very common: may affect more than 1 in 10 people

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.

 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.

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).

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® TABLETS
 Do not store above 30ºC. Store in the original package.
 Keep out of the sight and reach of children.
 Do not use this medicine after the expiry date which is printed on the
carton label.
 If your doctor stops treatment return any unused medicine to your
pharmacist for safe disposal. Only keep this medicine, if your doctor
tells you to.
 If your tablets show signs of deterioration or discolouration, you should
seek the advice of your pharmacist who will tell you what to do.
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.

Very rare: may affect up to 1 in 10,000 people
 Severe rash, blisters, or red patches on the skin.
 A severe allergic reaction (called anaphylaxis) which may cause
difficulty in breathing or shock.
 Rapid swelling of the skin, usually around the eyes, lips and throat
(angioedema).
 A serious blistering condition of the skin, mouth, eyes and genitals
(Stevens-Johnson syndrome).
 Inappropriate secretion of a hormone that controls urine volume.
 Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Seroquel® Tablets contains
Each film-coated tablet contains 300mg quetiapine (as fumarate).
Each tablet also contains macrogol, povidone, calcium hydrogen
phosphate, microcrystalline cellulose (E460), lactose, sodium starch
glycollate, magnesium stearate, hypromellose, and titanium dioxide
(E171).

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® Tablets during their pregnancy.
The class of medicines to which Seroquel® Tablets 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.

What Seroquel® Tablets looks like and the contents of the pack
Each white, capsule shaped, film-coated tablet is marked SEROQUEL®`
on one side, ‘300’ on the reverse.
Seroquel® Tablets are available as blister packs of 60 tablets.
Who manufactured your medicine
Seroquel® Tablets are manufactured by AstraZeneca UK Ltd., Silk Road
Business Park, Macclesfield, Cheshire SK10 2NA, UK and is procured
from within the EU and repackaged by Product Licence Holder
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0346

POM

Revision date: 03.01.2017
Leaflet reference: SER300 /UT
Seroquel® is a trade mark of the AstraZeneca group of companies.

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:

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Beachcourse, Tel: 020 8896 9054
for help.
3

+ 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.

Hide