SEROQUEL XL 50 MG PROLONGED-RELEASE TABLETS

Active substance: QUETIAPINE FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

P036522

Seroquel XL 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
prolonged-release tablets
quetiapine fumarate
Read all of this leaflet carefully before you
start taking this medicine.
•  eep this leaflet. You may need to read it again.
K
I
• f you have any further questions, ask your
doctor or pharmacist.
T
•  his 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.
I
• f 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:
W
1.  hat Seroquel XL is and what it is used for
B
2.  efore you take Seroquel XL
H
3.  ow to take Seroquel XL
4.  ossible side effects
P
5.  ow to store Seroquel XL
H
6. Further information
1. What Seroquel XL is and what it is used for
Seroquel XL contains a substance called
quetiapine. This belongs to a group of medicines
called anti-psychotics. Seroquel XL can be used
to treat several illnesses, such as:
S
•  chizophrenia: 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.
M
•  ania: where you may feel very excited,
elated, agitated, enthusiastic or hyperactive or
have poor judgment including being aggressive
or disruptive.
•  ipolar depression and major depressive
B
episodes in major depressive disorder: 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.
When Seroquel XL is being taken to treat major
depressive episodes in major depressive disorder,
it will be taken in addition to another drug being
used to treat this illness.
Your doctor may continue to prescribe
Seroquel XL even when you are feeling better.
2. Before you take Seroquel XL
Do not take Seroquel XL if:
• you are allergic (hypersensitive) to quetiapine
or any of the other ingredients of Seroquel XL
(see section 6: Further information)
• you are taking any of the following medicines:
--  rotease inhibitors, such as nelfinavir (for
p
HIV infection)
--  zole medicines (for fungal infections)
a
--  edicines for an infection (like erythromycin
m
or clarithromycin)
--  efazodone (for depression).
n
Do not take Seroquel XL if the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Seroquel XL.
Take special care with Seroquel XL
Before you take your medicine, tell your doctor if:
• You, or someone in your family, have or have
had any heart problems such as a very fast
heart beat 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.
• 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 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 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 XL.
• You are an elderly person with dementia (loss
of brain function). If you are, Seroquel XL should
not be taken because the group of medicines
that Seroquel XL 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.
Tell your doctor immediately if you experience any
of the following after taking Seroquel XL:
• 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.
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 XL. You and your doctor should check
your weight regularly.
Taking other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines because it
may affect the way the medicines work. This
includes medicines obtained without a prescription
and herbal medicines.
Do not take Seroquel XL if you are taking any of
the following medicines:
•  ome medicines for HIV.
S
•  zole medicines (for fungal infections).
A
E
•  rythromycin or clarithromycin (for infections).
•  efazodone (for depression).
N

Tell your doctor or pharmacist if you are taking
any of the following medicines:
• Epilepsy medicines (like phenytoin or
carbamazepine).
• High blood pressure medicines.
• Rifampicin (for tuberculosis).
• 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).
Before you stop taking any of your medicines,
please talk to your doctor or pharmacist first.
Taking Seroquel XL with food and drink
S
•  eroquel XL should be taken without food, at
least one hour before a meal or at bedtime.
•  e careful how much alcohol you drink. This is
B
because the combined effect of Seroquel XL
and alcohol can make you sleepy.
•  o not drink grapefruit juice while you are
D
taking Seroquel XL. It can affect the way the
medicine works.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or
breast-feeding, talk to your doctor or pharmacist
before taking Seroquel XL. You should not take
Seroquel XL during pregnancy unless this has
been discussed with your doctor. Seroquel should
not be taken if you are breast-feeding.
The following symptoms may occur in newborn
babies of mothers that have used Seroquel XL
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 XL.
Important information about some of the
ingredients of Seroquel XL
Seroquel XL contains lactose which is a type of
sugar. If you have been told by your doctor that
you have an intolerance to some sugars, talk to
your doctor before taking this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking
Seroquel XL 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.
If you have been on other medication for this
condition, and that medication has stopped your
periods, changing to Seroquel XL may allow them
to return.
3. How to take Seroquel XL
Always take Seroquel XL 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 150 mg and
800 mg each day. It will depend on your illness
and needs.
• You will take your tablets once a day.


• Swallow your tablets whole with a drink of
water.

• Do not split, chew or crush the tablets.

• Take your tablets without food (at least one
hour before a meal or at bedtime, your doctor
will tell you when).

• Do not drink grapefruit juice while you are
taking Seroquel XL. It can affect the way the
medicine works.
• Do not stop taking your tablets even if you feel

better, unless your doctor tells you.
Seroquel XL tablets are available in 5 different
strengths.

• Even though the dose might stay the same, it
might be supplied as different strength tablets.
For example one 400 mg tablet (white) or two
200 mg tablets (yellow).

• 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 XL should not be used by children and
adolescents aged under 18 years.
If you take more Seroquel XL than you should
If you take more Seroquel XL than prescribed
by your doctor, you may feel sleepy, feel faint
or dizzy and experience abnormal heart beats.
Contact your doctor or nearest hospital straight
away. Take the Seroquel XL tablets with you.
If you forget to take a dose of Seroquel XL
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 XL
If you suddenly stop taking Seroquel XL, 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Seroquel XL can cause side
effects, although not everybody gets them. If any
of the following side effects get serious, or if you
notice side effects not listed in this leaflet, please
tell your doctor or pharmacist.

214221
UK
02
31 January 2014
P036522
630170L4
Pharma Code:

15:34

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1119
Seroquel XR Leaflet

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If any of the following happens, stop taking
Seroquel XL and contact a doctor or go to the
nearest hospital straight away, as you may
need urgent medical attention:
Uncommon (may affect up to 1 in 100 people):
•  its or seizures
F
•  llergic reactions that may include raised
A
lumps (weals), swelling of the skin and swelling
around the mouth.
•  ncontrollable movements, mainly of your face
U
or tongue (Tardive dyskinesia).
Rare (may affect up to 1 in 1,000 people):
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”).
•  ellowing of the skin and eyes (jaundice).
Y
• nflammation of the liver (hepatitis).
I
•  long-lasting and painful erection (Priapism).
A
B
•  lood 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 (may affect up to 1 in 10,000 people):
S
•  evere allergic reaction (called anaphylaxis)
that may include difficulty in breathing,
dizziness, shock and collapse.
•  apid swelling of the skin, usually around the
R
eyes, lips and throat (angioedema).
A
•  serious blistering condition of the skin,
mouth, eyes and genitals (Stevens-Johnson
syndrome).
Other possible side effects:
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 XL) (may lead to falls).
• Discontinuation symptoms (symptoms which
occur when you stop taking Seroquel XL)
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 (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or
has skipped beats.
• Constipation, upset stomach (indigestion).
• 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 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.
• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
Uncommon (may affect up to 1 in 100 people):
• Unpleasant sensations in the legs (also called
restless legs syndrome).
• Difficulty swallowing.
• 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.
Rare (may affect up to 1 in 1,000 people):
• 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.
• A condition (called “metabolic syndrome”)
where you may 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.
Very rare (may affect up to 1 in 10,000 people):
• Worsening of pre-existing diabetes.
• Severe rash, blisters, or red patches on the skin.
• Inappropriate secretion of a hormone that
controls urine volume.
• Breakdown of muscle fibres 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)
The class of medicines to which Seroquel XL
belongs can cause heart rhythm problems, which
can be serious and in severe cases 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:
M
•  en and women to have swelling of breasts
and unexpectedly produce breast milk.
•  omen to have no monthly period or irregular
W
periods.
Your doctor may ask you to have blood tests from
time to time.
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 (may affect more than 1 in
10 people):
• ncrease in blood pressure.
I

The following side effects have been seen more
often in children and adolescents:
Very Common (may affect more than 1 in
10 people):
• ncrease in the amount of a hormone called
I
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.
Common (may affect up to 1 in 10 people):
•  eeling weak, fainting (may lead to falls).
F
• 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 XL
D
•  o not store above 30°C. Store in the original
package.
K
•  eep your Seroquel XL tablets in a safe place,
where children cannot see or reach them.
•  o not use Seroquel XL after the expiry date
D
which is stated on the container. The expiry
date refers to the last day of that month.
•  edicines should not be disposed of via
M
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Further information
What Seroquel XL contains
•  ach tablet contains either 50 mg, 150 mg,
E
200 mg, 300 mg or 400 mg of quetiapine (as
quetiapine fumarate).
•  he other ingredients are microcrystalline
T
cellulose, sodium citrate, lactose monohydrate,
magnesium stearate, hypromellose,
macrogol 400, titanium dioxide (E171). The
50 mg, 200 mg and 300 mg tablets also
contain ferric oxide (E172).
What Seroquel XL looks like and contents of
the pack
All tablet strengths are capsule shaped and
marked with XR and the strength. 50 mg tablets
are peach coloured; 150 mg tablets are white
coloured; 200 mg tablets are yellow coloured;
300 mg tablets are pale yellow coloured; 400 mg
tablets are white coloured.
Pack sizes of 10, 30, 50, 60 and 100 tablets are
registered for all strengths. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and
Manufacturer
T
•  he marketing authorisations for Seroquel XL
are held by AstraZeneca UK Ltd,
600 Capability Green, Luton, LU1 3LU, United
Kingdom.
•  he tablets are made by AstraZeneca UK Ltd,
T
Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, United Kingdom.
This leaflet was last updated in December 2013
Seroquel XL is a trade mark of the AstraZeneca
group of companies.
© AstraZeneca 2013
You can also get information on mental health
from the following national organisations:
•  IND (National Association for Mental Health):
M
Mindinfoline: 0845 7660163
•  ETHINK (Formerly the National Schizophrenia
R
Fellowship) Advice Service: 0208 9746814
•  ational Schizophrenia Fellowship (Scotland):
N
0131 662 4359
S
•  ANELINE Helpline: 0845 7678000

To listen to, or request
a copy of this leaflet in
Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the
following information:
Product
Reference
name
number
Seroquel XL PL 17901/0249
prolonged
release tablets
50 mg
Seroquel XL PL 17901/0259
prolonged
release tablets
150 mg
Seroquel XL PL 17901/0250
prolonged
release tablets
200 mg
Seroquel XL PL 17901/0251
prolonged
release tablets
300 mg
Seroquel XL PL 17901/0252
prolonged
release tablets
400 mg
This is a service provided by
the Royal National Institute
of Blind People.
CNS 13 0019a

P036522

214221
UK
02
31 January 2014
P036522
630170L4
Pharma Code:

15:34

Black

Profile

Technical
Info

1119
Seroquel XR Leaflet

Font information
Font family: Nimbus Sans
Body text size: 9 pt

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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