SEROQUEL 25 MG FILM-COATED TABLETS

Active substance: QUETIAPINE

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Marketing Authorisation Holder and Manufacturer

The following side effect has been seen only in
children and adolescents:

•  he Marketing Authorisations for Seroquel are
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held by AstraZeneca UK Limited, 600 Capability
Green, Luton, LU1 3LU, United Kingdom.

Very Common (may affect more than 1 in
10 people):
• ncrease in blood pressure.
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The following side effects have been seen more
often in children and adolescents:

You can also get information on mental health from
the following national organisations:
•  IND (National Association for Mental Health).
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MindinfoLine: 0845 766 0163.
•  ETHINK (Formerly the National Schizophrenia
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Fellowship). Advice Service: 0208 974 6814.
•  ational Schizophrenia Fellowship (Scotland):
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0131 662 4359.
•  ANELINE Helpline: 0845 767 8000.
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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:

5. How to store Seroquel

Product name
Reference number
Seroquel 25 mg
film-coated tablets
PL 17901/0038
Seroquel 100 mg
film-coated tablets
PL 17901/0039
Seroquel 150 mg
film-coated tablets
PL 17901/0041
Seroquel 200 mg
film-coated tablets
PL 17901/0040
Seroquel 300 mg
film-coated tablets
PL 17901/0088

•  eep your Seroquel tablets in the original pack
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and do not store above 30°C.
•  eep your Seroquel tablets in a safe place, where
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children cannot see or reach them.
•  o not take your tablets after the expiry date
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which is stated on the container. The expiry date
refers to the last day of that month.
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
•  eroquel tablets contain 25 milligrams (mg),
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100 mg, 150 mg, 200 mg or 300 mg of quetiapine
(as quetiapine fumarate).
•  he other ingredients are calcium hydrogen
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phosphate dihydrate, hypromellose, lactose,
magnesium stearate, microcrystalline cellulose,
polyethylene glycol, povidone, sodium starch
glycollate and titanium dioxide. The 25 mg,
100 mg and 150 mg tablets also contain
ferric oxide.
What Seroquel looks like and contents of
the pack
The following packs are available: 25 mg film-coated
tablets (coloured peach) 60 tablet pack; 100 mg
film-coated tablets (coloured yellow) 60 tablet pack;
150 mg film-coated tablets (coloured pale yellow)
60 tablet pack; 200 mg film-coated tablets (coloured
white) 60 tablet pack; and 300 mg film-coated tablets
(coloured white) 60 tablet pack.

N/A
Seroquel Leaflet

In this leaflet:
1.  hat Seroquel is and what it is used for
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2.  efore you take Seroquel
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3.  ow to take Seroquel
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4.  ossible side effects
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5.  ow to store Seroquel
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6. Further information

Tell your doctor immediately if you experience any of
the following after taking Seroquel:
•  combination of fever, severe muscle stiffness,
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sweating or a lowered level of consciousness (a
disorder called “neuroleptic malignant syndrome”).
Immediate medical treatment may be needed.
•  ncontrollable movements, mainly of your face or
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tongue.
•  izziness or a severe sense of feeling sleepy.
D
This could increase the risk of accidental injury
(fall) in elderly patients.
• Fits (seizures).
•  long-lasting and painful erection (Priapism).
A
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.

Your doctor may continue to prescribe Seroquel even
when you are feeling better.
2. Before you take Seroquel
Do not take Seroquel if:
•  ou are allergic (hypersensitive) to quetiapine
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or any of the other ingredients of Seroquel (see
Section 6: Further information).
•  ou are taking any of the following medicines:
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--  rotease inhibitors, such as nelfinavir (for HIV
p
infection)
--  zole medicines (for fungal infections)
a
--  edicines for an infection (like erythromycin or
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clarithromycin)
--  efazodone (for depression).
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CNS 13 0017

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

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UK

Pharma Code:

Read all of this leaflet carefully before you start
taking this medicine.
--  eep this leaflet. You may need to read it again.
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-- f you have any further questions, ask your doctor
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or pharmacist.
--  his medicine has been prescribed for you. Do
T
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
-- f any of the side effects get serious, or if you
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notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Seroquel contains a substance called quetiapine.
This belongs to a group of medicines called antipsychotics. Seroquel can be used to treat several
illnesses, such as:
•  chizophrenia: where you may hear or feel things
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that are not there, believe things that are not true
or feel unusually suspicious, anxious, confused,
guilty, tense or depressed.
•  ania: where you may feel very excited, elated,
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agitated, enthusiastic or hyperactive or have poor
judgment including being aggressive or disruptive.
•  ipolar depression: where you may feel sad all
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the time or you may find that you feel depressed,
feel guilty, lack energy, lose your appetite or can’t
sleep.

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Before you take your medicine, tell your doctor if:
•  ou, or someone in your family, have or have had
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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.
•  ou have low blood pressure.
Y
•  ou have had a stroke, especially if you are elderly.
Y
•  ou have problems with your liver.
Y
•  ou have ever had a fit (seizure).
Y
•  ou know that you have had low levels of white
Y
blood cells in the past (which may or may not
have been caused by other medicines).
•  ou have diabetes or have a risk of getting diabetes.
Y
If you do, your doctor may check your blood sugar
levels while you are taking Seroquel.
•  ou are an elderly person with dementia (loss
Y
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.
•  ou or someone else in your family has a history
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of blood clots, as medicines like these have been
associated with formation of blood clots.

1. What Seroquel is and what it is used for

4

AWO-Leaflet-2013.02596-V01

Take special care with Seroquel

© AstraZeneca 2013

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.

Black

quetiapine fumarate

Leaflet prepared: August 2013.
Seroquel is a trade mark of the AstraZeneca group
of companies.

Common (may affect up to 1 in 10 people):
•  eeling weak, fainting (may lead to falls).
F
• Stuffy nose.
• Feeling irritated.

13 September 2013 11:33

Seroquel 25 mg, 100 mg, 150 mg, 200 mg and 300 mg
film-coated tablets

•  he tablets are made by AstraZeneca UK Limited,
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Silk Road Business Park, Macclesfield, Cheshire,
SK10 2NA, United Kingdom, or AstraZeneca
Pharmaceuticals LP, 587 Old Baltimore Pike,
Newark, Delaware 19702, USA.

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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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.

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.

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.

Do not take Seroquel if you are taking any of the
following medicines:
•  ome medicines for HIV.
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•  zole medicines (for fungal infections).
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•  rythromycin or clarithromycin (for infections).
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•  efazodone (for depression).
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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 150 mg and 800 mg
each day. It will depend on your illness and needs.
•  ou will take your tablets once a day, at bedtime
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or twice a day, depending on your illness.
•  wallow your tablets whole with a drink of water.
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•  ou can take your tablets with or without food.
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•  o not drink grapefruit juice while you are taking
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Seroquel. It can affect the way the medicine
works.
•  o not stop taking your tablets even if you feel
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better, unless your doctor tells you.

Tell your doctor if you are taking any of the following
medicines:
•  pilepsy medicines (like phenytoin or
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carbamazepine).
•  igh blood pressure medicines.
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•  ifampicin (for tuberculosis).
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•  arbiturates (for difficulty sleeping).
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•  hioridazine or Lithium (other anti-psychotic
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medicines).
•  edicines that have an impact on the way your
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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).

Seroquel tablets come in 5 different strengths and
each strength is a different colour or shape.
•  ven though the dose might stay the same, it
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might be supplied as different strength tablets. For
example, one 300 mg tablet (white) or two 150 mg
tablets (pale yellow).
•  o don’t be surprised if the colour of your tablets
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changes from time to time.

Before you stop taking any of your medicines, please
talk to your doctor first.
Taking Seroquel with food and drink
•  eroquel can be taken with or without food.
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•  e careful how much alcohol you drink. This is
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because the combined effect of Seroquel and
alcohol can make you sleepy.
•  o not drink grapefruit juice while you are taking
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Seroquel. It can affect the way the medicine works.

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

Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or breastfeeding, talk to your doctor 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 breastfeeding.

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
experience abnormal heart beats. Contact your
doctor or nearest hospital straight away. Take the
Seroquel tablets with you.

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.

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.

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.

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.

Hospital - If you go into hospital, tell the medical
staff that you are taking Seroquel.
Important information about some of the
ingredients of Seroquel
Seroquel contains lactose which is a type of sugar.
If you have been told by your doctor that you have
an intolerance to some sugars, talk to your doctor
before taking this medicine.

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

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UK
13 September 2013 11:33
AWO-Leaflet-2013.02596-V01
296340L1
Pharma Code:

N/A
Seroquel Leaflet

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Like all medicines, Seroquel 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.
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 (may affect up to 1 in 100 people):
•  its or seizures.
F
•  llergic reactions that may include raised lumps
A
(weals), swelling of the skin and swelling around
the mouth.
•  ncontrollable movements, mainly of your face or
U
tongue (Tardive dyskinesia).

Rare (may affect up to 1 in 1,000 people):
•  welling of breasts and unexpected production of
S
breast milk (galactorrhoea).
• Menstrual disorder.
•  alking, talking, eating or other activities while
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you are asleep.
•  ody temperature decreased (hypothermia).
B
• nflammation of the pancreas, which causes
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severe pain in the abdomen and back.
•  condition (called “metabolic syndrome”) where
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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.

Rare (may affect up to 1 in 1,000 people):
•  combination of high temperature (fever),
A
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
•  lood clots in the veins especially in the legs
B
(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):
•  evere rash, blisters, or red patches on the skin.
S
•  orsening of pre-existing diabetes.
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• nappropriate secretion of a hormone that controls
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urine volume.
•  reakdown of muscle fibres and pain in muscles
B
(rhabdomyolysis).

Very rare (may affect up to 1 in 10,000 people):
•  evere allergic reaction (called anaphylaxis) that
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may include difficulty in breathing, dizziness,
shock and collapse.
•  apid swelling of the skin, usually around the
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eyes, lips and throat (angioedema).
•  serious blistering condition of the skin, mouth,
A
eyes and genitals (Stevens-Johnson syndrome).

Not known (frequency cannot be estimated from
the available data):
•  kin rash with irregular red spots (erythema
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multiforme).
•  erious, sudden allergic reaction with
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symptoms such as fever and blisters on the
skin and peeling of the skin (toxic epidermal
necrolysis)

Other possible side effects:
Very common (may affect more than 1 in 10 people):
•  izziness (may lead to falls), headache, dry mouth.
D
•  eeling sleepy (this may go away with time, as
F
you keep taking Seroquel) (may lead to falls).
•  iscontinuation symptoms (symptoms which occur
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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.
•  utting on weight.
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•  bnormal muscle movements. These include
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difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.

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:
•  en and women to have swelling of the breasts
M
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.

Common (may affect up to 1 in 10 people):
• Rapid heartbeat.
•  eeling like your heart is pounding, racing or has
F
skipped beats.
•  pset stomach (indigestion) or constipation.
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•  welling of arms or legs.
S
• ncreased levels of sugar in the blood.
I
•  ow blood pressure when standing. This may
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make you feel dizzy or faint (may lead to falls).
• Blurred vision.
•  bnormal dreams and nightmares.
A
•  eeling more hungry.
F
• Feeling irritated.
•  isturbance in speech or language.
D
•  houghts of suicide and worsening of your depression.
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•  hortness of breath.
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•  omiting (mainly in the elderly).
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• Fever.

Children and adolescents
The same side effects that may occur in adults may
also occur in children and adolescents.

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Uncommon (may affect up to 1 in 100 people):
•  npleasant sensations in the legs (also called
U
restless legs syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
•  eeling weak, fainting (may lead to falls).
F
• Stuffy nose.
• Diabetes.
•  hange in electrical activity of the heart seen on
C
ECG (QT prolongation).
•  slower than normal heart rate which may
A
occur when starting treatment and which may be
associated with low blood pressure and fainting.

4. Possible side effects

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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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