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PSYQUET XL 50 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Psyquet XL 50 mg,150 mg,
200 mg, 300 mg, 400 mg
Prolonged-release Tablets
Quetiapine
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Psyquet XL is and what it is used for
2. What you need to know before you take Psyquet XL
3. How to take Psyquet XL
4. Possible side effects
5. How to store Psyquet XL
6. Contents of the pack and other information

1

What Psyquet XL is and what it is
used for

Psyquet XL contains a substance called quetiapine.
This belongs to a group of medicines called
antipsychotics. Psyquet XL can be used to treat
several illnesses, such as:
• Bipolar depression and major depressive episodes
in major depressive disorder: 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
judgment 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.
When Psyquet XL is being taken to treat major
depressive episodes in major depressive disorder,
it will be taken in addition to another medicine being
used to treat this illness.
Your doctor may continue to prescribe Psyquet XL
even when you feel better.

2

What you need to know before you
take Psyquet XL

Do not take Psyquet XL
• If you are allergic to quetiapine or any of the other
ingredients of this medicine (listed in section 6)
• 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 Psyquet XL if the above applies to you.
If you are not sure, talk to your doctor or pharmacist
before taking Psyquet XL.
Warnings and precautions
Talk to your doctor before taking Psyquet XL 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
Psyquet XL.
• 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, Psyquet XL should not
be taken because the group of medicines that
Psyquet 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 Psyquet 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.
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 Psyquet
XL 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
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
Psyquet XL. You and your doctor should check
your weight regularly.

Children and Adolescents
Psyquet XL is not for use in children and
adolescents below 18 years of age.

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Other medicines and Psyquet XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Psyquet XL 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).
In particular, 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, medicines that can
cause an imbalance in electrolytes (low levels
of potassium or magnesium) such as diuretics
(water pills) or certain antibiotics (medicines to
treat infections).
• Medicines that can cause constipation.
Before you stop taking any of your medicines,
please talk to your doctor first.
Psyquet XL with food, drink and alcohol
• Psyquet XL can be affected by food and you
should therefore take your tablets at least one
hour before a meal or at bedtime.
• Be careful how much alcohol you drink. This is
because the combined effect of Psyquet XL and
alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking
Psyquet XL. 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 are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
You should not take Psyquet XL during pregnancy
unless this has been discussed with your doctor.
Psyquet XL 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 Psyquet 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.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking
Psyquet 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.
Psyquet XL contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3

How to take Psyquet XL

Always take this medicine exactly as your doctor or
pharmacist 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.
• Do not split, chew or crush the tablets.
• Swallow your tablets whole with a drink of water.
• 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
Psyquet 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 to.
Patients with liver problems
If you have liver problems your doctor may change
your dose.
Older people
If you are elderly your doctor may change your dose.
Use in children and adolescents
(under 18 years)
Psyquet XL should not be used by children and
adolescents aged under 18 years.
If you take more Psyquet XL than you should
If you take more Psyquet XL 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
Psyquet XL tablets with you.
If you forget to take a dose of Psyquet 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 dose.
If you stop taking Psyquet XL
If you suddenly stop taking Psyquet 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
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
STOP taking Psyquet XL and contact your
doctor immediately or go to the nearest hospital
if you experience any of the following serious
side effects:
Uncommon (may affect up to 1 in 100 people):
• Fits or seizures
• Uncontrollable movements, mainly of your face or
tongue.
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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).”
• A long-lasting and painful erection (priapism).
• 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.
• A combination of fever, flu-like symptoms, sore
throat, or any other infection with very low white
blood cell count, a condition called
agranulocytosis.
Very rare (may affect up to 1 in 10,000 people):
• 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).
Not known (frequency cannot be estimated from
the available data):
• Serious, sudden allergic reaction with symptoms
such as fever and blisters on the skin and peeling
of the skin (toxic epidermal necrolysis)
• Skin rash with irregular red spots (erythema
multiforme)
You may experience any of the following side
effects listed below. If the side effect is severe
or persistent, you should contact your doctor.
Very common (may affect more than
1 in 10 people):
• Dizziness (may lead to falls), headache or dry
mouth.
• Feeling sleepy - this may go away with time, as
you keep taking Psyquet XL (may lead to falls).
• Discontinuation symptoms (symptoms which
occur when you stop taking Psyquet 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.
• 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)
Common (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has
skipped beats.
• Constipation or 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 of breasts

and unexpectedly produce breast milk.
- Women to have no monthly period or irregular

periods.
Uncommon (may affect up to 1 in 100 people):
• 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
• 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
Rare (may affect up to 1 in 1,000 people):
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis)
• 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
• 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.
• Bowel obstruction.
• Increased blood creatine phosphokinase (a
substance from the muscles)
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 fibers and pain in muscles
(rhabdomyolysis).
Not known (frequency cannot be estimated from
the available data):
• Symptoms of withdrawal may occur in newborn
babies of mothers that have used quetiapine
during their pregnancy.
The class of medicines to which Psyquet XL
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 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
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 (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 (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 (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 Psyquet XL

Keep this medicine out of the sight and reach of
children.
Do not use Psyquet XL after the expiry date which
is stated on the container after EXP. The expiry
date refers to the last day of that month.
HDPE bottle: after first opening, use before the
expiry date stated on the container after EXP.
Psyquet XL does not require any special storage
conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment

6

Contents of the pack and other
information

What Psyquet XL contains
• The active substance is quetiapine. Psyquet XL
tablets contain 50 mg, 150 mg, 200 mg, 300 mg
or 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: lactose anhydrous; methacrylic
acid – ethyl acrylate copolymer (1:1), type A;
crystalline maltose; magnesium stearate; and talc.
Tablet coating: methacrylic acid – ethyl acrylate
copolymer (1:1), type A; triethyl citrate.
What Psyquet XL looks like and contents of the
pack
• The 50 mg prolonged-release tablets are white to
off white, round biconvex, engraved with ‘50’
on one side, 7.1 mm in diameter and 3.2mm in
thickness.
• The 150 mg prolonged-release tablets are white
to off white, oblong biconvex and engraved with
‘150’ on one side, 13.6 mm in length, 6.6 mm in
width and 4.2 mm in thickness.
• The 200 mg prolonged-release tablets are white
to off white, oblong biconvex and engraved with
‘200’ on one side, 15.2 mm in length, 7.7 mm in
width and 4.8 mm in thickness.
• The 300 mg prolonged-release tablets are white
to off white, oblong biconvex and engraved with
‘300’ on one side and 18.2 mm in length, 8.2 mm
in width and 5.4 mm in thickness.
• The 400 mg prolonged-release tablets are white
to off white, oval biconvex and engraved with
‘400’ on one side and 20.7 mm in length,
10.2 mm in width and 6.3 mm in thickness.
• Psyquet XL prolonged-release tablets are
available as PVC/PCTFE- Aluminium foil blisters
packed in a cardboard box.
• Psyquet XL prolonged-release tablets are also
available as white opaque HDPE bottle with child
resistant polypropylene screw cap and induction
seal liner.
The pack sizes for the blisters are: 10, 30, 50, 56,
60 and 100 tablets.
The pack sizes for the bottles are: 60 and 120 tablets.
The pack size of 120 tablets is limited for hospital
use and dose dispensing.
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK
Manufacturer
Pharmathen International S.A
Sapes Industrial Park Block 5,
Rodopi,
69300,
Greece
Or
Pharmathen S.A
Dervenakion str.6,
Pallini,
15351,
Attiki,
Greece
Or
Salutas Pharma GmbH,
Barleben,
Germany
This leaflet was last revised in 04/2016.
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draft: 44066136, 44066137,
44066138, 44066139,
44066160
laetus code: supplier to add
mat.no.: supplier to add

Artwork Proof Box
Ref: V004 - Addn. of bottles + responses
Proof no.
004.0

Date prepared:
25/04/2016

Colours:
Black
Dimensions: 170 x 600 mm

Font size:
9pt
Fonts:
Helvetica

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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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