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SONDATE XL 200MG PROLONGED-RELEASE TABLET

Active substance(s): QUETIAPINE FUMARATE

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Sondate XL 50 mg, 150 mg,
200 mg, 300 mg, 400 mg
Prolonged-release Tablets
quetiapine
PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 Sondate XL is and what it is used for
2. What you need to know before you take
Sondate XL
3. How to take Sondate XL
4. Possible side effects
5. How to store Sondate XL
6. Contents of the pack and other information

1

What Sondate XL is and what it is used
for

Sondate XL contains a substance called quetiapine.
This belongs to a group of medicines called
anti-psychotics. Sondate 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 Sondate 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 Sondate XL
even when you feel better.

2

What you need to know before you take
Sondate XL



Colours Used:
460 mm
160 mm

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
quetiapine. You and your doctor should check your
weight regularly.
Children and Adolescents
Quetiapine Teva is not for use in children and
adolescents below 18 years of age.
Other medicines and Sondate XL
Tell your doctor if you are taking or have recently
taken or might take any other medicines,.
Do not take Sondate 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).
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.

Do not take Sondate 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).

Before you stop taking any of your medicines,
please talk to your doctor first.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Sondate 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 Sondate
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, Sondate XL should
not be taken because the group of medicines
that Sondate 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.
• 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

If you are pregnant, or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine. You should not take Sondate XL during
pregnancy unless this has been discussed with
your doctor. Sondate XL should not be taken if you
are breast-feeding.

Sondate XL with food, drink and alcohol
• Sondate XL can be affected by food and you
should therefore take your tablets at least one
hour before a meal or prior to bedtime.
• Be careful how much alcohol you drink. This is
because the combined effect of Sondate XL and
alcohol can make you sleepy.
• Do not drink grapefruit juice while you are
taking Sondate XL. It can affect the way the
Do not take Sondate XL if the above applies to you.
medicine works.
If you are not sure, talk to your doctor or
pharmacist before taking Sondate XL.
Pregnancy and breast-feeding

Tell your doctor immediately if you experience any
of the following after taking Sondate 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 Quetiapine Teva to be stopped and/or
treatment to be given.

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.
Driving and using machines
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.



Do not drive while taking this medicine until you
know how it affects you.
It is an offence to drive if this medicine affects
your ability to drive.

However, you would not be committing an offence if:




The medicine has been prescribed to treat a
medical or dental problem and
You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking
Sondate 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.

3

Version:

231-30-30108-F LEA QUETIAPINE (Sondate XL) A/S TAB TUK
How to take Sondate XL

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.
• 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 Sondate 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.
Liver problems
If you have liver problems your doctor may change
your dose.

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Elderly people
If you are elderly your doctor may change your dose. •
Use in children and adolescents
Sondate XL should not be used by children and
adolescents aged under 18 years.
If you take more Sondate XL than you should
If you take more Sondate 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 Sondate XL tablets with you.






If you forget to take a dose of Sondate 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 Sondate XL
If you suddenly stop taking Sondate 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.
Very common side effects (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 Sondate XL) (may lead to falls).
• Discontinuation symptoms (symptoms which occur
when you stop taking Sondate 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 side effects (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).
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:
o Men and women to have swelling of breasts
and unexpectedly produce breast milk.
o Women to have no monthly period 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
or 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

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
Teva during their pregnancy.

The class of medicines to which Sondate 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 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: 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 Sondate XL

Keep this medicine out of the sight and reach of
children.
Do not use Sondate XL after the expiry date which
is stated on the container after EXP. The expiry date
refers to the last day of that month.
Sondate 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 Sondate XL contains
- The active substance is quetiapine. Sondate XL
tablets contain 50 mg, 150 mg, 200 mg, 300 mg
or 400 mg of quetiapine (as quetiapine fumarate).
Rare side effects (may affect up to 1 in 1,000 people):
- The other ingredients are:
• A combination of high temperature (fever),
Tablet core: hypromellose, cellulose
sweating, stiff muscles, feeling very drowsy or
microcrystalline, sodium citrate anhydrous,
faint (a disorder called “neuroleptic malignant
magnesium stearate.
syndrome’’).
Tablet coating: titanium dioxide (E171),
• Yellowing of the skin and eyes (jaundice).
hypromellose, macrogol/PEG 400, polysorbate 80.
• Inflammation of the liver (hepatitis).
The 50 mg, 200 mg and 300 mg tablets contain Iron
• A long-lasting and painful erection (priapism).
Oxide Yellow (E172) and Iron Oxide Red (E172). The
• Swelling of breasts and unexpected production 50 mg and 300 mg tablets also contain Iron Oxide
of breast milk (galactorrhoea).
Black (E172).
• Menstrual disorder.
What Sondate XL looks like and contents of the pack
• Blood clots in the veins especially in the legs
All strengths of Sondate XL Prolonged-release
(symptoms include swelling, pain and redness
Tablets are capsule shaped, film-coated tablets. 50
in the leg), which may travel through blood
mg tablets are brown coloured, debossed “Q 50”
vessels to the lungs causing chest pain and
difficulty in breathing. If you notice any of these on one side, plain on the other; 150 mg tablets are
white coloured, debossed “Q 150” on one side,
symptoms seek medical advice immediately.
• Walking, talking , eating or other activities while plain on the other; 200 mg tablets are yellow
coloured, debossed “Q 200” on one side, plain on
you are asleep.
the other; 300 mg tablets are light yellow coloured,
• Body temperature decreased (hypothermia).
debossed “Q 300” on one side, plain on the other
• Inflammation of the pancreas
and 400 mg tablets are white coloured, debossed
• A condition (called “metabolic syndrome”)
“Q 400” on one side, plain on the other.
where you may have a combination of 3 or
more of the following: an increase in fat around Packs of 10, 20, 30, 50, 50x1 (hospital pack), 56
your abdomen, a decrease in “good cholesterol” (calendar pack), 60, 90 and100 tablets are registered
(HDL-C), an increase in a type of fat in your
for all strengths. Not all pack sizes may be available.
blood called triglycerides, high blood pressure
Marketing Authorisation Holder and Manufacturer
and an increase in your blood sugar.
Teva UK Limited, Eastbourne, BN22 9AG, United
• Combination of fever, flu-like symptoms, sore
Kingdom
throat, or any other infection with very low
white blood cell count, a condition called
This leaflet was last revised in 03/2016.
agranulocytosis.
30108-F
PL 00289/1219, 1553, 1220, 1221 & 1222

14-Jun-2016

TEVA UK Ref:

Version:

231-30-22211-E LEA QUETIAPINE (Sondate XL) A/S TAB TUK
Dimensions:
Length:
Width:
Depth:

Colours Used:

323 mm
320 mm
folded to160 mm

1

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PANTONE® GREEN C
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PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)
FOLD

• Breakdown of muscle fibers and pain in
muscles (rhabdomyolysis).

5

How to store Sondate XL

Keep this medicine out of the sight and
reach of children.

• 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 Teva during their
pregnancy.

Do not use Sondate XL after the expiry date
which is stated on the container after EXP.
The expiry date refers to the last day of that
month.

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:

are brown coloured, debossed “Q 50” on
one side, plain on the other; 150 mg tablets
are white coloured, debossed “Q 150” on
one side, plain on the other; 200 mg tablets
are yellow coloured, debossed “Q 200” on
one side, plain on the other; 300 mg tablets
are light yellow coloured, debossed “Q 300”
on one side, plain on the other and 400 mg
tablets are white coloured, debossed “Q
400” on one side, plain on the other.

Sondate 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
The class of medicines to which Sondate XL protect the environment.
belongs can cause heart rhythm problems,
of the pack and other
which can be serious and in severe cases
6 Contents
information
may be fatal.
Some side effects are only seen when a
blood test is taken. These include changes in What Sondate XL contains
the amount of certain fats (triglycerides and - The active substance is quetiapine.
Sondate XL tablets contain 50 mg, 150
total cholesterol) or sugar in the blood,
mg, 200 mg, 300 mg or 400 mg of
changes in the amount of thyroid hormones
quetiapine (as quetiapine fumarate).
in your blood, increased liver
The
other ingredients are:
enzymes,decreases in the number of certain
Tablet
core: hypromellose, cellulose
types of blood cells, decrease in the amount
microcrystalline,
sodium citrate anhydrous,
of red blood cells, increased blood creatine
magnesium stearate.
phosphokinase (a substance in the
Tablet
coating:
titanium
dioxide (E171),
muscles), decrease in the amount of sodium
in the blood and increases in the amount of hypromellose, macrogol/PEG 400,
polysorbate
80.
The
50
mg,
200 mg and 300
the hormone prolactin in the blood.
Increases in the hormone prolactin could in mg tablets contain Iron Oxide Yellow (E172)
and
Iron
Oxide
Red
(E172).
The
50 mg and
rare cases lead to the following:
300 mg tablets also contain Iron Oxide Black
• Men and women to have swelling of
(E172).
breasts and unexpectedly produce breast
milk.
What Sondate XL looks like and contents of
• Women to have no monthly period or
the pack
irregular periods.
All strengths of Sondate XL
Your doctor may ask you to have blood tests Prolonged-release Tablets are capsule
from time to time.
shaped, film-coated tablets. 50 mg tablets

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

Packs of 10, 20, 30, 50, 50x1 (hospital pack),
56 (calendar pack), 60, 90 and100 tablets are
registered for all strengths. Not all pack sizes
may be available.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG,
United Kingdom
This leaflet was last revised in 03/2016.
PL 00289/1219, 1553, 1220, 1221 & 1222

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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Sondate XL if:
• You, or someone in your family, have or
have had any heart problems, for
PACKAGE LEAFLET: INFORMATION
example heart rhythm
FOR THE USER
problems,weakening of the heart muscle
Read all of this leaflet carefully before you
or inflammation of the heart or if you are
start taking this medicine because it
taking any medicines that may have an
contains important information for you.
impact on the way your heart beats.
• Keep this leaflet. You may need to read it • You have low blood pressure.
again.
• You have had a stroke, especially if you
• If you have any further questions, ask
are elderly.
your doctor or pharmacist.
• You have problems with your liver.
• This medicine has been prescribed for
• You have ever had a fit (seizure).
you only. Do not pass it on to others. It
• You have diabetes or have a risk of
may harm them, even if their signs of
getting diabetes. If you do, your doctor
illness are the same as yours.
may check your blood sugar levels while
• If you get any side effects talk to your
you are taking Sondate XL.
doctor or pharmacist. This includes any
• You know that you have had low levels of
possible side effects not listed in this
white blood cells in the past (which may
leaflet. See section 4.
or may not have been caused by other
medicines).
What is in this leaflet:
• You are an elderly person with dementia
1. What Sondate XL is and what it is used
(loss of brain function). If you are,
for
Sondate XL should not be taken because
2. What you need to know before you take
the group of medicines that Sondate XL
Sondate XL
belongs to may increase the risk of
3. How to take Sondate XL
stroke, or in some cases the risk of death,
4. Possible side effects
in elderly people with dementia.
5. How to store Sondate XL
• You or someone else in your family has a
6. Contents of the pack and other
history of blood clots, as medicines like
information
these have been associated with
formation of blood clots.
Sondate XL is and what it is
• You have or have had a condition where
1 What
used for
you stop breathing for short periods
during your normal nightly sleep (called
Sondate XL contains a substance called
“sleep apnoea”) and are taking
quetiapine. This belongs to a group of
medicines that slow down the normal
medicines called anti-psychotics. Sondate
activity of the brain (“depressants”).
XL can be used to treat several illnesses,
• You have or have had a condition where
such as:
you can’t completely empty your bladder
• Bipolar depression and major depressive
(urinary retention), have an enlarged
episodes in major depressive disorder:
prostate, a blockage in your intestines, or
where you feel sad. You may find that you
increased pressure inside your eye. These
feel depressed, feel guilty, lack energy,
conditions are sometimes caused by
lose your appetite or can’t sleep.
medicines (called “anti-cholinergics”) that
• Mania: where you may feel very excited,
affect the way nerve cells function in
elated, agitated, enthusiastic or
order to treat certain medical conditions
hyperactive or have poor judgment
including being aggressive or disruptive. Tell your doctor immediately if you
experience any of the following after taking
• Schizophrenia: where you may hear or
Sondate XL:
feel things that are not there, believe
things that are not true or feel unusually • A combination of fever, severe muscle
stiffness, sweating or a lowered level of
suspicious, anxious, confused, guilty,
consciousness (a disorder called
tense or depressed.
“neuroleptic malignant syndrome”).
When Sondate XL is being taken to treat
Immediate medical treatment may be
major depressive episodes in major
needed.
depressive disorder, it will be taken in
• Uncontrollable movements, mainly of
addition to another drug being used to treat
your face or tongue.
this illness.
• Dizziness or a severe sense of feeling
Your doctor may continue to prescribe
sleepy. This could increase the risk of
Sondate XL even when you feel better.
accidental injury (fall) in elderly patients.
• Fits (seizures).
you need to know before you • A long-lasting and painful erection
2 What
take Sondate XL
(Priapism).
These conditions can be caused by this type
Do not take Sondate XL:
of medicine.
- If you are allergic to quetiapine or any of
Tell your doctor as soon as possible if you
the other ingredients of this medicine
have:
(listed in section 6).
• A fever, flu-like symptoms, sore throat, or
- If you are taking any of the following
any other infection, as this could be a
medicines:
result of a very low white blood cell
- some medicines for HIV
count, which may require Quetiapine Teva
- azole medicines (for fungal infections)
to be stopped and/or treatment to be
- erythromycin or clarithromycin (for
given.
infections)
• Constipation along with persistent
- nefazodone (for depression).
abdominal pain, or constipation which
Do not take Sondate XL if the above applies
has not responded to treatment, as this
to you. If you are not sure, talk to your
may lead to a more serious blockage of
doctor or pharmacist before taking
the bowel.
Sondate XL.

Sondate XL
50 mg, 150 mg, 200 mg, 300 mg,
400 mg Prolonged-release Tablets
quetiapine

22211-E
320 x 323

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Pharma code 81 (010010)
First bar is 105mm from top edge.

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

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TEVA UK Ref:

231-30-22211-E LEA QUETIAPINE (Sondate XL) A/S TAB TUK
Dimensions:
Length:
Width:
Depth:

323 mm
320 mm
folded to160 mm

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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.

this has been discussed with your doctor.
Sondate 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
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.
Driving and using machines
The medicine can affect your ability to drive
as it may make you sleepy or dizzy.
• Do not drive while taking this medicine
until you know how it affects you.
• It is an offence to drive if this medicine
affects your ability to drive.
However, you would not be committing an
offence if:

• The medicine has been prescribed to
treat a medical or dental problem and
Weight gain
• You have taken it according to the
Weight gain has been seen in patients taking
instructions given by the prescriber or in
quetiapine. You and your doctor should
the information provided with the
check your weight regularly.
medicine and

It
was not affecting your ability to drive
Children and Adolescents
safely
Quetiapine Teva is not for use in children
and adolescents below 18 years of age.
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
Other medicines and Sondate XL
while taking this medicine.
Tell your doctor if you are taking or have
recently taken or might take any other
Effect on Urine Drug Screens
medicines,.
If you are having a urine drug screen, taking
Do not take Sondate XL if you are taking any Sondate XL may cause positive results for
of the following medicines:
methadone or certain drugs for depression
• Some medicines for HIV.
called tricyclic antidepressants (TCAs) when
• Azole medicines (for fungal infections).
some test methods are used. even though
• Erythromycin or clarithromycin (for
you may not be taking methadone or TCAs.
infections).
If this happens, a more specific test can be
• Nefazodone (for depression).
performed.
Tell your doctor if you are taking any of the
following medicines:
3 How to take Sondate XL
• Epilepsy medicines (like phenytoin or
Always take this medicine exactly as your
carbamazepine).
doctor has told you. Check with your doctor
• High blood pressure medicines.
or pharmacist if you are not sure. Your
• Barbiturates (for difficulty sleeping).
doctor will decide on your starting dose. The
• Thioridazine or Lithium (other
maintenance dose (daily dose) will depend
anti-psychotic medicineS).
on your illness and needs but will usually be
• Medicines that have an impact on the
way your heart beats, for example, drugs between 150 mg and 800 mg.
• You will take your tablets once a day.
that can cause an imbalance in
• Do not split, chew or crush the tablets.
electrolytes (low levels of potassium or
• Swallow your tablets whole with a drink
magnesium) such as diuretics (water
of water.
pills) or certain antibiotics (drugs to treat
• Take your tablets without food (at least
infections).
one hour before a meal or at bedtime,
• Medicines that can cause constipation.
your doctor will tell you when).
• Medicines (called “anti-cholinergics”) that

Do
not drink grapefruit juice while you
affect the way nerve cells function in
are taking Sondate XL . It can affect the
order to treat certain medical conditions.
way the medicine works.
Before you stop taking any of your
• Do not stop taking your tablets even if you
medicines, please talk to your doctor first.
feel better, unless your doctor tells you.
Sondate XL with food, drink and alcohol
Liver problems
• Sondate XL can be affected by food and
If you have liver problems your doctor may
you should therefore take your tablets at change your dose.
least one hour before a meal or prior to
Elderly people
bedtime.
If you are elderly your doctor may change
• Be careful how much alcohol you drink.
your dose.
This is because the combined effect of
Sondate XL and alcohol can make you
Use in children and adolescents
sleepy.
Sondate XL should not be used by children
• Do not drink grapefruit juice while you
and adolescents aged under 18 years.
are taking Sondate XL. It can affect the
If you take more Sondate XL than you
way the medicine works.
should
Pregnancy and breast-feeding
If you take more Sondate XL than
If you are pregnant, or breast-feeding, think prescribed by your doctor, you may feel
you may be pregnant or are planning to
sleepy, feel dizzy and experience abnormal
have a baby, ask your doctor for advice
heart beats. Contact your doctor or nearest
before taking this medicine. You should not hospital straight away.
take Sondate XL during pregnancy unless
Keep the Sondate XL tablets with you.

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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
If you stop taking Sondate XL
called restless legs syndrome).
If you suddenly stop taking Sondate XL, you

Difficulty
swallowing.
may be unable to sleep (insomnia), or you
• Uncontrollable movements, mainly of
may feel sick (nausea), or you may
your face or tongue.
experience headache, diarrhoea, being sick
• Sexual dysfunction.
(vomiting), dizziness or irritability. Your

Diabetes.
doctor may suggest you reduce the dose
• Change in electrical activity of the heart
gradually before stopping treatment.
seen on ECG (QT prolongation).
If you have any further questions on the use • A slower than normal heart rate which
of this medicine, ask your doctor or
may occur when starting treatment and
pharmacist.
which may be associated with low blood
pressure and fainting.
4 Possible side effects
• Difficulty in passing urine.

Fainting
(may lead to falls).
Like all medicines, this medicine can cause
• Stuffy nose.
side effects, although not everybody gets

Decrease
in the amount of red blood
them.
cells.
Very common side effects (may affect more

Decrease
in the amount of sodium in the
than 1 in 10 people):
blood.
• Dizziness (may lead to falls), headache,

Worsening
of pre-existing diabetes
dry mouth.
If you forget to take a dose of Sondate 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.

• Feeling sleepy (this may go away with
time, as you keep taking Sondate XL)
(may lead to falls).
• Discontinuation symptoms (symptoms
which occur when you stop taking
Sondate 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 side effects (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).
• 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:
o Men and women to have swelling of
breasts and unexpectedly produce
breast milk.
o Women to have no monthly period or
irregular periods.

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 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.
• 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.

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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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