SONDATE XL 50MG PROLONGED-RELEASE TABLET

Active substance: QUETIAPINE FUMARATE

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PAGE 1: FRONT FACE (INSIDE OF REEL)
Top of page cut-off to middle of registration mark: 44 mm.

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
PACKAGE LEAFLET: INFORMATION FOR THE USER
about two weeks but sometimes longer. These thoughts may also
Read all of this leaflet carefully before you start taking this
be increased if you suddenly stop taking your medication.
medicine.
You may be more likely to think like this if you are a young adult.
• Keep this leaflet. You may need to read it again.
Information from clinical trials has shown an increased risk of
• If you have any further questions, ask your doctor or
suicidal thoughts and/or suicidal behaviour in young adults aged
pharmacist.
less than 25 years with depression.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
If you have thoughts of harming or killing yourself at any time,
same as yours.
contact your doctor or go to a hospital straight away. You may find
• If any of the side effects gets serious, or if you notice any side it helpful to tell a relative or close friend that you are depressed,
effects not listed in this leaflet, please tell your doctor or
and ask them to read this leaflet. You might ask them to tell you if
pharmacist.
they think your depression is getting worse, or if they are worried
about changes in your behaviour.
IN THIS LEAFLET:
Weight gain has been seen in patients taking quetiapine. You and
1. What SONDATE XL is and what it is used for
your doctor should check your weight regularly.
2. Before you take SONDATE XL
Taking other medicines
3. How to take SONDATE XL
Please tell your doctor if you are taking or have recently taken
4. Possible side effects
any other medicines, including medicines obtained without a
5. How to store SONDATE XL
prescription and herbal medicines.
6. Further information
Do not take SONDATE XL if you are taking any of the following
WHAT SONDATE XL IS AND WHAT IT IS USED FOR medicines:
1
• Some medicines for HIV
• Azole medicines (for fungal infections)
SONDATE XL contains a substance called quetiapine. This
• Erythromycin or clarithromycin (for infections)
belongs to a group of medicines called anti-psychotics.
• Nefazodone (for depression)
SONDATE XL can be used to treat several illnesses, such as:
• Schizophrenia: where you may hear or feel things that are not Tell your doctor if you are taking any of the following medicines:
there, believe things that are not true or feel unusually
• Epilepsy medicines (like phenytoin or carbamazepine)
suspicious, anxious, confused, guilty, tense or depressed
• High blood pressure medicines
• Mania: where you may feel very excited, elated, agitated,
• Barbiturates (for difficulty sleeping)
enthusiastic or hyperactive or have poor judgment including
• Thioridazine (another anti-psychotic medicine)
being aggressive or disruptive
• Medicines that have an impact on the way your heart beats, for
• Bipolar depression and major depressive episodes in major
example, drugs that can cause an imbalance in electrolytes (low
depressive disorder: where you feel sad. You may find that you
levels of potassium or magnesium) such as diuretics (water pills)
feel depressed, feel guilty, lack energy, lose your appetite or
or certain antibiotics (drugs to treat infections).
can’t sleep.
Before you stop taking any of your medicines, please talk to your
doctor first.
When SONDATE XL is being taken to treat major depressive
episodes in major depressive disorder, it will be taken in addition Taking SONDATE XL with food and drink
to another drug being used to treat this illness.
• SONDATE XL can be affected by food and you should
therefore take your tablets at least one hour before a meal or
Your doctor may continue to give you SONDATE XL when you
prior to bedtime
are feeling better.
• Be careful how much alcohol you drink. This is because the
combined effect of SONDATE XL and alcohol can make you
2 BEFORE YOU TAKE SONDATE XL
sleepy
• Do not drink grapefruit juice while you are on SONDATE XL
Do not take SONDATE XL:
treatment. It can affect the way the medicine works.
• if you are allergic (hypersensitive) to quetiapine or any of the
Pregnancy and breast-feeding
other ingredients of SONDATE XL
If you are pregnant, trying to get pregnant, or breast-feeding, talk
• if you are taking any of the following medicines:
to your doctor before taking SONDATE XL. You should not take
• some medicines for HIV
SONDATE XL during pregnancy unless this has been discussed
• azole medicines (for fungal infections)
with your doctor. SONDATE XL should not be taken if you are
• erythromycin or clarithromycin (for infections)
breast-feeding.
• nefazodone (for depression).
Do not take SONDATE XL if the above applies to you. If you are
The following symptoms may occur in newborn babies, of
not sure, talk to your doctor or pharmacist before taking
mothers that have used quetiapine in the last trimester (last
SONDATE XL.
three months of their pregnancy): shaking, muscle stiffness
and/or weakness, sleepiness, agitation, breathing problems, and
Take special care with SONDATE XL
difficulty in feeding. If your baby develops any of these
Before you take your medicine, tell your doctor if:
symptoms you may need to contact your doctor.
• You, or someone in your family, have or have had any heart
problems, for example heart rhythm problems or if you are
Driving and using machines
taking any medicines that may have an impact on the way
Your tablets may make you feel sleepy. Do not drive or use any
your heart beats
tools or machines until you know how the tablets affect you.
• You have low blood pressure.
Effect on Urine Drug Screens
• You have had a stroke, especially if you are elderly
If you are taking quetiapine and have a urine drug screen, some
• You have problems with your liver
test methods may cause positive results for methadone or TCAs
• You have ever had a fit (seizure)
(drugs for depression called tricyclic antidepressants), even
• You have diabetes or have a risk of getting diabetes. If you do,
though you may not be taking methadone or TCAs. If this
your doctor may check your blood sugar levels while you are
happens, a more specific test can be performed.
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
3 HOW TO TAKE SONDATE XL
medicines)
Always take SONDATE XL exactly as your doctor has told you.
• You are an elderly person with dementia (loss of brain
You should check with your doctor or pharmacist if you are not
function). If you are, SONDATE XL should not be taken
because the group of medicines that SONDATE XL belongs to sure. Your doctor will decide on your starting dose. The
maintenance dose (daily dose) will depend on your illness and
may increase the risk of stroke, or in some cases the risk of
needs but will usually be between 150 mg and 800 mg.
death, in elderly people with dementia
• You will take your tablets once a day
• You or someone else in your family has a history of blood
• Do not split, chew or crush the tablets
clots, as medicines like these have been associated with
• Swallow your tablets whole with a drink of water
formation of blood clots.
• Take your tablets without food (at least one hour before a meal
Tell your doctor immediately if you experience:
or at bedtime, your doctor will tell you when)
• Fever, severe muscle stiffness, sweating or a lowered level of
• Do not drink grapefruit juice while you are taking SONDATE XL
consciousness (a disorder called “neuroleptic malignant
treatment. It can affect the way the medicine works
syndrome”). Immediate medical treatment may be needed
• Do not stop taking your tablets even if you feel better, unless
• Uncontrollable movements, mainly of your face or tongue
your doctor tells you.
• Dizziness or a severe sense of feeling sleepy. This could
Liver problems
increase the risk of accidental injury (fall) in elderly patients
If you have liver problems your doctor may change your dose.
• Fits (seizures)
• A long-lasting and painful erection (Priapism).
Elderly people
If you are elderly your doctor may change your dose.

SONDATE XL 50 mg, 200 mg,
300 mg, 400 mg PROLONGED-RELEASE TABLETS
Quetiapine

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Children and adolescents under 18 years
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 experience sleepiness, dizziness and 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), 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.

Pharma code 604
First bar is 105mm from topedge.

• Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis).
Not known (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 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.
If you have any further questions on the use of this product, ask
Increases in the hormone prolactin could in rare cases lead to
your doctor or pharmacist.
the following:
• Men and women to have swelling of breasts and unexpectedly
POSSIBLE SIDE EFFECTS
4
produce breast milk
Like all medicines, SONDATE XL can cause side effects, although • Women to have no monthly period or irregular periods.
not everybody gets them. If any of the side effects gets serious, or Your doctor may ask you to have blood tests from time to time.
Children and adolescents
if you notice any side effects not listed in this leaflet, please tell
The same side effects that may occur in adults may also occur in
your doctor or pharmacist.
children and adolescents.
Very common (affects more than 1 patient in 10):
The following side effect has been seen only in children and
• Dizziness (may lead to falls), headache, dry mouth
• Feeling sleepy (this may go away with time, as you keep taking adolescents:
Very Common (affects more than 1 patient in 10):
SONDATE XL) (may lead to falls)
• Increase in blood pressure.
• Discontinuation symptoms (symptoms which occur when you
The following side effects have been seen more often in children
stop taking SONDATE XL) include not being able to sleep
(insomnia), feeling sick (nausea), headache, diarrhoea, being sick and adolescents:
(vomiting), dizziness, and irritability. Gradual withdrawal over a
Very Common (affects more than 1 patient in 10):
period of at least 1 to 2 weeks is advisable
• Increase in the amount of a hormone called prolactin, in the
• Putting on weight.
blood. Increases in the hormone prolactin could in rare cases
lead to the following:
Common (affects 1 to 10 patients in 100):
• Boys and girls to have swelling of breasts and
• Rapid heartbeat
unexpectedly produce breast milk
• Feeling like your heart is pounding, racing or has skipped beats
• Girls to have no monthly period or irregular periods.
• Stuffy nose
• Increased appetite
• Constipation, upset stomach (indigestion)
• Abnormal muscle movements. These include difficulty starting
• Feeling weak, fainting (may lead to falls)
muscle movements, shaking, feeling restless or muscle
• Swelling of arms or legs
stiffness without pain.
• 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
5 HOW TO STORE SONDATE XL
• Blurred vision
• Abnormal muscle movements. These include difficulty starting
Keep out of the reach and sight of children.
muscle movements, shaking, feeling restless or muscle stiffness
Do not use SONDATE XL after the expiry date which is stated on the
without pain
container after EXP. The expiry date refers to the last day of that month.
• Abnormal dreams and nightmares
SONDATE XL does not require any special storage conditions.
• Increased appetite
• Feeling irritated
Medicines should not be disposed of via wastewater or
• Disturbance in speech and language
household waste. Ask your pharmacist how to dispose of
• Thoughts of suicide and worsening of your depression
medicines no longer required. These measures will help to
• Shortness of breath
protect the environment.
• Vomiting (mainly in the elderly)
• Fever.
6 FURTHER INFORMATION
Uncommon (affects 1 to 10 patients in 1,000):
• Fits or seizures
What SONDATE XL contains
• Allergic reactions that may include raised lumps (weals),
• The active substance is quetiapine. SONDATE XL tablets
swelling of the skin and swelling around the mouth
contain 50 mg, 200 mg, 300 mg or 400 mg of quetiapine (as
• Unpleasant sensations in the legs (also called restless legs
quetiapine fumarate)
syndrome)
• The other ingredients are:
• Difficulty swallowing
Tablet core: hypromellose, cellulose microcrystalline, sodium
• Uncontrollable movements, mainly of your face or tongue
citrate anhydrous, magnesium stearate.
• Sexual dysfunction
Tablet coating: titanium dioxide (E171), hypromellose,
• Worsening of pre-existing diabetes
macrogol/PEG 400, polysorbate 80. The 50 mg, 200 mg and
• Change in electrical activity of the heart seen on ECG (QT
300 mg tablets contain Iron Oxide Yellow (E172) and Iron Oxide
prolongation).
Red (E172). The 50 mg and 300 mg tablets also contain Iron
Oxide Black (E172).
Rare (affects 1 to 10 patients in 10,000):
• A combination of high temperature (fever), sweating, stiff
What SONDATE XL looks like and contents of the pack
muscles, feeling very drowsy or faint (a disorder called
All strengths of SONDATE XL prolonged-release tablets are
“neuroleptic malignant syndrome’’)
capsule shaped, film-coated tablets. 50 mg tablets are brown
• Yellowing of the skin and eyes (jaundice)
coloured, debossed “Q 50” on one side, plain on the other; 200 mg
• Inflammation of the liver (hepatitis)
tablets are yellow coloured, debossed “Q 200” on one side, plain
• A long-lasting and painful erection (priapism)
on the other; 300 mg tablets are light yellow coloured, debossed
• Swelling of breasts and unexpected production of breast milk
“Q 300” on one side, plain on the other and 400 mg tablets are
(galactorrhoea)
white coloured, debossed “Q 400” on one side, plain on the other.
• Menstrual disorder
Packs of 10, 20, 30, 50, 50x1 (hospital pack), 56 (calendar pack),
• Blood clots in the veins especially in the legs (symptoms include
60, 90 and 100 tablets are registered for all strengths. Not all
swelling, pain and redness in the leg), which may travel through blood
pack sizes may be available.
vessels to the lungs causing chest pain and difficulty in breathing. If
Marketing Authorisation Holder and Manufacturer
you notice any of these symptoms seek medical advice immediately
Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom.
• Walking, talking, eating or other activities while you are asleep
• Body temperature decreased (hypothermia)
This leaflet was last revised in September 2012
• Inflammation of the pancreas.
PL 00289/1219
Very rare (affects less than 1 patient in 10,000):
PL 00289/1220
• Worsening of pre-existing diabetes
PL 00289/1221
• Inflammation of the liver (hepatitis)
PL 00289/1222
• 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)
40108-B
• Inappropriate secretion of a hormone that controls urine volume

SONDATE XL 50 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.
• 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:

1. What SONDATE XL is and what it is used
for
2. Before you take SONDATE XL
3. How to take SONDATE XL
4. Possible side effects
5. How to store SONDATE XL
6. Further 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:
• 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.
• Mania: where you may feel very excited,
elated, agitated, enthusiastic or hyperactive
or have poor judgment including being
aggressive or disruptive.
• 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.
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 give you
SONDATE XL when you are feeling better.

2 BEFORE YOU TAKE SONDATE XL
Do not take SONDATE XL:
• if you are allergic (hypersensitive) to
quetiapine or any of the other ingredients
of 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).
Do not take SONDATE XL if the above applies
to you. If you are not sure, talk to your doctor
or pharmacist before taking SONDATE XL.
Take special care with SONDATE XL
Before you take your medicine, tell your
doctor if:
• You, or someone in your family, have or
have had any heart problems, for example
heart rhythm problems 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.
Tell your doctor immediately if you
experience:
• 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
quetiapine. 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,
including medicines obtained without a
prescription and herbal 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 (another anti-psychotic medicine)
• 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 first.
Taking SONDATE XL with food and drink
• 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
on SONDATE XL treatment. 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 before
taking SONDATE XL. 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.
The following symptoms 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
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 taking quetiapine and have a urine
drug screen, some test methods may cause
positive results for methadone or TCAs (drugs
for depression called tricyclic antidepressants),
even though you may not be taking methadone
or TCAs. If this happens, a more specific test
can be performed.

3 HOW TO TAKE SONDATE XL
Always take SONDATE 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.
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 treatment. It can affect
the way the medicine works
• Do not stop taking your tablets even if you
feel better, unless your doctor tells you.
Liver problems
If you have liver problems your doctor may
change your dose.
Elderly people
If you are elderly your doctor may change
your dose.
Children and adolescents under 18 years
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 experience sleepiness,
dizziness and 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), 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, SONDATE XL can cause
side effects, although not everybody gets
them. If any of the side effects gets serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Very common (affects more than 1 patient in 10):
• 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.
Common (affects 1 to 10 patients in 100):
• Rapid heartbeat
• Feeling like your heart is pounding, racing
or has skipped beats
• Stuffy nose
• Constipation, upset stomach (indigestion)
• Feeling weak, fainting (may lead to falls)
• 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
• Increased appetite
• Feeling irritated
• Disturbance in speech and language
• Thoughts of suicide and worsening of your
depression
• Shortness of breath
• Vomiting (mainly in the elderly)
• Fever.
Uncommon (affects 1 to 10 patients in 1,000):
• 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
• Worsening of pre-existing diabetes
• Change in electrical activity of the heart
seen on ECG (QT prolongation).
Rare (affects 1 to 10 patients in 10,000):
• 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.
Very rare (affects less than 1 patient in
10,000):
• Worsening of pre-existing diabetes
• Inflammation of the liver (hepatitis)
• 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)
• Inappropriate secretion of a hormone that
controls urine volume
• Breakdown of muscle fibers and pain in
muscles (rhabdomyolysis).
Not known (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 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..
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 (affects more than 1 patient in
10):
• Increase in blood pressure.
The following side effects have been seen
more often in children and adolescents:
Very Common (affects more than 1 patient in
10):
• 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.
• Abnormal muscle movements. These
include difficulty starting muscle
movements, shaking, feeling restless or
muscle stiffness without pain.

5 HOW TO STORE SONDATE XL
Keep out of the reach and sight 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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6 FURTHER INFORMATION
What SONDATE XL contains
• The active substance is quetiapine.
SONDATE XL tablets contain 50 mg,
200 mg, 300 mg or 400 mg of quetiapine
(as quetiapine fumarate)
• The other ingredients are:
Tablet core: hypromellose, cellulose
microcrystalline, sodium citrate anhydrous,
magnesium stearate.
Tablet coating: titanium dioxide (E171),
hypromellose, macrogol/PEG 400,
polysorbate 80. The 50 mg, 200 mg and
300 mg tablets contain Iron Oxide Yellow
(E172) and Iron Oxide Red (E172). The 50
mg and 300 mg tablets also contain Iron
Oxide Black (E172).
What SONDATE XL looks like and contents of
the pack
All strengths of SONDATE XL
prolonged-release tablets are capsule
shaped, film-coated tablets. 50 mg tablets are
brown coloured, debossed “Q 50” 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.
Packs of 10, 20, 30, 50, 50x1 (hospital pack),
56 (calendar pack), 60, 90 and 100 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 September 2012
PL 00289/1219
PL 00289/1220
PL 00289/1221
PL 00289/1222

30108-B

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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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