Medication Guide App

SONDATE XL 400MG PROLONGED-RELEASE TABLET

Active substance: QUETIAPINE FUMARATE

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newborn babies of mothers that have
used Quetiapine Teva during their
pregnancy.

Sondate XL does not require any special
storage conditions.
Do not throw away any medicines via

The class of medicines to which Sondate XL pharmacist how to throw away medicines
belongs can cause heart rhythm problems,
you no longer use. These measures will help
which can be serious and in severe cases
protect the environment.
may be fatal.
Some side effects are only seen when a
6 Contents of the pack and other
blood test is taken. These include changes in
information
What Sondate XL contains
changes in the amount of thyroid hormones
in your blood, increased liver

Tablet core: hypromellose, cellulose
microcrystalline, sodium citrate anhydrous,
magnesium stearate.

polysorbate 80. The 50 mg, 200 mg and
300 mg tablets contain Iron Oxide Yellow
breasts and unexpectedly produce breast
milk
and 300 mg tablets also contain Iron Oxide

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:

What Sondate XL looks like and contents of
the pack

shaped, film-coated tablets. 50 mg tablets
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.

: Information
for the user

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.

may be available.

are elderly

doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

getting diabetes. If you do, your doctor
may check your blood sugar levels while
you are taking Sondate XL.

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:

feel things that are not there, believe
things that are not true or feel unusually
suspicious, anxious, confused, guilty,
tense or depressed.

This leaflet was last revised in 11/2014.
Common side effects (may affect up to 1 in
10 people):

When Sondate XL is being taken to treat
depressive disorder, it will be taken in
addition to another drug being used to treat
this illness.

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

Your doctor may continue to prescribe
Sondate XL even when you feel better.

2

www.mhra.gov.uk/yellowcard

What you need to know before you
take Sondate XL

Do not take Sondate XL:

provide more information on the safety of
this medicine.

the other ingredients of this medicine

How to store Sondate XL

medicines:

Keep this medicine out of the sight and
reach of children.
Do not use Sondate XL after the expiry date
The expiry date refers to the last day of that
month.

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

or may not have been caused by other

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.
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
Sondate XL:
stiffness, sweating or a lowered level of
Immediate medical treatment may be
needed.
your face or tongue
sleepy. This could increase the risk of

including being aggressive or disruptive

include difficulty starting muscle
movements, shaking, feeling restless or
muscle stiffness without pain.

5

Warnings and precautions
Talk to your doctor or pharmacist before
taking Sondate XL if:

you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.

elated, agitated, enthusiastic or

Marketing Authorisation Holder and
Manufacturer

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.

your doctor or pharmacist.

where you feel sad. You may find that you
feel depressed, feel guilty, lack energy,
lose your appetite or can’t sleep.

breasts and unexpectedly produce
breast milk
irregular periods

SONDATE XL
50 mg, 150 mg, 200 mg, 300 mg,
400 mg PROLONGED-RELEASE
TABLETS
quetiapine

again.

Sondate XL tablets contain 50 mg, 150 mg,
200 mg, 300 mg or 400 mg of quetiapine

types of blood cells, decrease in the amount
of red blood cells, increased blood creatine
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:

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These conditions can be caused by this type
of medicine.
Tell your doctor as soon as possible if you
have:
any other infection, as this could be a
result of a very low white blood cell
count, which may require Sondate XL to
be stopped and/or treatment to be given
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

Top of page cut-off to middle of registration mark = 44 mm

FOLD
LINE.

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clinical trials has shown an increased risk of Driving and using machines
suicidal thoughts and/or suicidal behaviour The medicine can affect your ability to drive
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
until you know how it affects you
go to a hospital straight away. You may find
it helpful to tell a relative or close friend that
affects your ability to drive.
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, offence if:
or if they are worried about changes in your
behaviour.
treat a medical or dental problem and
Weight gain
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
Children and Adolescents
Quetiapine Teva is not for use in children
and adolescents below 18 years of age.

safely.

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If you stop taking Sondate XL
If you suddenly stop taking Sondate XL, you
your face or tongue
experience headache, diarrhoea, being sick
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

may occur when starting treatment and
which may be associated with low blood
pressure and fainting

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):
dry mouth

blood.
Rare side effects (may affect up to 1 in 1,000
people):

Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.

Other medicines and Sondate XL
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 test methods are used. even though

Tell your doctor if you are taking any of the
following medicines:

FOLD
LINE.

If this happens, a more specific test can be
performed.

3

How to take Sondate XL

or pharmacist if you are not sure. Your
doctor will decide on your starting dose. The
way your heart beats, for example, drugs on your illness and needs but will usually be
that can cause an imbalance in electrolytes between 150 mg and 800 mg.

which occur when you stop taking
headache, diarrhoea, being sick
Gradual withdrawal over a period of at
least 1 to 2 weeks is advisable.
include difficulty starting muscle
movements, shaking, feeling restless or
muscle stiffness without pain.

Common side effects (may affect up to 1 in
10 people):
racing or has skipped beats

through blood vessels to the lungs causing
chest pain and difficulty in breathing. If
you notice any of these symptoms seek
medical advice immediately.
while you are asleep

combination of 3 or more of the
following: an increase in fat around your
abdomen, a decrease in “good

of water
of fat in your blood called triglycerides,
high blood pressure and an increase in
your blood sugar

one hour before a meal or at bedtime,
medicines, please talk to your doctor first.
Sondate XL with food, drink and alcohol
you should therefore take your tablets at
least one hour before a meal or prior to
bedtime
This is because the combined effect of
Sondate XL and alcohol can make you
sleepy.
are taking Sondate 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 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.

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.
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

The following symptoms which can
hospital straight away.
represent withdrawal may occur in newborn
Keep the Sondate XL tablets with you.
babies, of mothers that have used
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.

sore throat, or any other infection with
very low white blood cell count, a
condition called agranulocytosis

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.

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.

your depression
Very rare side effects (may affect up to 1 in
10,000 people):
hormones in your blood
of blood cells

the skin
in breathing or shock

measured in the blood
prolactin in the blood. Increases in the
hormone prolactin could in rare cases
lead to the following:
breasts and unexpectedly produce
breast milk

mouth, eyes and genitals
controls urine volume

irregular periods.
Uncommon side effects (may affect up to 1
in 100 people):Fits or seizures.
swelling around the mouth

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

symptoms such as fever and blisters on

If you forget to take a dose of Sondate XL

SONDATE XL 50 mg, 150 mg,
200 mg, 300 mg, 400 mg
PROLONGED-RELEASE TABLETS
Quetiapine

If you stop taking Sondate XL
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

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

4

Possible side effects

Children and Adolescents

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

Other medicines and Sondate XL

Very common side effects (may affect more than 1
in 10 people):

What Sondate XL is and what it is used for

Common side effects (may affect up to 1 in 10
people):

Side effects in children and adolescents

Sondate XL with food, drink and alcohol
Very Common side effects (may affect more than 1
in 10 people):

2

What you need to know before you take
Sondate XL

Pregnancy and breast-feeding

Do not take Sondate XL:

Common side effects (may affect up to 1 in 10
people):

Reporting of side effects:
Warnings and precautions
Uncommon side effects (may affect up to 1 in 100
people): Fits or seizures.
Driving and using machines

5

How to store Sondate XL

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

6
Effect on Urine Drug Screens
Rare side effects (may affect up to 1 in 1,000
people):

3

Contents of the pack and other
information

What Sondate XL contains

How to take Sondate XL

What Sondate XL looks like and contents of the
pack

Liver problems

Elderly people
Thoughts of suicide and worsening of your
depression

Marketing Authorisation Holder and Manufacturer

Use in children and adolescents

If you take more Sondate XL than you should

Very rare side effects (may affect up to 1 in 10,000
people):

This leaflet was last revised in 11/2014.

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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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