Skip to Content

UK Edition. Click here for US version.

SONDATE XL 300 MG PROLONGED-RELEASE TABLET

Active substance(s): QUETIAPINE FUMARATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

FOLD
LINE.

PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

• Swelling of breasts and unexpected
production of breast milk (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating or other
activities while you are asleep.
• Body temperature decreased
(hypothermia).
• 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.
• Increased blood creatine
phosphokinase (a substance from the
muscles).
Very rare side effects (may affect up to 1 in
10,000 people):
• Inappropriate secretion of a hormone
that controls urine volume.

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 and blister
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.

• Symptoms of withdrawal may occur in
of the pack and other
6 Contents
newborn babies of mothers that have
information
used Quetiapine Teva during their
What Sondate XL contains
pregnancy.
- The active substance is quetiapine.
Some side effects are only seen when a
Sondate XL tablets contain 50 mg, 150 mg,
blood test is taken. These include changes in
200
mg, 300 mg or 400 mg of quetiapine
the amount of certain fats (triglycerides and
(as quetiapine fumarate).
total cholesterol) or sugar in the blood,
changes in the amount of thyroid hormones - The other ingredients are:
Tablet core: hypromellose, cellulose
in your blood, increased liver enzymes,
decreases in the number of certain types of microcrystalline, sodium citrate anhydrous,
magnesium stearate.
blood cells, decrease in the amount of red
Tablet coating: titanium dioxide (E171),
blood cells, increased blood creatine
hypromellose, macrogol/PEG 400, polysorbate
phosphokinase (a substance in the
muscles), decrease in the amount of sodium 80. The 50 mg, 200 mg and 300 mg tablets
in the blood and increases in the amount of contain Iron Oxide Yellow (E172) and Iron
Oxide Red (E172). The 50 mg and 300 mg
the hormone prolactin in the blood.
Increases in the hormone prolactin could in tablets also contain Iron Oxide Black (E172).
What Sondate XL looks like and contents of
the pack
- Sondate XL 50 mg Prolonged-release
Tablets
Brown, biconvex, oblong film-coated
tablets with debossing “Q50” on one side
- Sondate XL 150 mg Prolonged-release
Tablets
White,
biconvex, oblong film-coated tablets
Side effects in children and adolescents
with debossing “Q150” on one side
The same side effects that may occur in adults
- Sondate XL 200 mg Prolonged-release
may also occur in children and adolescents.
Tablets
The following side effects have been seen
Yellow,
biconvex, oblong film-coated
more often in children and adolescents
tablets with debossing “Q200” on one side
or have not been seen in adults:
- Sondate XL 300 mg Prolonged-release
Very Common side effects (may affect more
Tablets
than 1 in 10 people):
Light yellow, biconvex, oblong
• Increase in the amount of a hormone
film-coated tablets with debossing
called prolactin, in the blood. Increases
“Q300” on one side
in the hormone prolactin could in rare - Sondate XL 400 mg Prolonged-release
cases lead to the following:
Tablets
- Boys and girls to have swelling of
White, biconvex oblong film-coated tablets
breasts and unexpectedly produce
with debossing “Q400” on one side
breast milk.
Packs
of 10, 20, 30, 50, 50x1 (perforated unit
- Girls to have no monthly period or
dose
blister)
(hospital pack), 56 (calendar
irregular periods.
pack), 60, 90 and100 tablets are registered
• Increased appetite.
for all strengths. Not all pack sizes may be
• Vomiting
available.
• Abnormal muscle movements. These
Marketing Authorisation Holder and
include difficulty starting muscle
Manufacturer
movements, shaking, feeling restless
or muscle stiffness without pain.
Teva UK Limited, Eastbourne, BN22 9AG,
• Increase in blood pressure
United Kingdom
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.

Common side effects (may affect up to 1 in
10 people):
• Feeling weak, fainting (may lead to
falls).

This leaflet was last revised in 01/2018.
PL 00289/1219, 1553, 1220, 1221 & 1222
EAS2068a

22211-G

320 x 323

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





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

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
Tell your doctor immediately if you
disruptive.
• Schizophrenia: where you may hear or experience any of the following after taking
Sondate XL:
feel things that are not there, believe
• A combination of fever, severe muscle
things that are not true or feel
stiffness, sweating or a lowered level
unusually suspicious, anxious,
of consciousness (a disorder called
confused, guilty, 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,
- If you are taking any of the following
or any other infection, as this could be
medicines:
a result of a very low white blood cell
- some medicines for HIV
count, which may require Quetiapine
- azole medicines (for fungal infections)
Teva to be stopped and/or treatment to
- erythromycin or clarithromycin (for
be 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 doctor
may lead to a more serious blockage
or pharmacist before taking Sondate XL.
of the bowel.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Sondate XL if:
• You, or someone in your family, have
Peel Here To Open

Pharma code 696 (010111001)
First bar is 105mm from top edge.

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

• Stuffy nose.
• Feeling irritated.

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

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

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

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

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.
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.

FOLD
LINE.

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

- Unexplained muscle pain, tenderness or
If you forget to take a dose of Sondate XL
weakness. These might be early signs of
If you forget to take a dose, take it as soon
potentially severe muscle degradation.
as you remember. If it is almost time to take
the next dose, wait until then. Do not take a Other possible side effects
double dose to make up for a forgotten tablet.
Very common side effects (may affect more
If you stop taking Sondate XL
than 1 in 10 people):
If you suddenly stop taking Sondate XL, you
• Dizziness (may lead to falls), headache,
may be unable to sleep (insomnia), or you
dry mouth.
may feel sick (nausea), or you may
• Feeling sleepy (this may go away with
experience headache, diarrhoea, being sick
time, as you keep taking Sondate XL)
(vomiting), dizziness or irritability. Your
(may lead to falls).
doctor may suggest you reduce the dose
• Discontinuation symptoms (symptoms
gradually before stopping treatment.
which occur when you stop taking
Sondate XL) include not being able to
If you have any further questions on the use
sleep (insomnia), feeling sick (nausea),
of this medicine, ask your doctor or
headache, diarrhoea, being sick
pharmacist.
(vomiting), dizziness, and irritability.
Gradual withdrawal over a period of at
4 Possible side effects
least 1 to 2 weeks is advisable.
Like all medicines, this medicine can cause
• Putting on weight.
side effects, although not everybody gets
• Abnormal muscle movements. These
them.
include difficulty starting muscle
movements, shaking, feeling restless
If you get any of the following serious side
or muscle stiffness without pain.
effects, stop taking Sondate XL and go to
• Decreased level of haemoglobin (protein
your doctor or to the nearest hospital
straight away:
in red blood cells that carry oxygen)
• Changes in the amount of certain fats
Common side effects (may affect up to 1 in
(triglycerides and total cholesterol).
10 people):
- Thoughts of suicide and worsening of
your depression
Uncommon side effects (may affect up to 1
in 100 people):
- Sudden fever, especially with sore throat
and other flu-like symptoms. These can
be signs of an abnormal low
concentration of white blood cells.
- Signs of skin reactions such as skin rash,
hives, lumps, redness, itching, maybe
with swelling of the face, eyelids, and
lips. This could additionally lead to
difficulty in breathing, dizziness or shock.
- Fits or seizures
- Uncontrollable movements, mainly of
your face or tongue (tardive dyskinesia)
- Feeling your heart is pounding or racing
together with dizziness or fainting. This
can be signs of serious heart rhythm
problems and in severe cases may be fatal.

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.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
• Changes in the amount of thyroid
hormones in your blood.
• Changes 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):
- Severe pain and/or swelling and redness
in one of your legs; sudden severe pain in
the chest which may reach the left arm or
sudden breathlessness. These can be
signs of blood clots in the veins.
- Severe upper stomach pain, often
radiating to the back, sometimes together
with nausea and vomiting. This can be a
sign of inflammation of the pancreas.
- 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.
- Yellowing of the skin and eyes (jaundice), Uncommon side effects (may affect up to
dark coloured urine, especially together
1 in 100 people):
with unusual tiredness or fever (signs of a
• Unpleasant sensations in the legs (also
hepatitis).
called restless legs syndrome).
- A long lasting and painful erection.
• Difficulty swallowing.
- A combination of fever, sweating, stiff
• Sexual dysfunction.
muscles, feeling very drowsy or faint (a
• Diabetes.
disorder called “neuroleptic malignant
• A slower than normal heart rate which
syndrome’’).
may occur when starting treatment
and which may be associated with low
Very rare side effects (may affect up to 1 in
blood pressure and fainting.
10,000 people):

Difficulty
in passing urine.
- Severe skin reactions with rash or
• Fainting (may lead to falls).
blisters, irregular red spots or patches
• Stuffy nose.
and/or peeling of the skin, maybe around
• Decrease in the amount of sodium in
mouth, eyes or genitals and often
the blood.
together with sudden fever or flu-like
• Worsening of pre-existing diabetes
symptoms. These reactions may develop
quickly.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide