2. What should I know before I use SYQUET?
Do not use if you have ever had an allergic reaction to quetiapine fumarate or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use SYQUET? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with SYQUET and affect how it works.
4. How do I use SYQUET?
Your doctor will tell you how many tablets you will need to take each day and how
long you need to take it.
Swallow your SYQUET tablets whole with a full glass of water. You can take them with
or without food.
5. What should I know while using SYQUET?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using SYQUET.
Tell your doctor or mental health professional immediately, or go to the nearest hospital,
if you have any suicidal thoughts or other mental/mood changes.
If you become pregnant while taking it, tell your doctor immediately.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking it.
|
|
Things you should not do
|
Do not stop using this medicine suddenly.
Do not use SYQUET to treat other complaints unless your doctor or pharmacist tells
you to.
Do not give SYQUET to anyone else, even if they have the same symptoms or condition
as yours.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how SYQUET
affects you. It can make some people dizzy or sleepy.
|
|
Drinking alcohol
|
Combining SYQUET and alcohol can make you more sleepy or dizzy.
|
|
Looking after your medicine
|
Store below 25 °C.
|
6. Are there any side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Most common side effects include feeling sleepy, weight gain, increased appetite,
feeling weak, dry mouth.
Serious side effects include falling, feeling dizzy or faint on standing up, flat
and red skin lesions or substantial hemorrhages under the skin (purpura), difficulty
in speaking, difficulty in swallowing, rapid heart beat.
Very Serious side effects include long lasting and painful erection, fainting (particularly
in children). For more information, including what to do if you have any side effects,
see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Quetiapine fumarate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SYQUET. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using SYQUET.
Where to find information in this leaflet:
1. Why am I using SYQUET?
SYQUET contains the active ingredient quetiapine fumarate. SYQUET belongs to a group
of medicines called antipsychotics.
SYQUET helps to correct chemical imbalances in the brain. It is used to treat conditions
such as:
Schizophrenia, an illness with disturbances in thinking, feelings and behaviour
Bipolar disorder, an illness in which there are sustained mood swings either up (mania)
or down (depression). During mania, patients experience episodes of overactivity,
elation or irritability. During depression, patients may feel depressed or guilty,
lack of energy, lose their appetite and have trouble sleeping.
SYQUET is available only with a doctor’s prescription.
2. What should I know before I use SYQUET?
Warnings
Do not use SYQUET if:
you are allergic to quetiapine fumarate, or any of the ingredients listed at the end
of this leaflet. Some of the symptoms of an allergic reaction may include shortness
of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or
other parts of the body; rash, itching or hives on the skins or you may feel faint.
Always check the ingredients to make sure you can use this medicine.
it is beyond expiry date which is printed on the pack.
the packaging is torn or shows signs of tampering.
You are pregnant or breastfeeding unless your doctor says so. Ask your doctor about
the risks and benefits involved.
Do not give SYQUET to children or adolescents unless recommended by your doctor.
The effects of SYQUET have only been studied in children aged between 10 and 17 years
with mania and in children aged between 13 and 17 years with schizophrenia. There
is not enough information on its effects in children to recommend its use in other
age groups or for other conditions.
SYQUET, as with other anti-psychotic medicines, is recommended for use with caution
in the elderly and is not approved for treatment of dementia and behavioural disturbances.
In clinical studies with this group of medicines for the treatment of dementia and
behavioural disturbances in the elderly, have suggested an increased risk of cardiovascular
adverse events including stroke, and increased mortality risk for elderly patients
has been reported.
If it has expired or is damaged, return it to your pharmacist for disposal
If you are not sure whether you should start taking SYQUET, talk to your doctor or
pharmacist.
Check with your doctor if you:
have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
have or have had any medical conditions, especially the following:
heart or blood vessel problems or a family history of heart or blood vessel problems
including high or low blood pressure, stroke, problems with your circulation or any
condition that affects blood flow to the brain, problems with the way your heart beats
or a history of heart attack
liver problems
diabetes (or a family history of diabetes). Patients with diabetes or who have a higher
chance of diabetes should have their blood sugar checked before and during treatment
with SYQUET.
increased cholesterol levels
inflammation of pancreas
difficulty swallowing
epilepsy (seizures or fits)
dementia or related behavioural disorders (especially in elderly patients)
low white blood cell count
sleep apnoea - a condition where you stop breathing for short periods during your
normal nightly sleep
urinary retention (a condition where you can't completely empty your bladder)
an enlarged prostate
a blockage in your intestines
increased pressure inside your eyes or glaucoma
history of alcohol or drug abuse
depression or other conditions that are treated with antidepressants. The use of these
medicines together with SYQUET can lead to serotonin syndrome, a potentially life-threatening
condition. (see “What if I am taking other medicines?)
Tell your doctor or mental health professional if you have any mental/mood changes
or suicidal thoughts.
Depression and other mental illnesses can increase the risk of suicide. It is important
to discuss all the risks of treating depression and mental illness as well as the
risks of not treating it. You should discuss all treatment choices with your doctor,
not just the use of antidepressants.
Patients (and caregivers of patients) need to monitor for any worsening of their condition
and/or the emergence of thoughts of suicide or suicidal behaviour or thoughts of harming
themselves and to seek medical advice immediately if these symptoms present.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take SYQUET if you are pregnant or breastfeeding unless your doctor says so.
Ask your doctor about the risks and benefits involved.
It is not known if it is safe for you to take it while you are pregnant.
Neonates exposed to antipsychotic drugs (including quetiapine) may experience agitation,
hypertonia (high level muscle tone), hypotonia (decreased muscle tone), tremor, somnolence,
respiratory distress and feeding disorder following delivery (extrapyramidal neurological
disturbances and/or withdrawal symptoms). These complications have varied in severity;
while in some cases symptoms have been self-limited, in other cases neonates have
required additional medical treatment or monitoring.
However, if you need to take it during your pregnancy, the doctor will discuss the
risks and benefits of taking it with you.
It is recommended that you do not breastfeed while taking it, as it may pass into
breast milk.
Before your doctor starts you on SYQUET your doctor may want to take some tests (eg
blood tests, blood pressure, weight or height measurements). These tests may help
to prevent side effects.
Tell your doctor if you are lactose intolerant.
SYQUET tablets contain lactose.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with SYQUET and affect how it works.
Some medicines and SYQUET may interfere with each other. These include:
medicines used to treat anxiety, depression, mood swings, attention deficit hyperactivity
disorder (ADHD) or other mood disorders
lorazepam - a medicine used to help you sleep
medicines for high blood pressure (including diuretics or fluid tablets) or heart
conditions
thioridazine - an antipsychotic medicine
medicines used to treat Parkinson's disease
stimulants such as amphetamines
medicines that have anti-cholinergic (muscarinic) effects
These medicines may be affected by SYQUET, or may affect how well it works. You may
need different amounts of your medicine, or you may need to take different medicines.
Your doctor will advise you.
Anti-depressants may interact with SYQUET and you may experience symptoms such as
involuntary, rhythmic contractions of muscles, including the muscles that control
movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor,
exaggeration of reflexes, increased muscle tension, body temperature above 38 °C (serotonin
syndrome). Contact your doctor when experiencing such symptoms.
Medicines that may increase the effect of SYQUET include:
some antibiotics such as erythromycin
medicines used for fungal infections such as ketoconazole
medicines for Human Immunodeficiency Virus (HIV)
Medicines that may reduce the effect of SYQUET include:
phenytoin or carbamazepine - medicines for epilepsy
some antibiotics such as rifampicin
glucocorticoids - medicines used to treat inflammation
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking SYQUET.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SYQUET.
4. How do I use SYQUET?
How much to take/use
Your doctor will tell you how many tablets you will need to take each day and how
long you need to take it. This depends on your condition and whether or not you are
taking any other medicines.
SYQUET is usually started as a low dose that will be gradually increased by your doctor.
Your doctor will recommend a dose especially for you. This will depend on various
factors including your age, condition being treated, other medical conditions (eg
liver problems), other medicines you are taking and how you may react to SYQUET. Your
doctor will monitor your condition and may change your dose depending on how you respond
to it. Your doctor will use the lowest dose for the least amount of time to keep you
well.
Follow the instructions provided and use SYQUET until your doctor tells you to stop.
When to take/use SYQUET
SYQUET is taken once or twice a day depending on your condition. Your doctor will
tell you how you should take it.
You can take them with or without food.
How to use SYQUET
Swallow your SYQUET tablets whole with a full glass of water.
How long to use it
Continue taking the tablets for as long as your doctor tells you.
SYQUET helps control your condition but does not cure it. Therefore, you must take
it every day.
Do not stop taking it unless your doctor tells you to - even if you feel better.
If you forget to use SYQUET
SYQUET should be used regularly at the same time each day. If you miss your dose at
the usual time, take it as soon as you remember.
If it is almost time for your next dose (within 6 hours), skip the dose you missed
and take your next dose when you are meant to. Otherwise, take it as soon as you remember,
and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much SYQUET
If you think that you have used too much SYQUET, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too many SYQUET tablets you may feel drowsy, sleepy, dizzy or have fast
heart beats.
Patients with pre-existing severe cardiovascular disease may be at an increased risk
of the effects of overdose.
There were cases reported of QT prolongation (abnormal electrocardiogram) with overdose.
There have been very rare reports of overdose of quetiapine alone resulting in death
or coma.
5. What should I know while using SYQUET?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking it.
If you are about to be started on any new medicines, tell your doctor, dentist or
pharmacist that you are taking it.
Tell your doctor or mental health professional immediately, or go to the nearest hospital,
if you have any of the following suicidal thoughts or other mental/mood changes:
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts of self-harm
increase in aggressive behaviour, irritability or agitation
worsening of depression
Occasionally, the symptoms of depression may include thoughts of suicide or self-harm.
These symptoms may continue or get worse during the early stages of treatment until
the effect of the medicine becomes apparent. All mentions of suicide or violence must
be taken seriously.
If you become pregnant while taking it, tell your doctor immediately.
If you plan to have surgery that needs a general anesthetic, tell your doctor or dentist
that you are taking it.
If you need to have any medical tests (including urine drug screening) while you are
taking it, tell your doctor.
It may affect the results of some tests.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
Your doctor will check your progress and may want to take some tests (eg blood tests,
blood pressure, weight or height measurements) from time to time. These tests may
help to prevent side effects.
Call your doctor straight away if your:
condition worsens or does not improve.
Remind any doctor, dentist or pharmacist you visit that you are using SYQUET.
Things you should not do
Do not stop using this medicine suddenly.
Do not stop taking it, or change the dosage, even if you are feeling better, without
checking with your doctor.
If you stop taking it suddenly, your condition may worsen or your chance of getting
an unwanted side effect may increase. To prevent this, your doctor may gradually reduce
the amount of SYQUET you take each day before stopping completely.
Do not give it to anyone else, even if their symptoms seem similar or they have the
same condition as you.
Do not take it to treat any other complaints unless your doctor tells you to.
Do not take any medicines that cause drowsiness while you are taking it, unless recommended
by your doctor.
Things to be careful of
Avoid getting over-heated or dehydrated - do not over-exercise, in hot weather stay
inside in a cool place, stay out of the sun, do not wear too much or heavy clothing,
drink plenty of water. Keep warm in cool weather.
SYQUET may affect the way your body reacts to temperature changes.
Avoid drinking large quantities of grapefruit juice.
This medicine may be affected by grapefruit juice. Talk to your doctor or pharmacist
if you have any concerns.
Talk to your doctor or pharmacist about these things if you think they may bother
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SYQUET
affects you.
It can make some people dizzy or sleepy. Make sure you know how you react to it before
you do anything that could be dangerous if you are dizzy or sleepy. Children should
be careful when riding bicycles or climbing trees.
If it makes you feel light-headed, dizzy or faint, be careful when getting up from
a sitting or lying position.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while you are taking it.
Combining SYQUET and alcohol can make you more sleepy or dizzy. Your doctor may suggest
you avoid alcohol while you are being treated with it.
Looking after your medicine
Store below 25 °C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
If your doctor tells you to stop taking it or the tablets have passed their expiry
date, ask your pharmacist what to do with any that are left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Very Serious side effects
|
Serious side effects
|
What to do
|
|
long lasting and painful erection
fainting (particularly in children)
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal
very marked drowsiness
reduced consciousness
abnormal muscle movements, including difficulty starting muscle movements, shaking,
restlessness or muscle stiffness without pain.
worm-like movements of the tongue or other uncontrolled movements of the tongue, mouth,
cheeks or jaw which may progress to the arms and legs (a disorder called tardive dyskinesia)
a sudden increase in body temperature, with sweating, or a fast heart beat
fits (seizures)
widespread skin rash that may include blistering or peeling of the skin, often accompanied
by flu like symptoms, fever, swelling of the face and/or swollen lymph nodes (painful,
warm, or red lump under your skin - often under your chin, on your neck, groin, armpit
or behind your ear). These symptoms may also be associated with changes in your blood
(eg white blood cell increase, as sometimes seen in allergic reactions) or liver function.
These are some of the symptoms of potentially life- threatening conditions called
Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction
with eosinophilia and systemic symptoms (DRESS).
severe allergic reaction (may include severe difficulty breathing, shock, swelling
of the face, lips, tongue or other parts of the body, skin rash, hayfever, or you
may feel faint)
severe upper stomach pain, often with nausea and vomiting (particularly in patients
with other risk factors such as gallstones, alcohol consumption and/or increased levels
of certain fats within the blood). These are symptoms of pancreatitis.
Combination of fever, very marked drowsiness, muscle stiffness, marked increase in
blood pressure or heartbeats and reduced consciousness (a disorder called “neuroleptic
malignant syndrome”). widespread skin rash that may include blistering or peeling
of the skin, often accompanied by flu like symptoms, fever, swelling of the face and/or
swollen lymph nodes (painful, warm, or red lump under your skin - often under your
chin, on your neck, groin, armpit or behind your ear). These symptoms may also be
associated with changes in your blood (eg white blood cell increase, as sometimes
seen in allergic reactions) or liver function. These are some of the symptoms of potentially
life- threatening conditions called Stevens-Johnson Syndrome (SJS), toxic epidermal
necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS).
severe allergic reaction (may include severe difficulty breathing, shock, swelling
of the face, lips, tongue or other parts of the body, skin rash, hayfever, or you
may feel faint)
severe upper stomach pain, often with nausea and vomiting (particularly in patients
with other risk factors such as gallstones, alcohol consumption and/or increased levels
of certain fats within the blood). These are symptoms of pancreatitis.
Combination of fever, very marked drowsiness, muscle stiffness, marked increase in
blood pressure or heartbeats and reduced consciousness (a disorder called “neuroleptic
malignant syndrome”).
|
These are very serious side effects. Stop using SYQUET if
you develop these symptoms. You may need urgent medical attention or
hospitalization
|
Occasionally, SYQUET may be associated with changes in your liver function or blood
(eg blood fat levels such as cholesterol or triglycerides, blood sugar levels, blood
pressure, thyroid hormone levels, white blood cells). These can only be found when
your doctor does tests from time to time to check your progress.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Reporting side effects
After you have received medical advice for any side effects you experienced, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SYQUET contains
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Active ingredient
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Quetiapine fumarate
|
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Other ingredients
|
Povidone
Calcium hydrogen phosphate
Microcrystalline cellulose
Sodium starch glycollate type A
Lactose monohydrate
Magnesium stearate
Tablet coating:
200 mg and 300 mg
Hypromellose
Macrogol 400
Titanium dioxide
25 mg
Opadry complete film coating system 03B84929 pink (ARTG No.106711)
100 mg
Opadry complete film coating system 03B52117 yellow (ARTG No.106712)
|
Do not take this medicine if you are allergic to any of these ingredients.
SYQUET tablets do not contain gluten or sucrose.
What SYQUET looks like
SYQUET 25 mg are pink coloured, round, biconvex, film-coated tablets plain on both
sides. Available in pack sizes of 20 or 60 tablets. AUST R 204152
SYQUET 100 mg are yellow coloured, round, biconvex, film-coated tablet plain on both
sides. Available in pack sizes of 20 or 90 tablets. AUST R 203592
SYQUET 200 mg are white to off white, round, biconvex, film-coated tablet, plain on
both sides. Available in pack sizes of 20 or 60 tablets. AUST R 203593
SYQUET 300 mg are white to off white, capsule shaped, biconvex, film-coated tablet,
with ‘300’ debossed on one side and plain on other side. Available in pack sizes of
20, 60, or 100 tablets. AUST R 203594
Who distributes SYQUET
Sponsor
Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne Victoria 3004
Australia
Distributor
SYQUET is distributed in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in December 2025.