General Information
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about Seroquel. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Seroquel against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Seroquel is used for
Seroquel is used to treat mental illnesses 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 energy, lose their appetite and have trouble sleeping.
Seroquel belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness.
Your doctor may prescribe this medicine for another reason. Ask your doctor if you have any questions about why Seroquel has been prescribed for you
Seroquel is not addictive.
This medicine is available only with a doctor's prescription.
Before you take Seroquel
When you must not take it
Do not take Seroquel if you have an allergy to
quetiapine, the active ingredient in Seroquel
any of the other 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 skin or you may feel faint.
Do not take Seroquel if you are pregnant or breast feeding 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 Seroquel while you are pregnant. However, if you need to take Seroquel 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 Seroquel, as it is not known whether Seroquel passes into breast milk.
Seroquel is not recommended for use in children. There is not enough information on its effects in children.
Do not use Seroquel after the use by (expiry) date printed on the pack.
Do not use Seroquel if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking Seroquel, talk to your doctor or pharmacist.
Before you start to take it
You must tell your doctor if:
1. you have any allergies to:
any other medicines
any other substances, such a foods, dyes or preservatives
2. you have or have had any medical conditions, especially the following:
heart or blood vessel problems including low blood pressure, stroke, problems with your circulation or any condition that affects blood flow to the brain 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 Seroquel.
epilepsy, seizures or fits
dementia or related behavioural disorders (especially in elderly patients)
low white blood cell count
Depression and other mental illnesses can lead to 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.
Tell your doctor if you are lactose intolerant. Seroquel tablets contain lactose.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Seroquel may interfere with each other. These include:
medicines used to treat anxiety
medicines used to help you sleep
medicines used to control depression or mood swings
medicines for epilepsy such as phenytoin or carbamazepine
medicines for high blood pressure or heart conditions
some antibiotics such as rifampicin and erythromycin
medicines used for fungal infections such as ketoconazole
medicines for Human Immunodeficiency Virus (HIV)
other antipsychotic medicines such as thioridazine
medicines used to treat Parkinson's disease
stimulants such as amphetamines
medicines used to treat pain
These medicines may be affected by Seroquel, 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.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Seroquel.
If you have not told your doctor about any of these things, tell them before you take any Seroquel.
How to take Seroquel
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
How much to take
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.
Seroquel is usually started as a low dose that will be gradually increased by your doctor. The usual dose of Seroquel is between 150 mg and 800 mg each day. Your doctor will tell you how much Seroquel to take.
If you are elderly, or have liver problems, your doctor will adjust your dose to suit you.
When to take it
Seroquel is taken once or twice a day depending on your condition. Your doctor will tell you how you should take Seroquel.
Swallow your Seroquel tablets whole with a full glass of water.
You can take them with or without food.
How long to take it
Continue taking the tablets for as long as your doctor tells you.
Seroquel helps control your condition, but does not cure it. Therefore you must take Seroquel every day.
Do not stop taking Seroquel unless your doctor tells you to - even if you feel better.
If you forget to take it
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 have 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 take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Seroquel. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too many Seroquel tablets you may feel drowsy, sleepy, dizzy or have fast heart beats.
While you are taking Seroquel
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Seroquel.
If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are taking Seroquel.
If you become pregnant while taking Seroquel, tell your doctor immediately.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Seroquel.
If you need to have any medical tests while you are taking Seroquel, tell your doctor. Seroquel 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 blood tests from time to time. This helps to prevent unwanted side effects.
If you or someone you know is demonstrating any of the following warning signs of suicide while taking Seroquel, contact your doctor or a mental health professional immediately or go to the nearest hospital for treatment:
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.
Things you must not do
Do not give Seroquel to anyone else, even if their symptoms seem similar or they have the same condition as you.
Do not take Seroquel to treat any other complaints unless your doctor tells you to.
Do not stop taking Seroquel, or change the dosage, even if you are feeling better, without checking with your doctor. If you stop taking Seroquel 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 Seroquel you take each day before stopping completely.
Do not take any medicines that cause drowsiness while you are taking Seroquel, unless recommended by your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how Seroquel affects you. Seroquel can make some people dizzy or sleepy. Make sure you know how you react to Seroquel before you do anything that could be dangerous if you are dizzy or sleepy.
If Seroquel 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.
Be careful when drinking alcohol while you are taking Seroquel. Combining Seroquel and alcohol can make you more sleepy or dizzy. Your doctor may suggest you avoid alcohol while you are being treated with Seroquel.
Make sure you keep cool in hot weather and keep warm in cool weather. Seroquel 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.
Please talk to your doctor or pharmacist about these things if you think they may bother you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Seroquel. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
feeling sleepy
falling, feeling dizzy or faint on standing up
weight gain, increased appetite
feeling weak
constipation
dry mouth
runny or stuffy nose
indigestion
upset stomach
swelling of your hands, feet or ankles
blurred vision
difficulty swallowing
abnormal dreams, nightmares
irritability
These side effects are usually mild. Some of these side effects may go away after a while.
If any of the following happen, tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest hospital:
long lasting and painful erection
fainting
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
rapid heart beat
very marked drowsiness
abnormal muscle movements, including difficulty starting muscle movements, shaking, restlessness or muscle stiffness without pain.
uncontrolled movements of the tongue, mouth, cheeks or jaw
a sudden increase in body temperature, with sweating, or a fast heart beat
very fast breathing
muscle stiffness
fits (seizures)
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)
These are serious side effects. You may need urgent medical attention or hospitalisation.
Occasionally, Seroquel may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking Seroquel
Storage
Keep your Seroquel tablets in the blister pack until it is time to take them. If you take Seroquel out of the blister pack it will not keep well.
Keep it in a cool dry place where the temperature stays below 30 degrees C.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking Seroquel or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What Seroquel looks like
The following Seroquel tablets are round, film coated:
25 mg - peach coloured
100 mg - yellow coloured
150 mg - pale yellow coloured
200 mg - white coloured
The following Seroquel tablet is capsule shaped, film coated:
300 mg - white coloured.
The pack sizes for each strength are
Seroquel 25 mg - 20 or 60 tablets.
Seroquel 100 mg - 20 or 90 tablets.
Seroquel 150 mg - 60 tablets
Seroquel 200 mg - 20 or 60 tablets
Seroquel 300 mg - 20, 60 or 100* tablets.
Ingredients
Each Seroquel tablet contains quetiapine fumarate as the active ingredient equivalent to quetiapine 25 mg, 100 mg, 150 mg, 200 mg or 300 mg
plus,
Povidone
Calcium hydrogen phosphate
Microcrystalline cellulose (E 460)
Sodium starch glycollate
Lactose
Magnesium stearate (E572)
Hypromellose
Macrogol 400
Titanium dioxide (E 171)
in addition
Seroquel 25 mg contains
iron oxide yellow CI77492 (E 172)
iron oxide red CI77491 (E 172)
Seroquel 100 mg and 150 mg contain
iron oxide yellow CI77492 (E 172).
Seroquel tablets do not contain gluten or sucrose.
Supplier
AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113
This leaflet was prepared 28 January 2009.
Australian Registration Number:
Seroquel 25 mg: 58112
Seroquel 100 mg: 58113
Seroquel 150 mg : 78360*
Seroquel 200 mg: 58114
Seroquel 300 mg: 78361
*Not Marketed
SEROQUEL is a trade mark of the AstraZeneca group of companies