onsumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about SEROQUEL XR.
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 XR 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 XR is used for
SEROQUEL XR is used to treat schizophrenia, an illness with disturbances in thinking, feelings and behaviour.
SEROQUEL XR 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 have prescribed this medicine for another reason. Ask your doctor if you have any questions about why SEROQUEL XR has been prescribed for you.
This medicine is only available with a doctor's prescription.
SEROQUEL XR is not addictive.
Before you take SEROQUEL XR
When you must not take it
Do not take SEROQUEL XR if you have an allergy to:
quetiapine, the active ingredient in SEROQUEL and SEROQUEL XR
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 XR 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 SEROQUEL XR while you are pregnant. However, if you need to take SEROQUEL XR 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 XR, as it is not known whether SEROQUEL XR passes into breast milk.
SEROQUEL XR is not recommended for use in children. There is not enough information on its effects in children.
Do not take SEROQUEL XR after the use by (expiry) date printed on the pack.
Do not take SEROQUEL XR 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 XR talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor if you have any allergies to:
any other medicines
any other substances such as foods, dyes or preservatives
Tell your doctor or pharmacist if 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
diabetes or a family history of diabetes
epilepsy, seizures or fits
dementia or related behavioural disorders (especially in elderly patients)
low white blood cell count
Tell your doctor if you are lactose intolerant. SEROQUEL XR tablets contain lactose.
Taking other medicines
Tell your doctor 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 XR may interfere with each other, these include:
medicines for epilepsy such as phenytoin or carbamazepine
medicines for high blood pressure or heart conditions
medicines used to help you sleep
medicines used to control depression or mood swings
medicines used to treat anxiety
medicines for fungal infections such as ketoconazole
some antibiotics such as rifampicin and erythromycin
other antipsychotic medicines such as thioridazine
medicines used to treat Parkinson's disease
stimulants such as amphetamine
medicines used to treat pain
medicines for Human Immunodeficiency Virus (HIV)
These medicines may be affected by SEROQUEL XR, 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 about medicines to be careful with or avoid while taking SEROQUEL XR. If you have not told your doctor about any of these things, tell them before you take any SEROQUEL XR.
How to take SEROQUEL XR
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 to take it
Swallow your SEROQUEL XR tablets whole with a full glass of water. Do not split, chew or crush the tablets. If you split, chew or crush the tablets they will not work properly.
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 XR is usually started at 300 mg for the first day. Following this the dose will be adjusted by your doctor. The usual dose of SEROQUEL XR is 400 to 800 mg per day. Depending on your response you may require a higher or lower dose.
If you are elderly, or have liver problems, your doctor will generally start you on 50 mg on the first day, then increase this to a higher dose depending on your response.
Your doctor may have switched your treatment from SEROQUEL tablets to SEROQUEL XR tablets. Your doctor will generally prescribe you a once daily dose of SEROQUEL XR, which is equivalent to your total daily dose of SEROQUEL tablets. Your doctor will tell you how many tablets you will need to take each day.
When to take it
SEROQUEL XR should be taken once a day, at approximately the same time each day. Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets. SEROQUEL XR tablets should be taken without food. How long to take it
Continue taking the tablets for as long as your doctor tells you. SEROQUEL XR helps control your condition, but does not cure it. Therefore you must take SEROQUEL XR every day.
Do not stop taking SEROQUEL XR 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, 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 that you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much
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 XR. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too many SEROQUEL XR tablets you may feel drowsy, sleepy, dizzy or have fast heart beats.
While you are taking SEROQUEL XR
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking SEROQUEL XR.
If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are taking SEROQUEL XR.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking SEROQUEL XR.
If you become pregnant while taking SEROQUEL XR, tell your doctor immediately.
If you need to have any medical tests while you are taking SEROQUEL XR, tell your doctor. SEROQUEL XR 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.
Things you must not do
Do not stop taking SEROQUEL XR, or change the dosage, even if you are feeling better, without checking with your doctor. If you stop taking SEROQUEL XR 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 XR you take each day before stopping completely.
Do not take SEROQUEL XR to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if their symptoms seem similar or they have the same condition as you.
Do not take any medicines that cause drowsiness while you are taking SEROQUEL XR, unless recommended by your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how SEROQUEL XR affects you.
SEROQUEL XR can make some people dizzy or sleepy. Make sure you know how you react to SEROQUEL XR before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or sleepy.
If SEROQUEL XR makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position. Getting up slowly may help.
Be careful when drinking alcohol while you are taking SEROQUEL XR. Combining SEROQUEL XR and alcohol can make you more sleepy or dizzy. Your doctor may suggest you avoid alcohol while you are being treated with SEROQUEL XR.
Make sure you keep cool in hot weather and keep warm in cool weather. SEROQUEL XR 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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SEROQUEL XR. 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 dizzy or faint on standing up
small increase in weight
swelling of the hands, ankles or feet
runny or stuffy nose
abnormal dreams, nightmares
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 immediately or go to Accident and Emergency at your nearest hospital.
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
rapid heart beat
very marked drowsiness
long-lasting and painful erections
severe allergic reaction (may include severe difficulty in breathing, shock, swelling of the face, lips, tongue or other parts of the body, skin rash, hayfever, or you may feel faint)
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Occasionally, SEROQUEL XR 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 here 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 XR
Keep your SEROQUEL XR tablets in the blister pack until it is time to take them. If you take SEROQUEL XR out of the blister pack it will not keep well.
Keep it in a cool dry place where the temperature stays below 30 °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 children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking SEROQUEL XR or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What SEROQUEL XR looks like
SEROQUEL XR tablets are capsule shaped and are embossed with "XR" and the strength on one side, and plain on the other. Each tablet strength is a different colour:
50 mg - peach
200 mg - yellow
300 mg - pale yellow
400 mg - white
SEROQUEL XR tablets are available in blister packs of 10 (sample pack), 60 and 100# tablets.
# not available in Australia for the 50 mg, 200 mg or 400 mg tablets
Each SEROQUEL XR tablet contains quetiapine fumarate as the active ingredient equivalent to quetiapine 50 mg, 200 mg, 300 mg or 400 mg.
Plus the following inactive ingredients:
Microcrystalline cellulose (E460)
Magnesium stearate (E572)
Titanium dioxide (E 171)
Iron oxide red CI77491 (E 172 - 50 mg only)
Iron oxide yellow CI77492 (E172 - 50 mg, 200 mg and 300 mg)
SEROQUEL XR tablets do not contain gluten or sucrose. Supplier
AstraZeneca Pty Ltd
ABN 54 009 682 311
NORTH RYDE NSW 2113
This leaflet was prepared August 2008.
SEROQUEL XR Australian Registration Numbers:
50 mg - AUST R 138917
200 mg - AUST R 138920
300 mg - AUST R 138921
400 mg - AUST R 138922
SEROQUEL and SEROQUEL XR are trade marks of the AstraZeneca group of companies.