SEROQUEL XR®
| Consumer Medicine Information (CMI) summary |
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
| 1. Why am I using SEROQUEL XR? |
SEROQUEL XR contains the active ingredient quetiapine fumarate. SEROQUEL XR is used to correct chemical imbalances in the brain. For more information, see Section 1. Why am I using SEROQUEL XR? in the full CMI.
| 2. What should I know before I use SEROQUEL XR? |
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 SEROQUEL XR? in the full CMI.
| 3. What if I am taking other medicines? |
Some medicines may interfere with SEROQUEL XR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
| 4. How do I use SEROQUEL XR? |
- 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 SEROQUEL XR tablets whole with a full glass of water. It should be taken without food.
More instructions can be found in Section 4. How do I use SEROQUEL XR? in the full CMI.
| 5. What should I know while using SEROQUEL XR? |
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Drinking alcohol |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using SEROQUEL XR? in the full CMI.
| 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, 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.
SEROQUEL XR®
Active ingredient(s): Quetiapine fumarate
| Consumer Medicine Information (CMI) |
This leaflet provides important information about using SEROQUEL XR. 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 SEROQUEL XR.
Where to find information in this leaflet:
1. Why am I using SEROQUEL XR?
2. What should I know before I use SEROQUEL XR?
3. What if I am taking other medicines?
4. How do I use SEROQUEL XR?
5. What should I know while using SEROQUEL XR?
6. Are there any side effects?
7. Product details
| 1. Why am I using SEROQUEL XR? |
SEROQUEL XR contains the active ingredient quetiapine fumarate. SEROQUEL XR belongs to a group of medicines called antipsychotics.
SEROQUEL XR helps to correct chemical imbalances in the brain. It is used to treat conditions such as:
- 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.
- Recurrent major depressive disorder, an illness where depression is longer lasting and/or more severe than the "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.
- Generalised anxiety disorder, where patients have excessive anxiety and worry.
- Schizophrenia, an illness with disturbances in thinking, feelings and behaviour.
- SEROQUEL XR is available only with a doctor's prescription.
| 2. What should I know before I use SEROQUEL XR? |
Warnings
Do not use SEROQUEL XR 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.
SEROQUEL XR is not recommended for use in children.
There is not enough information on its effects in children.
SEROQUEL XR, 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 SEROQUEL XR, 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 SEROQUEL XR.
- 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
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 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 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 SEROQUEL XR 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.
SEROQUEL XR 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 SEROQUEL XR and affect how it works.
Some medicines and SEROQUEL XR may interfere with each other. These include:
- medicines for high blood pressure (including diuretics or fluid tablets) or heart conditions
- lorazepam - a medicine used to help you sleep
- medicines used to treat anxiety, depression, mood swings, attention deficit hyperactivity disorder (ADHD) or other mood disorders
- 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 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.
Medicines that may increase the effect of SEROQUEL XR include:
- medicines for fungal infections such as ketoconazole
- some antibiotics such as erythromycin
- medicines for Human Immunodeficiency Virus (HIV)
Medicines that may reduce the effect of SEROQUEL XR 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 SEROQUEL XR.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SEROQUEL XR.
| 4. How do I use SEROQUEL XR? |
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.
- SEROQUEL XR is usually started as a low dose that will be 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 SEROQUEL XR. 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.
- 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.
- Follow the instructions provided and use SEROQUEL XR until your doctor tells you to stop.
When to take / use SEROQUEL XR
- 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.
- It should be taken without food.
How to use SEROQUEL XR
- 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 long to use 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 it every day.
- Do not stop taking it unless your doctor tells you to - even if you feel better.
If you forget to use SEROQUEL XR
SEROQUEL XR 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, 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 SEROQUEL XR
If you think that you have used too much SEROQUEL XR, 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 SEROQUEL XR tablets you may feel drowsy, sleepy, dizzy or have fast heart beats.
SEROQUEL XR overdose may lead to gastric bezoar (tightly packed partially digested material in stomach) formation.
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 SEROQUEL XR? |
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 anaesthetic, 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 SEROQUEL XR.
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 SEROQUEL XR 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.
- 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.
- 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 SEROQUEL XR affects you.
It can make some people dizzy or sleepy. Make sure you know how you react to it before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or sleepy.
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 SEROQUEL XR 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 30°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
| Less serious side effects | What to do |
These side effects are usually mild. Some of these side effects may go away after a while. | Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
These are serious side effects. You may need medical attention. | Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Very Serious side effects
| Very Serious side effects | What to do |
| These are very serious side effects. Stop using SEROQUEL XR if you develop these symptoms. You may need urgent medical attention or hospitalization. |
Occasionally, SEROQUEL XR 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 that is 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 experience, 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 SEROQUEL XR contains
| Active ingredient | Quetiapine fumarate |
| Other ingredients |
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Do not take this medicine if you are allergic to any of these ingredients.
SEROQUEL XR tablets do not contain gluten or sucrose.
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. Tablet colouring is as follows:
- 50 mg - peach
- 150 mg - white
- 200 mg - yellow
- 300 mg - pale yellow
- 400 mg - white
All strengths are available in packs of 10 or 60 tablets.
SEROQUEL XR Australian Registration Numbers:
50 mg - AUST R 138917
150 mg - AUST R 153883
200 mg - AUST R 138920
300 mg - AUST R 138921
400 mg - AUST R 138922
Who distributes SEROQUEL XR
Luye Pharma Australia Pty Ltd
ABN 56 637 287 80
Level 3, 160 Sussex Street
SYDNEY NSW 2000
Telephone: +61 8 7079 0504
This leaflet was prepared in December 2022.
Published by MIMS July 2023