Consumer medicine information

Quetia XR

Quetiapine

BRAND INFORMATION

Brand name

Quetia XR

Active ingredient

Quetiapine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Quetia XR.

SUMMARY CMI

QUETIA XR

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about taking QUETIA XR, speak to your doctor or pharmacist.

1. Why am I taking QUETIA XR?

QUETIA XR contains the active ingredient quetiapine (as fumarate). QUETIA XR is taken to correct chemical imbalances in the brain. For more information, see Section 1. Why am I taking QUETIA XR? in the full CMI.

2. What should I know before I take QUETIA XR?

Do not take if you have ever had an allergic reaction to quetiapine (as 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 take QUETIA XR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with QUETIA 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 take QUETIA XR?

  • Your doctor will tell you how many QUETIA XR tablets you will need to take each day and how long you need to take it.
  • Swallow QUETIA 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 take QUETIA XR? in the full CMI.

5. What should I know while taking QUETIA XR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking QUETIA XR.
  • 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 QUETIA XR, tell your doctor immediately.
Things you should not do
  • Do not stop taking QUETIA XR suddenly.
  • Do not take QUETIA XR to treat other complaints unless your doctor or pharmacist tells you to.
  • Do not give QUETIA XR 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 QUETIA XR affects you. It can make some people dizzy or sleepy.
Drinking alcohol
  • Combining QUETIA XR and alcohol can make you more sleepy or dizzy.
Looking after your medicine
  • Keep QUETIA XR in a cool dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while taking QUETIA XR? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with QUETIA XR. It is important to be aware of them so that you can identify any symptoms if they occur. 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.



FULL CMI

QUETIA XR

Active ingredient: Quetiapine (as fumarate)


Consumer Medicine Information (CMI)

This leaflet provides important information about taking QUETIA 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 taking QUETIA XR.

Where to find information in this leaflet:

1. Why am I taking QUETIA XR?
2. What should I know before I take QUETIA XR?
3. What if I am taking other medicines?
4. How do I take QUETIA XR?
5. What should I know while taking QUETIA XR?
6. Are there any side effects?
7. Product details

1. Why am I taking QUETIA XR?

QUETIA XR contains the active ingredient quetiapine (as fumarate). QUETIA XR belongs to a group of medicines called antipsychotics.

QUETIA 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.
  • QUETIA XR is available only with a doctor's prescription.

2. What should I know before I take QUETIA XR?

Warnings

Do not take QUETIA XR if:

  • You are allergic to quetiapine (as 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 skin or you may feel faint.
    Always check the ingredients to make sure you can take QUETIA XR.
  • 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.

QUETIA XR is not recommended for use in children.
There is not enough information on its effects in children.

QUETIA 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 QUETIA 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 QUETIA 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 cannot 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 QUETIA 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 QUETIA XR 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 QUETIA 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 QUETIA XR, as it may pass into breast milk.

Before your doctor starts you on QUETIA XR your doctor may want to take some tests (e.g. blood tests, blood pressure, weight or height measurements). These tests may help to prevent side effects.

Tell your doctor if you are lactose intolerant.

QUETIA XR tablets contain lactose monohydrate.

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 QUETIA XR and affect how it works.

Some medicines and QUETIA 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 QUETIA 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 QUETIA 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 QUETIA XR include:

  • Phenytoin or carbamazepine, medicines used to treat 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 QUETIA 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 QUETIA XR.

4. How do I take QUETIA XR?

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.
  • QUETIA XR 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 (e.g. liver problems), other medicines you are taking and how you may react to QUETIA 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 Quetiapine immediate release tablets to QUETIA XR tablets. Your doctor will generally prescribe you a once daily dose of QUETIA XR, which is equivalent to your total daily dose of Quetiapine immediate release tablets. Your doctor will tell you how many tablets you will need to take each day.
  • Follow the instructions provided and take QUETIA XR until your doctor tells you to stop.

When to take it

  • QUETIA 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.

How to take it

  • Swallow your QUETIA XR tablets whole with a full glass of water. It should be taken without food.
  • Do not split, chew or crush the tablets.
  • If you split, chew or crush the tablets they will not work properly.

How long to take it

  • Continue taking QUETIA XR tablets for as long as your doctor tells you.
  • QUETIA XR helps control your condition but does not cure it. Therefore, you must take it every day.
  • Do not stop taking QUETIA XR unless your doctor tells you to, even if you feel better.

If you forget to take QUETIA XR

QUETIA XR should be taken 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 take too much QUETIA XR

If you think that you have taken too much QUETIA 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 QUETIA XR tablets you may feel drowsy, sleepy, dizzy or have fast heartbeats.

QUETIA 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 taking QUETIA 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 QUETIA XR, tell your doctor immediately.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking QUETIA XR.

If you need to have any medical tests (including urine drug screening) while you are taking QUETIA XR, 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 (e.g. 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 taking QUETIA XR.

Things you should not do

  • Do not stop taking QUETIA XR suddenly.
  • Do not stop taking QUETIA XR, or change the dosage, even if you are feeling better, without checking with your doctor.
  • If you stop taking QUETIA 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 QUETIA XR you take each day before stopping completely.
  • Do not give QUETIA XR to anyone else, even if their symptoms seem similar or they have the same condition as you.
  • Do not take QUETIA XR to treat any other complaints unless your doctor tells you to.
  • Do not take any medicines that cause drowsiness while you are taking QUETIA XR, 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.
  • QUETIA XR may affect the way your body reacts to temperature changes.
  • Avoid drinking large quantities of grapefruit juice. QUETIA XR 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 QUETIA XR affects you.

It can make some people dizzy or sleepy. Make sure you know how you react to QUETIA XR 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 QUETIA XR.

Combining QUETIA 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

  • Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they will not keep well.
  • Store below 25°C.
  • Follow the instructions on 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 QUETIA XR 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 take QUETIA XR or it is out of date, take it to any pharmacy for safe disposal.

Do not take QUETIA XR 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 effectsWhat to do
  • Feeling sleepy.
  • Weight gain, increased appetite.
  • Dry mouth.
  • Upset stomach, constipation, indigestion, vomiting (mainly in elderly or children).
  • Feeling weak.
  • Swelling of the hands, ankles or feet.
  • Runny or stuffy nose (particularly in children).
  • Blurred vision.
  • Abnormal dreams, nightmares.
  • Irritability.
  • Confusion.
  • Shortness of breath, difficulty in breathing and/or tightness in the chest.
  • Fast or irregular heartbeats (palpitations).
  • Muscle pain or swelling or weakness.
  • Headache.
  • Insomnia.
  • Diarrhoea.
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 effectsWhat to do
  • Difficulty swallowing.
  • Falling, feeling dizzy or faint on standing up.
  • Flat and red skin lesions or substantial hemorrhages under the skin (purpura).
  • Difficulty in speaking.
  • Rapid heartbeat.
  • Symptoms of high sugar levels in the blood (including passing large amounts of urine, excessive thirst, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell).
  • Breast enlargement, unusual secretion of breast milk.
  • Cutaneous vasculitis, with skin symptoms such as lesions, including palpable purpura (discolouration of skin, raised and can be felt), petechiae (tiny spots of bleeding under the skin), urticaria, ulcers, livedo reticularis (a type of skin disorder) and nodules.
These are serious side effects. You may need urgent 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 effectsWhat to do
  • Abnormal muscle movements, including difficulty starting muscle movements, shaking, restlessness or muscle stiffness without pain.
  • Worm-like movements of the tongue or other uncontrolled movement 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 heartbeat.
  • Bleeding or bruising more easily than normal.
  • Very marked drowsiness.
  • Reduced consciousness.
  • Fits (seizures).
  • Long-lasting and painful erections.
  • Fainting (particularly in children).
  • 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 chin, on your neck, groin, armpit or behind your ear). These symptoms may also be associated with changes in your blood (e.g. 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 Steven-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systematic symptoms (DRESS).
  • 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 may feel faint.
  • Signs of frequent infections such as fever, chills, sore throat or mouth ulcers.
  • 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 taking QUETIA XR if you develop these symptoms. You may need urgent medical attention or hospitalisation.

Occasionally, QUETIA XR may be associated with changes in your liver function or blood (e.g. 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 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

QUETIA XR is only available with a doctor's prescription.

What QUETIA XR contains

Active ingredient
(main ingredient)
  • Quetiapine (as fumarate)
Other ingredients
(inactive ingredients)
  • Lactose monohydrate
  • Microcrystalline cellulose
  • Magnesium oxide, light
  • Carrageenan
  • Povidone
  • Magnesium stearate
  • Macrogol 400
  • Titanium dioxide (E171)
  • Iron oxide red (50 mg tablet only)
  • Iron oxide yellow (50 mg tablet, 200 mg tablet and 300 mg tablet)
Potential allergensN/A

QUETIA XR contains sugars as lactose.

QUETIA XR does not contain gluten or sucrose.

Do not take QUETIA XR if you are allergic to any of these ingredients.

What QUETIA XR looks like

QUETIA XR 50 mg Tablet

Light pink to pink, capsule shaped, biconvex, coated tablet, plain on both sides. AUST R 199878.

QUETIA XR 150 mg Tablet

White to off-white, round, biconvex, coated tablet, plain on both sides. AUST R 199886.

QUETIA XR 200 mg Tablet

Yellow, capsule shaped, biconvex, coated tablet, plain on both sides. AUST R 199872.

QUETIA XR 300 mg Tablet

Pale yellow, capsule shaped, biconvex, coated tablet, plain on both sides. AUST R 199874.

QUETIA XR 400 mg Tablet

White to off-white, capsule shaped, biconvex, coated tablet, plain on both sides. AUST R 199889.

QUETIA XR is available in pack size of 60 tablets*.

*Not all strengths may be available.

Who distributes QUETIA XR

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel St
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in October 2024.

Published by MIMS December 2024