PHARMACOR QUETIAPINE FILM COATED TABLETS

PHARMACOR QUETIAPINE FILM COATED TABLETS

Active ingredient(s): Quetiapine (as fumarate)

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Consumer Medicine Information (CMI)

This leaflet provides important information about using PHARMACOR QUETIAPINE. 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 PHARMACOR QUETIAPINE.

Where to find information in this leaflet:

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

1. Why am I using PHARMACOR QUETIAPINE?

PHARMACOR QUETIAPINE contains the active ingredientQuetiapine (as fumarate)

PHARMACOR QUETIAPINE belongs to a group of medicines called antipsychotics. It 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 energy, lose their appetite and have trouble sleeping.

Your doctor may have prescribed PHARMACOR QUETIAPINE for another reason.

Ask your doctor if you have any questions about why PHARMACOR QUETIAPINE has been prescribed for you.

You may find it helpful to tell a friend or relative that you are suffering from these symptoms, and ask them to read this leaflet. You might ask them to tell you if they think your symptoms are getting worse, or if they are worried about any other changes in your behaviour.

PHARMACOR QUETIAPINE is not addictive

PHARMACOR QUETIAPINE is available only with a doctor’s prescription.

Do not give PHARMACOR QUETIAPINE to children or adolescents unless recommended by your doctor.

The effects of PHARMACOR QUETIAPINE 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.

PHARMACOR QUETIAPINE, as with other antipsychotic 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.

2. What should I know before I use PHARMACOR QUETIAPINE?

There are some people who shouldn’t take PHARMACOR QUETIAPINE. Please read the list below. If you think any of these situations apply to you or you have any questions, please see your doctor.

Warnings

Do not use PHARMACOR QUETIAPINE if:

• you are allergic to quetiapine, or any of the ingredients listed at the end of this leaflet.
• always check the ingredients to make sure you can use this medicine.

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.

• the packaging is torn or shows signs of tampering
• the expiry date (EXP) printed in the pack has passed
• If you are not sure whether you should start taking PHARMACOR QUETIAPINE, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor if you have allergies to:

• Any other medicines
• Any other substances, such as foods, preservatives ordyes

Tell your doctor if you 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 PHARMACOR QUETIAPINE.
• 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.

Do not take PHARMACOR QUETIAPINE 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 PHARMACOR QUETIAPINE 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.

PHARMACOR QUETIAPINE tablets contain lactose.

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?

• If you have not told your doctor or pharmacist about any of the above, tell them before you start taking PHARMACOR QUETIAPINE.

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 PHARMACOR QUETIAPINE and affect how it works. Medicines that can affect how your body processes PHARMACOR QUETIAPINE 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
• phenytoin or carbamazepine – medicines for epilepsy
• medicines for high blood pressure (including diuretics or fluid tablets) or heart conditions
• some antibiotics such as rifampicin and erythromycin
• medicines used for fungal infections such as ketoconazole
• medicines for Human Immunodeficiency Virus (HIV)
• thioridazine – an antipsychotic medicine
• medicines used to treat Parkinson’s disease
• stimulants such as amphetamines
• glucocorticoids – medicines used to treat inflammation
• medicines that have anticholinergic (muscarinic) effects

These medicines may be affected by PHARMACOR QUETIAPINE 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.

• Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PHARMACOR QUETIAPINE.

4. How do I use PHARMACOR QUETIAPINE?

How much to take

• Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

Your doctor or pharmacist 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.

PHARMACOR QUETIAPINE 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 PHARMACOR QUETIAPINE. 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.

• If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
• Do not change your dose without the advice of your doctor even if you feel better.

Follow the instructions provided and take PHARMACOR QUETIAPINE until your doctor tells you to stop.

When to take PHARMACOR QUETIAPINE

PHARMACOR QUETIAPINE is taken once or twice a day depending on your condition. Your doctor will tell you how you should take it.

Swallow your PHARMACOR QUETIAPINE tablets whole with a full glass of water.

You can take them with or without food.

How to take PHARMACOR QUETIAPINE

• Continue taking the tablets for as long as your doctor tells you.

PHARMACOR QUETIAPINE helps control your condition but does not cure it. Therefore, you must take PHARMACOR QUETIAPINE every day.

• Do not stop taking it unless your doctor tells you to –even if you feel better.

If you forget to take PHARMACOR QUETIAPINE

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 doseyou missed.

This may increase the chance of you getting an unwantedside effect.

• If you are not sure what to do, ask your doctor or pharmacist.
• If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much PHARMACOR QUETIAPINE

• It is important that you do not take more PHARMACOR QUETIAPINE tablets than your doctor has prescribed.

If you think that you have used too much PHARMACOR QUETIAPINE, you may need urgent medical attention.

If you take too much, 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.

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.
• If anyone accidentally swallows any of your PHARMACOR QUETIAPINE tablets, call your nearest Poisons Information Centre for advice (Australian telephone: 13 11 26), or go to Accident and Emergency at your nearest hospital. Keep the telephone number for those places handy whilst taking any medications.
• You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using PHARMACOR QUETIAPINE?

Things you should do

• Tell any other doctors, dentists and pharmacists who are treating you that you are taking PHARMACOR QUETIAPINE.
• you are about to be started on any new medicines
• 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.

• you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking it.
• you become pregnant while taking PHARMACOR QUETIAPINE, tell your doctor immediately.
• you need to have any medical tests while you are taking PHARMACOR QUETIAPINE
  PHARMACOR QUETIAPINE 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.

Things you should not do

• Do not stop taking PHARMACOR QUETIAPINE, or lower the dosage, even if you are feeling better, without checking with your doctor.

If you stop taking PHARMACOR QUETIAPINE 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 PHARMACOR QUETIAPINE you take each day before stopping completely.

• Do not take PHARMACOR QUETIAPINE to treat any other complaints unless your doctor tells you to.
• Do not take any medicines that cause drowsiness while you are taking PHARMACOR QUETIAPINE, unless recommendedby your doctor.
• You should not take PHARMACOR QUETIAPINE together with certain medications (see also under “Do not use PHARMACOR QUETIAPINE if”) as they can affect how your body processes PHARMACOR QUETIAPINE.

Do not give PHARMACOR QUETIAPINE to anyone else, even if their symptoms seem similar or they have the same condition as you.

Things to be careful of

Driving or using machines

• Be careful before you drive or use any machines or tools until you know how PHARMACOR QUETIAPINE 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

• Be careful when drinking alcohol while you are taking it.

Combining PHARMACOR QUETIAPINE and alcohol can make you more sleepy or dizzy. Your doctor may suggest you avoid alcohol while you are being treated with it.

• 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.

PHARMACOR QUETIAPINE 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.

Looking after your medicine

Follow the instructions in the carton on how to take care ofyour medicine properly.

Store it in a cool dry place away from moisture, heat orsunlight; 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 (as relevant)

Discard the medicine when the expiry date (EXP) printed onthe pack has passed.

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?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking it.

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. Some side effects may be related to the dose of PHARMACOR QUETIAPINE or may be more likely to occur during long term treatment. Therefore, it is important that you tell your doctor as soon as possible

if you notice anything that is making you feel unwell, even if you think the problems are not connected with this medicine. Your doctor may then decide to adjust your dose or use a different medicine.

Ask your doctor or pharmacist to answer any questions you may have.

Less serious side effects

What to do

feeling sleepy weight gain, increased appetite feeling weak dry mouth runny or stuffy nose (particularly in children) indigestion, upset stomach, constipation, vomiting (mainly in elderly or children) swelling of your hands, feet or ankles 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

Serious side effects

Serious side effects

What to do

falling, feeling dizzy or faint on standing up flat and red skin lesions or substantial hemorrhages under the skin (purpura) difficulty in speaking difficulty swallowing rapid heart beat 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 (discoloration 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.

Tell your doctor as soon as possible if you notice the following if you notice any of these 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) 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, hay fever, 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 PHARMACOR QUETIAPINE if you develop these symptoms. You may need urgent medical attention or hospitalisation.

Occasionally, PHARMACOR QUETIAPINE 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 elsethat may be making you feel unwell.

Other side effects not listed here may occur in some people.

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 yourmedicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What PHARMACOR QUETIAPINE contains

Active ingredient (main ingredient)	Quetiapine (as fumarate)
Other ingredients (inactive ingredients)	Povidone Calcium hydrogen phosphate Microcrystalline cellulose Sodium starch glycollate Lactose Magnesium Stearate Hypromellose Macrogol 400 (25mg, 150mg, 200mg and 300mg) Macrogol 4000 (100mg) Titanium dioxide PHARMACOR QUETIAPINE 25 contains iron oxide yellow iron oxide red PHARMACOR QUETIAPINE 100 and 150 contains iron oxide yellow PHARMACOR QUETIAPINE does not contain gluten or sucrose

Do not take this medicine if you are allergic to any ofthese ingredients.

What PHARMACOR QUETIAPINE looks like

The following PHARMACOR QUETIAPINE Tablets are round, film coated:

• 25 mg – peach coloured, debossed with “262” on one side and plain on the other side
• 100 mg – yellow coloured, debossed with “261” on one side and plain on the other side
• 150 mg – off white to light yellow coloured, debossed with “353” on one side and plain on the other side
• 200 mg – white coloured, debossed with “260” on one side and plain on the other side

The following PHARMACOR QUETIAPINE Tablets are capsule shaped, film coated:

• 300 mg – white coloured debossed with “259” on one side and plain on the other side.

The pack sizes for each strength are

• PHARMACOR QUETIAPINE 25 – 20 or 60 tablets.
• PHARMACOR QUETIAPINE 100 – 20 or 90 tablets.
• PHARMACOR QUETIAPINE 150 – 60 tablets
• PHARMACOR QUETIAPINE 200 – 20 or 60 tablets
• PHARMACOR QUETIAPINE 300 – 20, 60 or 100 tablets.

PHARMACOR QUETIAPINE is registered on the Australian register of Therapeutic Goods and has the Australia Register numbers:

Australian Register Number:

PHARMACOR QUETIAPINE 25: 204843

PHARMACOR QUETIAPINE 100: 204829

PHARMACOR QUETIAPINE 150: 204838

PHARMACOR QUETIAPINE 200: 204819

PHARMACOR QUETIAPINE 300: 204824

Who distributes PHARMACOR QUETIAPINE

PHARMACOR QUETIAPINE is supplied in Australia by:

Pharmacor Pty Ltd.
Suite 803, Level 8, Tower A,
The Zenith, 821 Pacific Highway,
Chatswood, NSW 2067,
Australia
www.pharmacor.com.au

This leaflet was prepared in 03/2023