Details for: QUETIAPINE XR
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02417782 | QUETIAPINE XR | QUETIAPINE (QUETIAPINE FUMARATE) | 50 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02417790 | QUETIAPINE XR | QUETIAPINE (QUETIAPINE FUMARATE) | 150 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02417804 | QUETIAPINE XR | QUETIAPINE (QUETIAPINE FUMARATE) | 200 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02417812 | QUETIAPINE XR | QUETIAPINE (QUETIAPINE FUMARATE) | 300 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02417820 | QUETIAPINE XR | QUETIAPINE (QUETIAPINE FUMARATE) | 400 MG | TABLET (EXTENDED-RELEASE) | ORAL |
Summary Reports
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Urinary Retention
Summary Safety Review - Atypical Antipsychotics - Liver failure
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
QUETIAPINE XR (quetiapine fumarate extended-release tablets) is used to:
- Treat the symptoms of schizophrenia, such as hallucinations (hearing or seeing things which are not there), fixed false beliefs, unusual suspiciousness or emotional withdrawal. Patients may also feel depressed, anxious or tense.
- Treat the symptoms of mania associated with bipolar disorder, such as racing thoughts, irritability, aggressiveness, agitation, impulsive behaviour or excessively elevated mood.
- Treat the symptoms of depression associated with bipolar disorder, such as sadness, feeling guilty, lack of energy, loss of appetite and/or sleep disturbance.
- Treat the symptoms of patients with depression who have failed treatment with currently available antidepressant medications due to lack of appropriate response and/or due to side effect issues. QUETIAPINE XR is a new treatment for depression and belongs to a class of drug known as ‘atypical antipsychotic’. It is important to discuss with your doctor about your depressive symptoms and possible side effects.
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.
Your doctor may have prescribed QUETIAPINE XR for another
reason. Ask your doctor if you have any questions about why
QUETIAPINE XR has been prescribed for you.
QUETIAPINE XR is not a cure for your condition but it can help
manage your symptoms and help you feel better.
What it does
QUETIAPINE XR is a medication that belongs to a class of medicines called “atypical antipsychotics”.
Illnesses that affect the brain, such as schizophrenia, bipolar disorder and major depressive disorder, may be due to certain chemicals in the brain being out of balance. These imbalances may cause some of the symptoms you may be experiencing. Doctors and scientists are not sure what causes these imbalances to occur. QUETIAPINE XR is thought to work by regulating the imbalance of chemicals in the brain.
When it should not be used
Do not take QUETIAPINE XR if you have had an allergic reaction to quetiapine or any of the ingredients listed in the “nonmedicinal ingredients” section of this leaflet.
What the medicinal ingredient is
Quetiapine fumarate.
What the non-medicinal ingredients are
Colloidal silicon dioxide, hydrogenated vegetable oil, lactitol, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, red iron oxide (50 mg tablets only), succinic acid, talc, titanium dioxide and yellow iron oxide (50 mg, 200 mg and 300 mg tablets only).
What dosage form it comes in
QUETIAPINE XR comes in 5 tablet strengths: 50 mg (capsule shape, peach colour), 150 mg (capsule shape, white colour), 200 mg (capsule shape, yellow colour), 300 mg (capsule shape, pale yellow colour) and 400 mg (capsule shape, white colour).
Warnings and precautions
Serious Warnings and Precautions
Studies with various medications of the group to which QUETIAPINE XR belongs, including quetiapine immediate release tablets, when used in elderly patients with dementia have been associated with an increased rate of death. QUETIAPINE XR is not indicated in elderly patients with dementia.
Before starting QUETIAPINE XR, be sure to tell your doctor:
- If you have had an allergic reaction to any medicine which you have taken previously to treat your condition, or if you think you might be sensitive or allergic to any of the ingredients in QUETIAPINE XR.
- About any other medications - prescription, nonprescription or alternative - that you are taking or plan to take. Certain medications can seriously affect the way other medications work.
- If you are pregnant or plan to become pregnant while taking QUETIAPINE XR.
- If you are breast-feeding or are planning on breastfeeding while taking QUETIAPINE XR. You should not breast-feed while taking QUETIAPINE XR.
- If you drink alcohol or use street drugs.
- If you have a history of alcohol or drug abuse.
- If you have any health problems.
- If you have low or high blood pressure or have had a stroke.
- If you or a family member have a history of any problems with the way your heart beats or have a history of heart disease or heart problems or if you are taking any medicines that may have an impact on the way your heart beats.
- If you have a history of seizures (fit).
- If you have diabetes, a family history of diabetes or high blood sugar during pregnancy.
- If you have a history of liver or kidney problems.
- If you know that you had a low white blood cell count in the past which may or may not have been caused by other medicines.
- If you exercise vigorously or work in hot or sunny places.
- If you have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives (“The Pill”).
- If you suffer or have ever suffered from severe constipation, obstruction of the bowel or any other condition which has affected your large bowel.
- If you have or have had a condition where you stop breathing for short periods during your normal nightly sleep (called “sleep apnea”) and are taking medicines that slow down normal activity of the brain (“depressants”) or breathing.
- If you have or have had a condition where your bladder does not empty or does not empty completely (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eyes. These conditions are sometimes caused by medicines called “anticholinergics”.
Tell your doctor as soon as possible if you have:
- Fever, flu-like symptoms, sore throat, or any other infection, as this could be a result of a very low white blood cell count, which may require QUETIAPINE XR to be stopped and/or treatment to be given.
- Constipation along with persistent stomach pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.
In clinical studies with quetiapine fumarate extended-release
tablets and other drugs of this type, an increased risk of death has
been reported in elderly patients with dementia and behavioural
disturbances. QUETIAPINE XR is not approved for this use.
Pancreatitis (inflammation of the pancreas) has been reported in
some patients. Many of these patients also had factors which are
known to be associated with pancreatitis such as increased
triglyceride (a fatty substance in the blood) levels, gallstones and
alcohol consumption.
Cardiomyopathy (weakening of the heart muscle) and myocarditis
(inflammation of the heart) have been reported in some patients,
however, it is not known if quetiapine fumarate extended-release
treatment is related to these problems.
If you already have diabetes, you should be monitored for
worsening of your diabetes.
Do not drive or operate machinery until you know your response
to this medication, as QUETIAPINE XR can cause drowsiness.
Thoughts of suicide and worsening of your depression or other mental illnesses
If you are depressed and/or have other mental illnesses you may
sometimes have thoughts of harming or killing yourself. These
may be increased when first starting treatment, since these
medicines all take time to work, usually about two weeks but
sometimes longer.
If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you
are depressed or have other mental illnesses, and ask them to read
this leaflet. You might ask them to tell you if they think your
depression or mental illness is getting worse, or if they are
worried about changes in your behaviour.
Severe cutaneous adverse reactions (SCARs)
Serious skin rashes, which can be life threatening, have occurred
with the use of QUETIAPINE XR. Symptoms include blistering,
peeling of the lips eyes, mouth or genitals, swelling of the face
and/or tongue, and hives. These serious skin rashes may progress
to widespread blistering or peeling of the skin and are often
accompanied by flu like symptoms, blood abnormalities (increase
in a type of white blood cells sometimes seen in allergic
reactions) and swollen glands (enlarged lymph nodes).
Stop using QUETIAPINE XR if you develop these symptoms and
contact your doctor or seek medical attention immediately.
Effects on Newborns:
In some cases, babies born to a mother taking quetiapine fumarate
extended-release tablets during pregnancy have experienced
symptoms of withdrawal that are severe and require the newborn
to be hospitalized. Sometimes, the symptoms may resolve on
their own. Be prepared to seek immediate emergency medical
attention for your newborn if they have difficulty breathing, are
overly sleepy, have muscle stiffness, or floppy muscles (like a rag
doll), are shaking, or are having difficulty feeding.
Interactions with this medication
Because certain medications can seriously affect the way other
medications work, it is important to tell all doctors, dentists, and
pharmacists who are treating you that you are taking
QUETIAPINE XR. As well, be sure to tell them about any other
medications - prescription, non-prescription or alternative - that
you are taking or plan to take.
You should not drink alcohol while taking QUETIAPINE XR, as
the combination could increase the effects of the alcohol.
You should tell your doctor if you are taking or about to stop
taking medications for anxiety, depression, epilepsy (such as phenytoin or carbamazepine), high blood
pressure, or to help you
sleep.
Dopamine agonists, e.g. levodopa (antiparkinsonian agent), may
decrease the effect of QUETIAPINE XR.
Medications known to interact with QUETIAPINE XR include
carbamazepine (anticonvulsant), phenytoin (anticonvulsant),
ketoconazole (antifungal), and protease inhibitors (for treating
Human Immunodeficiency Virus).
You should tell your doctor if you are taking erythromycin
(antibiotic), clarithromycin (antibiotic), nefazodone, thioridazine
(antipsychotic), diltiazem or verapamil (blood pressure
medications), medications that can cause constipation or medicines
called “anticholinergics” that may affect your ability to empty your
bladder. You should also tell your doctor if you are taking
medicines that have an impact on the way and how slow your heart
beats, for example drugs that can cause an imbalance in
electrolytes (low levels of potassium or magnesium) such as
diuretics (water pills) or certain antibiotics (drugs to treat
infections).
Effect on Urine Drug Screens:
QUETIAPINE XR may cause positive results for methadone or
certain drugs for depression called tricyclic antidepressants (TCAs)
when some test methods are used, even though you may not be
taking these drugs. Confirmation of the results by more specific
tests is recommended.
Proper use of this medication
QUETIAPINE XR is not recommended for use in patients under 18 years old.
Usual Dose
Adult
In order for QUETIAPINE XR to help you feel better, it is very important to take it every day exactly as your doctor tells you to. Take the exact number of tablets your doctor has prescribed at the right time every day.
Recommended Dose
Schizophrenia and Bipolar Mania
The usual titration schedule is day 1: 300 mg, day 2: 600 mg and up to 800 mg from day 3 onwards taken once daily. The maximum dose is 800 mg per day.
Bipolar Depression
The usual titration schedule is day 1: 50 mg, day 2: 100 mg, day 3: 200 mg and day 4 and onwards: 300 mg taken once daily. Your doctor may further increase the dose depending on your response and tolerability. The maximum dose is 600 mg per day.
Major Depressive Disorder
The usual titration schedule is 50 mg on days 1 and 2 and 150 mg
on day 3. Your doctor may adjust the dose upwards or downwards
within the recommended dose range of 50 - 300 mg per day during the course of your treatment depending
on your response and
tolerability.
It takes time to feel better and you should expect some symptoms
to improve slowly over the first few weeks of treatment. Do not
stop taking QUETIAPINE XR, or change the times of day you
take QUETIAPINE XR without talking to your doctor first.
If you stop taking QUETIAPINE XR abruptly you may
experience withdrawal symptoms such as insomnia (inability to
sleep), nausea and vomiting.
To make sure you are getting the most benefit from
QUETIAPINE XR, you must:
- Continue taking QUETIAPINE XR every day and
- Keep your doctor well informed of how you are feeling, both good and bad.
By doing these two things, you and your doctor together will be able to make sure that you are getting the best dose of QUETIAPINE XR for you.
You may take QUETIAPINE XR with or without food. Tablets should be swallowed whole. Do not split,
crush or
chew
Do not give QUETIAPINE XR to anyone else. Your doctor has
prescribed QUETIAPINE XR for you only.
Switching from Pro-Quetiapine tablets to QUETIAPINE XR tablets:
If you are currently being treated with divided doses of ProQuetiapine (quetiapine, immediate-release formulation) your doctor may switch you to QUETIAPINE XR at an equal total daily dose taken once daily.
Overdose
If you think you have taken too much QUETIAPINE XR, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
In case of QUETIAPINE XR overdose or if you think you or anyone else are experiencing severe episodes of any of the side effects of QUETIAPINE XR (especially drowsiness, including also rapid heart beat, lightheadedness and/or dizziness, especially when standing up quickly or getting out of bed), call your doctor or poison control centre or go to the nearest hospital emergency department right away. Make sure to bring your medication bottle with you.
Missed Dose
QUETIAPINE XR should be taken at the same time each day. If
you miss a dose from the previous day, you should take your next
regular dose of QUETIAPINE XR the next day at the normal
time.
Here are some tips that can help you remember to take each dose
of QUETIAPINE XR:
- Take your QUETIAPINE XR at the same time every day.
- Take QUETIAPINE XR during daily events which will help you remember to take your medicine as well, e.g., mealtime or bedtime.
- Use a pill container that will separate your QUETIAPINE XR doses by the day of the week.
- Use a calendar to note the day and time after you have taken each dose to help you keep track of when you need to take your QUETIAPINE XR.
- Keep a written reminder to take your QUETIAPINE XR that can be easily seen, e.g., on a mirror or on the refrigerator.
- Have a family member or friend remind you to take your medication.
Side effects and what to do about them
Like any medication, QUETIAPINE XR may produce side effects
in some people.
Increases in blood glucose (sugar) and hyperglycaemia (high blood
sugar) have been observed with QUETIAPINE XR. Also,
occasional cases of diabetes have been reported. Your doctor may
take blood tests to check your blood sugar before starting
QUETIAPINE XR. They may continue to monitor your blood
sugar for as long as you are being treated.
Lightheadedness and dizziness (symptoms of postural
hypotension) and drowsiness are among the most common side
effects you may experience while taking QUETIAPINE XR,
particularly during the first week of treatment or after an increase
in dose. The dizziness and drowsiness are usually mild and should
go away with time. To help prevent these feelings, be careful to
move slowly when you are getting up from a sitting or lying
position. Dizziness and drowsiness may lead to falls.
Low blood pressure in standing position is common, which may
result in dizziness or feeling faint (may lead to falls).
As feelings of drowsiness are also common at the start of
treatment, or when your dose is increased, if you have to drive,
operate machinery or do anything else that requires you to be fully
alert, use extra caution until you are sure QUETIAPINE XR does
not cause you to be drowsy.
Dry mouth and weight gain have also been reported very
commonly in patients taking quetiapine fumarate extended-release
tablets. Your doctor may take your body weight before starting
QUETIAPINE XR and continue to monitor it for as long as you
are being treated.
Discontinuation symptoms which occur upon stopping
QUETIAPINE XR have been reported very commonly and include
insomnia (inability to sleep), nausea, headache, diarrhea, vomiting,
dizziness and irritability. Gradual withdrawal over a period of at
least one to 2 weeks is advisable.
Other common side effects may include: headache, rapid heart
beat, feeling like your heart is pounding, racing or has skipped
beats, shortness of breath, constipation, indigestion, feeling weak, swelling of arms and legs, fever,
upset stomach or abdominal
pain, vomiting (mainly in the elderly), blurred vision, abnormal
dreams and nightmares, irritability, feeling more hungry,
disturbance in speech and language and changes in laboratory
tests for liver and thyroid functions.
There have been uncommon cases of difficulty swallowing,
fainting (may lead to falls), stuffy nose, difficulty in passing
urine, and a slower than normal heart rate which may occur
when starting treatment and which may be associated with low
blood pressure and fainting.
There have also been reports, in a small number of patients, of
changes to the lens of the eye. Although it is not known whether
or not these changes are caused by QUETIAPINE XR, your
doctor may advise you that a specific type of eye exam is
recommended in order to maximize safe use of this drug.
In rare cases, there have been reports of decreased body
temperature (hypothermia) , a combination of fever, flu-like
symptoms, sore throat, or any other infection with very low white
blood cell count (a condition called agranulocytosis), bowel
obstruction, and walking, talking, eating or other activities while
asleep.
In very rare cases, this type of medicine can interfere with your
body’s ability to control body temperature. Therefore, take care to
avoid becoming overheated or dehydrated (for example with
vigorous exercise, or exposure to extreme heat) while taking
QUETIAPINE XR.
Side effects that are of unknown frequency (cannot be estimated
from available data) include:
- Symptoms of withdrawal in newborn babies of mothers that have used QUETIAPINE XR during their pregnancy.
- Formation of a gum like sticky mass of tablets in the stomach may occur when you take more QUETIAPINE XR than you should. Please contact your doctor immediately as it may require endoscopy for removal of the sticky mass.
The following may also occur with QUETIAPINE XR, and may be seen in routine blood testing:
- Decrease in the amount of white blood cells. These changes will normally disappear when stopping the treatment of QUETIAPINE XR.
- Decrease in the amount of red blood cells. These are the cells that transport oxygen throughout the body.
- Increase in the amount of eosinophils. These are a type of white blood cell sometimes seen in allergic reactions.
- Decrease in platelets (thrombocytopenia), which are cells that help you stop bleeding if you get a cut.
- Increase in the amount of liver enzymes. These changes will normally disappear when continuing the treatment of QUETIAPINE XR.
- Changes in the amount of fatty substances (lipid levels, such as triglycerides and cholesterol) in the blood.
- Increase in the amount of “creatine phosphokinase”, a substance in the muscles.
- Increase in the amount of sugar (glucose) in the blood.
- Increase in the amount of hormone prolactin in the blood. Rarely (< 0.1% - ≥ 0.01%) this may lead to swelling of breasts and unexpected production of breast milk in women and in some men, and changes in the regularity of monthly period.
- Changes in the amount of thyroid hormones in your blood. These changes usually do not affect how you feel.
- If you have high levels of prolactin and a condition called hypogonadism you may be at an increased risk of breaking a bone due to osteoporosis. This may occur in both men and women.
One of the most important things for you to do to minimize the risks from side effects, while helping QUETIAPINE XR work for you, is to contact your doctor or pharmacist if you notice any symptom that worries you, even if you think it is not connected with this medicine or is not listed here.
| Symptom / effect | Talk with your doctor right away Only if severe | Talk with your doctor right away In all cases | Stop taking drug and seek immediate emergency assistance |
|---|---|---|---|
| Very Common | |||
| Abnormal muscle movements, including difficulty starting muscle movements, shaking, restlessness or muscle stiffness without pain | ✔ | ||
| Common | |||
| New or worsening constipation | ✔ | ||
| Uncommon | |||
| Involuntary movements, mainly of your face or tongue (Tardive dyskinesia) | ✔ | ||
| Symptoms of allergic reactions such as skin lumps, bumps or swelling | ✔ | ||
| Restless legs (unpleasant sensations in the legs) | ✔ | ||
| Seizure (i.e., loss of consciousness with uncontrollable shaking “fit”) | ✔ | ||
| Not being able to pass urine (called “urinary retention”) | ✔ | ||
| Rare | |||
| Long-lasting (greater than 4 hours in duration) and painful erection of the penis | ✔ | ||
| Combination of high fever, muscle stiffness, marked increase in blood pressure and/or heartbeats, and reduced consciousness (called neuroleptic malignant syndrome) | ✔ | ||
| Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations | ✔ | ||
| Liver Disorder, or inflammation of the liver with or without jaundice (a yellowish discolouration of the skin/palms or whites of your eyes), dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| Very Rare | |||
| Anaphylaxis (severe form of allergic reaction; symptoms may include swelling of the mouth, face, lips or tongue, may include severe difficulty breathing and shock) | ✔ | ||
| Stop breathing for short periods during your normal nightly sleep (called “sleep apnea”) | ✔ | ||
| Not Known | |||
| Combination of widespread rash, high body temperature, abnormalities seen in a blood test (liver enzyme elevations, increase in a type of white blood cells sometimes seen in allergic reactions) and enlarged lymph nodes (a condition called “drug reaction with eosinophilia and systemic symptoms”) may occur. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking QUETIAPINE XR, contact your doctor or pharmacist.
How to store
Store QUETIAPINE XR at room temperature (between 15°C -
30°C) and well out of reach of children.
The expiry date of this medicine is printed on the package label.
Do not use the medicine after this date.
If your doctor tells you to stop taking QUETIAPINE XR or you
find that it has passed its expiry date, please return any left over
medicine to your pharmacist.
Reporting side effects
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about QUETIAPINE XR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.
This leaflet was prepared by
Pro Doc Ltée, Laval, Québec, H7L 3W9.
Last revised: February 10, 2021