PHL-Quetiapine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

phl-QUETIAPINE (quetiapine fumarate) (pronounced KETIAPIN) 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.

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 phl-QUETIAPINE for another reason. Ask your doctor if you have any questions about why phl-QUETIAPINE has been prescribed for you.

phl-QUETIAPINE is not a cure for your condition but it can help manage your symptoms and help you feel better.

What it does:

phl-QUETIAPINE is a medication that belongs to a class of medicines called "atypical antipsychotics".

Illnesses that affect the brain, such as schizophrenia and bipolar 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. phl-QUETIAPINE is thought to work by regulating the imbalance of chemicals in the brain.

When it should not be used:

Do not take phl-QUETIAPINE if you have had an allergic reaction to phl-QUETIAPINE or any of the ingredients listed in the “non-medicinal ingredients” section of this leaflet.

What the medicinal ingredient is:

Quetiapine fumarate.

What the non-medicinal ingredients are:

The core of the tablet contains the excipients: dibasic calcium phosphate, lactose, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The coating of each tablet contains: polyethylene glycol, titanium dioxide and hydroxypropyl methylcellulose. The coating of the 25 mg tablet also contains iron oxide red and iron oxide yellow. The coating of the 100 mg tablet contains iron oxide yellow. The coating of the 200 mg and 300 mg strengths also contains talc.

What dosage forms it comes in:

Tablets: 25 mg, 100 mg, 200 mg and 300 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medications of the group to which quetiapine fumarate belongs, including quetiapine fumarate, when used in elderly patients with dementia have been associated with an increased rate of death. phl-QUETIAPINE is not indicated in elderly patients with dementia.

Before starting phl-QUETIAPINE, 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 phl-QUETIAPINE.
• about any other medications - prescription, non-prescription 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 phl-QUETIAPINE.

• if you are breast-feeding or are planning on breast-feeding while taking phl-QUETIAPINE. You should not breast-feed while taking phl-QUETIAPINE.
• if you drink alcohol or use street drugs.
• 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.

In clinical studies with quetiapine fumarate and other drugs of this type, an increased risk of death has been reported in elderly patients with dementia and behavioural disturbances. phl-QUETIAPINE 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.

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 phl-QUETIAPINE 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.

Effects on Newborns:

In some cases, babies born to a mother taking quetiapine fumarate during pregnancy have experienced symptoms 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 ragdoll), 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 phl-QUETIAPINE. 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 phl-QUETIAPINE, 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 phl-QUETIAPINE.

Medications known to interact with phl-QUETIAPINE 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).

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:

phl-QUETIAPINE 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

phl-QUETIAPINE is not recommended for use in patients under 18 years old.

USUAL DOSE:

Adults

In order for phl-QUETIAPINE 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:

Your dose will be titrated based on your clinical response and tolerability.

Schizophrenia:

The usual starting dose is 25 mg, twice daily. The recommended dose range is 50 to 800 mg/day, taken twice daily.

Bipolar Mania:

The usual starting dose is 50 mg, twice daily. The recommended dose range is 100 to 800 mg/day, taken twice daily.

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 phl-QUETIAPINE, or change the times of day you take phl-QUETIAPINE, without talking to your doctor first.

If you stop taking phl-QUETIAPINE 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 phl-QUETIAPINE, you must:

• Continue taking phl-QUETIAPINE everyday 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 phl-QUETIAPINE for you.

You may take phl-QUETIAPINE with or without food.

Do not give phl-QUETIAPINE to anyone else. Your doctor has prescribed phl-QUETIAPINE for you only.

OVERDOSE:

In case of drug overdose, contact a health care

practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

In case of phl-QUETIAPINE overdose or if you think you, or anyone else, are experiencing severe episodes of any of the side effects of phl-QUETIAPINE (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 room right away. Make sure to bring your medication bottle with you.

MISSED DOSE:

If you miss a dose by only a few hours, take it as soon as possible. If most of the day has passed since your missed dose, skip that dose and wait until your next scheduled dose. Never take two doses at once.

Here are some tips that can help you remember to take each dose of phl-QUETIAPINE;

• Take your phl-QUETIAPINE at the same time every day.

  • Take phl-QUETIAPINE 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 phl-

    QUETIAPINE 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 phl-QUETIAPINE;
  • Keep a written reminder to take your.
  • phl-QUETIAPINE 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, phl-QUETIAPINE may produce side effects in some people.

Increases in blood glucose (sugar) and hyperglycaemia (high blood sugar) have been observed with quetiapine fumarate. Also, occasional cases of diabetes have been reported. Your doctor may take blood tests to check your blood sugar before starting phl-QUETIAPINE. They may continue to monitor your blood sugar for as long as you are being treated

Increases in blood glucose (sugar) and hyperglycaemia (high blood sugar) have been observed with quetiapine fumarate. Also, occasional cases of diabetes have been reported.

Light-headedness and dizziness (symptoms of postural hypotension) and drowsiness are among the most common side effects you may experience while taking phl-QUETIAPINE, 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 phl-QUETIAPINE does not cause you to be drowsy.

Dry mouth and weight gain have also been reported very commonly in patients taking quetiapine fumarate. Your doctor may take your body weight before starting phl-QUETIAPINE and continue to monitor it for as long as you are being treated.

Discontinuation symptoms which occur upon stopping quetiapine fumarate 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 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 phl-QUETIAPINE, 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) 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 phl-QUETIAPINE.

The following may also occur with phl-QUETIAPINE 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 phl-QUETIAPINE.

• 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 cells 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 phl-QUETIAPINE.

• 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.

  • If you have high levels of prolactin and a condition called hypogonadism you may be at 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 phl-QUETIAPINE 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.

This is not a complete list of side effects. For any unexpected effects while taking phl-QUETIAPINE, immediately contact your doctor or pharmacist.

HOW TO STORE IT

Store phl-QUETIAPINE between 15°C and 30°C and well out of the 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 phl-QUETIAPINE or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect .

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Important Note: This leaflet alerts you to some of the times you should call your doctor while you are taking phl-QUETIAPINE. Other situations that cannot be predicted may arise. Nothing about this leaflet should stop you from calling your doctor or pharmacists with any questions or concerns you have about using phl-QUETIAPINE.

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmel Inc. at 1-888-550-6060.

Pharmel Inc.

Montreal Quebec

H4P 2T4

Last revised: November 22, 2012