Ava-Quetiapine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

AVA-QUETIAPINE (quetiapine fumarate) 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 aggressiveness, agitation, impulsive behaviour or excessively elevated mood.

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

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

What it does:

AVA-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. AVA-QUETIAPINE is thought to work by regulating the imbalance of chemicals in the brain.

When it should not be used:

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

What the medicinal ingredient is:

Quetiapine Fumarate

What the important nonmedicinal ingredients are:

AVA-QUETIAPINE tablets contain the following nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose 7FP, fumaric acid, hydroxypropyl cellulose type LF, hydroxypropyl methylcellulose 2910 E5, magnesium stearate, polyethylene glycol 8000, red ferric oxide (25 mg only), titanium dioxide, yellow ferric oxide (25 mg and 100 mg only).

What dosage forms it comes in:

Tablets – 25 mg, 100 mg, and 200 mg

WARNINGS AND PRECAUTIONS

Before starting AVA-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 AVA-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 AVA-QUETIAPINE.

• if you are breast-feeding or are planning on breast-feeding while taking AVA-QUETIAPINE. You should not breast-feed while taking AVA-QUETIAPINE.
• if you drink alcohol or use street drugs.
• if you have any health problems.
• if you have any heart problems and/or low blood pressure or have had a stroke.
• if you have a history of seizures.
• 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 already have diabetes, you should be monitored for worsening of your diabetes.

Serious Warnings and Precautions

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

Do not drive or operate machinery until you know your response to this medication, as AVA-QUETIAPINE can cause drowsiness.

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 AVA-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 AVA-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, or depression or to help you sleep.

Dopamine agonists, e.g. levodopa (antiparkinsonian agent), may decrease the effect of AVA-QUETIAPINE.

Medications known to interact with AVA-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), diltiazem, verapamil, nefazodone, thioridazine (antipsychotic), or blood pressure medications.

PROPER USE OF THIS MEDICATION

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

Usual adult dose:

In order for AVA-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.

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

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

• Continue taking AVA-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 AVA-QUETIAPINE for you.

  You may take AVA-QUETIAPINE with or without food.

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

Overdose:

In case of AVA-QUETIAPINE overdose or if you think you, or anyone else, are experiencing severe episodes of any of the side effects of AVA-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 AVA-QUETIAPINE:

• Take your AVA-QUETIAPINE at the same time every day;
• Take AVA-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 AVA-

  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 AVA-QUETIAPINE;

• Keep a written reminder to take your AVA-

  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, AVA-QUETIAPINE may produce side effects in some people.

Increases in blood glucose (sugar) and hyperglycaemia (high blood sugar) have been observed with AVA-QUETIAPINE. 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 AVA-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.

Discontinuation symptoms which occur upon stopping AVA-QUETIAPINE have been reported very commonly and include insomnia (inability to sleep), nausea, headache, diarrhea, vomiting, dizziness, and irritability. These symptoms usually go away after 1 week from your last dose.

Other common side effects may include: headache, rapid heart beat, constipation, indigestion, dry mouth, feeling weak, swelling of arms and legs, fainting, stuffy nose, upset stomach or abdominal pain, blurred vision, some weight gain, and changes in laboratory tests for liver and thyroid functions.

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 AVA-QUETIAPINE does not cause you to be drowsy.

There have been uncommon cases of difficulty swallowing and disturbance in speech and language.

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 AVA-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 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 AVA-QUETIAPINE.

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

• Increase in one type of white blood cells

  (eosinophilia) which is sometimes seen in allergic reactions.

• Increase in the amount of liver enzymes. These

  changes will normally disappear when continuing the treatment of AVA-QUETIAPINE.

• Increase 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.

  One of the most important things for you to do to minimize the risks from side effects, while helping AVA-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 AVA-QUETIAPINE, contact your doctor or pharmacist.

HOW TO STORE IT

Store at controlled room temperature 15-30°C (59-86°F) and well out of the reach of children.

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 0701D

    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

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting AVANSTRA INC. at:

Telephone: 1-855-708-3678

Email: medinfo@avanstra.com

Last revised: February 16, 2011