Quetiapine (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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.

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

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

What it does:

Quetiapine is a medication that belongs to a class of medicines called “atypical antipsychotics”.

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

When it should not be used:

Do not take QUETIAPINE 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 tablets contain the active ingredient quetiapine fumarate.

What the important nonmedicinal ingredients are:

Each tablet contains either 25, 100, 150, 200 or 300 mg of

quetiapine (as quetiapine fumarate) as the active ingredient and the following inactive ingredients: Calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.

The film coating contains:

25 mg: FD&C yellow #6, FD&C red #40, FD&C blue #2, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide

100 mg: iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide

150 mg: FD&C red # 40, FD&C blue #2, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide

200 & 300 mg: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide

What dosage forms it comes in:

QUETIAPINE comes in five strengths, with the following descriptions:

25 mg: Peach, film-coated, round, biconvex tablet with ‘QT’ on one side and ‘ ’ on the other.

100 mg: Yellow, film-coated, round, biconvex tablet with ‘ ’ on one side and ‘ ’ on the other.

150 mg: Yellow, film-coated, round, biconvex tablet with ‘ ’ on one side and ‘ ’ on the other.

200 mg: White to off-white, film-coated, round, biconvex tablet with ‘ ’ on one side and ‘ ’ on the other.

300 mg: White to off-white, film-coated, capsule-shaped, biconvex tablet with ‘ ’ on one side and ‘ ’ on the other.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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

Before starting 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 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

QUETIAPINE.

$ if you are breast-feeding or are planning on breast-feeding

while taking QUETIAPINE. You should not breast-feed while taking 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.

Do not drive or operate machinery until you know your response to this medication, as 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 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 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 QUETIAPINE.

Medications known to interact with 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

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

Usual adult dose:

In order for 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 QUETIAPINE, or change the times of day you take QUETIAPINE, without talking to your doctor first.

If you stop taking 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 QUETIAPINE, you must:

• Continue taking 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 QUETIAPINE for you.

You may take QUETIAPINE with or without food.

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

Overdose:

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

• Take your QUETIAPINE at the same time every day;

• Take 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 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 QUETIAPINE;

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

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

The following may also occur with 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 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 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 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 QUETIAPINE, contact your doctor or pharmacist.

HOW TO STORE IT

Store QUETIAPINE at room temperature (between 15 - 30°C) and well out of the reach of children. Protect from light.

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 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 0701C

  Ottawa, ON 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.

MORE INFORMATION

Important Note: This leaflet alerts you to some of the times you should call your doctor while you are taking 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 QUETIAPINE.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals Inc., at: 1-866-254-6111

Last revised: January 27, 2010