Oleptro: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

OLEPTRO^™ (trazodone hydrochloride extended-release caplets) is an antidepressant used to treat the symptoms of major depressive disorder (MDD) in adults over 18 years old.

What it does:

Depression is an illness that is believed to be caused by an imbalance of a chemical called serotonin. OLEPTRO^™ belongs to a group of medicines called Serotonin 2A/2C Antagonist and Reuptake Inhibitors (SARIs). OLEPTRO^™ is thought to work by increasing the levels of serotonin in your brain.

OLEPTRO^™ is an extended-release formulation designed to work over a 24-hour period. It may take several weeks of treatment before you notice an improvement. It is important for you to continue therapy as directed by your doctor.

When it should not be used:

You should not use OLEPTRO^™ if you are allergic to trazodone or any of the nonmedicinal ingredients in the product (see What the nonmedicinal ingredients are). Contact your doctor immediately if you experience an allergic reaction (e.g., skin rash, hives) or any severe or unusual side effects.

What the medicinal ingredient is:

Trazodone hydrochloride.

What the nonmedicinal ingredients are:

Hydroxypropyl distarch phosphate (Contramid^®), hypromellose, sodium stearyl fumarate, colloidal silicon dioxide, iron oxide yellow (CI number 77492), iron oxide red (CI number 77491), talc, polyethylene glycol 3350, polyvinyl alcohol, titanium dioxide (CI number 77891), iron oxide black (CI number 77499), shellac glaze, ethanol, isopropyl alcohol, N-butyl alcohol, propylene glycol, ammonium hydroxide.

What dosage forms it comes in:

OLEPTRO^™ caplets are extended-release caplets and are available in 150 mg and 300 mg strengths. Caplets are scored on

both sides.

WARNINGS AND PRECAUTIONS

During treatment with these types of medications, it is important that you and your doctor have good ongoing communication about how you are feeling.

OLEPTRO^™ is not for use in children under 18 years of age.

New or Worsened Emotional or Behavioural Problems

Particularly in the first weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Do not discontinue your medication on your own.

BEFORE you use OLEPTRO^™ talk to your doctor or pharmacist if you:

• have a history or a family history of heart problems, including: heart disease, heart attack, QT prolongation, arrhythmias (irregular heart beat), or a family history of sudden cardiac death at age younger than 50 years
• have liver problems
• have kidney problems
• have or have had fainting or dizziness
• have electrolyte disturbances (e.g., low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration)
• have an eating disorder or are following a strict diet
• have diabetes, especially with associated nerve disorders
• have or have had abnormal bleeding
• have bipolar disorder
• have blood pressure problems
• have had breast tumours
• have had pituitary tumours

• have conditions that might predispose you to priapism,

  (painful erections greater than 4 hours in duration) such as sickle cell anemia, multiple myeloma, or leukemia, or if you have any anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease)

• are taking or have recently taken any prescription, non-prescription, or natural/herbal medications (see Interactions with this Medication)

• are pregnant or thinking about becoming pregnant

• are breastfeeding
• are older than 65 years of age

Do not drive a vehicle or perform hazardous tasks while taking OLEPTRO^™.

INTERACTIONS WITH THIS MEDICATION

There are medications that may cause OLEPTRO^™ caplets to be less effective, or may cause you to have some side effects or drug reactions.

The following list includes some, but not all, of the drugs that may interact with OLEPTRO^™.

Drugs (or therapies) that may interact with OLEPTRO^™ include:

• Acetylsalicylic acid (ASA)
• Alcohol
• Anaesthetics for surgery
• Analgesics for pain (e.g., opioids)
• Antiarrythmics (for irregular heart rhythm)

• Antibiotics (e.g., erythromycin, clarithromycin,

  moxifloxacin, ciprofloxacin, etc.)

• Anticonvulsants (e.g., phenytoin)
• Antidepressants other than OLEPTRO
• Antifungals (e.g. ketoconazole, fluconazole, voriconazole)
• Antihypertensive drugs (for high blood pressure)
• Anti-infectives
• Antipsychotics
• Asthma drugs (e.g., formoterol, salmeterol)
• Barbiturates
• Coumarin
• Corticosteroids
• Digoxin or phenytoin
• Diuretics

• Drugs that alter CYP3A4 metabolism (e.g., ritonavir,

  ketoconazole, indinavir, itraconazole, carbamazepine),

• Drugs to treat nausea and vomiting (e.g., ondansetron,

  dolasetron, domperidone)

• Electroshock therapy
• Epilepsy drugs
• Laxatives or enemas
• Natural or herbal products (e.g., St. John’s Wort)
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Pentamidine

• Serotoninergic drugs (including SSRIs, SNRIs and triptans)

  and drugs that impair metabolism of serotonin (including MAOIs (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegeline))

• Trazadone
• Warfarin

You should check with your doctor or pharmacist before taking any other medication with OLEPTRO^™. Be sure to also talk to your doctor about any street drug consumption.

Consumption of grapefruit, grapefruit juice, or products containing grapefruit extract should be avoided while taking OLEPTRO^™.

Do not drink alcohol while taking OLEPTRO^™.

PROPER USE OF THIS MEDICATION

Usual adult dose:

OLEPTRO^™ caplets are intended for a once-a-day treatment. The caplets should be taken orally at the same time every day, in the late evening on an empty stomach.

The recommended starting dose of OLEPTRO^™ is 150 mg/day. Your doctor may recommend to increase the dose by 75 mg/day every three days (i.e., start 225 mg/day on Day 4 of therapy). The maximum dose should not exceed 375 mg/day.

OLEPTRO^™ should be swallowed whole or broken in half along the score line. OLEPTRO^™ caplets should not be chewed or crushed.

In order to break the caplets accurately and easily, hold the caplet between your thumbs and index fingers close to the caplet score. Then with the caplet score facing you, apply pressure and snap the caplet segments apart.

Dosage directions should be followed carefully. Never exceed the prescribed dose.

Discontinuing OLEPTRO^™

It is very important that you do NOT stop taking OLEPTRO^™ without first consulting your doctor. See the section SIDE EFFECTS AND WHAT TO DO ABOUT THEM for more information.

Elderly (65 years of age or older):

If you are older than 65 years of age, your doctor may recommend a lower dose.

Overdose:

In case of drug overdose, contact your regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

Do not take more than one dose per day. If you miss a dose, do not double the next dose. Do not take the missed dose during the day; instead, the next dose should be taken as scheduled in the late evening.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, OLEPTRO^™ can cause some side effects. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

The most common side effects of OLEPTRO^™ are:

• Headache
• Drowsiness
• Dry mouth
• Dizziness (lightheadedness)
• Nausea
• Sedation
• Fatigue
• Diarrhea
• Constipation
• Back pain
• Blurred vision

This is not a complete list of side effects. For any unexpected effects while taking OLEPTRO^™, contact your doctor or pharmacist.

Discontinuation Symptoms

Even if you have side effects, contact your doctor before stopping or reducing your dosage of OLEPTRO^™. Discontinuation symptoms including anxiety, agitation and sleep disturbances, have been reported with trazodone. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of OLEPTRO^™ to alleviate the symptoms.

Effect on the Hormone Prolactin

In women, medicines of this type may cause changes in the regularity of their monthly period or leakage of milk from the breast even if they are not pregnant. In some men, after prolonged treatment, there may be some diminished sexual function and breast enlargement may be experienced. Tell your doctor if you experience any of these symptoms.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

New or Worsened Emotional or Behavioural Problems

Particularly in the first weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, consult your doctor immediately. Do not discontinue your medication on your own. See also the WARNINGS AND PRECAUTIONS section.

Other effects may include the following:

Heart pounding, heart racing, ringing in the ears, vomiting, weakness, feeling jittery, disturbance in attention, tingling sensation, musculoskeletal stiffness, erectile dysfunction (in men), tremors, hot flashes, sore throat, changes in blood sugar, decreased appetite, changes in sense of taste, sweating, restlessness, nervousness, urinary urgency, excessively frequent urination, confusion, memory problems, painful menstrual periods.

Effects on Newborns

Some newborns whose mothers took certain antidepressants, such as OLEPTRO^™, during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. In most cases, the antidepressant was taken during the third trimester of pregnancy. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

* Stop taking drug; do not take the next dose. Seek emergency medical attention.

HOW TO STORE IT

OLEPTRO^™ should be stored at room temperature (15ºC to 30ºC). Keep it in a tight container and out of the light.

Do not use OLEPTRO^™ caplets after the expiry date. All expired medications should be returned to your pharmacist.

Keep this and all medicines in a safe place away from 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 in the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

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

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.website.document

or by contacting the sponsor, Angelini Pharma Inc., at: 1-800-XXX-XXXX

Imported by:

OLEPTRO is a trademark of Angelini Pharma Inc. Contramid is a registered trademark of Labopharm Inc.

© Angelini Pharma Inc.

Last revised: October 7, 2014