Consumer Information for: PMS TRAZODONE HCL TAB 50MG

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

pms-TRAZODONE (trazodone hydrochloride) is an antidepressant used to treat the symptoms of depression in adults over 18 years old.

What it does

pms-TRAZODONE belongs to a group of medicines called antidepressants. Depression is thought to be caused by an imbalance of certain chemicals that occur naturally in the brain. pms-TRAZODONE works to correct the imbalance in one of these chemicals (serotonin). This may help ease emotional and physical symptoms of depression.

When it should not be used

Do not use pms-TRAZODONE if:

  • you are allergic to trazodone or any other ingredients of this medicine. (see What the non medicinal ingredients are).
What the medicinal ingredient is

Trazodone hydrochloride

What the non-medicinal ingredients are

Croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and the following: 50 mg & 75 mg also contain: FD&C Yellow #6

What dosage form it comes in

Tablets: 50 mg, 75 mg & 100 mg

Warnings and precautions

pms-TRAZODONE is not for use in children and adolescents under 18 years of age.

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

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 new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide, or harm to others. Suicidal thoughts and actions can occur in any age group but may be more likely in patients 18 to 24 years old. Should this happen to you, or to those in your care, talk to your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

BEFORE you use pms-TRAZODONE 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, thinking about becoming pregnant or breastfeeding
  • are older than 65 years of age

Do not drive or operate any tools or machines until you know how pms-TRAZODONE affects you.

Effects on Newborns
Some newborns whose mothers took certain antidepressants, such as trazodone, 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.

Interactions with this medication

There are medications that may cause pms-TRAZODONE to be less effective, or may cause you to have side effects or drug reactions.

The following list includes some, but not all, of the drugs that may interact with pms-TRAZODONE:

  • Other antidepressants, such as SSRIs, SNRIs, certain tricyclics,
    • drugs used to treat schizophrenia (e.g. olanzapine, risperidone), or bipolar depression (e.g. lithium).
  • Other drugs that affect serotonin, such as lithium, drugs containing tryptophan, St. John’s Wort, triptans (used to treat migraine)
  • Drugs that alter CYP3A4 metabolism (e.g., ritonavir, ketoconazole, indinavir, itraconazole, carbamazepine)
  • Certain medicines used to treat pain, such as opioids.
  • Medicines which may affect blood clotting and increase bleeding such as aspirin, other non-steroidal anti-inflammatory drugs (e.g. ibuprofen), warfarin.
  • Antibiotics and antifungals such clarithromycin, erythromycin, ciprofloxacin, ketoconazole, fluconazole
  • Some heart medications to treat irregular heart rate, high blood pressure, diuretics (water pills), digoxin
  • Barbiturates
  • Phenytoin
  • Drugs to treat nausea and vomiting (e.g., ondansetron, dolasetron, domperidone)
  • Laxatives or enemas
  • Pentamidine

Consumption of grapefruit, grapefruit juice, or products containing grapefruit extracts should be avoided while taking pms-TRAZODONE.

Do not drink alcohol while taking pms-TRAZODONE.

Proper use of this medication

It is very important that you take your medication exactly as your doctor has instructed. Never exceed the prescribed dose.

pms-TRAZODONE should be taken shortly after a meal or light snack

Usual Adult Dose

  • 150 mg to 200 mg daily, in two or three divided doses
  • Doses may be increased by increments of 50 mg, usually up to 300 mg daily in divided doses.

Elderly (65 years of age or older):

Doses should not exceed half the recommended adult dosages

Discontinuing the medication:

Continue to take pms-TRAZODONE for as long as your doctor recommends. Do not suddenly stop taking or change the dose of your medicine without talking to your doctor first. See the section SIDE EFFECTS AND WHAT TO DO ABOUT THEM for more information

Overdose

If you think you have taken too much pms-TRAZODONE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms

Missed Dose

Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Side effects and what to do about them

Like all medicines, pms-TRAZODONE can cause side effects, although not everybody gets them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Talk to your doctor if you experience side effects and they worry you, as the dose may have to be adjusted.

The most common side effects of pms-TRAZODONE are:

  • Headache
  • Drowsiness, sedation
  • Dry mouth
  • Dizziness (light-headedness)
  • Nausea
  • Fatigue
  • Diarrhea
  • Constipation
  • Back pain
  • Blurred vision

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, nervousness, urinary urgency, excessively frequent urination, confusion, memory problems, painful menstrual periods.

This is not a complete list of side effects. If you develop any other unusual side effects while taking pms-TRAZODONE, please talk to your doctor.

Effect on the hormone Prolactin
In women, medicines of this type may cause changes in the regularity of their monthly periods 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.

Discontinuation Symptoms
Even if you have side effects, contact your doctor before stopping or reducing your dosage of pms-TRAZODONE. 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 pms-TRAZODONE to reduce the symptoms.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
Low blood pressure: feeling dizzy, lightheaded   ✔  
Uncommon
Fainting     ✔
Rare
Painful erection lasting more than 4 hours     ✔
Uncontrollable movements of the body or face   ✔  
Inability to urinate   ✔  
Unknown
Allergic reactions (red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing)     ✔
Bruising or unusual bleeding from the skin or other areas   ✔  
Low sodium level in blood (symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles)   ✔  
Mania/Hypomania (elevated or irritable mood, decreased need for sleep, racing thoughts)   ✔  
Convulsions     ✔
Serotonin Syndrome (a combination of most or all of the following: confusion, restlessness, sweating, shaking, sudden jerking of the muscles, hallucinations, fast heartbeat)     ✔
Heart rhythm problem (dizziness, palpitations or fast heartbeat, fainting)     ✔
Akathisia (feeling restless and unable to sit or stand still)   ✔  
Dark-coloured, tarry stools   ✔  
Sore throat, fever, general feeling of being unwell   ✔  
See warnings and precautions
Thoughts of death or suicide     ✔
New or worsened emotional or behavioural problems   ✔  
How to store

Store between 15°C and 30°C. Protect from light.

Do not use pms-TRAZODONE 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 side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
                    Health Canada, Postal Locator 0701E
                    Ottawa, ON
                    K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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

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

This leaflet was prepared by
        Pharmascience Inc.
        Montréal, Canada
        H4P 2T4

www.pharmascience.com

Last revised: April 15, 2015

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