Details for: PMS-TRAZODONE
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02237339 | PMS-TRAZODONE | TRAZODONE HYDROCHLORIDE | 75 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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
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.
| 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
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