Patient Medication Information: uses, side effects, how to take - Co Mirtazapine
ABOUT THIS MEDICATION
What the medication is used for:
CO Mirtazapine has been prescribed to you by your doctor to relieve your symptoms of depression. Depression is a condition that includes sadness, inactivity, difficulty with concentration, a significant increase or decrease in appetite and time spent sleeping, hopelessness and suicidal thoughts.
What it does:
CO Mirtazapine belongs to a group of medicines known as antidepressants and works by slowing the removal of certain chemicals, known as neurotransmitters, from the brain.
When it should not be used:
CO Mirtazapine should not be used:
if you are allergic to mirtazapine or to any ingredients in the
formulation or components of the container.
What the medicinal ingredient is:
mirtazapine
What the important nonmedicinal ingredients are: Carnauba wax, colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, red iron oxide, titanium dioxide, triacetin and yellow iron oxide.
What dosage forms it comes in:
30 mg tablets
WARNINGS AND PRECAUTIONS
BEFORE you use CO Mirtazapine talk to your doctor or pharmacist:
About all your medical conditions, including a history of
seizures, liver or kidney disease, heart problems, diabetes, low blood pressure, glaucoma (increased intra-ocular pressure), high cholesterol and/or high triglycerides (fats in the blood) difficulties in urinating as a result of an enlarged prostate;
About any medications (prescription or nonprescription)
which you are taking, especially monoamine oxidase inhibitors (MAOI) (e.g., phenelzine sulphate, moclobemide, tranylcypromine sulphate, or selegiline), or any other antidepressants, drugs to treat anxiety;
About any natural or herbal products you are taking (e.g., St.
John’s Wort)
If you are pregnant or thinking of becoming pregnant, or if you are breast feeding;
About your habits of alcohol consumption.
Other Precautions:
Refrain from potentially hazardous tasks, such as driving a car or operating dangerous machines, until you are certain that this medication does not affect your mental alertness or physical coordination.
- Avoid alcoholic drinks while taking CO Mirtazapine. • Contact your doctor before stopping or reducing your dosage of CO Mirtazapine. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating or other symptoms may occur after stopping or reducing the dosage of CO Mirtazapine. Such symptoms may also occur if a dose is missed. These symptoms usually disappear without medical treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of CO Mirtazapine to alleviate the symptoms.
- Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressants during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.
If you are pregnant and taking an SSRI or other newer antidepressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor.
Discontinuation Symptoms
Do not stop taking CO Mirtazapine without consulting your doctor due to risk of discontinuation symptoms.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with CO Mirtazapine include: Drugs that affect liver metabolism
Drugs metabolized by Cytochrome P4502D6 (e.g., 2D6, 1A2, 3A4)
Diazepam
St. John’s Wort herbal remedy
Alcohol
PROPER USE OF THIS MEDICATION
Usual dose:
It is very important that you take CO Mirtazapine exactly as your doctor has instructed. Generally, most people take between 15 mg and 45 mg per day.
Never increase or decrease the amount of CO Mirtazapine you, or those in your care if you are a caregiver or guardian, are taking unless your doctor tells you to and do not stop taking this medication without consulting your doctor (see under Warnings and Precautions when taking CO Mirtazapine).
Some symptoms may begin to improve within about two weeks but significant improvement can take several weeks. Continue to follow the doctor’s instructions.
The tablets should be taken at the same time each day, preferably as a single evening dose (prior to sleep). You should swallow the tablets whole with water. Do not chew them.
Keep taking your tablets until the doctor tells you to stop. The doctor may tell you to take your medicine for several months. Continue to follow the doctor’s instructions.
Overdose:
If you have taken a large number of pills all at once, contact your doctor or the nearest hospital emergency department or your nearest Poison Control Centre immediately, even though you may not feel sick. Show the doctor your pack of pills.
Missed Dose:
Do not take a double dose to make up for the forgotten doses.
If you forget to take your evening dose, do not take the missed dose the next morning. Continue treatment at bedtime (prior to sleep) with your normal dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Particularly in the first few 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.
The most common non-serious side effects are:
Drowsiness or sleepiness
Dizziness
Increase in appetite
Swollen ankles or feet
Weight gain
Discontinuation Symptoms: Contact your doctor before abruptly stopping your dosage of CO Mirtazapine. The following symptoms have been reported upon discontinuation of mirtazapine tablets: dizziness, abnormal dreams, sensory disturbances (including paresthesias and electronic shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting and sweating or other symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Drowsiness or sleepiness Dizziness Increase in appetite Swollen ankles or feet Weight gain | T T T T T | ||
Uncommon (Rare Cases) (Very Rare Cases) | Seizures Attack of mania Yellow colouring of eyes or skin Rash Abnormal sensation in the skin** Restless legs Shortage of white blood cells, resulting in a lowering of the body resistance to infection/fever, sore throat, mouth ulcers or any other signs of infection | T T T T | T T T | |
**e.g., burning stinging, tickling or tingly
This is not a complete list of side effects. For any unexpected effects while taking, CO Mirtazapine contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature between 15° - 30°C (59° - 86°F) in the original package.
Keep CO Mirtazapine out of the reach and sight of children.
Do not use CO Mirtazapine after the expiry date indicated on the package.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
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
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, ON
L5N 2B8