Patient Medication Information: uses, side effects, how to take - Nu-Mirtazapine
ABOUT THIS MEDICATION
NU-MIRTAZAPINE is the generic brand name for a drug called mirtazapine.
What the medication is used for:
The most common use of NU-MIRTAZAPINE is for relief of depression symptoms.
What it does:
NU-MIRTAZAPINE is an antidepressant.
When it should not be used:
Do not use if allergic to mirtazapine or any of the nonmedicinal ingredients present in Nu-mirtazapine (See “What the important non-medicinal ingredients are” section below). Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
What the medicinal ingredient is:
NU-MIRTAZAPINE tablets contain the active ingredient called mirtazapine.
What the important nonmedicinal ingredients are:
NU-MIRTAZAPINE tablets contain the following nonmedicinal ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, yellow iron oxide (15 mg and 30 mg tablets only) and red iron oxide (30 mg tablets only).
What dosage forms it comes in:
Oral Tablets, 15 mg, 30 mg and 45 mg.
WARNINGS AND PRECAUTIONS
Before starting NU-MIRTAZAPINE and to get the best possible treatment, be sure to tell your doctor:
- 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
- any medications (prescription or nonprescription) which you are taking, especially monoamine oxidase inhibitors (e.g. phenelzine sulphate, moclobemide, tranylcypromine sulphate, or selegeline), any other antidepressants, or drugs to treat anxiety
- 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
your habits of alcohol consumption
- Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressants, such as NU-MIRTAZAPINE, 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 anti-depressant 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 anti-depressant, 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.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Nu-mirtazapine include monoamine oxidase inhibitors (e.g. phenelzine sulphate, moclobemide, tranylcypromine sulphate, or selegeline), any other antidepressants, drugs to treat anxiety, or any natural or herbal products (e.g. St. John’s Wort).
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 NU-MIRTAZAPINE.
Before you use NU-MIRTAZAPINE talk to your doctor or pharmacist.
PROPER USE OF THIS MEDICATION
This medicine has been prescribed for you personally and you should not pass it onto others. It may harm them, even if their symptoms are the same as yours.
Never increase or decrease the amount of NU-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.
Some symptoms may begin to improve within about two weeks but significant improvement can take several weeks. Continue to follow the doctor’s instructions.
Usual dose:
The initial recommended dose is 15 mg/day. Dose may be increased up to 45 mg/day for unresponsive patients.
Tablets should be administered as a single evening dose (prior to sleep).
Do not chew. Do not use in pregnancy or nursing.
Overdose:
If you have taken a large number of pills all at once, immediately contact your doctor or the nearest hospital emergency department or your nearest Poison Control Centre, even though you may not feel sick. Show the doctor your pack of pills.
Missed Dose:
If you forget to take your evening dose, do not take the missed dose the next morning. Continue treatment in the evening (prior to sleep) with your normal dose. Do not take a double dose to make up for forgotten doses. Contact your doctor or pharmacist right away in case of doubt. 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 NU-
MIRTAZAPINE.
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.
You may experience some side effects such as increase in appetite, weight gain, drowsiness or sleepiness, swollen ankles or feet, occasional dizziness or faintness (especially when you get up quickly from a lying or sitting position) and headache. In rare cases other effects may include seizures, attack of mania, yellow colouring of eyes or skin, rash, abnormal sensation in the skin (e.g. burning, stinging, tickling or tingly) or restless legs. Some side effects are temporary. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.
In very rare cases Nu-mirtazapine may cause a shortage of white blood cells, resulting in a lowering of the body resistance to infection. If you have a fever, sore throat, mouth ulcers or any other signs of infection, you should immediately contact your doctor.
This is not a complete list of side effects. For any unexpected effects while taking NU-MIRTAZAPINE, contact your doctor or pharmacist.
HOW TO STORE IT
Remember to keep NU-MIRTAZAPINE well out of reach of children. NU-MIRTAZAPINE should be stored at room temperature (15 to 30EC).
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated wit 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 Med Effect ™ Canada Web site at www.healtlcanada.gc.ca/medeffect.
NOTE: Should you require information related to the
management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm, Inc. at:
1-800-267-1438
Date of Revision: October 14, 2009