Patient Medication Information: uses, side effects, how to take - NTP-Mirtazapine Od Tablets
ABOUT THIS MEDICATION
What the medication is used for:
Mirtazapine belongs to a group of medications known as antidepressants. NTP-MIRTAZAPINE OD TABLETS have been prescribed to you to relieve your symptoms of depression. Treatment with theses types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.
What it does:
Mirtazapine affects the chemical messengers in your brain that help control depression.
When it should not be used:
Do not use NTP-MIRTAZAPINE OD TABLETS, if you are allergic to it or any of the components (see “What the important nonmedicinal ingredients are”). 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:
Mirtazapine
What the important nonmedicinal ingredients are: Aspartame, crospovidone, eudragit, magnesium stearate, mannitol, orange flavour, silicon dioxide and xylitol.
What dosage forms it comes in:
NTP-MIRTAZAPINE OD TABLETS are supplied as:
15 mg Tablets - white to off white, round, flat, beveled edge
tablet - one side of the tablet debossed with the number “93" and the other side debossed with the number “7303".
30 mg Tablets - white to off white, round, flat, beveled edge
tablet - one side of the tablet debossed with the number “93" and the other side debossed with
the number “7304".
45 mg Tablets - white to off white, round, flat, beveled edge
tablet - one side of the tablet debossed with the number “93" and the other side debossed with
the number “7305".
WARNINGS AND PRECAUTIONS
BEFORE you use NTP-MIRTAZAPINE OD TABLETS talk to your doctor or pharmacist about:
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;
- 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), or any other antidepressants, 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;
- anticipated medical procedures;
- any allergies to this drug or its ingredients or components of the container
INTERACTIONS WITH THIS MEDICATION
The presence of other medications may affect the use of NTP-MIRTAZAPINE OD TABLETS or NTP-MIRTAZAPINE OD TABLETS may affect the use of other medications. This may increase the cause of serious side effects. Examples are: Any medications (prescription or nonprescription) which you are taking, especially monoamine oxidase inhibitors (e.g., phenelzine sulphate, moclobemide, tranylcypromine sulphate, or selegeline), or any other antidepressants, including the herbal St. John’s Wort, drugs to treat anxiety (e.g. diazepam).
Avoid alcohol while taking mirtazapine.
Interactions with the laboratory tests have not been established.
PROPER USE OF THIS MEDICATION
Usual dose:
Mirtazapine is not indicated for use in children under the 18 years of age
It is very important that you take NTP-MIRTAZAPINE
OD TABLETS exactly as your doctor has instructed.
Generally, most people receive between 15 mg and 45 mg per day.
Never increase or decrease the amount of NTP-
MIRTAZAPINE OD TABLETS you 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.
- The tablets should be taken at the same time each day, preferably as a single evening dose (prior to sleep). 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.
- Take out the tablet (make sure hands are dry) and place it on the tongue. The tablet will rapidly disintegrate and can be swallowed with water.
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 a missed dose. If you forget to take the evening dose, wait and take your usual dose the next evening (before sleep).
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
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. Some side effects are temporary. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted. During discontinuation of treatment, you may experience the following symptoms:
Dizziness, abnormal dreams, sensory disturbances (including paresthesias and electric shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting and sweating
You should contact your doctor immediately if you have the 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
| Only if severe | In all cases | call your doctor or pharmacist | ||
| Common | anxiety, hostility, agitation, and self-harm or harm to others. | T | ||
| Uncommon | shortage of white blood cells, fever, sore throat, mouth ulcers or any other signs of infection, seizures, attack of mania (agitation, elation, and uncontrolled behaviour), yellowing of the skin or eyes (jaundice), rash, abnormal sensation in the skin or restless legs. | T | ||
This is not a complete list of side effects. For any unexpected effects while taking NTP-Mirtazapine OD Tablets, contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature, 15º - 30ºC. Protect from light and moisture. Use immediately upon opening individual tablet blister.
Keep in a safe place out of the reach of children.
Do not use NTP-MIRTAZAPINE OD TABLETS 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 obtained by contacting the sponsor, Teva Canada Ltd.,
at: 1-800-268-4127 ext. 5005
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9