GD Mirtazapine OD - Consumer Medicine Information
|Condition:||Depression, Major Depressive Disorder|
|Class:||Antidepressants, Tetracyclic antidepressants|
|Ingredients:||mirtazapine, crospovidone, mannitol, cellulose microcrystalline, aspartame (contains phenylalanine), colloidal anhydrous silica, magnesium stearate, strawberry flavor, peppermint flavor|
(Mirtazapine orally disintegrating tablets 15 mg, 30 mg & 45 mg)
About This Medication
What the Medication is Used For
GD-mirtazapine OD belongs to a group of medicines known as antidepressants.
GD-mirtazapine OD has been prescribed to you to relieve the symptoms of depression. Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.
What it Does
The way GD-mirtazapine OD works to treat depression is unknown. GD-mirtazapine OD is thought to have an effect in the brain on chemicals called serotonin and norepinephrine.
When it Should not Be Used
Do not use GD-mirtazapine OD tablets if you are:
- allergic to it or any of the components (see section: What the nonmedicinal ingredients are);
- currently taking or have recently taken monoamine oxidase (MAO) inhibitors (including some types of anti-depressants and anti-Parkinson treatments) See section – INTERACTIONS WITH THIS MEDICATION
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Crospovidone, mannitol, cellulose microcrystalline, aspartame (contains phenylalanine), colloidal anhydrous silica, magnesium stearate, strawberry flavor and peppermint flavor.
What Dosage Forms it Comes In
Orally disintegrating tablets 15 mg, 30 mg and 45 mg
Warnings and Precautions
During treatment with these types of medications, it is important that you and your doctor have good ongoing communication about how you are feeling.
GD-MIRTAZAPINE OD is not for use in children under 18 years of age.
New or Worsened Emotional or Behavioural Problems
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 those in your care if you are a caregiver or guardian, consult your doctor immediately; Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.
BEFORE you use GD-mirtazapine OD, 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 enlarged prostate; psychiatric diseases such as schizophrenia and bipolar disorder (alternating periods of elation/overactivity and depressed mood).
- about any medications (prescription or non-prescription) which you are taking (refer to the next section for specific interactions with GD-mirtazapine OD).
- 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
- if you have been told by your doctor that you have an intolerance to some sugars
GD-mirtazapine OD contains a source of phenylalanine. It may be harmful for people with phenylketonuria.
GD-mirtazapine OD is not for use in children under 18 years of age.
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.
Contact your physician before stopping or reducing your dosage of GD-mirtazapine OD. 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 GD-mirtazapine OD. Such symptoms may also occur if a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of GD-mirtazapine OD to alleviate the symptoms.
Effects on Pregnancy and Newborns
Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressants, such as GD-mirtazapine OD 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 or nursing and taking an SSRI or other newer anti-depressants, such as GD-mirtazapine OD, 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. See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM section.
Interactions With This Medication
Do not use GD-mirtazapine OD if you are taking or have recently taken monoamine oxidase inhibitors (e.g., phenelzine, moclobemide, tranylcypromine, selegeline, linezolid, methylene blue), thioridazine, or pimozide.
You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:
- other antidepressants, such as SSRIs, venlafaxine and certain tricyclics
- other drugs that affect serotonin such as tryptophan, triptans, lithium, tramadol, St. John's Wort
- ketoconazole(medicine for treating fungal infections)
- cimetidine (used to treat reflux and stomach ulcers)
- erythromycin [used to treat bacterial infections (antibiotic)]
- drugs used to treat Human Immunodeficiency Virus (HIV), such as a combination of fosamprenavir and ritonavir
- nefazodone (used to treat depression)
- certain drugs used to treat epilepsy, such as carbamazepine and phenytoin
- rifampicin (used to treat tuberculosis)
- warfarin (used to prevent blood clotting)
- benzodiazepines (e.g., midazolam, oxazepam and diazepam) as GD-mirtazapine OD may add to the sedative effects of these agents.
Avoid alcoholic drinks while taking GD-mirtazapine OD.
Proper Use of This Medication
It is very important that you take GD-mirtazapine OD tablets exactly as your doctor has instructed. Generally, most people take between 15 mg and 45 mg per day.
How to take GD-MIRTAZAPINE OD:
- Never increase or decrease the amount of GD-mirtazapine OD tablets you, or those in your care if you are a care giver 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 GDmirtazapineOD tablets.
- 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.
- 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.
The tablet(s) should be taken as follows:
- In order to prevent crushing the tablet, do not push against tablet pocket (Figure A)
- Each strip contains six tablet pockets, which are separated by perforations. Bend the strip as indicated. Tear off one tablet pocket along the dotted lines (Figure 1).
- Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3).
- Take out the tablet (make sure hands are dry) and place it on the tongue (Figure 4). The tablet will rapidly disintegrate and can be swallowed with or without water.
- The tablet should be used immediately after removal from its blister; once removed, it cannot be stored.
- Do not attempt to split the tablet.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
- If you have taken a large number of pills 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.
Do not take a double dose to make up for forgotten doses. 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.
Side Effects And What to Do About Them
Like other medications, GD-mirtazapine OD can cause some side effects. You may not experience any of them. For most patients, side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.
- You may experience some side effects such as increase in appetite, swollen ankles or feet, occasional dizziness or faintness (especially when you get up quickly from a lying or sitting position), nausea and headache.
- In rare cases other effects may include rash, abnormal sensation in the skin (e.g., burning, stinging, tickling or tingly) involuntary trembling of muscles (tremor), dry mouth, tiredness.
- In very rare cases, other effects may include abnormal sensations in the mouth, sensations of numbness in the mouth and swelling in the mouth.
In very rare cases, other effects may include abnormal sensations in the mouth, sensations of numbness in the mouth and swelling in the mouth.
Decrease in White Blood Cells
If you experience signs of infection such as sudden unexplainable high fever, chills, sore throat and mouth or nose sores, tell your doctor right away. In rare cases, GD-mirtazapine OD can cause a decrease in white blood cells, which are needed to fight infection.
New or Worsened Emotional or Behavioural Problems
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. Your doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own. See also the WARNINGS AND PRECAUTIONS section.
Contact your doctor before stopping or reducing your dosage of GD-mirtazapine OD. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating and other symptoms have been reported after stopping GD-mirtazapine OD. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of GD-mirtazapine OD to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section for more information.
Effects on Newborns
Some newborns whose mothers took an SSRI or other newer antidepressants during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can. See WARNING AND PRECAUTIONS section for more information.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your|
|Common||Drowsiness which can lead to|
Generally occurring during
the first few weeks of
|Rare||Bruising and/or unusual|
bleeding and symptoms of
infection such as sudden high
fever, sore throat,
mouth ulcers, severe
digestive system disturbances
or other signs of infection
(symptoms of blood cell
|Convulsions (loss of|
agitation or confusion.
visions or sounds)
|Mania (feeling elated or|
Emotionally 'high' )
|Akathisia (Feeling restless|
and unable to stand still)
|Restless legs (feeling of|
unrest during night mainly
located in the legs ombined
with sudden muscle
contractions in the legs)
|Pain in the joints or muscles||✓|
|Jaundice (yellowing of|
eyes or skin; dark urine)
|Symptoms of depression|
(anxiety and disturbed sleep)
|Severe skin reactions such as|
(fever, rash, swollen lymph
nodes, hives, sore mouth,
sore eyes or swelling of lips
|Low sodium levels in blood|
(feeling ill with symptoms of
confusion, combined with
achy, stiff or uncoordinated
|A combination of symptoms|
such as unexplainable fever,
sweating, increased heart
reflexes, restlessness, mood
changes and unconsciousness
(can be signs of serotonin
|New or worsened emotional|
or behavioural problems
This is not a complete list of side effects. For any unexpected effects while taking GD-mirtazapine OD tablets, contact your doctor or pharmacist.
How to Store It
- Store at room temperature (15 to 30°C) in a dry place. Protect from light. Use immediately upon opening individual tablet blister.
- Keep GD-mirtazapine OD tablets out of the reach and sight of children.
- Do not use GD-mirtazapine OD tablets after the expiry date indicated on the package.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with 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
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full Product Monograph, prepared for health professionals can be found at:
or by contacting the sponsor, GenMed, a division of Pfizer Canda Inc., at: