MEDICATION GUIDE

Mirtazapine Tablets, USP
(mir taz’ a peen)

Medication Guide available at www1.apotex.com/products/us

What is the most important information I should know

about mirtazapine tablets?

Mirtazapine tablets may cause serious side effects, including:

• Increased risk of suicidal thoughts or actions in
some children and young adults. Mirtazapine tablets,
and other antidepressant medicines may increase
suicidal thoughts or actions in some people 24 years of
age and younger, especially within the first few
months of treatment or when the dose is changed.
Mirtazapine tablets are not for use in children.
° Depression or other serious mental illnesses are
the most important causes of suicidal thoughts or

How can I watch for and try to prevent suicidal
thoughts and actions?

° Pay close attention to any changes, especially sudden
changes in mood, behavior, thoughts, or feelings, or if
you develop suicidal thoughts or actions. This is very
important when an antidepressant medicine is started
or when the dose is changed.
° Call your healthcare provider right away to report new
or sudden changes in mood, behavior, thoughts, or
feelings.
° Keep all follow-up visits with your healthcare provider
as scheduled. Call your healthcare provider between
visits as needed, especially if you have concerns
about symptoms.

Call your healthcare provider or get emergency medical
help right away if you or your family member have any
of the following symptoms, especially if they are new,
worse, or worry you:

• attempts to commit suicide
• acting aggressive, being angry or violent
• new or worse depression
• panic attacks
• new or worse irritability
• an extreme increase in activity or talking (mania)
• acting on dangerous impulses
• thoughts about suicide or dying
• new or worse anxiety
• feeling very agitated or restless
• trouble sleeping
• other unusual changes in behavior or mood

What are mirtazapine tablets?

Mirtazapine tablets are prescription medicines used to treat
a certain type of depression called Major Depressive
Disorder (MDD) in adults.
It is not known if mirtazapine tablets are safe and effective
for use to treat MDD in children.

Who should not take mirtazapine tablets? Do not take
mirtazapine tablets if you:
• take a Monoamine Oxidase Inhibitor (MAOI)
• have stopped taking an MAOI in the last 14 days
• are being treated with the antibiotic linezolid or
intravenous methylene blue
• if you are allergic to mirtazapine or any of the ingredients
in mirtazapine tablets. See the end of this Medication
Guide for a complete list of ingredients in mirtazapine
tablets

Ask your healthcare provider or pharmacist if you are not
sure if you take an MAOI, including the antibiotic linezolid or
intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after
you stop treatment with mirtazapine tablets.
Before taking mirtazapine tablets, tell your healthcare
provider about all your medical conditions, including if you:​

• have a history of suicide or depression
• have a history or family history of bipolar disorder, mania
or hypomania
• have a low white blood cell count
• have glaucoma (high pressure in the eye)
• have or had heart problems or stroke
• have an abnormal heart beat called QT prolongation or a
family history of QT prolongation
• have seizures
• have high cholesterol or triglyceride levels
• have low sodium levels in your blood
• have or had kidney or liver problems
• have low blood pressure
• are pregnant or plan to become pregnant. It is not known
if mirtazapine tablets will harm your unborn baby.

• Talk to your healthcare provider if you become pregnant
or think you may be pregnant during treatment with
mirtazapine tablets.
• If you become pregnant while taking mirtazapine tablets,
talk to your healthcare provider about registering with
the National Pregnancy Registry for Antidepressants. You
can register by calling 1-844-405-6185 or visiting online
at http://womensmentalhealth.org/clinical-and-researchprograms/
pregnancyregistry/antidepressants/. The
purpose of this registry is to monitor the pregnancy
outcomes in women who have been treated with
mirtazapine tablets at any time during pregnancy.
• are breastfeeding or plan to breastfeed. Mirtazapine may
pass into your breast milk. Talk to your healthcare
provider about the best way to feed your baby during
treatment with mirtazapine tablets.

Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
Mirtazapine tablets and other medicines may affect each
other causing possible serious side effects.
Mirtazapine tablets may affect the way other medicines
work and other medicines may affect the way mirtazapine
tablets work.

Especially tell your healthcare provider if you take:
• MAOIs
• medicines to treat migraine headaches known as
triptans
• tricyclic antidepressants
• fentanyl
• lithium
• tramadol
• tryptophan
• buspirone
• amphetamines
• benzodiazepines
• St. John’s Wort

• medicines used to treat mood, anxiety, psychotic or
thought disorders, including selective serotonin reuptake
inhibitors (SSRIs) and serotonin norepinephrine reuptake
inhibitors (SNRIs)
• medicines that may affect your heart rhythm (such as
certain antibiotics and some antipsychotics)
Ask your healthcare provider if you are not sure if you are
taking any of these medicines. Your healthcare provider can
tell you if it is safe to take mirtazapine tablets with your
other medicines.

Do not start or stop any other medicines during treatment
with mirtazapine tablets without talking to your healthcare
provider first. Stopping mirtazapine tablets suddenly may
cause you to have serious side effects. See, "What are the
possible side effects of mirtazapine tablets?"
Know the medicines you take. Keep a list of them to show
to your healthcare provider and pharmacist when you get a
new medicine.

How should I take mirtazapine tablets?
• Take mirtazapine tablets exactly as your healthcare
provider tells you to. Do not change your dose or stop
taking mirtazapine tablets without first talking to your
healthcare provider.
• Your healthcare provider may need to change the dose of
mirtazapine tablets until it is the right dose for you
• Take mirtazapine tablets 1 time each day, preferably in
the evening at bedtime
• If you take too much mirtazapine tablets call your
healthcare provider or poison control center at
1-800-222-1222 right away or go to the nearest hospital
emergency room.

What should I avoid while taking mirtazapine tablets?
• Do not drive, operate heavy machinery, or do other
dangerous activities until you know how mirtazapine
tablets affects you. Mirtazapine tablets can cause
sleepiness or may affect your ability to make decisions,
think clearly, or react quickly.
• Avoid drinking alcohol during treatment with mirtazapine
tablets.
• Avoid taking medicines used to treat anxiety, insomnia,
and seizures, called benzodiazepines, during treatment
with mirtazapine tablets. Ask your healthcare provider if
you are not sure if you take one of these medicines.

What are the possible side effects of mirtazapine tablets?
Mirtazapine tablets may cause serious side effects,
including:
• See, "What is the most important information I
should know about mirtazapine?"
• Low white blood cell count. Tell your healthcare
provider right away if you develop any signs or
symptoms of a low white blood cell count, including:
° fever
° sore throat
° flu-like symptoms
° chills
° mouth and nose sores
° infections

• Serotonin syndrome. A potentially
life-threatening problem called serotonin syndrome can
happen when you take mirtazapine tablets with certain
other medicines. See, "Who should not take
mirtazapine tablets?" Stop taking mirtazapine tablets
and call your healthcare provider or go to the nearest
hospital emergency room right away if you have any of
the following signs and symptoms of serotonin
syndrome:

° agitation
° confusion
° fast heart beat
° dizziness
° flushing
° tremors, stiff muscles, or muscle twitching
° seizures
° seeing or hearing things that are not real
(hallucinations)
° coma
° blood pressure changes
° sweating
° high body temperature (hyperthermia)
° loss of coordination nausea,
° vomiting, diarrhea

• Eye problems (angle-closure glaucoma). Mirtazapine
tablets may cause a certain type of eye problem called
angle-closure glaucoma. Call your healthcare provider if
you have eye pain, changes in your vision, or swelling or
redness in or around the eye. Only some people are at
risk for these problems. You may want to undergo an eye
examination to see if you are at risk and receive
preventative treatment if you are.

• Heart rhythm problems.

• Severe skin reaction. Mirtazapine tablets may cause a
severe skin reaction that may include rash, fever, swollen
glands, and other organ involvement such as liver,
kidney, lung and heart. The reaction may sometimes be
fatal. Tell your healthcare provider right away if you
experience any of these signs.
• Increased appetite and weight gain.
• Sleepiness. See, "What should I avoid while taking
mirtazapine tablets?"
• Mania or hypomania (manic episodes) in people who
have a history of bipolar disorder. Symptoms may
include:

° greatly increased energy
° racing thoughts
° unusually grand ideas
° talking more or faster than usual
° severe trouble sleeping
° reckless behavior
° excessive happiness or irritability

• Seizures (convulsions).
• Increased fat levels (cholesterol and triglycerides) in
your blood.
• Low sodium levels in your blood (hyponatremia). Low
sodium levels in your blood may be serious and may
cause death. Elderly people may be at greater risk for
this. Signs and Symptoms of low sodium levels in your
blood may include:
° headache
° memory changes
° weakness and unsteadiness on your feet which can
lead to falls
° difficulty concentrating
° confusion

In severe or more sudden cases, signs and symptoms
include:
° hallucinations (seeing or hearing things that are not
real)
° seizures
° respiratory arrest
° fainting
° coma
° death

• Changes in liver function tests.
• Discontinuation syndrome. Suddenly stopping
mirtazapine tablets may cause you to have serious side
effects. Your healthcare provider may want to decrease
your dose slowly. Symptoms may include:
° dizziness
° irritability and agitation
° anxiety
° sweating
° seizures
° ringing in your ears (tinnitus)
° nausea and vomiting
° problems sleeping
° tiredness
° confusion

° electric shock sensation (paresthesia)
° shaking (tremor)
° headache
° abnormal dreams
° changes in your mood
° hypomania

The most common side effects of mirtazapine tablets
include:
• sleepiness
• increased appetite
• weight gain
• dizziness
These are not all the possible side effects of mirtazapine
tablets.
Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.
How should I store mirtazapine tablets?
• Store mirtazapine tablets at room temperature between
68°F to 77°F (20°C to 25°C).
• Keep mirtazapine tablets away from light and moisture.

Keep mirtazapine tablets, and all medicines out of the
reach of children.
General information about the safe and effective use of
mirtazapine tablets.

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use
mirtazapine tablets for a condition for which it was not
prescribed. Do not give mirtazapine tablets to other people,
even if they have the same symptoms that you have. It may
harm them. You can ask your healthcare provider or
pharmacist for information about mirtazapine tablets that is
written for healthcare professionals.

What are the ingredients in mirtazapine tablets?
Active ingredient: mirtazapine
Inactive ingredients:

15 mg tablets: Croscarmellose sodium, hydroxypropyl
cellulose, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
titanium dioxide and iron oxide yellow.

30 mg tablets: Croscarmellose sodium, hydroxypropyl
cellulose, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
titanium dioxide and iron oxide yellow and iron oxide red.

Distributed By:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141

Manufactured By:
Apotex Inc.
Toronto, Ontario
Canada M9L 1T9

Revised: 02/2024
21495-2