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What is the most important information I should know about
mirtazapine?
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While you are taking mirtazapine you may need to be monitored for
worsening symptoms of depression and/ or suicidal thoughts at the start
of therapy or when doses are changed. This concern about the increased
risk of suicidal thoughts or behaviors may be greater if you are 18
years of age or younger and are taking mirtazapine. In patients younger
than 18 years, the period of risk may extend beyond start of therapy or
when doses are changed. Your doctor may want you to monitor for the
following symptoms: anxiety, panic attacks, difficulty sleeping,
irritability, hostility, impulsivity, severe restlessness, and mania (mental
and/ or physical hyperactivity). These symptoms may be associated with
the development of worsening symptoms of depression and/ or suicidal
thoughts or actions. Contact your healthcare provider if you develop any
new or worsening mental health symptoms during treatment with
mirtazapine. Do not stop taking mirtazapine. |
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It may be several weeks before you start to feel better. Even when
you start to feel better, do not stop taking mirtazapine without first
talking to your doctor. |
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Contact your doctor if you experience fever, chills, a sore throat,
flu-like symptoms, or sores in the mouth or nose. |
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Use caution when driving, operating machinery, or performing other
hazardous activities. Mirtazapine may cause drowsiness and dizziness. If
you experience drowsiness or dizziness, avoid these activities. |
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Dizziness is likely to occur when you rise from a sitting or lying
position. Rise slowly to prevent dizziness and a possible fall. |
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Avoid the use of alcohol while taking mirtazapine. Alcohol may
increase drowsiness and dizziness. |
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Mirtazapine is available in a regular tablet formulation (Remeron)
that should be swallowed with water. Mirtazapine is also available in a
rapidly-disintegrating formulation (Remeron SolTab) that will
disintegrate rapidly when placed on the tongue and can be swallowed with
or without water. |
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Mirtazapine is in a class of drugs called antidepressants.
Mirtazapine affects chemicals in your brain that may become unbalanced
and cause depression. |
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Mirtazapine is used to relieve symptoms of depression such as
feelings of sadness, worthlessness, or guilt; loss of interest in daily
activities; changes in appetite; tiredness; sleeping too much; insomnia;
and thoughts of death or suicide. |
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Mirtazapine may also be used for purposes other than those listed in
this medication guide. |
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What should I discuss with my healthcare provider before taking
mirtazapine?
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• |
While you are taking mirtazapine you may need to be monitored for
worsening symptoms of depression and/ or suicidal thoughts at the start
of therapy or when doses are changed. This concern about the increased
risk of suicidal thoughts or behaviors may be greater if you are 18
years of age or younger and are taking mirtazapine. In patients younger
than 18 years, the period of risk may extend beyond start of therapy or
when doses are changed. Your doctor may want you to monitor for the
following symptoms: anxiety, panic attacks, difficulty sleeping,
irritability, hostility, impulsivity, severe restlessness, and mania (mental
and/ or physical hyperactivity). These symptoms may be associated with
the development of worsening symptoms of depression and/ or suicidal
thoughts or actions. Contact your healthcare provider if you develop any
new or worsening mental health symptoms during treatment with
mirtazapine. Do not stop taking mirtazapine. |
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Do not take mirtazapine if you are currently taking, or have taken
within the last 14 days, a monoamine oxidase inhibitor such as
isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate). |
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Before taking mirtazapine, tell your doctor if you |
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have a manic-depressive disorder; |
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have high or low blood pressure or heart disease; |
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have had a heart attack in the last 6 weeks; or |
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have epilepsy or seizures. |
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You may not be able to take mirtazapine, or you may require a dosage
adjustment or special monitoring during treatment if you have any of the
conditions listed above. |
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The rapidly-disintegrating formulation of mirtazapine tablets (Remeron
SolTab) contains phenylalanine. People with the disease phenylketonuria
(PKU) need to monitor their intake of this additive. |
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Mirtazapine is in the FDA pregnancy category C. This means that it
is not known whether mirtazapine will harm an unborn baby. Do not take
mirtazapine without first talking to your doctor if you are pregnant or
could become pregnant during treatment. |
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It is not known whether mirtazapine passes into breast milk. Do not
take mirtazapine without first talking to your doctor if you are
breast-feeding a baby. |
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If you are over 60 years of age, you may be more likely to
experience side effects such as drowsiness, dizziness, unsteadiness,
feeling uncoordinated, and low blood pressure. You may require a lower
dose of this medication. |
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How should I take mirtazapine?
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Take mirtazapine exactly as directed by your doctor. If you do not
understand these directions, ask your pharmacist, nurse, or doctor to
explain them to you. |
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• |
Mirtazapine is available in a regular tablet formulation (Remeron)
that should be swallowed with water. Mirtazapine is also available in a
rapidly-disintegrating formulation (Remeron SolTab) that will
disintegrate rapidly when placed on the tongue and can be swallowed with
or without water. |
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If you are taking the mirtazapine rapidly-disintegrating tablets (Remeron
SolTab), open the blister pack with dry hands and use the tablet
immediately after removal from the blister pack. Do not attempt to split
the rapidly-disintegrating tablets. |
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Mirtazapine is usually taken once a day, preferably at bedtime.
Follow your doctor's instructions. |
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It may be several weeks before you start to feel better. Even when
you start to feel better, do not stop taking mirtazapine without first
talking to your doctor. |
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Store mirtazapine at room temperature away from moisture and heat. |
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What happens if I miss a dose?
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Take the missed dose as soon as you remember. However, if it is
almost time for the next dose, skip the missed dose and take only the
next regularly scheduled dose. Do not take a double dose of this
medication unless otherwise directed by your doctor. |
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What happens if I overdose?
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Seek emergency medical attention if an overdose is suspected. |
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Symptoms of a mirtazapine overdose include confusion, drowsiness,
poor memory, and a fast heartbeat. |
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What should I avoid while taking mirtazapine?
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Use caution when driving, operating machinery, or performing other
hazardous activities. Mirtazapine may cause drowsiness and dizziness. If
you experience drowsiness or dizziness, avoid these activities. |
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• |
Dizziness is likely to occur when you rise from a sitting or lying
position. Rise slowly to prevent dizziness and a possible fall. |
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Avoid the use of alcohol while taking mirtazapine. Alcohol may
increase drowsiness and dizziness. |
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What are the possible side effects of mirtazapine?
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If you experience any of the following serious side effects, stop
taking mirtazapine and call your doctor immediately or seek emergency
medical treatment: |
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an allergic reaction (swelling of the lips, face, or tongue;
difficulty breathing); |
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a fast or irregular heartbeat; or |
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fever, chills, a sore throat, flu-like symptoms, or sores in your
mouth or nose. |
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Other, less serious side effects may be more likely to occur.
Continue to take mirtazapine and talk to your doctor if you experience |
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increase in weight or appetite; |
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Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome. |
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What other drugs will affect mirtazapine?
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Do not take mirtazapine if you are currently taking, or have taken
within the last 14 days, a monoamine oxidase inhibitor such as
isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate). |
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Mirtazapine may increase the effects of other drugs that cause
drowsiness, including other antidepressants, alcohol, antihistamines,
sedatives (used to treat insomnia), pain relievers, anxiety medicines,
and muscle relaxants. Tell your doctor about all medicines that you are
taking, and do not take any medicine unless your doctor approves. |
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Drugs other than those listed here may also interact with
mirtazapine. Talk to your doctor and pharmacist before taking any
prescription or over-the-counter medicines, including vitamins, minerals,
and herbal products. |
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Where can I get more information?
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Your pharmacist has additional information about mirtazapine written
for health professionals that you may read. |
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Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed. |
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Every effort has been made to ensure that the information provided
by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
but no guarantee is made to that effect. Drug information contained
herein may be time sensitive. Multum information has been compiled for
use by healthcare practitioners and consumers in the United States and
therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug
information does not endorse drugs, diagnose patients or recommend
therapy. Multum's drug information is an informational resource designed
to assist licensed healthcare practitioners in caring for their patients
and/ or to serve consumers viewing this service as a supplement to, and
not a substitute for, the expertise, skill, knowledge and judgment of
healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug
or drug combination is safe, effective or appropriate for any given
patient. Multum does not assume any responsibility for any aspect of
healthcare administered with the aid of information Multum provides. The
information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist. |
Copyright 1996-2004 Cerner Multum, Inc. Version: 3.02. Revision date: 9/
27/ 04. |