REMERON- mirtazapine tablet, film coated 
REMERONSOLTAB- mirtazapine tablet, orally disintegrating 
Organon USA Inc.
Reference Label Set Id: 31f48378-27db-424f-a4c5-82584a553c35

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MEDICATION GUIDE
REMERON® (rĕm' - ĕ – rŏn)
(mirtazapine)
tablets, for oral use
REMERONSolTab® (rĕm' - ĕ - rŏn - sŏl' – tăb)
(mirtazapine)
orally disintegrating tablets, for oral use
This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised: 4/2020
What is the most important information I should know about REMERON and REMERONSolTab?
REMERON and REMERONSolTab may cause serious side effects, including:
  • Increased risk of suicidal thoughts or actions in some children and young adults. REMERON, REMERONSolTab, 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. REMERON and REMERONSolTab are not for use in children.
    • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

    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 is REMERON and REMERONSolTab?
REMERON and REMERONSolTab are prescription medicines used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults.
It is not known if REMERON and REMERONSolTab are safe and effective for use to treat MDD in children.
Who should not take REMERON and REMERONSolTab?
Do not take REMERON or REMERONSolTab 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 REMERON or REMERONSolTab. See the end of this Medication Guide for a complete list of ingredients in REMERON and REMERONSolTab.
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 REMERON or REMERONSolTab.
Before taking REMERON or REMERONSolTab, 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
  • have phenylketonuria (PKU). REMERONSolTab contains phenylalanine which is a part of aspartame.
  • are pregnant or plan to become pregnant. It is not known if REMERON and REMERONSolTab will harm your unborn baby.
    • Talk to your healthcare provider if you become pregnant or think you may be pregnant during treatment with REMERON and REMERONSolTab.
    • If you become pregnant while taking REMERON and REMERONSolTab, 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 https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. The purpose of this registry is to monitor the pregnancy outcomes in women who have been treated with REMERON and REMERONSolTab at any time during pregnancy.
  • are breastfeeding or plan to breastfeed. REMERON and REMERONSolTab may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REMERON and REMERONSolTab.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
REMERON and REMERONSolTab and other medicines may affect each other causing possible serious side effects.
REMERON and REMERONSolTab may affect the way other medicines work and other medicines may affect the way REMERON and REMERONSolTab 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 REMERON and REMERONSolTab with your other medicines.
Do not start or stop any other medicines during treatment with REMERON or REMERONSolTab without talking to your healthcare provider first. Stopping REMERON or REMERONSolTab suddenly may cause you to have serious side effects. See, "What are the possible side effects of REMERON and REMERONSolTab?"
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 REMERON or REMERONSolTab?
  • Take REMERON and REMERONSolTab exactly as your healthcare provider tells you to. Do not change your dose or stop taking REMERON or REMERONSolTab without first talking to your healthcare provider.
  • Your healthcare provider may need to change the dose of REMERON or REMERONSolTab until it is the right dose for you.
  • Take REMERON or REMERONSolTab 1 time each day, preferably in the evening at bedtime.
  • If you take too much REMERON or REMERONSolTab call your healthcare provider or poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.
How to take REMERONSolTab:
  • Keep REMERONSolTab in the blister pack until you are ready to take it. REMERONSolTab should be used immediately after opening the blister pack. Do not save it for future use.
  • Use dry hands to open the blister pack.
  • As soon as the blister pack is opened, remove REMERONSolTab right away and place it on the tongue.
  • Place REMERONSolTab on the tongue and allow it to melt (disintegrate). Do not chew, crush, or split REMERONSolTab.
  • REMERONSolTab will disintegrate rapidly on the tongue and can be swallowed with saliva. No water is needed for taking it.
What should I avoid while taking REMERON and REMERONSolTab?
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how REMERON and REMERONSolTab affects you. REMERON and REMERONSolTab can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.
  • Avoid drinking alcohol during treatment with REMERON and REMERONSolTab.
  • Avoid taking medicines used to treat anxiety, insomnia, and seizures, called benzodiazepines, during treatment with REMERON and REMERONSolTab. Ask your healthcare provider if you are not sure if you take one of these medicines.
What are the possible side effects of REMERON and REMERONSolTab?
REMERON and REMERONSolTab may cause serious side effects, including:
  • fever
  • sore throat
  • flu-like symptoms
  • chills
  • mouth or nose sores
  • infections
  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take REMERON or REMERONSolTab with certain other medicines. See, "Who should not take REMERON and REMERONSolTab?" Stop taking REMERON or REMERONSolTab 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). REMERON and REMERONSolTab 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.
  • Increased appetite and weight gain.
  • Sleepiness. See, "What should I avoid while taking REMERON and REMERONSolTab?"
  • 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 REMERON and REMERONSolTab 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 REMERON and REMERONSolTab include:
  • sleepiness
  • increased appetite
  • weight gain
  • dizziness
These are not all the possible side effects of REMERON and REMERONSolTab.
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 REMERON and REMERONSolTab?
  • Store REMERON and REMERONSolTab at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep REMERON and REMERONSolTab away from light and moisture.
Keep REMERON, REMERONSolTab, and all medicines out of the reach of children.
General information about the safe and effective use of REMERON and REMERONSolTab.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REMERON and REMERONSolTab for a condition for which it was not prescribed. Do not give REMERON and REMERONSolTab 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 REMERON and REMERONSolTab that is written for healthcare professionals.
What are the ingredients in REMERON and REMERONSolTab?
Active ingredient: mirtazapine
Inactive ingredients:
REMERON Tablets: Colloidal silicon dioxide anhydrous, corn starch, ferric oxide (yellow), hydroxypropyl cellulose, hypromellose, polyethylene glycol 8000, lactose monohydrate, magnesium stearate, and titanium dioxide. The 30 mg tablets also contain ferric oxide (red).
REMERONSolTab: Aspartame, citric acid anhydrous fine granular, crospovidone, hypromellose, magnesium stearate, mannitol, granular mannitol 2080, microcrystalline cellulose, natural and artificial orange flavor, polymethacrylate (Eudragit E100), povidone, sodium bicarbonate, sugar spheres (made of starch and sucrose).
Distributed by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright © 2020 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved.
For more information about REMERON/REMERONSolTab call 1-800-526-4099.
usmg-mk8246-t-tod-2004r011
Revised: 4/2020
Organon USA Inc.