Uses of Mirtazapine Tablets:

• It is used to treat low mood (depression).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Mirtazapine Tablets?

• If you are allergic to this medicine (mirtazapine tablets); any part of this medicine (mirtazapine tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Diazepam, linezolid, or methylene blue.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.

This is not a list of all drugs or health problems that interact with this medicine (mirtazapine tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (mirtazapine tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Mirtazapine Tablets?

• Tell all of your health care providers that you take this medicine (mirtazapine tablets). This includes your doctors, nurses, pharmacists, and dentists.
• It may take several weeks to see the full effects.
• Do not stop taking this medicine (mirtazapine tablets) all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine (mirtazapine tablets), you will want to slowly stop it as ordered by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (mirtazapine tablets) affects you.
• Some people may have a higher chance of eye problems with this medicine (mirtazapine tablets). Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
• Low white blood cell counts have rarely happened with this medicine (mirtazapine tablets). This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• An unsafe heartbeat that is not normal (long QT on ECG) has happened with this medicine (mirtazapine tablets). Sudden deaths have rarely happened in people taking this medicine (mirtazapine tablets). Talk with the doctor.
• This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking this medicine (mirtazapine tablets).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 65 or older, use this medicine (mirtazapine tablets) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Mirtazapine Tablets) best taken?

Use this medicine (mirtazapine tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take at bedtime if it causes sleepiness.
• Take with or without food.
• Keep taking this medicine (mirtazapine tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
• Redness or irritation of the palms of hands or soles of feet.
• Flu-like signs.
• Mouth irritation or mouth sores.
• Restlessness.
• Fast or abnormal heartbeat.
• Very bad dizziness or passing out.
• Joint pain.
• A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.

What are some other side effects of Mirtazapine Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Constipation.
• Dry mouth.
• More hungry.
• Weight gain.
• Strange or odd dreams.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Mirtazapine Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (mirtazapine tablets) is refilled. If you have any questions about this medicine (mirtazapine tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.