Mirtazapine Tablets

What is this medication?

MIRTAZAPINE (mir TAZ a peen) treats depression. It increases the amount of serotonin and norepinephrine in the brain, substances that help regulate mood.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Remeron

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder
• Dehydration
• Glaucoma
• Have had a stroke
• Heart or blood vessel conditions
• Kidney disease
• Liver disease
• Low blood pressure
• Low levels of sodium in the blood
• Low white blood cell levels
• Seizures
• Suicidal thoughts, plans, or attempt
• An unusual or allergic reaction to mirtazapine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking this medication unless your care team tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Levoketoconazole
• Linezolid
• MAOIs, such as Marplan, Nardil, and Parnate
• Methylene blue
• Pimozide
• Some medications for fungal infections, such as ketoconazole, posaconazole, voriconazole
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Benzodiazepines, such as lorazepam
• Cimetidine
• Clarithromycin
• Other medications that cause heart rhythm changes
• Opioids
• Rifampin
• Some medications for depression, anxiety, or other mental health conditions
• Some medication for migraines, such as sumatriptan
• Some medications for seizures, such as carbamazepine or phenytoin
• Stimulant medications for ADHD, weight loss, or staying awake
• Supplements, such as St. John's wort or tryptophan
• Warfarin

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

This medication may worsen depression and cause thoughts of suicide. This can happen at any time but is more common after first starting treatment and after a change in dose. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide. They can help you.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, or sore throat
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Increase in appetite
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.