Medication Guide

Mirtazapine Tablets, USP

(mer-TAH-zah-peen)

Read the Medication Guide that comes with Mirtazapine Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Mirtazapine Tablets, talk to your healthcare provider.

What is the most important information I should know about Mirtazapine Tablets?

Mirtazapine Tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• Mirtazapine Tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:
  • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when Mirtazapine Tablets are started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Mirtazapine Tablets may be associated with these serious side effects:

2. Manic episodes:

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

3. Decreased White Blood Cells called neutrophils, which are needed to fight infections. Tell your doctor if you have any indication of infection such as fever, chills, sore throat, or mouth or nose sores, especially symptoms which are flu-like.

4. Serotonin Syndrome. This condition can be life-threatening and may include:

• agitation, hallucinations, coma or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity

1. Visual problems

• eye pain
• changes in vision
• 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.

6. Seizures

7. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems

8. Sleepiness. It is best to take Mirtazapine Tablets close to bedtime.

9. Severe skin reactions: Call your doctor right away if you have any or all of the following symptoms:

• severe rash with skin swelling (including on the palms of the hands and soles of the feet)
• painful reddening of the skin and/or blisters/ulcers on the body or in the mouth

10. Severe allergic reactions: trouble breathing, swelling of the face, tongue, eyes or mouth

• rash, itchy welts (hives) or blisters, alone or with fever or joint pain

11. Increases in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

12. Increased cholesterol and triglyceride levels in your blood

Do not stop Mirtazapine Tablets without first talking to your healthcare provider. Stopping Mirtazapine Tablets too quickly may cause potentially serious symptoms including:

• dizziness
• abnormal dreams
• agitation
• anxiety
• fatigue
• confusion
• headache
• shaking
• tingling sensation
• nausea, vomiting
• sweating

What is Mirtazapine Tablets?

Mirtazapine Tablets is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Talk to your healthcare provider if you do not think that your condition is getting better with Mirtazapine Tablets treatment.

Who should not take Mirtazapine Tablets ?

Do not take Mirtazapine Tablets:

• 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.
• if you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
• Do not take an MAOI within 2 weeks of stopping Mirtazapine Tablets unless directed to do so by your physician.
• Do not start Mirtazapine Tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take Mirtazapine Tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

• high fever
• uncontrolled muscle spasms
• stiff muscles
• rapid changes in heart rate or blood pressure
• confusion
• loss of consciousness (pass out)

What should I tell my healthcare provider before taking Mirtazapine Tablets? Ask if you are not sure.

Before starting Mirtazapine Tablets, tell your healthcare provider if you:

• Are taking certain drugs such as:
  • Triptans used to treat migraine headache
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics
  • Tramadol used to treat pain
  • Over-the-counter supplements such as tryptophan or St. John’s wort
  • Phenytoin, carbamazepine, or rifampicin (these drugs can decrease your blood level of Mirtazapine Tablets)
  • Cimetidine or ketoconazole (these drugs can increase your blood level of Mirtazapine Tablets)
• Have or had:
  • liver problems
  • kidney problems
  • heart problems
  • seizures or convulsions
  • bipolar disorder or mania
  • a tendency to get dizzy or faint
  • are pregnant or plan to become pregnant. It is not known if Mirtazapine Tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
  • are breast-feeding or plan to breast-feed. Some Mirtazapine Tablets may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Mirtazapine Tablets.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Mirtazapine Tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take Mirtazapine Tablets with your other medicines. Do not start or stop any medicine while taking Mirtazapine Tablets without talking to your healthcare provider first.