Medication Guide

Mirtazapine Orally Disintegrating Tablets USP

Read the Medication Guide that comes with mirtazapine orally disintegrating 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 orally disintegrating tablets, talk to your healthcare provider.

What is the most important information I should know about mirtazapine orally disintegrating tablets?

Mirtazapine orally disintegrating tablets and other antidepressant medicines may cause serious side effects, including:

1.  Suicidal thoughts or actions:

• Mirtazapine orally disintegrating 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 orally disintegrating tablets is 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
• 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 orally disintegrating 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 or Neuroleptic Malignant Syndrome-like reactions. 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

5.  Seizures

6.  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

7.  Sleepiness. It is best to take mirtazapine orally disintegrating tablets close to bedtime.  

8.  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

9.  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

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

11.  Increased cholesterol and triglyceride levels in your blood

Do not stop mirtazapine orally disintegrating tablets without first talking to your healthcare provider. Stopping mirtazapine orally disintegrating tablets too quickly may cause potentially serious symptoms including:

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

What are mirtazapine orally disintegrating tablets?
Mirtazapine orally disintegrating 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 orally disintegrating tablets treatment.

Who should not take mirtazapine orally disintegrating tablets?
Do not take mirtazapine orally disintegrating tablets if you:

• are allergic to mirtazapine or any of the  ingredients in mirtazapine orally disintegrating tablets. See the end of this Medication Guide for a complete list of ingredients in mirtazapine orally disintegrating tablets.
• 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.
  •   it is recommended that mirtazapine orally disintegrating tablets not be used in combination with an MAOI within 14 days of initiating or discontinuing therapy with an MAOI.
  

People who take mirtazapine orally disintegrating 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 orally disintegrating tablets?

Ask if you are not sure.

Before starting mirtazapine orally disintegrating 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)
  •   Cimetidine or ketoconazole (these drugs can increase your blood level of mirtazapine)
• 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 orally disintegrating tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy

• are breastfeeding or plan to breastfeed. Some mirtazapine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking mirtazapine orally disintegrating tablets

Tell your healthcare provider about all the
medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Mirtazapine orally disintegrating 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 orally disintegrating tablets with your other medicines. Do not start or stop any medicine while taking mirtazapine orally disintegrating tablets without talking to your healthcare provider first.

If you take mirtazapine orally disintegrating tablets, you should not take any other medicines that contain mirtazapine including mirtazapine tablets.

How should I take mirtazapine orally disintegrating tablets?

• Take mirtazapine orally disintegrating tablets exactly as prescribed. Your healthcare provider may need to change the dose of mirtazapine orally disintegrating tablets until it is the right dose for you.
• Take mirtazapine orally disintegrating tablets at the same time each day, preferably in the evening at bedtime.
• Open the tablet blister pack with dry hands and place the tablet whole on the tongue, immediately after removal from the blister pack.
• Mirtazapine orally disintegrating tablets will disintegrate rapidly on the tongue and can be swallowed with saliva. No water is needed for taking it.
• Do not attempt to split the mirtazapine orally disintegrating tablets.
• It is common for antidepressant medicines such as mirtazapine orally disintegrating tablets to take up to a few weeks before you start to feel better. Do not stop taking mirtazapine orally disintegrating tablets if you do not feel results right away.
• Do not stop taking or change the dose of mirtazapine orally disintegrating tablets without first talking to your doctor, even if you feel better.
• Mirtazapine orally disintegrating tablets may be taken with or without food.
• If you miss a dose of mirtazapine orally disintegrating tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of mirtazapine orally disintegrating tablets at the same time.
  •   If you take too much mirtazapine orally disintegrating tablets, call your healthcare provider or poison control center right away, or get emergency treatment.  

What should I avoid while taking mirtazapine orally disintegrating tablets?

• Mirtazapine orally disintegrating tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how mirtazapine orally disintegrating tablets affect you.
• Avoid drinking alcohol or taking diazepam (a medicine used for anxiety, insomnia and seizures, for example) or similar medicines while taking mirtazapine orally disintegrating tablets. If you are uncertain about whether certain medication can be taken with mirtazapine orally disintegrating tablets, please discuss with your doctor.

What are the possible side effects of mirtazapine orally disintegrating tablets?

Mirtazapine orally disintegrating tablets may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about mirtazapine orally disintegrating tablets?"

Common possible side effects in people who take mirtazapine orally disintegrating tablets include:

• sleepiness
• increased appetite, weight gain
• dry mouth
• constipation
• dizziness
• abnormal dreams

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of mirtazapine orally disintegrating tablets. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store mirtazapine orally disintegrating tablets?

• Store mirtazapine orally disintegrating tablets at room temperature 68° to 77°F (20° to 25°C).
• Keep mirtazapine orally disintegrating tablets away from light and moisture.
• Use immediately upon opening individual tablet blister.

Keep mirtazapine orally disintegrating tablets and all medicines out of the reach of children.

General information about mirtazapine orally disintegrating tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mirtazapine orally disintegrating tablets for a condition for which it was not prescribed. Do not give mirtazapine orally disintegrating tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about mirtazapine orally disintegrating tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about mirtazapine orally disintegrating tablets that is written for healthcare professionals.

For more information about mirtazapine orally disintegrating tablets call 1-800-272-5525 or go to www.watson.com.

What are the ingredients in mirtazapine orally disintegrating tablets?
Active ingredient: mirtazapine
Inactive ingredients 15 mg and 30 mg tablets: Aspartame, citric acid anhydrous, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial orange flavor, sodium bicarbonate, hypromellose, povidone, sugar spheres, Eudragit E100.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

Distributed by:
Watson Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: August 2012