MIRTAZAPINE- mirtazapine tablet, orally disintegrating 
Teva Pharmaceuticals USA Inc

----------

MEDICATION GUIDE

Mirtazapine (mer-TAZE-uh-peen) Orally Disintegrating Tablets USP

Read the Medication Guide that comes with mirtazapine orally disintegrating tablets before you start taking them 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 actionsin some children, teenagers, or young adults within thefirst 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 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 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. 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. 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 orally disintegrating 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 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 are 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 tablet 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.
if you take an 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 orally disintegrating tablets unless directed to do so by your physician.
Do not start mirtazapine orally disintegrating tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

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 them.
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 many 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 at 20º to 25ºC (68º to 77ºF).
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 they were not prescribed. Do not give mirtazapine orally disintegrating tablets to other people, even if they have the same condition. They 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 1-888-838-2872.

What are the ingredients in mirtazapine  orally disintegrating tablets?

Active ingredient: mirtazapine, USP

Inactive ingredients: aspartame, corn dextrin, crospovidone, eudragit E100, FD&C yellow # 6, magnesium stearate, mannitol, modified corn starch, natural flavor, silicon dioxide, tapioca dextrin, and xylitol.

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

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. K 7/2014

Revised: 09/2014
 
Teva Pharmaceuticals USA Inc