When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to mirtazapine.

How to Use This Medicine:
Tablet, Dissolving Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Your doctor may tell you to take this medicine at bedtime, because it can make you sleepy.
• You may need to take this medicine for several weeks before you begin to feel better.
• Make sure your hands are dry before you handle the disintegrating tablet. Peel back the foil from the blister pack, then remove the tablet. Do not push the tablet through the foil. Place the tablet in your mouth. After it has melted, swallow or take a drink of water. Do not crush, split, or break the tablet.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the orally disintegrating tablet in the original package until you are ready to take it.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine and an MAO inhibitor within 14 days of each other.
• Some medicines can affect how mirtazapine works. Tell your doctor if you are using any of the following:
  
  • Buspirone, carbamazepine, cimetidine, diazepam, fentanyl, lithium, nefazodone, phenytoin, rifampicin, St John's wort, tramadol, or tryptophan
  • Other medicine to treat depression, a triptan medicine to treat migraine headaches, medicine to treat an infection, medicine to treat HIV, or a blood thinner (such as warfarin)
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, glaucoma, high cholesterol, heart or blood vessel disease, or a history of seizures, heart attack, or stroke. Tell your doctor if you have phenylketonuria.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  
  • Serotonin syndrome (may be life-threatening)
  • Decreased white blood cells, which can affect your body's ability to fight an infection
  • Low sodium levels in the blood
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Eye pain, vision changes, seeing halos around lights
• Confusion, weakness, muscle twitching
• Feeling more excited or energetic than usual
• Fever, chills, cough, sore throat, body aches
• Thoughts of hurting yourself or others, worsening depression, unusual behaviors

If you notice these less serious side effects, talk with your doctor:

• Dry mouth, constipation
• Increased appetite or weight gain
• Sleepiness, tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088