Remeron Tablets

GENERIC NAME: MIRTAZAPINE (mir-TAZ-a-peen)

COMMON USES: This medicine is a tetracyclic antidepressant used to treat depression. It may also be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE by mouth with or without food. TAKE THIS MEDICINE in the evening before bedtime unless your doctor tells you otherwise. Improvement should be noticed within 1 to 4 weeks of taking this medicine. DO NOT SUDDENLY STOP TAKING THIS MEDICINE without checking with your doctor. Side effects may occur. They may include abnormal dreams, numbness or tingling, confusion, dizziness, fatigue, mental or mood changes (eg, agitation, anxiety), headache, nausea, sweating, tremor, or vomiting. IF YOU NEED TO STOP TAKING THIS MEDICINE, your doctor will slowly lower your dose. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. Continue to take this medicine even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.

CAUTIONS: DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. THIS MEDICINE MAY CAUSE DROWSINESS OR DIZZINESS. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. DO NOT drive or perform other possibly unsafe tasks until you know how you react to it. DO NOT DRINK ALCOHOL while you are taking this medicine. Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause these effects. THIS MEDICINE MAY CAUSE DIZZINESS, LIGHTHEADEDNESS, OR FAINTING; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. CHILDREN, TEENAGERS, AND YOUNG ADULTS WHO TAKE THIS MEDICINE MAY BE AT INCREASED RISK FOR SUICIDAL THOUGHTS OR ACTIONS. Watch all patients who take this medicine closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. SEROTONIN SYNDROME is a possibly fatal syndrome that can be caused by this medicine. Your risk may be greater if you take this medicine with certain other medicines (eg, antidepressants, "triptans", MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; irritability; fever; fast or irregular heartbeat; tremor; excessive sweating; rigid muscles; severe headache or dizziness; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms. Use this medicine with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, confusion, or low blood sodium levels. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. If you are or will be breast-feeding while you use this medicine, check with your doctor. Discuss any possible risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include: abnormal dreams; abnormal thinking; constipation; dizziness; drowsiness; dry mouth; flu symptoms; increased appetite; weakness; weight gain. If they continue or are bothersome, check with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: mouth sores; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, trouble sleeping, restlessness, or inability to sit still; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; sluggishness; suicidal thoughts or actions; symptoms of infection (eg, fever, chills, sore throat); tremors; unusual or severe mental or mood changes; worsening of depression. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using this medicine outweigh the risks. Families and caregivers must closely watch patients who take this medicine. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor. DO NOT TAKE THIS MEDICINE if you are taking furazolidone, oxitriptan, tryptophan, or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days. SOME MEDICINES MAY INTERACT with this medicine. TELL YOUR HEALTH CARE PROVIDER if you are taking any other medicines, especially any of the following: fluvoxamine, linezolid, lithium, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin 5-HT1 receptor agonists (eg, sumatriptan), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), St. John's word, tramadol, tricyclic antidepressants (eg, amitriptyline), azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), nefazodone, carbamazepine, phenytoin, rifampin, warfarin, or clonidine. This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines you take. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including if you have liver problems, high cholesterol, kidney problems, heart problems, blood vessel problems, a low white blood cell count, low blood pressure, low blood volume, low blood sodium levels, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of dizziness or fainting, seizures, heart attack, angina (chest pain), stroke, mental or mood problems (eg, depression, bipolar disorder) or suicidal thoughts or behaviors. Tell your doctor if you take medicine to treat high blood pressure or if you are dehydrated. This medicine should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms may include agitation; disorientation; drowsiness or deep sleep; fast heartbeat; impaired memory; loss of consciousness; rigid muscles; sluggishness.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.