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Mirtazapine Orally Disintegrating Tablets

Generic Name: Mirtazapine Orally Disintegrating Tablets (mihr-TAZZ-uh-peen)
Brand Name: Remeron SolTab

Antidepressants may increase the risk of suicidal thoughts or actions in children and teenagers. The risk may be greater during the first few months that patients take Mirtazapine Orally Disintegrating Tablets. Be sure that the benefits of using Mirtazapine Orally Disintegrating Tablets outweigh the risks. Talk with the patient"s doctor if you have any questions.

Family and caregivers must closely observe patients who take Mirtazapine Orally Disintegrating Tablets. 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.

Mirtazapine Orally Disintegrating Tablets is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Mirtazapine Orally Disintegrating Tablets is a tetracyclic antidepressant. How Mirtazapine Orally Disintegrating Tablets improves depression symptoms is not fully understood. It is thought to increase the activity of certain chemicals in the brain (norepinephrine, serotonin), which help elevate mood.

Do NOT use Mirtazapine Orally Disintegrating Tablets if:

you are allergic to any ingredient in Mirtazapine Orally Disintegrating Tablets
you are taking furazolidone
you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mirtazapine Orally Disintegrating Tablets:

Some medical conditions may interact with Mirtazapine Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver or kidney disease, a low white blood cell count, or phenylketonuria (PKU), or have attempted or thought about suicide

Some MEDICINES MAY INTERACT with Mirtazapine Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin) because they may decrease Mirtazapine Orally Disintegrating Tablets"s effectiveness
Fluvoxamine, furazolidone, or MAOIs (eg, phenelzine) because side effects, such as nausea, dizziness, or seizures, may occur
Fluvoxamine because it may increase the risk of Mirtazapine Orally Disintegrating Tablets"s side effects
Clonidine because it may decrease Mirtazapine Orally Disintegrating Tablets"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mirtazapine Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mirtazapine Orally Disintegrating Tablets:

Use Mirtazapine Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Mirtazapine Orally Disintegrating Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Mirtazapine Orally Disintegrating Tablets refilled.
Take Mirtazapine Orally Disintegrating Tablets by mouth with or without food.
Take Mirtazapine Orally Disintegrating Tablets in the evening before bedtime unless your doctor tells you otherwise.
Do not remove the blister from the outer pouch until you are ready to take Mirtazapine Orally Disintegrating Tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Mirtazapine Orally Disintegrating Tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
Improvement should be noticed within 1 to 4 weeks of taking Mirtazapine Orally Disintegrating Tablets.
Continue to take Mirtazapine Orally Disintegrating Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Mirtazapine Orally Disintegrating Tablets, 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.

Ask your health care provider any questions you may have about how to use Mirtazapine Orally Disintegrating Tablets.

Important safety information:

Mirtazapine Orally Disintegrating Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Mirtazapine Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Children and teenagers who take Mirtazapine Orally Disintegrating Tablets may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Mirtazapine Orally Disintegrating Tablets 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.
Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Mirtazapine Orally Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Mirtazapine Orally Disintegrating Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mirtazapine Orally Disintegrating Tablets while you are pregnant. It is not known if Mirtazapine Orally Disintegrating Tablets is found in breast milk. If you are or will be breast-feeding while you use Mirtazapine Orally Disintegrating Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Mirtazapine Orally Disintegrating Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal dreams; abnormal thinking; constipation; dizziness; drowsiness; dry mouth; flu symptoms; increased appetite; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased ability to fight infection (fever, chills, sore throat); mental or mood changes; mouth sores; seizures; swelling of the legs and feet; thoughts of hurting yourself; tremors; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include agitation; disorientation; drowsiness or deep sleep; fast heartbeat; impaired memory; loss of consciousness; rigid muscles; sluggishness.

Proper storage of Mirtazapine Orally Disintegrating Tablets:

Store Mirtazapine Orally Disintegrating Tablets 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 Mirtazapine Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Mirtazapine Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
Mirtazapine Orally Disintegrating Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Mirtazapine Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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