MIRTAZAPINE- mirtazapine tablet, orally disintegrating
Watson Laboratories, Inc.
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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:
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:
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:
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:
5. Seizures
6. Low salt (sodium) levels in the blood.
Elderly people may be at greater risk for this. Symptoms may include:
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:
9. Severe allergic reactions: trouble breathing, swelling of the face, tongue, eyes or mouth
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:
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:
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:
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 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?
What should I avoid while taking mirtazapine orally disintegrating tablets?
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:
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?
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