| Specifications | Remeron Tablets medication guide Remeron Tablets medication guide mirtazapine, Remeron Tablets medication guide fda/cder |
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| Specifications | Remeron Tablets medication guide Remeron Tablets medication guide mirtazapine, Remeron Tablets medication guide fda/cder |
| Business section |
| Specifications | Remeron Tablets medication guide Remeron Tablets medication guide mirtazapine, Remeron Tablets medication guide fda/cder |
| Outline | NDA 20415 - Remeron Tablets Package Insert_clean NDA 20415 - REMERON Tablets Medication Guide_clean |
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| Content | Medication Guide REMERON® (rĕm - ĕ – rŏn) (mirtazapine) Tablets Read the Medication Guide that comes with REMERON 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 REMERON, talk to your healthcare provider. What is the most important information I should know about REMERON®? REMERON and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: x REMERON and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. x Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.or actions. x Watch for these changes and call your healthcare provider right away if you notice: x New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. x Pay particular attention to such changes when REMERON is 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: x attempts to commit suicide x acting on dangerous impulses x acting aggressive or violent x thoughts about suicide or dying x new or worse depression x new or worse anxiety or panic attacks x feeling agitated, restless, angry or irritable x trouble sleeping x an increase in activity or talking more than what is normal for you x 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. REMERON may be associated with these serious side effects: 2. Manic episodes: x greatly increased energy x severe trouble sleeping x racing thoughts x reckless behavior x unusually grand ideas x excessive happiness or irritability x 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 or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include: x agitation, hallucinations, coma or other changes in mental status x coordination problems or muscle twitching (overactive reflexes) x racing heartbeat, high or low blood pressure x sweating or fever x nausea, vomiting, or diarrhea x muscle rigidity |
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| Following Datasheets | ucm089809_1 (6 pages) ucm089823_1 (3 pages) UCM094979_1 (4 pages) UCM095018_1 (4 pages) UCM113945 (1 pages) ucm117684 (34 pages) ucm117686 (33 pages) UCM117701 (18 pages) UCM117706 (14 pages) UCM119207 (24 pages) |
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