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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  acting aggressive or violent should know about REMERON®?  thoughts about or dying REMERON and other  new or worse may cause serious side effects,  new or worse or panic including: attacks  feeling agitated, restless, angry or 1. Suicidal thoughts or actions: irritable  REMERON and other  trouble sleeping antidepressant medicines may  an increase in activity or talking increase suicidal thoughts or more than what is normal for you actions in some children,  other unusual changes in behavior teenagers, or young adults within or mood the first few months of treatment or when the dose is changed. Call your healthcare provider right away  Depression or other serious mental if you have any of the following illnesses are the most important symptoms, or call 911 if an emergency. causes of suicidal thoughts or REMERON may be associated with these actions. serious side effects:  Watch for these changes and call 2. Manic episodes: your healthcare provider right away  greatly increased energy if you notice:  severe trouble sleeping o New or sudden changes in  racing thoughts mood, behavior, actions,  reckless behavior thoughts, or feelings, especially  unusually grand ideas if severe.  excessive happiness or o Pay particular attention to such  talking more or faster than usual changes when REMERON is 3. Decreased White Blood Cells called started or when the dose is neutrophils, which are needed to fight changed. infections. Tell your doctor if you have any Keep all follow-up visits with your healthcare indication of infection such as fever, chills, provider and call between visits if you are sore throat, or mouth or nose sores, worried about symptoms. especially symptoms which are flu-like. 4. Syndrome. This condition Call your healthcare provider right away can be life-threatening and may include: if you have any of the following  agitation, hallucinations, coma or symptoms, or call 911 if an emergency, other changes in mental status especially if they are new, worse, or  coordination problems or muscle worry you: twitching (overactive reflexes)  attempts to commit suicide  racing heartbeat, high or low blood  acting on dangerous impulses pressure

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 sweating or fever  anxiety  , , or  fatigue  muscle rigidity  confusion 5. Visual problems   eye pain  shaking  changes in vision  tingling sensation  swelling or redness in or around the  nausea, vomiting eye  sweating Only some people are at risk for these problems. You may want to undergo an eye What is REMERON? examination to see if you are at risk and REMERON is a prescription used receive preventative treatment if you are. to treat depression. It is important to talk 6. Seizures with your healthcare provider about the risks 7. Low salt (sodium) levels in the blood. of treating depression and also the risks of Elderly people may be at greater risk for not treating it. You should discuss all this. Symptoms may include: treatment choices with your healthcare  headache provider.  weakness or feeling unsteady Talk to your healthcare provider if you do  confusion, problems concentrating not think that your condition is getting better or thinking or memory problems with REMERON treatment. 8. Sleepiness. It is best to take REMERON close to bedtime. Who should not take REMERON? 9. Severe skin reactions: Call your doctor Do not take REMERON: right away if you have any or all of the  if you are allergic to mirtazapine or following symptoms: any of the ingredients in REMERON.  severe rash with skin swelling See the end of this Medication (including on the palms of the hands Guide for a complete list of and soles of the feet) ingredients in REMERON.  painful reddening of the skin and/or  if you take a blisters/ulcers on the body or in the inhibitor (MAOI). Ask your mouth healthcare provider or pharmacist if 10. Severe allergic reactions: trouble you are not sure if you take an breathing, swelling of the face, tongue, MAOI, including the antibiotic eyes or mouth .  rash, itchy welts () or blisters,  Do not take an MAOI within 2 weeks alone or with fever or joint pain of stopping REMERON unless 11. Increases in or weight. directed to do so by your physician. Children and adolescents should have  Do not start REMERON if you height and weight monitored during stopped taking an MAOI in the last 2 treatment. weeks unless directed to do so by 12. Increased and your physician. levels in your blood People who take REMERON close in time

to an MAOI may have serious or even Do not stop REMERON without first life-threatening side effects. Get medical talking to your healthcare provider. help right away if you have any of these Stopping REMERON too quickly may cause symptoms: potentially serious symptoms including:  high fever  dizziness  uncontrolled muscle spasms  abnormal dreams  stiff muscles  agitation

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 rapid changes in heart rate or blood prescription and non-prescription medicines, pressure vitamins, and herbal supplements.  confusion REMERON and some medicines may  loss of consciousness (pass out) interact with each other, may not work as well, or may cause serious side effects. What should I tell my healthcare provider Your healthcare provider or pharmacist can before taking REMERON? tell you if it is safe to take REMERON with Ask if you are not sure. your other medicines. Do not start or stop Before starting REMERON, tell your any medicine while taking REMERON healthcare provider if you: without talking to your healthcare provider  Are taking certain drugs such as: first. o used to treat headache If you take REMERON, you should not take o Medicines used to treat mood, any other medicines that contain anxiety, psychotic or thought mirtazapine including REMERONSolTab®. disorders, including ,

, SSRIs, SNRIs, or How should I take REMERON?  Take REMERON exactly as prescribed. o used to treat pain Your healthcare provider may need to o Over-the-counter supplements change the dose of REMERON until it is such as or St. John’s the right dose for you. wort  Take REMERON at the same time each o Phenytoin, , or rifampicin (these drugs can day, preferably in the evening at decrease your blood level of bedtime. REMERON)  Swallow REMERON as directed. o or ketoconazole  It is common for antidepressant (these drugs can increase your medicines such as REMERON to take blood level of REMERON) up to a few weeks before you start to  Have or had: feel better. Do not stop taking o problems REMERON if you do not feel results o problems right away. o heart problems  Do not stop taking or change the dose o seizures or convulsions of REMERON without first talking to o bipolar disorder or your doctor, even if you feel better. o a tendency to get dizzy or faint  REMERON may be taken with or  are pregnant or plan to become without food. pregnant. It is not known if REMERON  If you miss a dose of REMERON, take will harm your unborn baby. Talk to your the missed dose as soon as you healthcare provider about the benefits remember. If it is almost time for the and risks of treating depression during next dose, skip the missed dose and take your next dose at the regular time.  are breastfeeding or plan to breastfeed. Do not take two doses of REMERON at Some REMERON may pass into your the same time. breast milk. Talk to your healthcare  If you take too much REMERON, call provider about the best way to feed your your healthcare provider or poison baby while taking REMERON control center right away, or get emergency treatment. Tell your healthcare provider about all the medicines that you take, including

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What should I avoid while taking  Keep REMERON bottle closed tightly. REMERON?  REMERON can cause sleepiness or Keep REMERON and all medicines out of may affect your ability to make the reach of children. decisions, think clearly, or react quickly. General information about REMERON You should not drive, operate heavy Medicines are sometimes prescribed for machinery, or do other dangerous purposes other than those listed in a activities until you know how REMERON Medication Guide. Do not use REMERON affects you. for a condition for which it was not  Avoid drinking or taking prescribed. Do not give REMERON to other (a medicine used for anxiety, people, even if they have the same and seizures, for example) or condition. It may harm them. similar medicines while taking REMERON. If you are uncertain about This Medication Guide summarizes the whether certain medication can be taken most important information about with REMERON, please discuss with REMERON. If you would like more your doctor. information, talk with your healthcare provider. You may ask your healthcare What are the possible side effects of provider or pharmacist for information about REMERON? REMERON that is written for healthcare REMERON may cause serious side effects, professionals. including all of those described in the For more information about REMERON call section entitled “What is the most important 1-800-526-4099 or go to information I should know about www.REMERON.com. REMERON?” What are the ingredients in REMERON? Common possible side effects in people Active ingredient: mirtazapine who take REMERON include: Inactive ingredients:  sleepiness  15 mg tablets: Starch (corn),  increased appetite, weight gain hydroxypropyl cellulose, magnesium  dry mouth stearate, colloidal silicon dioxide,  lactose, hypromellose, polyethylene  dizziness glycol 8000, titanium dioxide, ferric  abnormal dreams oxide (yellow). Tell your healthcare provider if you have  30 mg tablets: Starch (corn), any side effect that bothers you or that does hydroxypropyl cellulose, magnesium not go away. These are not all the possible stearate, colloidal silicon dioxide, side effects of REMERON. For more lactose, hypromellose, polyethylene information, ask your healthcare provider or glycol 8000, titanium dioxide, ferric pharmacist. oxide (yellow), ferric oxide (red).  45 mg tablets: Starch (corn), CALL YOUR DOCTOR FOR MEDICAL hydroxypropyl cellulose, magnesium ADVICE ABOUT SIDE EFFECTS. YOU stearate, colloidal silicon dioxide, MAY REPORT SIDE EFFECTS TO THE lactose, hypromellose, polyethylene FDA AT 1-800-FDA-1088. glycol 8000, titanium dioxide. How should I store REMERON?  Store REMERON at room temperature This Medication Guide has been approved 25°C (77°F). Storage at 15°C-30°C by the U.S. Food and Drug Administration. (59°F-86°F) is permitted occasionally.  Keep REMERON away from light.

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Manufactured by: N.V. Organon, Oss, The , a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2007, 2009 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved.

Revised: XX/20XX

usmg-mk8246-tb-XXXXXXXX

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