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Information For Patients About CYMBALTA ;duloxetine hydrochloride) Deiayed-Release Capsules Please read this information carefully before you start taking Cymbalta (sim-BALL-tah) and each time your prescription is refilled in case anything has changed or new information has become available. This information is not meant to take the place of discussions with your healthcare provider. Talk with your healthcare provider or pharmacist if there is something you do not understand or if you want to leam more about Cymbalta. Always follow your healthcare provider's instructions for taking Cymbalta. Warning: In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with depression and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidal thinking or behavior with antidepressants in adults older than 24; there was a reduction in risk with antidepressants in adults 65 and older. Suicide is a known risk of depression and some other psychiatric disorders. All patients starting antidepressant therapy should be monitored appropriately and observed closely. Families and caregivers should discuss with the healthcare provider right away any observations of worsening depression symptoms, suicidal thinking and behavior, or unusual changes in behavior. Cymbalta is not approved for use in patients under age 18. What is Cymbalta? Cymbalta is a prescription medicine that is approved to treat multiple conditions. Cymbalta is approved for the treatment of major depressive disorder (MOD) also called depression, generalized anxiety disorder (GAD), and for the management of diabetic peripheral neuropathic pain (DPNP) also called diabetic nerve pain. What is depression? Depression is a serious medical condition with a variety of symptoms. Symptoms may include sadness, loss of interest in things you once enjoyed, feelings of guilt or worthlessness, restlessness, trouble concentrating or making decisions, fatigue, vague aches and pains, headaches, and changes in weight or sleep patterns. For some, depression can include thoughts of death or suicide. These could be depression symptoms if they go on for two weeks or more and interfere with your daily activities. How does Cymbalta work? Although the way Cymbalta works in people is not fully known, it is believed to increase the activity of 2 chemicals in the brain, called serotonin and norepinephrine. In the brain, these 2 chemicals are thought to affect mood. These same chemicals are thought to be associated with regulating and reducing feelings of pain that come from the body. When will Cymbalta begin to work? In clinical studies, many people taking Cymbalta began to feel improvement in their symptoms as early as 1 to 4 weeks after starting Cymbalta. As with any treatment, results may vary from person to person. Who should NOT take Cymbalta? You should not take Cymbalta if: • You are allergic to duloxetine hydrochloride or the other ingredients in Cymbalta. • You are taking a type of antidepressant known as a monoamine oxidase inhibitor (MAOI), such as Nardil" (phenelzine sulfate), Parnate' (tranylcypromine sulfate) or Emsam' (selegiline transdermal system). Using an MAOI with many prescription medicines, including Cymbalta, can cause serious or even life threatening reactions You must wait at least 14 days after you have stopped taking an MAOI before you take Cymbalta. You need to wait at least 5 days after you stop taking Cymbalta before you take an MAOI. • You have uncontrolled narrow-angle glaucoma (an eye disease). • You are taking an antipsychotic medicine known as Mellaril' (thioridazine). What should I talk to my healthcare provider about? Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or whenever there is a change in dose. Tell your healthcare provider: • About any medical conditions you may have, including liver or kidney problems or glaucoma. • If you are taking or plan to take any prescription or nonprescription medicines, as Cymbalta may interact with some of these products. • If you take medications known as triptans, commonly prescribed for migraines. A potentially life-threatening condition may occur when triptans are used with Cymbalta. • About your alcohol consumption. • If you are pregnant, plan to become pregnant or are nursing. In clinical studies, some people taking Cymbalta experienced an increase in blood pressure. Your healthcare provider may periodically check your blood pressure. Dizziness or fainting may occur upon standing, due to a sudden drop in blood pressure. This may happen especially when first starting Cymbalta, when increasing the dose, or when used in combination with certain other drugs. How should I take Cymbalta? • Take Cymbalta exactly as directed by your healthcare provider. • Cymbalta should be taken by mouth. Do not open, break or chew the capsule; it must be swallowed whole. • Cymbalta can be taken with or without food. • If you miss a dose, take it as soon as you remember However, if it is time for your next dose, skip the missed dose and take only your regularly scheduled dose. Do not take more than the daily amount of Cymbalta that has been prescribed for you. • Remember to refill your prescription before you run out of Cymbalta. • Talk with your healthcare provider before stopping Cymbalta or changing your dose. What are the possible side effects of Cymbalta? Like all medicines, Cymbalta can cause side effects. • In clinical studies of depression, the most common side effect was nausea. For most people who had it, the nausea was mild to moderate and usually went away within 1-2 weeks. • Other common side effects included dry mouth, constipation, fatigue, decreased appetite, sleepiness, and increased sweating. This is not a complete list of side effects. For full patient information, visit www.cvmbalta.com Talk to your healthcare provider if you have questions or develop any side effects. What should I do if I think I have taken an overdose of Cymbalta? If you have taken more Cymbalta than has been prescribed for you, contact your healthcare provider, a hospital emergency department, or the nearest poison control center immediately. What happens when I stop taking Cymbalta? Like other antidepressants, Cymbalta should not be stopped suddenly. Stopping Cymbalta suddenly may result in symptoms including dizziness, nausea, or headache. Talk with your healthcare provider before stopping Cymbalta as he or she may wish to decrease the dose slowly to help you avoid these kinds of symptoms. Can children take Cymbalta? Cymbalta has not been studied in children under 18 and is not approved for this age group. See Boxed Warning above. General advice about Cymbalta • Store Cymbalta at room temperature and out of the reach of children. • Until you know how Cymbalta affects you, be careful when driving a car, or operating hazardous machinery. • Medicines are sometimes prescribed for purposes other than the ones listed. This medication has been prescribed for your particular condition. Do not use it for another condition or give this drug to anyone else. • If you have any questions or concerns, want to report any problems with the use of Cymbalta, or want more information, contact your healthcare provider or pharmacist. Additional information can be found at www.cymbalta.com. Eli Lilly and Company Lilly Corporate Center Indianapolis, IN - USA Mellaril, Nardil. Parnate, and Emsam are registered trade marks of their manufacturers. DD49130 © 2007 Eli Lilly and Company. All rights reserved. Cymbalta is a registered trademark of Eli Lilly and Company. Exclusive boob from USA WEEKEND Eat Smart EXTRA! ISSJr mrirttioui H Ijt Order today, ■ and soon 1 you’ll be cooking I those easy, nutritious meals that made Jean Carper famous. USA WEEKEND has selected the very best of Jean’s Eat Smart recipes. Available only at usaweekehd.com 99 great recipes for $9."! Plus shipping & handling Puzzle books by Stkkels Are you a Frame Games or Stickdoku fan? Millions can’t wait for their weekly fix of the popular USA WEEKEND puzzles. Now you don’t have to! Simply order your copies of these books today, and you’ll be 10 USA WEEKEND • Dec. 28-30,2007