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CYMBALTA- duloxetine hydrochloride capsule, delayed release


  1. Patient Information
  2. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  3. Call A Healthcare Provider Right Away If You Or Your Family Member Has Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You:
  4. What Else Do I Need To Know About Antidepressant Medicines?
  5. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  6. Call A Healthcare Provider Right Away If You Or Your Family Member Has Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You:
  7. What Else Do I Need To Know About Antidepressant Medicines?
  8. Revised: 7/2011document Id:
  9. 1. Suicidal Thoughts Or Actions:
  10. 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:
  11. 2. Liver Damage- Symptoms May Include:
  12. 3. Serotonin Syndrome - This Condition Can Be Life-threatening And May Include:
  13. 4. Abnormal Bleeding:
  14. 5. Severe Skin Reactions:
  15. 6. Manic Episodes:
  16. 10. Problems With Urination Include:
  17. What Is Cymbalta?
  18. Cymbalta Is Also Used To Treat Or Manage:
  19. Do Not Take Cymbalta If You:
  20. People Who Take Cymbalta 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:
  21. Before Starting Cymbalta, Tell Your Healthcare Provider If You:
  22. How Should I Take Cymbalta?
  23. What Should I Avoid While Taking Cymbalta?
  24. Common Possible Side Effects In People Who Take Cymbalta Include:
  25. How Should I Store Cymbalta?
  26. What Are The Ingredients In Cymbalta?
  27. Delayed Release Capsules:

Patient Information 

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member? 

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call A Healthcare Provider Right Away If You Or Your Family Member Has Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You: 

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

What Else Do I Need To Know About Antidepressant Medicines? 

  • Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses.It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines.Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children.Talk to your child's healthcare provider for more information.
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the US Food and Drug Administration for all antidepressants.

Patient Information revised December 4, 2008

PV 7090 AMP

How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member? 

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call A Healthcare Provider Right Away If You Or Your Family Member Has Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You: 

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

What Else Do I Need To Know About Antidepressant Medicines? 

  • Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses.It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines.Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children.Talk to your child's healthcare provider for more information.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the US Food and Drug Administration for all antidepressants.

Patient Information revised December 4, 2008

PV 7090 AMP

PACKAGE LABEL- Cymbalta 20 mg, bottle of 60

NDC 21695-657-60

60 Capsules

PU3235

Cymbalta

Duloxetine HCl DELAYED RELEASE CAPSULES

20 mg

Each capsule contains 22.4 mg of duloxetine hydrochloride equivalent to 20 mg duloxetine.

Rx Only

Cymbalta 20mg

CYMBALTA
duloxetine hydrochloride capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:21695-657(NDC:0002-3235)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Duloxetine hydrochloride(UNII: 9044SC542W) (Duloxetine - UNII:O5TNM5N07U)Duloxetine20 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin(UNII: 2G86QN327L)
Hypromelloses(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)(UNII: 24P2YXD2PW)
Sodium lauryl sulfate(UNII: 368GB5141J)
Sucrose(UNII: C151H8M554)
Talc(UNII: 7SEV7J4R1U)
Titanium dioxide(UNII: 15FIX9V2JP)
Triethyl citrate(UNII: 8Z96QXD6UM)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Colorgreen (opaque green)Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeLILLY;3235;20;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-657-6060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02142708/24/2004
Labeler -Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 7/2011document Id: 

7db112de-473a-4407-bc1c-35d0ab748700Set id: 7db112de-473a-4407-bc1c-35d0ab748700Version: 1Effective Time: 20110722Rebel Distributors Corp

1. Suicidal Thoughts Or Actions: 

  • Cymbalta and other antidepressant medicines may increase suicidal thoughts or actionsin some children, teenagers, or young adults within thefirst few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when Cymbalta 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: 

  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety or panic attacks
  • feeling agitated, restless, angry or irritable
  • trouble sleeping
  • an increase in activity or talking more than what is normal for you
  • other unusual changes in behavior or mood

2. Liver Damage- Symptoms May Include: 

  • itching
  • right upper abdominal pain
  • dark urine
  • hepatitis with yellow skin or eyes
  • enlarged liver
  • increased liver enzymes

3. Serotonin Syndrome - This Condition Can Be Life-threatening And May Include: 

  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
  • dizziness
  • flushing
  • tremor
  • seizures

4. Abnormal Bleeding: 

Cymbalta and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin*, Jantoven*), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Severe Skin Reactions: 

Cymbalta may cause serious skin reactions that may require stopping its use. This may need to be treated in a hospital and may be life-threatening. Call your doctor right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.

6. Manic Episodes: 

  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

7. Seizures or convulsions

8. Changes in blood pressure.Monitor your blood pressure before starting and throughout treatment. Cymbalta may:

  • increase your blood pressure.
  • decrease your blood pressure when standing and cause dizziness or fainting, mostly when first starting Cymbalta or when increasing the dose.

9. Low salt (sodium) levels in the blood.Elderly people may be at greater risk for this. Symptoms may include:

  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems

10. Problems With Urination Include: 

  • decreased urine flow
  • unable to pass any urine

11. Changes in appetite or weight.Children and adolescents should have height and weight monitored during treatment.

Do not stop Cymbalta without first talking to your healthcare provider.Stopping Cymbalta too quickly or changing from another antidepressant too quickly may result in serious symptoms including:

  • anxiety, irritability
  • feeling tired or problems sleeping
  • headache, sweating, dizziness
  • electric shock-like sensations
  • vomiting, nausea, diarrhea

What Is Cymbalta? 

Cymbalta 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.

Cymbalta Is Also Used To Treat Or Manage: 

  • Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder (GAD)
  • Diabetic Peripheral Neuropathic Pain (DPNP)
  • Fibromyalgia (FM)
  • Chronic Musculoskeletal Pain

Talk to your healthcare provider if you do not think that your condition is getting better with Cymbalta treatment.

Do Not Take Cymbalta If You: 

  • have uncontrolled narrow-angle glaucoma
  • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 5 days of stopping Cymbalta unless directed to do so by your physician.
  • Do not start Cymbalta if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People Who Take Cymbalta 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: 

  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
  • take Mellaril* (thioridazine) because this can cause serious heart rhythm problems or sudden death

What should I tell my healthcare provider before taking Cymbalta? Ask if you are not sure.

Before Starting Cymbalta, Tell Your Healthcare Provider If You: 

  • Are taking certain drugs such as:
    • Triptans used to treat migraine headache
    • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs or MAOIs
    • Tramadol and fentanyl
    • Cimetidine
    • The antibiotics ciprofloxacin, enoxacin
    • Medicine to control heart rate such as propafenone, flecainide, quinidine
    • Theophylline
    • The blood thinner warfarin (Coumadin*, Jantoven*)
    • Non-steroidal anti-inflammatory drug (NSAID), like ibuprofen, naproxen or aspirin.
    • Over-the-counter supplements such as tryptophan or St. John's Wort
  • have heart problems or high blood pressure
  • have diabetes (Cymbalta treatment worsens the control of blood sugar in some patients with diabetes)
  • have liver problems
  • have kidney problems
  • have glaucoma
  • have or had seizures or convulsions
  • have bipolar disorder or mania
  • have low sodium levels in your blood
  • have delayed stomach emptying
  • have or had bleeding problems
  • are pregnant or plan to become pregnant. It is not known if Cymbalta will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression or other conditions with Cymbalta during pregnancy. Lilly, the company that markets Cymbalta, maintains a pregnancy registry. The Cymbalta Pregnancy Registry collects information from voluntary participants who are pregnant and who have been exposed to Cymbalta at any time during pregnancy. Women who are interested in enrolling may contact the Registry directly by calling 1-866-814-6975 or by visiting www.cymbaltapregnancyregistry.com
  • are breast-feeding or plan to breast-feed. Some Cymbalta may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Cymbalta.

Tell your healthcare provider about all the medicines that you take,including prescription and non-prescription medicines, vitamins, and herbal supplements. Cymbalta 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 Cymbalta with your other medicines. Do not start or stop any medicine while taking Cymbalta without talking to your healthcare provider first.

If you take Cymbalta, you should not take any other medicines that contain duloxetine.

How Should I Take Cymbalta? 

  • Take Cymbalta exactly as prescribed. Your healthcare provider may need to change the dose of Cymbalta until it is the right dose for you.
  • Do not open, break or chew the capsule; it must be swallowed whole.
  • Cymbalta may be taken with or without food.
  • If you miss a dose of Cymbalta, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cymbalta at the same time.
  • If you take too much Cymbalta, call your healthcare provider or poison control center right away, or get emergency treatment.
  • When switching from another antidepressant to Cymbalta your doctor may want to lower the dose of the initial antidepressant first to potentially avoid side effects.

What Should I Avoid While Taking Cymbalta? 

  • Cymbalta can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Cymbalta affects you.
  • Use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use while taking Cymbalta.

Common Possible Side Effects In People Who Take Cymbalta Include: 

  • nausea
  • dry mouth
  • sleepiness
  • fatigue
  • loss of appetite
  • increased sweating
  • dizziness

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 Cymbalta. 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 Cymbalta? 

Store Cymbalta at room temperature between 59 F and 86 F (15 C to 30 C).

Keep Cymbalta and all medicines out of the reach of children.

General information about Cymbalta

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Cymbalta for a condition for which it was not prescribed. Do not give Cymbalta to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Cymbalta. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Cymbalta that is written for healthcare professionals.

For more information about Cymbalta call 1-800-Lilly Rx (1-800-545-5979) or go to www. Cymbalta.com.

What Are The Ingredients In Cymbalta? 

Active ingredient: duloxetine hydrochloride

Delayed Release Capsules: 

FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.

This Medication Guide has been approved by the U.S. Food and Drug Administration

*The brands listed are trademarks of their respective owners and not trademarks of Eli Lilly and Company.

Medication Guide revised: November 9, 2012

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

www.cymbalta.com

Cymbalta is a registered trademark of Eli Lilly and Company.

Copyright 2009, 2012, Eli Lilly and Company. All rights reserved.

PV 7094 AMP



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