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Medication Guide
Duloxetine Delayed-Release Capsules USP
Read the Medication Guide that comes with duloxetine delayed-release capsules before you start taking them 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. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about duloxetine delayed-
release capsules?
Duloxetine delayed-release capsules and other antidepressant medicines may 1. Suicidal thoughts or actions:
7. Seizures or convulsions
• Duloxetine delayed-release capsules and other antidepressant
8. Changes in blood pressure. Monitor your blood pressure before starting and
medicines may increase suicidal thoughts or actions in some children,
throughout treatment. Duloxetine delayed-release capsules may: teenagers, or young adults within the first few months of treatment or
when the dose is changed.
• decrease your blood pressure when standing and cause dizziness or • Depression or other serious mental illnesses are the most important causes fainting, mostly when first starting duloxetine delayed-release capsules or • Watch for these changes and call your healthcare provider right away if you 9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for
• New or sudden changes in mood, behavior, actions, thoughts, or feelings, • Pay particular attention to such changes when duloxetine delayed-release • confusion, problems concentrating or thinking or memory problems capsules are started or when the dose is changed. 10.Problems with urination include:
Keep all follow-up visits with your healthcare provider and call between visits if you Call your healthcare provider right away if you have any of the following
11.Changes in appetite or weight. Children and adolescents should have height
symptoms, or call 911 if an emergency, especially if they are new, worse, or
worry you:
Do not stop duloxetine delayed-release capsules without first talking to your
healthcare provider. Stopping duloxetine delayed-release capsules too quickly or
changing from another antidepressant too quickly may result in serious symptoms • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • an increase in activity or talking more than what is normal for you • other unusual changes in behavior or mood What are duloxetine delayed-release capsules?
Call your healthcare provider right away if you have any of the following
Duloxetine delayed-release capsules are a prescription medicine used to treat symptoms, or call 911 if an emergency. Duloxetine delayed-release capsules
depression. It is important to talk with your healthcare provider about the risks of may be associated with these serious side effects:
treating depression and also the risks of not treating it. You should discuss all 2. Liver damage- symptoms may include:
treatment choices with your healthcare provider. Duloxetine delayed-release capsules are also used to treat or manage: • Diabetic Peripheral Neuropathic Pain (DPNP) Talk to your healthcare provider if you do not think that your condition is getting better with duloxetine delayed-release capsules treatment. 3. Serotonin Syndrome - This condition can be life-threatening and may
Who should not take duloxetine delayed-release capsules?
include:
Do NOT take duloxetine delayed-release capsules if you: • agitation, hallucinations, coma or other changes in mental status • coordination problems or muscle twitching (overactive reflexes) take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or • racing heartbeat, high or low blood pressure pharmacist if you are not sure if you take an MAOI, including the antibiotic Do not take an MAOI within 5 days of stopping duloxetine delayed-release capsules unless directed to do so by your physician. Do not start duloxetine delayed-release capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. People who take duloxetine delayed-release capsules close in time to an
MAOI may have serious or even life-threatening side effects. Get medical
4. Abnormal bleeding: Duloxetine delayed-release capsules and other
help right away if you have any of these symptoms:
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 • rapid changes in heart rate or blood pressure 5. Severe skin reactions: Duloxetine delayed-release capsules 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 take Mellaril* (thioridazine) because this can cause serious heart rhythm
problems or sudden death
6. Manic episodes:
What should I tell my healthcare provider before taking duloxetine delayed-
release capsules? Ask if you are not sure.
Before starting duloxetine delayed-release capsules , tell your healthcare provider if • Triptans used to treat migraine headache • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs or MAOIs Tell your healthcare provider if you have any side effect that bothers you or that • The antibiotics ciprofloxacin, enoxacin does not go away. These are not all the possible side effects of duloxetine delayed- • Medicine to control heart rate such as propafenone, flecainide, quinidine release capsules. For more information, ask your healthcare provider or • The blood thinner warfarin (Coumadin*, Jantoven*) • Non-steroidal anti-inflammatory drug (NSAID), like ibuprofen, naproxen CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY
REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.
• Over-the-counter supplements such as tryptophan or St. John's Wort How should I store duloxetine delayed-release capsules?
have heart problems or high blood pressure Store duloxetine delayed-release capsules at room temperature between 20° to have diabetes (duloxetine delayed-release capsules treatment worsens the control of blood sugar in some patients with diabetes) Keep duloxetine delayed-release capsules and all medicines out of the reach of
children.
General information about duloxetine delayed-release capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use duloxetine delayed-release capsules for a condition for which it was not prescribed. Do not give duloxetine delayed-release capsules to other people, even if they have the same condition. They may harm them. This Medication Guide summarizes the most important information about are pregnant or plan to become pregnant. It is not known if duloxetine duloxetine delayed-release capsules. If you would like more information, talk with delayed-release capsules will harm your unborn baby. Talk to your your healthcare provider. You may ask your healthcare provider or pharmacist for healthcare provider about the benefits and risks of treating depression or information about duloxetine delayed-release capsules that is written for other conditions with duloxetine delayed-release capsules during For more information about duloxetine delayed-release capsules, call Citron are breast-feeding or plan to breast-feed. Some duloxetine hydrochloride Pharma LLC. at 1-855-5-CITRON (1-855-524-8766).
may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking duloxetine delayed-release capsules. What are the ingredients in duloxetine delayed-release capsules?
Tell your healthcare provider about all the medicines that you take, including
Active ingredient: duloxetine hydrochloride prescription and non-prescription medicines, vitamins, and herbal supplements. Duloxetine delayed-release capsules and some medicines may interact with each • Delayed-Release Capsules: crospovidone, hydroxy propyl cellulose,
other, may not work as well, or may cause serious side effects. hypromellose, hypromellose phthalate, methylene chloride, sugar spheres, Your healthcare provider or pharmacist can tell you if it is safe to take duloxetine talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule delayed-release capsules with your other medicines. Do not start or stop any shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In medicine while taking duloxetine delayed-release capsules without talking to your addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with If you take duloxetine delayed-release capsules, you should not take any other edible ink containing black iron oxide and shellac. This Medication Guide has been approved by the U.S. Food and Drug How should I take duloxetine delayed-release capsules?
Take duloxetine delayed-release capsules exactly as prescribed. Your *The brands listed are trademarks of their respective owners and not trademarks of healthcare provider may need to change the dose of duloxetine delayed release capsules until it is the right dose for you. Do not open, break or chew the capsule; it must be swallowed whole. Duloxetine delayed-release capsules may be taken with or without food. Citron Pharma LLC
If you miss a dose of duloxetine delayed-release capsules, 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 duloxetine delayed-release capsules at the same time. If you take too much duloxetine hydrochloride, call your healthcare provider or poison control center right away, or get emergency treatment. When switching from another antidepressant to duloxetine delayed-release capsules your doctor may want to lower the dose of the initial antidepressant first to potentially avoid side effects. What should I avoid while taking duloxetine delayed-release capsules?
Duloxetine delayed-release capsules 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 duloxetine delayed-release capsules affect you. Use of duloxetine delayed-release capsules concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use while taking duloxetine delayed-release capsules. What are the possible side effects of duloxetine delayed-release capsules?
Duloxetine delayed-release capsules may cause serious side effects, including all
of those described in the section entitled “What is the most important information
I should know about duloxetine delayed-release capsules?”
Common possible side effects in people who take duloxetine delayed-release
capsules include:

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Source: http://www.citronpharma.com/images/products/Duloxetine/Medication_guide.pdf