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STRATTERA (ATOMOXETINE HCL): MEDICATION GUIDE

Read the Medication Guide that comes with Strattera (Atomoxetine) before you or your child starts 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 doctor about your treatment or your child's treatment with Strattera (Atomoxetine) capsules.

What is the most important information I should know about Strattera (Atomoxetine HCl)?

The following have been reported with use of Strattera (Atomoxetine HCl) capsules:

Suicidal thoughts and actions in children and teenagers:

Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from Strattera (Atomoxetine Hydrochloride) clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager's doctor if your child or teenager (or there is a family history of):

  • has bipolar illness (manic-depressive illness)
  • had suicide thoughts or actions before starting Strattera (Atomoxetine Hydrochloride) capsules

    The chance for suicidal thoughts and actions may be higher:

  • early during Atomoxetine (Strattera) treatment
  • during dose adjustments

    Prevent suicidal thoughts and action in your child or teenager by:

  • paying close attention to your child or teenager's moods, behaviors, thoughts, and feelings during Atomoxetine (Strattera) capsules treatment
  • keeping all follow-up visits with your child or teenager's doctor as scheduled

    Watch for the following signs in your child or teenager during Atomoxetine HCl (Strattera) treatment:

  • agitation
  • anxiety
  • panic attacks
  • irritability
  • trouble sleeping
  • hostility
  • impulsivity
  • aggressiveness
  • restlessness
  • depression
  • mania
  • suicide thoughts

    Call your child or teenager's doctor or other healthcare professional right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

    Severe liver damage:

    Atomoxetine HCl (Strattera) capsules can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:

  • right upper belly pain
  • itching
  • dark urine
  • unexplained flu-like symptoms
  • yellow skin or eyes

    Heart-related problems:

  • stroke and heart attack in adults
  • increased blood pressure and heart rate
  • sudden death in patients who have heart problems or heart defects

    Tell your healthcare provider if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Atomoxetine Hydrochloride (Strattera).

    Your physician should check your blood pressure or your child's blood pressure and heart rate regularly during treatment with Atomoxetine Hydrochloride (Strattera) capsules.

    Call your doctor, pharmacist, or other healthcare professional right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Strattera (Atomoxetine).

    New mental (psychiatric) problems in children and teenagers:

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

    Call your child or teenager's healthcare provider right away about any new mental symptoms because adjusting or stopping Strattera treatment may need to be considered.


    What Is Strattera (Atomoxetine) capsules?

    Strattera (Atomoxetine HCl) is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). This medication may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

    Strattera (Atomoxetine HCl) capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

    This drug has not been studied in children less than 6 years old.


    Who should not take Strattera (Atomoxetine Hydrochloride)?

    This medicine should not be taken if you or your child:

  • have an eye problem called narrow angle glaucoma
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate) and Emsam (selegiline transdermal system).
  • have or have had a rare tumor called pheochromocytoma.
  • are allergic to anything in Strattera (Atomoxetine Hydrochloride) capsules. See the end of this Medication Guide for a complete list of ingredients.

    Atomoxetine (Strattera) may not be right for you or your child. Before starting this medication tell your physician or your child's doctor about all health conditions (or a family history of) including:

  • heart defects, heart problems, irregular heart beat, high blood pressure, or low blood pressure
  • have or had suicide thoughts or actions
  • liver problems
  • mental problems, mania, psychosis, bipolar illness, or depression

    Tell your doctor, pharmacist, or other healthcare professional if you or your child is pregnant, planning to become pregnant, or breastfeeding.


    Can Atomoxetine (Strattera) capsules be taken with other medicines?

    Tell your doctor or pharmacist about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Atomoxetine HCl (Strattera) and some medicines may interact with each other and cause serious side effects. Your healthcare provider will decide whether Atomoxetine HCl (Strattera) capsules can be taken with other medicines.

    Especially tell your physician if you or your child takes:

  • anti-depression medicines including MAOIs
  • asthma medicines
  • cold or allergy medicines that contain decongestants
  • blood pressure medicines

    Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

    Do not start any new medicine while taking Atomoxetine Hydrochloride (Strattera) without talking to your doctor first.


    How should Atomoxetine Hydrochloride (Strattera) capsules be taken?

  • Take Strattera exactly as prescribed. This drug comes in different dose strength capsules. Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or open the capsules. Swallow Strattera (Atomoxetine) capsules whole with water or other liquids. Tell your doctor, pharmacist, or other healthcare professional if you or your child cannot swallow Strattera (Atomoxetine) capsules whole. A different medicine may need to be prescribed.
  • Avoid touching a broken Strattera (Atomoxetine HCl) capsule. Wash hands and surfaces that touched an open Strattera capsule. If any of the powder gets in your eyes or your child's eyes, rinse them with water right away and call your doctor or pharmacist.
  • Strattera (Atomoxetine Hydrochloride) can be taken with or without food.
  • This medicine is usually taken once or twice a day. Take Strattera (Atomoxetine Hydrochloride) capsules at the same time each day to help you remember. If you miss a dose of this medication, take it as soon as you remember that day. If you miss a day of Atomoxetine (Strattera), do not double your dose the next day. Just skip the day you missed.
  • From time to time, your doctor may stop Atomoxetine (Strattera) capsules treatment for a while to check ADHD symptoms.
  • Your doctor, pharmacist, or other healthcare professional may do regular checks of the blood, heart, and blood pressure while taking Atomoxetine HCl (Strattera). Children should have their height and weight checked often while taking Atomoxetine HCl (Strattera) capsules. This drug treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much Atomoxetine Hydrochloride (Strattera) or overdoses, call your doctor or poison control center right away, or get emergency treatment.


    What are possible side effects of Atomoxetine Hydrochloride (Strattera) capsules?

    See "What is the most important information I should know about Strattera?" for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.

    Other serious side effects include:

  • serious allergic reactions (call your doctor if you have trouble breathing, see swelling or hives, or experience other allergic reactions)
  • problems passing urine including
  • slowing of growth (height and weight) in children
  • cannot fully empty the bladder
  • trouble starting or keeping a urine stream

    Common side effects in children and teenagers include:

  • decreased appetite
  • upset stomach
  • nausea or vomiting
  • tiredness
  • dizziness
  • mood swings

    Common side effects in adults include:

  • constipation
  • nausea
  • dry mouth
  • decreased appetite
  • trouble sleeping
  • dizziness
  • sexual side effects
  • problems passing urine
  • menstrual cramps

    Other information for children, teenagers, and adults:

  • Erections that won't go away (priapism) have occurred rarely during treatment with Strattera (Atomoxetine). If you have an erection that lasts more than 4 hours, seek medical help right away. Because of the potential for lasting damage, including the potential inability to have erections, priapism should be evaluated by a healthcare provider immediately.
  • Strattera (Atomoxetine) capsules may affect your ability or your child's ability to drive or operate heavy machinery. Be careful until you know how this medicine affects you or your child.
  • Talk to your doctor or pharmacist if you or your child has side effects that are bothersome or do not go away.

    This is not a complete list of possible side effects. Call your physician for medical advice about side effects.

    You may report side effects to US FDA.


    How should I store Strattera (Atomoxetine HCl)?

  • Store this medication in a safe place at room temperature, 59 to 86°F (15 to 30°C).
  • Keep Strattera (Atomoxetine HCl) capsules and all medicines out of the reach of children.


    General information about Strattera (Atomoxetine Hydrochloride)

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

    This Medication Guide summarizes the most important information about Atomoxetine (Strattera). If you would like more information, talk with your healthcare provider. You can ask your doctor or pharmacist for information about Atomoxetine HCl (Strattera) that was written for healthcare professionals.


    What are the ingredients in Atomoxetine (Strattera) capsules?

    Active ingredient: Atomoxetine Hydrochloride.

    Inactive ingredients: dimethicone, pregelatinized starch, gelatin, FD & C Blue No. 2, sodium lauryl sulfate, synthetic yellow iron oxide, red iron oxide, titanium dioxide, and edible black ink.

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

    Manufactured and distributed by Eli Lilly pharmaceutical company and its divisions.

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