MEDICATION GUIDE
Atomoxetine (A-toe-MOX-e-teen) Capsules USP
- Read the Medication Guide that comes with atomoxetine capsules 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 atomoxetine capsules.
What is the most important information I should know about atomoxetine capsules?
- The following have been reported with use of atomoxetine capsules:
1. Suicidal thoughts and actions in children and teenagers:
- Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine capsules 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):
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- has bipolar illness (manic-depressive illness)
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- had suicide thoughts or actions before starting atomoxetine capsules
- The chance for suicidal thoughts and actions may be higher:
2. Severe liver damage:
- Atomoxetine 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:
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- itching
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- right upper belly pain
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- dark urine
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- yellow skin or eyes
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- unexplained flu-like symptoms
3. Heart-related problems:
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- sudden death in patients who have heart problems or heart defects
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- stroke and heart attack in adults
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- increased blood pressure and heart rate
- Tell your doctor 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 capsules.
4. New mental (psychiatric) problems in children and teenagers:
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- 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 doctor right away about any new mental symptoms because adjusting or stopping atomoxetine capsules treatment may need to be considered.
What Are Atomoxetine Capsules?
- Atomoxetine capsules are selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
- Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
- Atomoxetine capsules have not been studied in children less than 6 years old.
Who should not take atomoxetine capsules?
- Atomoxetine capsules should not be taken if you or your child:
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- 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).
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- have an eye problem called narrow angle glaucoma
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- are allergic to anything in atomoxetine capsules. See the end of this Medication Guide for a complete list of ingredients.
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- have or have had a rare tumor called pheochromocytoma.
- Atomoxetine capsules may not be right for you or your child. Before starting atomoxetine capsules tell your doctor or your child's doctor about all health conditions (or a family history of) including:
Can atomoxetine capsules be taken with other medicines?
- Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Atomoxetine capsules and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine capsules can be taken with other medicines.
- Especially tell your doctor if you or your child takes:
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- asthma medicines
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- anti-depression medicines including MAOIs
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- blood pressure medicines
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- cold or allergy medicines that contain decongestants
- Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
How should atomoxetine capsules be taken?
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- Take atomoxetine capsules exactly as prescribed. Atomoxetine capsules come in different dose strength capsules. Your doctor may adjust the dose until it is right for you or your child.
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- Do not chew, crush, or open the capsules. Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow atomoxetine capsules whole. A different medicine may need to be prescribed.
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- Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine 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.
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- Atomoxetine capsule can be taken with or without food.
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- Atomoxetine capsule is usually taken once or twice a day. Take atomoxetine capsule at the same time each day to help you remember. If you miss a dose of atomoxetine capsules, take it as soon as you remember that day. If you miss a day of atomoxetine capsules, do not double your dose the next day. Just skip the day you missed.
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- From time to time, your doctor may stop atomoxetine capsules treatment for a while to check ADHD symptoms.
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- Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine capsules. Children should have their height and weight checked often while taking atomoxetine capsules. Atomoxetine capsules treatment may be stopped if a problem is found during these check-ups.
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- If you or your child takes too much atomoxetine capsules or overdoses, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of atomoxetine capsules?
- See “What is the most important information I should know about atomoxetine capsules?” for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.
- Other serious side effects include:
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- serious allergic reactions (call your doctor if you have trouble breathing, see swelling or hives, or experience other allergic reactions)
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- slowing of growth (height and weight) in children
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- problems passing urine including
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- trouble starting or keeping a urine stream
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- cannot fully empty the bladder
- Common side effects in children and teenagers include:
How should I store atomoxetine capsules?
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- Store atomoxetine capsules in a safe place at room temperature, 59°F to 86°F (15°C to 30°C).
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- Keep atomoxetine capsules and all medicines out of the reach of children.
General information about atomoxetine capsules
- Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine capsules for a condition for which it was not prescribed. Do not give atomoxetine capsules to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about atomoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine capsules that was written for healthcare professionals. For more information about atomoxetine capsules, call Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115.
What are the ingredients in atomoxetine capsules?
- Active ingredient: atomoxetine hydrochloride USP.
- Inactive ingredients: pregelatinized starch, gelatin, and titanium dioxide. The capsule shell for atomoxetine capsules USP, 18 mg contains D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide.
- The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contains D&C Red No. 28, FD&C Blue No.1, gelatin, and titanium dioxide.
- The capsule shell for atomoxetine capsules USP, 60 mg contains D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide.
- The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contains D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, and titanium dioxide.
The imprinting ink for atomoxetine capsules USP, 10 mg, 25 mg, 40 mg, 80 mg, and 100 mg has the following components: black iron oxide, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Blue No. 1, FD&C Red No. 40, methanol, propylene glycol, and shellac.
The imprinting ink for atomoxetine capsules USP, 18 mg and 60 mg has the following components: black iron oxide, propylene glycol, potassium hydroxide, strong ammonia solution, and shellac.
All trademarks are the property of their respective owners.
This Medication Guide has been approved by the US Food and Drug Administration.
Medication Guide available at
www.glenmarkpharma-us.com/medguides
Manufactured by:
Glenmark Pharmaceuticals Limited
India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
March 2023