Atoncy

A small number of children and teenagers 6 years and older who take atomoxetine for attention-deficit hyperactivity disorder (ADHD) may experience worsening of their symptoms, new or worsening mental/mood symptoms, or suicidal thoughts/attempts. Talk with your child's doctor about the risks and benefits of this medication.

Keep all follow-up appointments with your child's doctor so your child's symptoms can be checked regularly. Monitor your child closely every day, especially during the first few months of treatment or after a dose change. Tell the doctor right away if you notice worsening symptoms, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, hallucinations, delusions, impulsive actions, severe restlessness, or very rapid speech).

Read the Medication Guide, and if available, the Instructions for Use provided by your pharmacist before you start using atomoxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication with or without food as directed by your doctor, usually 1 to 2 times a day. The first dose is usually taken when you wake up in the morning. If a second dose is prescribed, take it as directed by your doctor, usually in the late afternoon/early evening. Taking this medication late in the day may cause trouble sleeping (insomnia).

Swallow the capsules whole. Do not crush, chew, or open the capsules. If the capsule is accidentally opened or broken, avoid contact with the powder and wash away any loose powder as soon as possible with water. If the medication gets in your eyes, flush with plenty of water right away and contact your doctor.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, response to treatment, and other drugs you may be taking. Children's dosage is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or take this drug more often than directed.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Stomach upset, nausea, vomiting, constipation, tiredness, loss of appetite/weight loss, dry mouth, dizziness, drowsiness, trouble sleeping, or decrease in sexual ability/desire may occur. In women, menstrual cramps or missed/irregular periods may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To lessen the chance of dizziness, get up slowly from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: difficulty urinating, unusually fast/irregular heartbeat, fainting, numbness/tingling.

Atomoxetine may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, dark urine, stomach/abdominal pain, yellowing eyes/skin.

This medication may rarely cause serious problems such as a heart attack or stroke. Get medical help right away if you experience any of the following: chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, confusion, trouble speaking, sudden vision changes.

Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking atomoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain adrenal gland tumor (pheochromocytoma), bladder or prostate problems, glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), high blood pressure, liver disease, personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), stroke.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If used for a long time, this drug may affect a child's growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child's weight and height regularly, and consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: unusually fast heartbeat, severe headache.

Do not share this medication with others.

Lab and/or medical tests (such as pulse, blood pressure, liver/heart function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If you don't remember until the next day, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Once the bottle is opened, the liquid form expires after 45 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.