Consumer Information for: TEVA-ATOMOXETINE

The following have been reported with use of atomoxetine hydrochloride and also with stimulant medications:

1. Suicidal thoughts and actions in children and teenagers

Some children and teenagers may have a higher chance of having suicidal thoughts or actions. 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 suicidal thoughts or actions before starting TEVA-ATOMOXETINE.

The chance for suicidal thoughts and actions are higher:

• early during TEVA-ATOMOXETINE 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 TEVA-ATOMOXETINE 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 TEVA-ATOMOXETINE treatment:

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

Call your child or teenager’s doctor 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.

Should any of the above signs also happen to you while taking TEVA-ATOMOXETINE, it is important that you talk to your doctor about how you are feeling.

2. Severe liver damage

Call your doctor right away if you or your child have the following signs of liver problems:

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

3. Heart-related problems:

• sudden death in patients who have heart problems or heart defects as well as in patients without pre-existing cardiac disease.
• stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor may wish to check you or your child carefully for heart problems before starting TEVA-ATOMOXETINE.

Your doctor may wish to check you or your child’s blood pressure and heart rate regularly during treatment with TEVA-ATOMOXETINE.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, irregular heart rate, palpitations, shortness of breath, dizziness or fainting while taking TEVA-ATOMOXETINE.

4. New mental (psychiatric) problems in children and teenagers:

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

Call your child or teenager’s doctor right away about any new mental symptoms. TEVA-ATOMOXETINE treatment may be stopped.

BEFORE you use TEVA-ATOMOXETINE, talk to your doctor or pharmacist if you or] your child:

• have or had suicidal thoughts or actions
• have structural heart abnormalities,
• inborn, acquired or family history of long QT interval
• have mental problems, including psychosis, mania, bipolar illness, or depression;
• have had seizures (convulsions, epilepsy) or abnormal EEGs (electroencephalograms);
• have or had any disorder of the blood vessels in the brain (e.g. aneurysm, stroke, vasculitis);
• have a family history of sudden death or death related to heart problems;
• do strenuous exercise;
• take other drugs for ADHD;
• have or had liver problems. You may need a lower dose;
• have mild high blood pressure. TEVAATOMOXETINE can increase blood pressure;
• have problems with your heart or an irregular heartbeat. TEVA-ATOMOXETINE can increase heart rate (pulse);
• have low blood pressure. TEVAATOMOXETINE can cause dizziness or fainting in people with low blood pressure
• are nursing, pregnant, or thinking of becoming pregnant.
• have circulation problems in fingers and toes, including numbness; feeling cold or pain (Raynaud’s Phenomenon).

Do not drive a car or operate hazardous machinery until you know how TEVAATOMOXETINE affects you. This medicine was prescribed for your use only. Do not let anyone else take your TEVAATOMOXETINE.