Atomoxetine Hydrochloride Oral capsule

What is this medicine?

ATOMOXETINE (AT oh mox e teen) is used to treat attention deficit/hyperactivity disorder, also known as ADHD. It is not a stimulant like other drugs for ADHD. This drug can improve attention span, concentration, and emotional control. It can also reduce restless or overactive behavior.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• glaucoma

• high or low blood pressure

• history of stroke

• irregular heartbeat or other cardiac disease

• liver disease

• mania or bipolar disorder

• pheochromocytoma

• suicidal thoughts

• an unusual or allergic reaction to atomoxetine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. If you have difficulty sleeping and you take more than 1 dose per day, take your last dose before 6 PM. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dofetilide

• dronedarone

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• pimozide

• reboxetine

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for lung disease like albuterol

• cold or allergy medicines

• fluoxetine

• medicines that increase blood pressure like dopamine, dobutamine, or ephedrine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• paroxetine

• quinidine

• stimulant medicines for attention disorders, weight loss, or to stay awake

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

It may take a week or more for this medicine to take effect. This is why it is very important to continue taking the medicine and not miss any doses. If you have been taking this medicine regularly for some time, do not suddenly stop taking it. Ask your doctor or health care professional for advice.

Rarely, this medicine may increase thoughts of suicide or suicide attempts in children and teenagers. Call your child's health care professional right away if your child or teenager has new or increased thoughts of suicide or has changes in mood or behavior like becoming irritable or anxious. Regularly monitor your child for these behavioral changes.

For males, contact you doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• dark urine

• fast, irregular heartbeat

• general ill feeling or flu-like symptoms

• high blood pressure

• males: prolonged or painful erection

• stomach pain or tenderness

• trouble passing urine or change in the amount of urine

• vomiting

• weight loss

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

• constipation or diarrhea

• headache

• loss of appetite

• menstrual period irregularities

• nausea

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.