Atomoxetine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat attention deficit hyperactivity disorder (ADHD). Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: selective norepinephrine reuptake inhibitor (SNRI)

Generic and brand names: atomoxetine, oral; Strattera

What is this medicine used for?

This medicine is taken by mouth to treat attention deficit hyperactivity disorder (ADHD) in children over 6 years of age and adults.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA) or blood vessel disease
• Glaucoma
• Heart problems such as angina, irregular heartbeat, or heart failure
• High or low blood pressure
• Liver or kidney disease
• Mental health problems such as depression, bipolar disorder, or other mental problems
• Pheochromocytoma (a tumor of the adrenal gland)
• Trouble urinating or an enlarged prostate gland

Tell your healthcare provider if anyone in your family has ever had heart problems or suicidal thoughts, bipolar disorder, or depression.

Do NOT take this drug if you are taking a MAO inhibitor or have taken one within the last 14 days.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 6.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Swallow the capsules whole. Do not chew, break, or crush the capsules.

If a capsule breaks, do not touch the powder. Wash your hands if you touch a broken capsule. If any of the powder gets in your eyes or your child’s eyes, rinse them with water right away and call your healthcare provider.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, dizziness, restlessness, tremors, hyperactivity, unusual behavior, blurred vision, dry mouth, fast heartbeat, seizures.

What should I watch out for?

This medicine may increase thoughts of suicide or suicide attempts in children and teens. Call your child's healthcare provider right away if your child or teen has:

• New or increased thoughts of suicide
• Changes in mood or behavior such as becoming irritable or anxious

When taken for a long time, this medicine may interfere with the growth of children. Talk to your healthcare provider about this.

You will need to have regular checkups to see how this medicine affects you. Keep all appointments. Call your healthcare provider right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking this medicine.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If you have an erection lasting more than 4 hours, get medical care right away. It can lead to permanent erectile dysfunction if not treated.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; seizures.

Serious (Report these to your healthcare provider right away.): Chest pain; irregular or fast heartbeat; trouble breathing; yellowing of eyes or skin; light-colored bowel movements; dark urine; severe stomach pain; severe nauseas or vomiting; severe itching; unusual or ongoing muscle pain, tenderness, or weakness, especially if you also have a fever or unusual tiredness; severe lightheadedness or fainting; trouble urinating; restlessness; anxiety; new or increased thoughts of suicide; unusual mood or behavior changes; confusion; hallucinations.

Other: Nausea, vomiting, mild dizziness, constipation, dry mouth, loss of appetite, weight loss, trouble sleeping, change in sexual ability or desire, stomach pain, headache, hot flashes, mild mood swings, dry eyes, tiredness, drowsiness, changes in menstrual cycle.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Abiraterone (Zytiga)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), and terazosin
• Antidepressants such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), and nortriptyline (Pamelor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton) and diphenhydramine (Benadryl)
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), and thioridazine
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cinacalcet (Sensipar)
• Clobazam (Onfi)
• Diet pills such as diethylpropion (Tenuate), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Ephedrine, epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen), phenylephrine (Neo-Synephrine, Sudafed PE), or pseudoephedrine (Sudafed)
• Linezolid (Zyvox)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), aminophylline, arformoterol (Brovana), fluticasone/salmeterol (Advair), formoterol (Perforomist), metaproterenol, mometasone/formoterol (Dulera), salmeterol (Serevent), terbutaline, and theophylline
• Natural remedies such as gotu kola, kava, SAMe, St. John's wort, tryptophan, and valerian
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Peginterferon alfa-2b (Sylatron)
• Procarbazine (Matulane)
• Quinidine
• Rasagiline (Azilect)
• Ritonavir (Norvir)
• Stimulants such as amphetamine/dextroamphetamine (Adderall), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Tedizolid (Sivextro)
• Terbinafine (Lamisil)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.