*Product Note: This product is very limited on quantity

ADDERALL 30mg Tablets (available from Shire Pharma & Teva Pharma)

Patient Education - English

• Generic Name: amphetamine and dextroamphetamine

• Pronounced: am FET a meen and DEX troe am FET a meen

• Brand Names: Adderall, Adderall XR

What is the most important information I should know about amphetamine and dextroamphetamine?

Do not take this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take amphetamine and dextroamphetamine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to amphetamine and dextroamphetamine, or if you have hardened arteries (arteriosclerosis), heart disease, moderate to severe high blood pressure (hypertension), overactive thyroid, glaucoma, severe anxiety or agitation, or a history of drug or alcohol addiction.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking amphetamine and dextroamphetamine, tell your doctor if you have any type of heart problems.

Long-term use of amphetamine and dextroamphetamine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Amphetamine and dextroamphetamine is a drug of abuse and may be habit-forming. Keep track of the amount of medicine used from each new bottle. You should be aware if anyone is using your medicine improperly or without a prescription. Using this medication improperly can cause death or serious side effects on the heart.

What is amphetamine and dextroamphetamine?

Amphetamine and dextroamphetamine is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Amphetamine and dextroamphetamine is used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD).

Amphetamine and dextroamphetamine may also be used for other purposes not listed in this medication guide.

What should I discuss with my doctor before taking amphetamine and dextroamphetamine?

Do not take this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take amphetamine and dextroamphetamine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to amphetamine and dextroamphetamine or if you have:

• heart disease or moderate to severe high blood pressure (hypertension);
• arteriosclerosis (hardening of the arteries);
• overactive thyroid;
• glaucoma;
• severe anxiety, tension, or agitation; or
• if you have a history of drug or alcohol addiction.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking this medication, tell your doctor if you have:

• a congenital heart defect;
• high blood pressure;
• heart failure, heart rhythm disorder, or recent heart attack;
• a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt;
• epilepsy or other seizure disorder; or
• tics (muscle twitches) or Tourette's syndrome.

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. It could cause premature birth, low birth weight, or withdrawal symptoms in a newborn if the mother takes amphetamine and dextroamphetamine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Amphetamine and dextroamphetamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Long-term use of amphetamine and dextroamphetamine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

How should I take amphetamine and dextroamphetamine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not take amphetamine and dextroamphetamine in the evening because it may cause sleep problems (insomnia).

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using amphetamine and dextroamphetamine.

Store at room temperature away from moisture, heat, and light.

Amphetamine and dextroamphetamine is a drug of abuse and may be habit-forming. Keep track of the amount of medicine used from each new bottle. You should be aware if anyone is using your medicine improperly or without a prescription. Using this medication improperly can cause death or serious side effects on the heart.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose, or if it is already evening. Taking this medicine late in the day can cause sleep problems. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine and dextroamphetamine can be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, panic, aggressiveness, unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, uneven heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking amphetamine and dextroamphetamine?

Amphetamine and dextroamphetamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not take amphetamine and dextroamphetamine late in the day. A dose taken too late in the day can cause sleep problems (insomnia).

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine and dextroamphetamine. These can make your body absorb less of the medicine.

What are the possible side effects of amphetamine and dextroamphetamine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeats;
• feeling light-headed, fainting;
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
• tremor, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches).

Less serious side effects may include:

• headache or dizziness;
• sleep problems (insomnia);
• dry mouth or an unpleasant taste in your mouth;
• diarrhea, constipation;
• loss of appetite, weight loss; or
• loss of interest in sex, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect amphetamine and dextroamphetamine?

Tell your doctor about all other medicines you use, especially:

• blood pressure medications;
• a diuretic (water pill);
• cold or allergy medicines (antihistamines);
• acetazolamide (Diamox);
• chlorpromazine (Thorazine);
• ethosuximide (Zarontin);
• haloperidol (Haldol);
• lithium (Eskalith, Lithobid);
• methenamine (Hiprex, Mandelamine, Urex);
• phenytoin (Dilantin), phenobarbital (Luminal, Solfoton);
• propoxyphene (Darvon, Darvocet);
• reserpine;
• antacids, sodium bicarbonate (Alka-Seltzer);
• stomach acid reducers such as cimetidine (Tagamet),esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), or ranitidine (Zantac); or
• an antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), or nortriptyline (Pamelor).

This list is not complete and other drugs may interact with amphetamine and dextroamphetamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about amphetamine and dextroamphetamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.