Amphetamine extended-release oral disintegrating tablet

What is this medicine?

AMPHETAMINE (am FET a meen) is used to treat attention-deficit hyperactivity disorder (ADHD).

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Leave the tablet in the sealed blister pack until you are ready to take it. With dry hands, open the blister and gently remove the tablet. Do not try to push the tablet through the foil backing. If the tablet breaks or crumbles, throw it away and take a new tablet out of the blister pack. Place the tablet in the mouth and allow it to dissolve, and then swallow. Do not cut, crush or chew this medicine. This medicine will be taken once daily, in the morning. You can take it with or without food. If it upsets your stomach, take it with food. 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 of age for selected conditions, precautions do apply.

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

• changes in emotions or moods

• fingers or toes feel numb, cool, painful

• hallucination, loss of contact with reality

• high blood pressure

• males: prolonged or painful erection

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm, or leg; trouble walking; dizziness; loss of balance or coordination

• suicidal thoughts or other mood changes

• uncontrollable head, mouth, neck, arm, or leg movements

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

• anxious

• diarrhea

• dizziness

• dry mouth

• fever

• headache

• loss of appetite

• nausea, vomiting

• stomach pain

• trouble sleeping

• weight loss

What may interact with this medicine?

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

• alcohol

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

• other stimulant medicines for attention disorders

This medicine may also interact with the following medications:

• acetazolamide

• ammonium chloride

• antacids

• ascorbic acid

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole

• glutamic acid

• guanethidine

• methenamine; sodium acid phosphate

• reserpine

• sodium bicarbonate

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.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the blister packaging until you are ready to take or give it. Store the blister packages in the hard plastic travel case provided. Throw away any unused medicine after the expiration date.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Discard unused medicine and used packaging carefully. Follow the directions in the MedGuide. Do not use the medicine after the expiration date.

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

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

• circulation problems in fingers and toes

• heart disease or a heart defect

• high blood pressure

• history of a drug or alcohol abuse problem

• history of stroke

• kidney disease

• mental illness

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• Tourette's syndrome

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

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. This prescription requires that you follow special procedures with your doctor and pharmacy. You will need to have a new written prescription from your doctor every time you need a refill.

This medicine may affect your concentration, or hide signs of tiredness. Until you know how this drug affects you, do not drive, ride a bicycle, use machinery, or do anything that needs mental alertness.

Tell your doctor or health care professional if this medicine loses its effects, or if you feel you need to take more than the prescribed amount. Do not change the dosage without talking to your doctor or health care professional.

For males, contact your 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 a serious problem and must be treated right away to prevent permanent damage.

Decreased appetite is a common side effect when starting this medicine. Eating small, frequent meals or snacks can help. Talk to your doctor if you continue to have poor eating habits. Height and weight growth of a child taking this medication will be monitored closely.

Do not take this medicine close to bedtime. It may prevent you from sleeping.

Tell your doctor or healthcare professional right away if you notice unexplained wounds on your fingers and toes while taking this medicine. You should also tell your healthcare provider if you experience numbness or pain, changes in the skin color, or sensitivity to temperature in your fingers or toes.