Lisdexamfetamine Dimesylate Oral capsule

What is this medicine?

LISDEXAMFETAMINE (lis DEX am fet a meen) is used to treat attention-deficit hyperactivity disorder (ADHD). Federal law prohibits giving this medicine to any person other than the person for whom it was prescribed. Do not share this medicine with anyone else.

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

• hardening or blockages of the arteries or heart blood vessels

• heart disease or a heart defect

• high blood pressure

• history of alcohol or drug abuse

• psychotic illness, depressed mood, or suicidal thoughts

• seizure disorder

• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days

• thyroid problems

• Tourette's syndrome

• an unusual or allergic reaction to lisdexamfetamine, other amphetamines, tartrazine, 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. Follow the directions on the prescription label. Swallow the capsules with a drink of water. You may open capsule and add to a glass of water, then drink right away. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not suddenly stop your medicine. You must gradually reduce the dose or you may feel withdrawal effects. Ask your doctor or health care professional for 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.

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:

• alcohol

• certain migraine headache medicines like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• lithium

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

• melatonin

• meperidine

• other stimulant medications like dexmethylphenidate, methylphenidate, modafinil

• pimozide

• procarbazine

This medicine may also interact with the following medications:

• acetazolamide

• ammonium chloride

• green tea

• levodopa

• linezolid

• medicines for colds, sinus, and breathing difficulties

• medicines for depression, anxiety, or psychotic disturbances

• medicines for seizures

• medicines for sleep during surgery

• medicines for the heart or blood pressure

• methenamine

• norepinephrine

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• propoxyphene

• sodium acid phosphate

• sodium bicarbonate

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?

Visit your doctor for regular check ups. 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 medicine 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 your dose without talking to your doctor or health care professional.

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 medicine will be monitored closely.

This medicine can keep you from getting to sleep. Avoid drinks that contain caffeine and try to stick to a regular bedtime every night.

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

• anxiety, or severe nervousness

• changes in mood or behavior

• chest pain

• fast, irregular heartbeat

• fever, or hot, dry skin

• hallucinations

• high blood pressure

• muscle twitching

• 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):

• dizzy, lightheaded

• headache

• loss of appetite

• nervous, restless

• nausea, vomiting

• stomach cramps

• trouble sleeping

• weight loss

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. 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 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.

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