Lisdexamfetamine Dimesylate

Read the Medication Guide provided by your pharmacist before you start taking lisdexamfetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication with or without food as directed by your doctor, usually once daily in the morning. Do not take this medication in the afternoon or evening because it may cause you to have trouble sleeping. The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully.

If you are taking the chewable tablet, chew the tablet thoroughly and then swallow.

If you are taking the capsule form of this medication, swallow the capsule whole. However, if you have trouble swallowing the capsule, you may open the capsule and pour all of its contents (powder) in a glass of water or orange juice or mix it in yogurt. Use a spoon to break apart any powder that is stuck together. Stir well until the contents dissolve completely. Drink or eat the mixture right away. Do not prepare a supply in advance. It is normal to see a filmy coating on the inside of your glass or container after you drink or eat all of the medicine.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

During treatment, your doctor may occasionally recommend stopping the medication for a short time to see whether there are any changes in your behavior and whether the medication is still needed.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as severe tiredness, sleep problems, mental/mood changes such as depression). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used lisdexamfetamine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition does not improve or if it worsens.

Nausea, vomiting, constipation, stomach/abdominal pain, loss of appetite, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability, and restlessness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: blurred vision, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior, suicidal thoughts/attempts), uncontrolled movements, muscle twitching/shaking, signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, outbursts of words/sounds, change in sexual ability/interest, swelling ankles/feet, extreme tiredness, rapid/unexplained weight loss, frequent/prolonged erections (in males).

Get medical help right away if you have any very serious side effects, including: shortness of breath, fainting, chest/jaw/left arm pain, seizures, weakness on one side of the body, trouble speaking, confusion, sudden vision changes.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as amphetamine or dextroamphetamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease), certain mental/mood conditions (such as severe agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat, coronary artery disease, previous heart attack, heart failure, cardiomyopathy, problems with heart structure such as valve problems), family history of heart problems (such as sudden death, irregular heartbeat), history of stroke, high blood pressure, overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), seizures, kidney disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal/family history of uncontrolled muscle movements (such as Tourette's syndrome).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially weight loss. This medication may slow down a child's growth. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor right away if you notice possible mood changes, agitation, or unusual tiredness in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/ "ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Lisdexamfetamine is very similar to amphetamine or dextroamphetamine. Do not use medications containing amphetamine or dextroamphetamine while using lisdexamfetamine.

This medication may interfere with certain lab tests (such as blood and urine steroid levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe mental/mood changes (such as confusion, hallucinations), seizures, irregular heartbeat, severe restlessness, fast breathing.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as blood pressure, heart rate, growth monitoring in children) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember in the morning hours. If it is after noon or near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.