Uses of Amphetamine Oral Suspension:

• It is used to treat attention deficit problems with hyperactivity.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Amphetamine Oral Suspension?

• If you are allergic to amphetamine oral suspension (dyanavel XR); any part of amphetamine oral suspension (dyanavel XR); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette's syndrome or tics.
• If you have any of these health problems: Glaucoma, agitation, anxiety, or overactive thyroid.
• If you have ever had any of these health problems: Drug abuse or stroke.
• If you are taking acetazolamide.
• If you are taking sodium bicarbonate.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are breast-feeding. Do not breast-feed while you take amphetamine oral suspension (dyanavel XR).

This is not a list of all drugs or health problems that interact with amphetamine oral suspension (dyanavel XR).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take amphetamine oral suspension (dyanavel XR) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Amphetamine Oral Suspension?

• Tell all of your health care providers that you take amphetamine oral suspension (dyanavel XR). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how amphetamine oral suspension (dyanavel XR) affects you.
• If you have been taking amphetamine oral suspension (dyanavel XR) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if amphetamine oral suspension (dyanavel XR) stops working well. Do not take more than ordered.
• If you have been taking amphetamine oral suspension (dyanavel XR) for many weeks, talk with your doctor before stopping. You may want to slowly stop amphetamine oral suspension (dyanavel XR).
• You may need to have some heart tests before starting amphetamine oral suspension (dyanavel XR). If you have questions, talk with your doctor.
• This medicine may cause high blood pressure.
• Check blood pressure and heart rate as the doctor has told you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take amphetamine oral suspension (dyanavel XR).
• You may need to avoid drinking alcohol with some products. Talk with your doctor or pharmacist to see if you need to avoid drinking alcohol with amphetamine oral suspension (dyanavel XR).
• New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with amphetamine oral suspension (dyanavel XR). Tell your doctor if you or a family member have any mental or mood problems like depression or bipolar illness, or if a family member has committed suicide. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take amphetamine oral suspension (dyanavel XR) with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using amphetamine oral suspension (dyanavel XR) while you are pregnant.

How is this medicine (Amphetamine Oral Suspension) best taken?

Use amphetamine oral suspension (dyanavel XR) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take amphetamine oral suspension (dyanavel XR) early in the day to prevent sleep problems.
• Take with or without food.
• Shake well before use.
• Measure liquid doses carefully. Use the measuring device that comes with amphetamine oral suspension (dyanavel XR). If there is none, ask the pharmacist for a device to measure amphetamine oral suspension (dyanavel XR).
• Do not add to food.
• Do not mix with other liquids.
• Put the cap back on after you are done using your dose.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Different brands of amphetamine oral suspension (dyanavel XR) may be for use in different ages of children. Talk with the doctor before giving amphetamine oral suspension (dyanavel XR) to a child.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Shakiness.
• Change in eyesight.
• Seizures.
• Trouble controlling body movements.
• Change in color of hands or feet from pale to blue or red.
• Numbness, pain, tingling, or cold feeling of the hands or feet.
• Any sores or wounds on the fingers or toes.
• Muscle pain or weakness, dark urine, or trouble passing urine.
• Not able to get or keep an erection.
• Change in sex interest.
• For males, erections (hard penis) that happen often or that last a long time.
• Heart attacks, strokes, and sudden deaths have happened in adults taking amphetamine oral suspension (dyanavel XR). Sudden deaths have also happened in children with some heart problems or heart defects. Call your doctor right away if you have a fast, slow, or abnormal heartbeat; weakness on 1 side of the body; trouble speaking or thinking; change in balance; drooping on 1 side of the face; change in eyesight; chest pain or pressure; shortness of breath; or severe dizziness or passing out.

What are some other side effects of Amphetamine Oral Suspension?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, tired, or weak.
• Dry mouth.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Trouble sleeping.
• Headache.
• Weight loss.
• Bad taste in your mouth.
• Feeling nervous and excitable.
• Restlessness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Amphetamine Oral Suspension?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time amphetamine oral suspension (dyanavel XR) is refilled. If you have any questions about amphetamine oral suspension (dyanavel XR), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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