- It is used to treat phenylketonuria (PKU).
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
This drug may interact with other drugs or health problems.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Talk with the doctor if your child has a fever or is sick. Your child’s dose may need to be changed.
- Have your child follow the diet plan your child’s doctor told you about.
- Some people have had low blood phenylalanine levels with this drug. The chance is raised in children younger than 7 years of age. Blood levels that are too low for a long time may lead to very bad health problems. Talk with the doctor.
If your child is pregnant or breast-feeding a baby:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
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 child’s doctor or get medical help right away if your child has 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.
- Black, tarry, or bloody stools.
- Throwing up blood or throw up that looks like coffee grounds.
- Very bad belly pain.
- Wheezing or coughing.
- Shortness of breath.
- Very upset stomach or throwing up.
- Fidgeting, moving around too much, or talking too much.
- Chest pain or pressure or passing out.
- Passing urine more often.
- Swelling in the arms or legs.
- Feeling agitated.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Runny nose.
- Stuffy nose.
- Sore throat.
- Joint pain.
- Belly pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- To gain the most benefit, do not miss giving your child doses.
- Give this drug at the same time of day.
- Give this drug with meals.
- This drug may be swallowed whole or mixed in water or apple juice.
- If mixing the tablets, mix with 1/2 to 1 cup (4 to 8 ounces/120 to 240 mL) of water or apple juice. Have your child drink within 15 minutes of mixing. It may take a few minutes for the tablets to melt. You may stir or crush the tablets to help the tablets melt faster. Rinse glass with more juice or water and have your child drink.
- This drug may not melt all the way. You may see small pieces floating on the top of the water or apple juice. This is normal and safe to swallow.
- This drug may also be crushed and mixed in a small amount of soft food like applesauce or pudding.
- Do not open until you are ready to use.
- Be sure you know what the dose of this drug is. Be sure you know which types of packets to use to make up the dose. Talk to the doctor if you are not sure.
- Empty packet in water or apple juice as you have been told. Mix well and have your child drink within 30 minutes of mixing.
- This drug may also be mixed in a small amount of soft food like applesauce or pudding.
- Give a missed dose as soon as you think about it on the same day your child missed the dose.
- If it is the next day, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses on the same day.
- Store at room temperature.
- Store 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.
- Store in original container.
- Keep lid tightly closed.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, 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.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.