- A very bad and sometimes deadly blood problem called aplastic anemia has happened with this drug. This blood problem can happen to anyone taking this drug at any time during care. Signs of this blood problem may not show for a few months of taking this drug. If your child stops taking this drug, the chance of anemia may still be raised for some time. Call the doctor right away if your child has any fever, sore throat, mouth sores, infections, easy bruising, or purple “splotches” on the skin. Talk with the doctor.
- Very bad and sometimes deadly liver problems have happened with this drug. Call your child’s doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- This drug is not for use in people who have ever had liver problems. Talk with the doctor.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- It is used to treat seizures.
- You must be given information and a consent form must be signed for your child to use this drug.
- 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.
- If your child has ever had any of these health problems: Blood problems or liver disease.
This is not a list of all drugs or health problems that interact with this drug.
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 wear disease medical alert ID (identification).
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of seizures. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
If your child is or may be sexually active:
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Be sure your child uses some other kind of birth control also, like a condom, when taking this drug.
If your child is pregnant or breast-feeding a baby:
- Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.
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.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Change in balance.
- Feeling confused.
- If seizures are worse or not the same after starting this drug.
- Feeling very tired or weak.
- Any unexplained bruising or bleeding.
- Purple spots or redness of the skin.
- Change in eyesight.
- Not able to control passing urine.
- Patients who take this drug may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
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:
- Feeling sleepy.
- Upset stomach or throwing up.
- Not able to sleep.
- Not hungry.
- Feeling tired or weak.
- Signs of a common cold.
- Feeling nervous and excitable.
- Belly pain.
- Change in taste.
- Weight loss.
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.
- Give this drug with or without food. Give with food if it causes an upset stomach.
- Do not change the dose or stop your child’s drug. This could cause seizures. Talk with your child’s doctor.
- To gain the most benefit, do not miss giving your child doses.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Shake well before use.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- 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.
- 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.