- Certain other drugs (carbamazepine, phenytoin, or phenobarbital) are not to be taken with this drug when treating Dravet syndrome. Talk with the doctor.
- Rarely, people taking this drug have had hallucinations and other mental problems. Tell the doctor if your child has ever had any mental problems.
- It is used to treat seizures.
- 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 is taking any of these drugs: Carbamazepine or theophylline.
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- 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.
- Have your child’s blood work checked often. Talk with your child’s 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.
- Avoid use of caffeine (for example, tea, coffee, cola) and chocolate.
- Do not switch between different forms of this drug without first talking with the doctor.
- This drug may cause your child to not be as hungry or to lose weight. Your child may need to take a diet aid or you may need to add more food to how much food your child eats while taking this drug. Children and teens may need regular growth checks. Talk with the doctor.
If your child is pregnant or breast-feeding a baby:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy.
- 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.
- If your child has PKU, talk with your child’s doctor. Some products have phenylalanine.
- 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- 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.
- Change in balance.
- Change in thinking clearly and with logic.
- Fever or chills.
- Sore throat.
- Flu-like signs.
- Bad dreams.
- Very bad dizziness or passing out.
- Shakiness, trouble moving around, or stiffness.
- Trouble speaking.
- Not able to focus.
- Any bruising or bleeding.
- Feeling very tired or weak.
- 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. Watch people who take this drug closely. 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.
- Back pain.
- Feeling sleepy.
- Skin irritation.
- Not hungry.
- Belly pain.
- Upset stomach or throwing up.
- Feeling tired or weak.
- Not able to sleep.
- Weight gain or loss.
- To gain the most benefit, do not miss giving your child doses.
- Give as you have been told, even if your child feels well.
- Give this drug at the same time of day.
- Give this drug with food.
- Do not take this drug with milk or other dairy products, fizzy drinks, or fruit juice.
- 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.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- Give this drug with a full glass of water.
- Mix the powder with a glass of water. Have your child drink right away after mixing. Do not store the mixture for later use.
- 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 in the original container at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- 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 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.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.