LaMICtal; LaMICtal ODT; LaMICtal Starter; LaMICtal XR; Subvenite; Subvenite Starter Kit-Blue; Subvenite Starter Kit-Green; Subvenite Starter Kit-Orange
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if your child takes valproic acid or divalproex sodium with this drug, if your child starts taking this drug at too high of a dose, or if your child’s dose is raised too fast. Skin reactions have also happened without any of these. Talk with the doctor.
- Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor.
- This drug is not approved for use in children younger than 13 years old. Talk with the doctor.
- It is used to help control certain kinds of seizures.
- It is used to treat bipolar problems.
- 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 dofetilide.
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 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.
- It may take several weeks to see the full effects.
- 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 side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- If you stop giving this drug, talk with the doctor. Your child may need to be restarted at a lower dose and raise the dose slowly.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with your child’s doctor before giving your child other drugs and natural products that may slow your child’s actions.
- A very bad and sometimes deadly reaction has happened with this drug. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
- Use with care in children. Talk with the doctor.
- Some drugs may look the same as this drug or may have names that sound like this drug. Always check to make sure you have the right product. If you see any change in the way this drug looks like shape, color, size, or wording, check with your pharmacist.
- Birth control pills and other hormone-based birth control may change how much of this drug is in the body. Talk to the doctor before your child starts or stops any hormone-based birth control. The chance of side effects may be raised when taking birth control pills during the week that the pills are not active. Talk with the doctor.
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:
For all uses of this drug:
- 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.
- 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.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Swollen gland.
- Very bad muscle pain or weakness.
- Change in eyesight.
- Any unexplained bruising or bleeding.
- Feeling very tired or weak.
- Very bad joint pain or swelling.
- Very bad dizziness or passing out.
- Change in balance.
- Not able to control eye movements.
- Chest pain or pressure.
- Flu-like signs.
- 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.
- This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call the doctor right away if your child has a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother the eyes, feeling sleepy, or feeling confused.
If your child has menstrual periods:
- Painful periods.
- Period (menstrual) changes. These include spotting or bleeding between cycles.
- If seizures are worse or not the same after starting this drug.
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.
- Feeling tired or weak.
- Not able to sleep.
- Nose or throat irritation.
- Loose stools (diarrhea).
- Hard stools (constipation).
- Weight loss.
- Dry mouth.
- Back 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.
- Give this drug with or without food.
- To gain the most benefit, do not miss giving your child doses.
- Do not change the dose or stop your child’s drug. This could cause seizures. Talk with your child’s doctor.
- 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.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- If your child has trouble swallowing, talk with the doctor.
Chewable dispersible tablet:
- It may be swallowed whole, chewed, or mixed in water or fruit juice.
- If chewed, have your child drink a little water or fruit juice to help swallow it.
- You may break up tablet by adding liquid to cover tablet in a glass or spoon. Wait at least 1 minute until fully broken up, then mix and have your child drink.
- Place on your child’s tongue and let it melt. Water is not needed. Do not let your child swallow it whole. Do not let your child chew, break, or crush it.
- 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.
- Protect from light.
- 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.