- This drug can cause dizziness, loss of balance, ringing in the ears, anxiety, paranoia, low mood (depression), seizures, not thinking clearly or with logic, mood changes, changes in actions, or hallucinations. These side effects may last for a few months or can be long-lasting and not go away even after the drug is stopped. Do not give this drug to prevent malaria if your child has mental or mood problems. Call your child’s doctor right away if your child has any of these side effects.
- It is used to treat or prevent malaria.
- If your child has an allergy to this drug or any part of this drug.
- If your child has an allergy to quinidine or quinine.
- 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: Anxiety, low mood (depression), psychosis, any other mood problem, or seizures.
- If your child is taking any of these drugs: Chloroquine, quinidine, or quinine.
- If your child is taking any of these drugs: Halofantrine or ketoconazole. Do not give these drugs within 15 weeks of your child’s last dose of this drug.
- If your child has recently had a live vaccine.
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.
For all uses of this drug:
- 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.
- Have your child’s patient safety card with you at all times.
- Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
- Have your child get an eye exam as you have been told by the doctor.
- This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to the doctor to see if your child has a greater chance of seizures while taking this drug.
- This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
- Use with care in children. Talk with the doctor.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy while taking this drug and for 3 months after stopping this drug.
If your child is pregnant or breast-feeding a baby:
- If your child gets pregnant while taking this drug or within 3 months after her last dose, call the doctor right away.
- Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
- Other measures are needed along with this drug including using screens, bed netting, insect repellent (10% to 35% DEET), and permethrin spray on clothing and nets. Avoid spraying most insect repellents on children. Lower evening and night-time outdoor activity.
- If your child has a fever after leaving a malaria area, call your child’s doctor right away.
- If your child is pregnant and is traveling to a malaria-infested place, talk to the doctor about the risks first.
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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Chest pain or pressure or a fast heartbeat.
- Slow heartbeat.
- A heartbeat that does not feel normal.
- Very bad dizziness or passing out.
- Change in eyesight, eye pain, or very bad eye irritation.
- Not able to sleep.
- Some people taking this drug have killed themselves (suicide). It is not known if this drug was the reason for the suicides. Tell your child’s doctor if your child is thinking about killing himself/herself.
- Unsafe blood cell count problems have happened with this drug. This includes a type of anemia called aplastic anemia and a type of low white blood cell count. Report any fever or chills, shortness of breath, feeling very tired or weak, any unexplained bruising or bleeding, or purple “splotches” on your child’s skin to the doctor right away.
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.
- Belly pain.
- Loose stools (diarrhea).
- Not hungry.
- Muscle pain.
- Feeling tired or weak.
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.
For all uses of this drug:
- Give this drug with the largest meal of the day.
- Do not give on an empty stomach.
- Give this drug with a full glass of water.
- Tablet can be crushed and mixed with water, milk, or other liquid.
- 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.
- Talk with the doctor to find out what to do if your child throws up after taking a dose of this drug.
- Give as you have been told to help prevent malaria.
- If using to prevent malaria, start this drug before traveling to the high risk place.
- Most of the time, 1 dose of this drug is needed. If you miss giving your child the dose, give it as soon as you think about it with food. If your child needs to take more than 1 dose of this drug, follow what your child’s doctor has told you to do.
For all uses of 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.
- If you miss giving your child a dose before leaving for your trip, call your doctor.
- 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.