- Long-term safety of this drug is not known. Lymphoma, skin cancer, and other types of cancer have rarely happened in people treated with this drug. Do not use this drug without a break for a long time unless told to do so by the doctor. Use only on skin that has eczema. If you have questions, talk with the doctor.
- This drug is not approved for use in children younger than 2 years of age. Talk with the doctor.
Protopic ointment 0.1%:
- This drug is not approved for use in children younger than 16 years of age. Talk with the doctor.
- It is used to treat eczema.
- It may be given to your child for other reasons. Talk with the doctor.
- 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 any of these health problems: Skin areas that have cancers or precancers, a skin disease called Netherton’s syndrome, other skin problems that may weaken the skin, a skin infection like chickenpox or herpes, or a weak immune system.
If your child is breast-feeding a baby:
- Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
- 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.
- Do not have your child use longer than you have been told by your child’s doctor.
- Have your child avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.
- There is a chance of skin cancer. Have your child avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects your child from the sun.
- Do not let your child have any kind of light therapy while using this drug.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with your child’s doctor before you use other drugs or products on your child’s skin.
- Your child may need to have skin checks while taking this drug. Talk with the doctor.
- It is common to have burning, stinging, soreness, or itching where this drug is put on. Most of the time, these happen during the first few days of treatment and go away as skin gets better. Call your child’s doctor if any of these effects are very bad, bother your child, or do not go away.
- This drug may cause harm if swallowed. If this drug is swallowed, call a doctor or poison control center right away.
If your child is pregnant:
- 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.
- Signs of skin infection like oozing, heat, swelling, redness, or pain.
- 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.
- Ear pain.
- Very bad skin irritation.
- A skin lump or growth.
- Swollen gland.
- Muscle pain.
- Skin tingling.
- Skin irritation.
- Not able to handle heat or cold.
- Stuffy nose.
- Flu-like signs.
- Pimples (acne).
- Hair bumps.
- Upset stomach.
- Follow how to give this drug as you have been told by your child’s doctor. Do not give more than you were told to give.
- Do not give by mouth. Use on your child’s skin only. Keep out of your child’s mouth, nose, and eyes (may burn).
- Wash your hands before and after use.
- Clean affected part before use. Make sure to dry well.
- Put a thin layer on the affected part and rub in gently.
- Do not put on healthy skin.
- Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
- Do not let your child bathe, shower, or swim right after using.
- Stop this drug when health problem is gone.
- Use this drug for short periods of time. If signs show up again, talk with the doctor.
- If your child’s signs do not get better after 6 weeks of care, talk with your child’s doctor.
- Practice good skin care and avoid the sun.
- Put on 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 put on 2 doses or extra doses.
- Store at room temperature. Do not freeze.
- 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.
- 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.