Onmel; Sporanox; Sporanox Pulsepak
- Do not give to your child to treat nail fungus if your child has or has ever had a weak heart. Get medical help right away if your child has signs of a weak heart like shortness of breath, a big weight gain, coughing up white or pink mucus, waking up at night more than normal, or swelling in the arms or legs while taking this drug.
- Do not give this drug to your child if your child is taking any of these drugs: Cisapride, dihydroergotamine, disopyramide, dofetilide, dronedarone, eplerenone, ergonovine, ergotamine, felodipine, irinotecan, lovastatin, lurasidone, methadone, methylergonovine, oral midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, ticagrelor, or triazolam. Taking them with this drug can cause very bad and sometimes deadly heart problems like a heartbeat that is not normal and heart attack. Talk with the doctor..
- If your child has kidney or liver problems, do not give this drug if your child is also taking fesoterodine, solifenacin, telithromycin, or a drug that has colchicine in it.
- It is used to treat fungal infections.
- 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 pregnant:
- If your child is being treated for a nail infection.
- 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.
- If your child has dizziness or a change in eyesight, have your child avoid tasks or actions that could be unsafe.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- If your child has high blood sugar (diabetes), talk with the doctor. This drug may lower blood sugar. High blood sugar drugs may need to be changed.
- Do not switch brands or types of this drug (like tablets, liquid) unless you talk with the doctor. They may not work the same.
- This drug may interact with many other drugs. This may affect how well this drug works or cause side effects. In some cases, it may lead to life-threatening effects or sudden death. Be sure the doctor and pharmacist know all of the drugs that your child takes.
- Do not give to your child longer than you have been told. A second infection may happen.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Your child may get sunburned more easily. 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.
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.
- Have your child use birth control to prevent pregnancy while taking this drug and for 2 months after stopping 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.
- 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 low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- A burning, numbness, or tingling feeling that is not normal.
- Blood in the urine.
- Breast pain.
- Enlarged breasts.
- Not able to pass urine or change in how much urine is passed.
- Chest pain or pressure or a fast heartbeat.
- Change in sex ability.
- Low mood (depression).
- Trouble swallowing.
- Very bad dizziness or passing out.
- Fever or chills.
- Sore throat.
- Hair loss.
- Joint pain.
- Ringing in ears.
- Not able to sleep.
- Any bruising or bleeding.
- Dry mouth.
- Dry eyes.
- Change in eyesight.
- Feeling very tired or weak.
- Hearing loss has happened with this drug. Many times this has happened when this drug was taken along with quinidine. This will most often go away after this drug is stopped but may last for a long time in some people. Talk with your doctor.
- Very bad and sometimes deadly liver problems have rarely happened with this drug. Sometimes this happened within 7 days of starting this drug. Call the 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.
- Belly pain.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Runny nose.
- Bad taste in your mouth.
- 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.
Tablets and capsules:
- Give capsule with a full meal.
- If your child has low stomach acid or your child takes another drug to lower stomach acid, give this drug with an acidic drink like non-diet cola.
- Do not give antacids within 2 hours of this drug.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- Give liquid (solution) on an empty stomach. Give 1 hour before or 2 hours after meals.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, get an oral syringe, a dropper, a spoon, or a cup (only for older children) from your pharmacist.
- For fungal infections in the mouth, throat, or swallowing tube (esophagus): Have your child swish in the mouth for a few seconds and swallow.
- 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. Do not freeze.
- 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 child’s 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.