Onmel is an antifungal medication that is used in adults to treat infections caused by fungus. This includes infections in any part of the body including the lungs, mouth or throat, toenails, or fingernails.

Some brands of itraconazole are not for use in treating fungal infections of the fingernails or toenails. Avoid medication errors by using only the brand and strength your doctor prescribes.

Onmel may also be used for purposes not listed in this medication guide.

You should not take Onmel if you have ever had heart failure.

If you have liver or kidney disease, you should not take Onmel with colchicine, fesoterodine, or solifenacin.

Onmel may harm an unborn baby. Avoid getting pregnant while taking this medicine and for 2 months after your last dose.

Stop using Onmel and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Life-threatening side effects may occur if you take Onmel with certain other drugs. Tell your doctor about all your current medicines and any you start or stop using.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not share Onmel with another person, even if they have the same symptoms you have.

The Onmel capsule should be taken with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Take Onmel oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

The Sporanox PulsePak has a special dosing schedule that includes not taking the medicine for several days in a row. Follow all dosing instructions carefully.

Onmel capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Avoid medication errors by using only the form and strength your doctor prescribes.

If you also take a stomach acid reducer (Tagamet, Pepcid, Axid, Zantac, and others), take Onmel with an acidic drink such as non-diet cola.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Onmel will not treat a viral infection such as the flu or a common cold.

You may need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

You should not take this medicine if you are allergic to Onmel or similar medicines such as fluconazole or ketoconazole, or if you have ever had congestive heart failure.

Life-threatening side effects may occur if you take Onmel with certain other drugs. Your doctor may change your treatment plan if you have used other medicines in the past 2 weeks, especially:

• avanafil;

• cisapride;

• eliglustat;

• irinotecan;

• isavuconazonium;

• methadone;

• naloxegol;

• ranolazine;

• ticagrelor;

• lurasidone or pimozide (anti-psychotic medications);

• lomitapide, lovastatin, simvastatin (cholesterol-lowering medicines);

• dihydroergotamine, ergonovine, ergotamine, or methylergonovine (ergot medicines);

• eplerenone, felodipine, ivabradine, or nisoldipine (heart or blood pressure medicines);

• disopyramide, dofetilide, dronedarone, or quinidine (medicines for heart rhythm disorders); or

• oral midazolam, or triazolam (Valium-like sedatives).

If you have liver or kidney disease, you should not take Onmel with colchicine, fesoterodine, solifenacin, or telithromycin.

Onmel may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Tell your doctor if you have ever had:

• heart problems;

• cystic fibrosis or other lung problems;

• liver or kidney disease; or

• a weak immune system.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how Onmel will affect you. Your reactions could be impaired.

Avoid taking antacids within 1 hour before or 2 hours after you take Onmel. Some antacids can make it harder for your body to absorb this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Onmel and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Keep taking Onmel but call your doctor at once if you have:

• confusion, a light-headed feeling (like you might pass out);

• blurred vision, double vision, ringing in your ears, problems with hearing;

• fast heartbeats;

• numbness or tingly feeling, loss of bladder control;

• little or no urinating, pain or burning when you urinate;

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle weakness or limp feeling;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting; or

• liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Onmel may include:

• headache, dizziness, drowsiness, tiredness;

• increased blood pressure;

• rash, itching;

• nausea, vomiting, stomach pain, diarrhea, constipation;

• swelling;

• abnormal liver function or blood tests;

• fever, muscle or joint pain;

• unusual or unpleasant taste in your mouth;

• hair loss;

• impotence, erection problems; or

• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect Onmel, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.