Orungal

• Sporanox®

Active Ingredients: itraconazole

Therapeutic actions: Itraconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection.

Indications: Itraconazole capsules are used to treat fungal infections that begin in the lungsand can spread through the body. Itraconazole capsules are also used to treat fungal infections of the fingernails and/or toenails.

Contraindications and cautions: Before taking itraconazole,

• tell your doctor and pharmacist if you are allergic to itraconazole; other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral),or voriconazole (Vfend); orany other medications. If you are taking itraconazole oral solution, tell your doctor if you are allergic to saccharin or sulfa medications.
• do not take itraconazole if you are taking any of the medications listed in the IMPORTANT WARNING section or any of the following medications: ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), and methysergide (Sansert); lovastatin (Mevacor); simvastatin (Zocor); or triazolam (Halcion).
• you should know that itraconazole may remain in your body for several months after you stop taking it. Tell your doctor that you have recently stopped taking itraconazole before you start taking any other medications during the first few months after your treatment.
• if you are taking an antacid, take it 1 hour before or 2 hours after you take itraconazole.
• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, AIDS, cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction),or any condition that decreases the amount of acid in your stomach.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not take itraconazole to treat nail fungus if you are pregnant or could become pregnant. You may start to take itraconazole to treat nail fungus only on the second or third day of your menstrual period when you are sure you are not pregnant. You must use effective birth control during your treatment and for 2 months afterward. If you become pregnant while taking itraconazole to treat any condition, call your doctor.

Adverse effects: Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Itraconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea or loose stools
• constipation
• gas
• stomach pain
• heartburn
• sore or bleeding gums
• sores in or around the mouth
• headache
• dizziness
• sweating
• muscle pain
• decreased sexual desire or ability
• nervousness
• depression
• runny nose and other cold symptoms
• unusual dreams

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• excessive tiredness
• loss of appetite
• upset stomach
• vomiting
• yellowing of the skin or eyes
• dark urine
• pale stools
• tingling or numbness of the hands or feet
• fever, chills, or other signs of infection
• frequent or painful urination
• shaking hands that you cannot control
• rash
• hives
• itching
• difficulty breathing or swallowing

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

Interactions: It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Especially if you are using the folowing: alfentanil (Alfenta); alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); atorvastatin (Lipitor); buspirone (BuSpar); busulfan (Myleran); calcium channel blockers such as amlodipine (Norvasc), felodipine (Plendil), isradipine (Dynacirc), nifedipine (Adalat, Procardia) nicardipine (Cardene) nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); carbamazepine (Tegretol); cerivastatin (Baycol) (not available in the United States); cilostazol (Pletal); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diazepam (Valium); digoxin (Lanoxin); disopyramide (Norpace); docetaxel (Taxotere); eletriptan (Relpax); erythromycin (E.E.S., Erythrocin, E-Mycin); halofantrine (Halfan); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); midazolam (Versed); nevirapine (Viramune)' oral contraceptives (birth control pills); oral medicine for diabetes; phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sirolimus (Rapamune); steroids such as dexamethasone (Decadron), budesonide (Entocort EC), and methylprednisolone (Medrol); tacrolimus (Prograf); , trimetrexate (Neutrexin); vinblastine (Velban); vincristine (Oncovin); and vinorelbine (Navelbine).
Many other medications may also interact with itraconazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

Additional Information: DO NOT SHARE THIS MEDICINE with others. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, if needed during treatment, out of the reach of children. Do not reuse needles, syringes, or other materials.