Important Safety Information

 

Indication

  • Oravig® is indicated for the local treatment of oral thrush in adults.

 

Important Safety Information

  • Read the Patient Information that comes with Oravig before you start taking it and each time you get a refill. There may be new information. This brochure does not take the place of talking with your doctor or about your medical condition or your treatment.
  • Do not use Oravig if you:
    • are allergic to miconazole (M-Zole, Monistat, Vusion).
    • are allergic to milk protein concentrate.
    • are allergic to any of the ingredients in Oravig. See Prescribing Information for a complete list of ingredients in Oravig.
  • Before taking Oravig, tell your doctor if you:
    • have liver problems.
    • have any other medical conditions.
    • are pregnant or plan to become pregnant. It is not known if Oravig will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
    • are breast-feeding or plan to breast-feed. It is not known if Oravig passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Oravig.
  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
  • Oravig may affect the way other medicines work, and other medicines may affect how Oravig works.
  • Especially tell your doctor if you take:
    • a diabetes medicine.
    • phenytoin (Dilantin, Phenytek).
    • an ergot medicine. Ask your doctor or pharmacist if you are not sure if your medicine is an ergot medicine.
    • the blood thinner medicine warfarin sodium (Coumadin, Jantoven).
  • Allergic reactions. Tell your doctor or get emergency medical help right away if you have any of the symptoms below:
    • skin rash or hives.
    • swelling of your face, eyes, lips, tongue or throat.
    • trouble swallowing or breathing.
  • The most common side effects of Oravig include diarrhea, change in taste, headache, upper stomach (abdominal) pain, nausea and vomiting. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oravig. For more information, ask your doctor or pharmacist.
  • You are encouraged to report any negative side efects of prescription drugs to the FDA. Visit FDA.gov/medwatch, or call 1-800-FDA-1088.

 

Please see Full Prescribing Information.