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Brand Names: ORAVIG

Generic Name: miconazole oral (buccal) (Pronunciation: mye KON a zole (BUK al))

• What is miconazole (ORAVIG)?
• What are the possible side effects of miconazole buccal (ORAVIG)?
• What is the most important information I should know about miconazole buccal (ORAVIG)?
• What should I discuss with my health care provider before using miconazole buccal (ORAVIG)?
• How should I use miconazole buccal (ORAVIG)?
• What happens if I miss a dose (ORAVIG)?
• What happens if I overdose (ORAVIG)?
• What should I avoid while using miconazole buccal (ORAVIG)?
• What other drugs will affect miconazole buccal (ORAVIG)?
• Where can I get more information?

What is miconazole (ORAVIG)?

Miconazole is an antifungal medication that fights infections caused by fungus.

Miconazole buccal is used to treat candida (yeast) infections inside the mouth.

Miconazole buccal may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of miconazole buccal (ORAVIG)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe burning or pain in your mouth;
• new sores in your mouth or on your tongue;
• tooth problems;
• pain or swelling in your gums; or
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Less serious side effects may include:

• decreased sense of taste;
• unusual or unpleasant taste;
• mild pain or discomfort in your mouth or tongue;
• cough, dry mouth;
• nausea, vomiting, diarrhea;
• headache; or
• tired feeling.

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.

What is the most important information I should know about miconazole buccal (ORAVIG)?

You should not use this medication if you are allergic to miconazole or milk proteins.

Before using miconazole buccal, tell your doctor if you have ever had an allergic reaction to any antifungal drug such as fluconazole (Diflucan), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), itraconazole (Sporanox), posaconazole (Noxafil), or voriconazole (Vfend).

You may eat and drink normally while the tablet is in place, but avoid chewing gum.

Call your doctor at once if you have severe burning or pain in your mouth, new mouth sores, tooth problems, pain or swelling in your gums, pale skin, feeling light-headed or short of breath, rapid heart rate, or trouble concentrating.

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