Oravig 50 mg buccal tablet

Generic name:
Miconazole tablet - buccal

Pronunciation
(mye-KON-a-zole)

Brand name(s)
Oravig

This medication is used to treat fungal infection in the mouth or throat. Miconazole is known as an azole antifungal drug. It works by stopping the growth of fungus.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using miconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication by mouth as directed by your doctor, usually once daily in the morning, after brushing your teeth. Before applying the tablet, locate the area in your mouth at which to place the tablet. It should be placed at the upper gum, just above the left or right incisor tooth. The incisors are the teeth just to the left and right of your two front teeth. With dry hands, place one tablet in your mouth with the round side facing against your gum and gently push it into place. Remove your hand from inside your mouth and apply a slight pressure with your finger on the outside of your upper lip for 30 seconds. This will make the tablet stick to your gum. Leave the tablet in place until it is dissolved (usually 6 hours or longer). You may eat and drink while using this medication. Do not crush, chew or swallow the tablet. Check if the tablet is still in place after you brush your teeth, rinse your mouth, eat, or drink. Before applying the next dose, clear away any remaining tablet pieces. Change sides of the mouth with each dose.

It is okay if the tablet sticks to your gum, or to the inside of your lip or cheek. If it does not stick or if it falls off your gum within the first 6 hours, apply it again as directed. If it still does not stick, replace it with a new tablet. If you accidentally swallow the tablet within the first 6 hours after placement, drink a glass of water and apply a new dose to your gum.

If it is 6 hours or longer after placement and the tablet falls off or is accidentally swallowed, do not apply a new dose. Just use your next dose at your usual time.

Avoid activities that may prevent the buccal tablet from sticking to your gum, including touching or pressing the tablet after placement, wearing an upper denture that interferes with tablet placement, chewing gum, hitting the tablet when brushing your teeth, or rinsing your mouth too forcefully.

Antifungals work best when the amount of medicine in your body is kept at a constant level. Use this drug at evenly spaced intervals.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Discomfort, sores, taste changes, or irritation/pain in the mouth may occur. Nausea, vomiting, diarrhea, abdominal pain, or headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using miconazole buccal tablets, tell your doctor or pharmacist if you are allergic to miconazole; or if you have any other allergies. This product may contain inactive ingredients (such as milk protein concentrate), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• warfarin

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.