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. The information on this website does not take the place of talking with your doctor or about your medical condition or your treatment.

What is Oravig^®?

Oravig^® is a prescription antifungal medicine used in adults to treat fungal (yeast) infections of the mouth and the throat.

It is not known if Oravig^® is safe and effective in children under the age of 16 years. It is not known if children can follow the instructions on what to do with the buccal tablet. In younger children, there is a possible risk of choking.

Who should not use Oravig^®?

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 the bottom of this page for a complete list of ingredients in Oravig^®.

What should I tell my doctor before using 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)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Oravig^®?

• Always use Oravig^® exactly as your doctor tells you. Oravig^® is usually applied in the morning after you brush your teeth.
• Oravig^® is placed 1 time each day to your upper gum for 14 days.
• You may eat and drink while using Oravig^®.
• Do not crush, chew or swallow Oravig^®.
• You should change where you place Oravig^®, between the left and right side of your upper gum with each use.
• It is okay if Oravig^® sticks to your cheek, the inside of your lip or your gum. If Oravig^® does not stick or falls off of your gum within the first 6 hours, re-apply it. If it still does not stick, replace it with a new tablet.
• If you swallow Oravig^® within the first 6 hours of placing, drink a glass of water and place a new Oravig^® to your gum.
• If Oravig^® falls off or is swallowed after it was in place for 6 hours or more, do not apply a new Oravig^®. Just place your next dose at your regular time.
• Check to see if Oravig^® is still in place after you brush your teeth, rinse your mouth, eat, or drink.

Directions for Use:

Before applying the tablet

1. Locate the area on the upper gum, just above either the left or the right incisor. The incisor tooth is the tooth just to the right or left of your two front teeth. (See Figure A)

Figure A

2. Take one Oravig^® tablet out of the bottle. Oravig^® is round on one side and flat on the other side (Figures B). The tablet is marked with an “L” on the flat side.

Figure B

3. Place the flat side of the Oravig^® tablet on your dry fingertip. Gently push the round side of the tablet against your upper gum in the area shown in Figure C. Push the Oravig^® tablet up as high as it will go on your gum. The flat side will be facing the inside of your lip.

Figure C

4. Hold the Oravig^® tablet in place by applying 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 (See Figure D).

Figure D

5. Leave the tablet in place until it dissolves.
6. Before applying your next dose, be sure to clear away any remaining Oravig^® tablet material.
7. Subsequent applications of Oravig^® should be made to alternate sides of the mouth.

What should I avoid while using Oravig^®?

You should avoid activities that may prevent Oravig^® from sticking to your gum, including:

• touching or pressing Oravig^® after placement
• wearing upper dentures that interfere with placement of the tablet
• chewing gum.
• hitting tablet when brushing your teeth
• rinsing your mouth too vigorously

What are the possible side effects of Oravig^®?

Oravig^® may cause serious side effects, including:

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
• 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Oravig^®?

• Store Oravig^® between 68° to 77°F (20° to 25°C)
• Keep Oravig^® dry
• Keep Oravig^® and all medicine out of the reach of children.

General information about the safe and effective use of Oravig^®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information page. Do not use Oravig^® for a condition for which it was not prescribed. Do not give Oravig^® to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information page summarizes the most important information about Oravig^®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Oravig^® that is written for health professionals. You can also visit www.Oravig.com for more information.

What are the ingredients in Oravig^®?

Active ingredient: miconazole

Inactive ingredients: hypromellose, milk protein concentrate, corn starch, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, and talc.

Manufactured By:
Catalent Germany Schorndorf GmbH
Steinbeisstraße 1-2
73614 Schorndorf
Germany

Distributed by:
Galt Pharmaceuticals
3350 Riverwood Parkway
Suite 1900
Atlanta, GA 30339
Phone:678-821-2428

Address medical inquiries to::
Galt Pharmaceuticals
3350 Riverwood Parkway
Suite 1900
Atlanta, GA 30339
Phone:678-821-2428

US patent numbers: 6,916,485; 7,651,698; 8,518,442.

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