Safety Guide

Safety First

If you have never had a vaginal yeast infection before, see your doctor before using any MONISTAT^® product. Do not use MONISTAT^® for external vaginal (vulvar) itching due to causes other than a yeast infection.

Before using a MONISTAT^® product, make sure to read the safety information provided below, or in your product insert.

Do's and dont's when using MONISTAT^® products:

• Do not use tampons, douches, spermicides or other vaginal products.
• Do not rely on condoms or diaphragms for contraception and disease prevention as they may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). For 1-Day products, the use of condoms and diaphragms is not recommended for one day after using the vaginal insert.
• Do not have vaginal intercourse.
• Be aware that a mild increase in vaginal burning, itching or irritation may occur.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask your doctor if:

• Symptoms do not improve in three days.
• Symptoms last more than seven days.
• You get a rash or hives, abdominal pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge.

These may be signs that this product is not working. There may be a more serious condition present or you could be experiencing an allergic reaction.

What side effects may occur with MONISTAT^®?
A mild increase in vaginal burning, itching, irritation or headache may occur when the product is used. Abdominal cramping has also been reported.

Stop use and ask your doctor if you have:

• abdominal pain
• hives
• skin rash
• severe vaginal burning
• itching
• irritation
• swelling

Warning Awareness

It's important to know that MONISTAT^® products:

• Are for vaginal use only.
• Are not intended to be taken by anyone under the age of 13.
• Should not be used if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have:

• Vaginal itching, burning and discomfort for the first time. You may need a different treatment.
• Lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You could have a more serious condition.
• Vaginal yeast infections often (such as once a month or three in six months). You could be pregnant or have a serious underlying cause for your symptoms, including diabetes or a weakened immune system.
• Been exposed to the human immunodeficiency virus (HIV) that causes AIDS.

Consult a doctor or pharmacist before use if you are taking the prescription blood-thinning medicine, Warfarin (i.e., Coumadin), because bleeding or bruising may occur.

What is Warfarin?
Warfarin is a drug that causes an anticoagulant effect (prevents clotting). It is often used in patients at risk for a stroke. Patients on Warfarin should be continuously monitored.

There are many drugs that interact with Warfarin to increase or decrease the anticoagulant action. If a drug interaction occurs, causing circulatory levels of Warfarin to increase, the patient becomes at risk for bleeding.

Why do miconazole nitrate and Warfarin interact?
The liver metabolizes both drugs, so taking them together may increase the levels of Warfarin in the blood. Such an interaction with Warfarin occurs with many drugs that are metabolized by the liver.

Do Warfarin interactions occur with all miconazole nitrate products?
Warfarin may interact with all miconazole nitrate products from all suppliers.

What are the chances of an interaction with Warfarin occurring?
Chances generally are low, but the risk in each individual is variable. You should follow the instructions on the package and consult a physician before using both products together.

Why are we hearing about this interaction with Warfarin now and do you plan to address this issue?
In late 2000, the FDA informed our company that since topical miconazole nitrate products may interact with Warfarin, we should take steps to inform the public.

We currently communicate the Warfarin interaction on the MONISTAT^® carton to both consumers and professionals as well as the insert of all MONISTAT^® topical miconazole nitrate products (and on this website, too).

Does the “Interaction With Warfarin” warning appear on all MONISTAT^® products?
Our company placed the following warning on all topical miconazole nitrate-based MONISTAT^® products: "Ask a doctor or pharmacist before use if you are taking the prescription blood-thinning medicine Warfarin, because bleeding or bruising may occur." There have been no reported cases of interactions with our tioconazole product.

Do other medications interact with miconazole nitrate?
Warfarin is currently the only drug known to interact with miconazole nitrate.

Does this interaction with Warfarin occur with other yeast infection products?
The drug interaction may occur with Fluconazole, and is described in the prescribing information. This interaction with Warfarin is included on all miconazole nitrate products, including private label brands.

Questions of a medical nature should be taken up with your doctor. If you have any other questions or need more information about MONISTAT^® products, call our HEALTHCARE SPECIALIST STAFFED ANSWER LINE: 1-877-MONISTAT (1-877-666-4782), between 8:00 A.M. and 5:00 P.M. EST, Monday through Friday. It's toll-free. And anything discussed is strictly confidential.