MONISTAT® Safety Guide

MONISTAT® should only be used for the treatment of vaginal yeast infections. Certain MONISTAT® products
also offer a tube of external itch relief cream to soothe and relieve vaginal itching and irritation associated
with yeast infections.

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.

Some do's and don'ts 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).
  • Do not have vaginal intercourse.
  • Do not scratch the skin outside the vagina. Scratching can cause more irritation and can spread the infection.
  • Be aware that a mild increase in vaginal burning, itching or irritation may occur.
  • Do use during your menstrual period.
  • If pregnant or breast feeding, ask a health professional before use.
  • Tell your doctor about any drugs you are currently taking.
  • 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 any of the following
side effects while using MONISTAT®:

  • Abdominal pain
  • Hives
  • Skin rash
  • Severe vaginal burning   
  • Vaginal itching
  • Vaginal irritation
  • Vaginal swelling
  • Headache

Warning Awareness

It's important to know MONISTAT® products:

  • Are for vaginal use only.
  • Are not intended to be taken by anyone under the age of 12.
  • Should not be used without seeing your doctor if you are having vaginal itching
    and discomfort for the first time.

Ask a doctor before use if you have:

  • Vaginal itching, burning and discomfort for the first time.
  • Lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge.
    You could have a more serious medical 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?

The risk in each individual is variable. You should follow the instructions on the package and consult a physician
before using both products together.*

* If you are using FROM THE MAKERS OF MONISTAT® 1-Day Tioconazole, you do not need to see a doctor about
potential interactions with the prescription warfarin because such interactions are not expected.

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.

If you have any other questions or need more information about MONISTAT® products, call our
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.

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