Butoconazole vaginal cream

What is this medication?

BUTOCONAZOLE (byoo toe KOE na zole) is an antifungal medicine. It is used to treat yeast infections of the vagina.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Gynazole-1

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

•an unusual or allergic reaction to butoconazole, other medicines, foods, dyes or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I use this medication?

This medicine is for use in the vagina. Do not take by mouth. Wash hands before and after use. Read package directions carefully before using. If using the vaginal cream, screw the applicator onto the end of the tube and squeeze the tube to fill the applicator. If using individually packaged or filled applicators, remove the outer covering. Lie on your back. Gently insert the applicator tip high in the vagina and push the plunger to release the cream into the vagina. Gently remove the applicator. Wash the applicator well with warm water and soap. Use at regular intervals. Finish the full course prescribed by your doctor or health care professional even if you think your condition is better. Do not stop using this medicine if your menstrual period starts during the time of treatment.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Interactions are not expected. Do not use any other vaginal products without telling your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care professional if your symptoms do not start to get better within a few days.

If you develop abdominal pain, a high fever, or foul-smelling vaginal discharge, contact your doctor or health care professional. Do not self-treat if you have these symptoms. These symptoms are signs of a more serious infection and you will need examined by a health care professional.

Your sexual partner may also need treatment. It is better not to have sex until you have finished your treatment. Do not rely on condoms, diaphragms, cervical caps or other barrier devices to prevent pregnancy. This medicine may damage these devices. This medicine can also interfere with the proper action of spermicides. This can lead to failure of these methods to prevent pregnancy.

Your clothing may get soiled. To help prevent reinfection, wear freshly washed cotton, not synthetic, underwear.

Do not use tampons or douches while using this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•pain or difficulty passing urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

•vaginal irritation, itching or burning

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.