M-Zole 3

If this is the first time that you have ever had symptoms of a vaginal yeast infection, consult your doctor before using this medication.

You should not use miconazole vaginal if you have ever had an allergic reaction to it.

To make sure miconazole vaginal is safe for you, tell your doctor if you have:

• a fever,

• abdominal pain,

• foul-smelling discharge,

• diabetes, or

• HIV or AIDS.

Do not use this medicine without a doctor's advice if you are pregnant.

Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take this medicine by mouth. It is for use only in your vagina.

Wash your hands before and after using miconazole vaginal.

Insert the tablet, suppository, or cream into the vagina using the applicator as directed.

You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

Use this medication for the full prescribed length of time, even during your menstrual period. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to miconazole vaginal.

If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.

If this medication gets in your eyes, rinse with water.

Store at room temperature away from moisture and heat.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• mild burning or itching;

• skin irritation around the vagina; or

• urinating more than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to miconazole topical: topical cream, topical gel/jelly, topical kit, topical lotion, topical ointment, topical powder, topical spray, topical tablet effervescent, topical tincture

Along with its needed effects, miconazole topical (the active ingredient contained in M-Zole 3) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking miconazole topical:

• Blistering, burning, redness, skin rash, or other sign of skin irritation not present before use of this medicine

Applies to miconazole topical: compounding powder, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical powder, topical spray, topical tincture, vaginal cream, vaginal cream with applicator, vaginal kit, vaginal suppository, vaginal tampon

Local

Local side effects have been reported frequently with topical miconazole therapy. When administered intravaginally or topically, itching, burning and rash have been reported. Contact dermatitis, confirmed by patch testing, has been reported.[Ref]

Nervous system

Nervous system side effects have rarely included headache.[Ref]

Genitourinary

Genitourinary side effects have included cramping, pain, and bleeding with the intravaginal use of miconazole.[Ref]

Some side effects of M-Zole 3 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.