Gynazole-1

Butoconazole is a medicine that treats infections caused by fungus.

Gynazole-1 (for use in the vagina) is used to treat vaginal Candida (yeast) infections.

Gynazole-1 may also be used for other reasons that are not included in this medication guide.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

You should not use Gynazole-1 if you are allergic to it.

To make sure Gynazole-1 is safe for you, inform your doctor about all your medical conditions.

It is not known if Gynazole-1 will harm an unborn baby. Inform your doctor if you are pregnant.

It is not known if butoconazole vaginal passes into breast milk or if it could harm a nursing baby. Inform your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

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

Call your doctor right away if you have new or worsening vaginal symptoms.

Common side effects of Gynazole-1 may include:

• pelvic pain or cramps;
• vaginal burning or itching;
• vaginal pain and swelling; or
• mild vaginal irritation after use.

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

Gynazole-1 is usually given as a single dose. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take Gynazole-1 by mouth. It is for use only in your vagina.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The single-use applicator is for one use only. Throw the applicator away after one use, even if there is still some medicine left in it after inserting your dose.

Call your doctor if your symptoms do not improve, or if your infection goes away and comes back. Frequent vaginal yeast infections that do not clear up with treatment may be a sign of a more serious condition.

Gynazole-1 contains mineral oil, which can weaken the latex rubber in a condom or diaphragm. These forms of birth control may be less effective if you use them during your treatment with this medicine. Use another form of birth control while you are using butoconazole and for at least 3 full days after your treatment ends.

Store at room temperature away from moisture and heat. Do not warm the medicine applicator before using Gynazole-1.

Since Gynazole-1 is taken as a single dose, there is no daily dosing schedule.

Since Gynazole-1 is used as a single dose from a prefilled applicator, an overdose is unlikely to happen.

Avoid wearing tight-fitting, synthetic clothing like nylon underwear or panty hose that does not allow air to circulate. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Do not use other vaginal products at the same time as Gynazole-1, unless your doctor instructs you to.

It is not likely that other drugs you take by mouth or through injection will affect butoconazole vaginal. However, many drugs can interact with each other. Inform all your healthcare providers about all the medicines you are using, including prescription and over-the-counter medicines, vitamins, and herbal products.