Gynazole-1

Read the Patient Information Leaflet if available from your pharmacist before you start using butoconazole, and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

This product is for vaginal use only. Wash your hands before and after use. Avoid contact of this cream with your eyes. If it gets into your eyes, wash them right away with plenty of water. Call your doctor if eye irritation persists.

Use this product as directed by your doctor, usually given as a single dose. Learn all preparation and usage instructions in the product package. Lie on your back with your knees toward your chest. Insert the applicator filled with medication into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator in to apply the full dose of the cream.

Do not use tampons or douches while using this medication. Unscented sanitary napkins may be used for your menstrual period or to protect your clothing from leakage of the medication.

Tell your doctor if your condition does not improve or if it returns within 2 months. You may need a different or additional medication to treat your condition.

Increased vaginal/urethral burning/itching/pain, or mild abdominal cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A different type of infection (bacterial vaginosis) or a more serious condition (Pelvic Inflammatory Disease-PID) may require different treatment. Tell your doctor right away if you have any of the following symptoms: flu-like symptoms (including fever/chills), foul-smelling discharge from the vagina, stomach/abdominal pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems (such as HIV-AIDS), frequent vaginal yeast infections (more than 4 per year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using this product. This product may weaken rubber products (such as latex condoms, diaphragms, cervical caps) and lead to failure. This can result in pregnancy. Therefore, do not use these products during treatment with this medication and for 3 days after treatment is over. Consult your doctor about other forms of barrier protection/birth control (such as polyurethane condoms) during this time.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnant women should use extra care when using the vaginal applicator. Follow your doctor's instructions closely on how to insert the medication using the applicator.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may increase the risk of vaginal yeast infections include antibiotics, corticosteroids (such as prednisone), and drugs that suppress the immune system (such as cyclosporine, methotrexate).

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Missed Doses:

Not applicable. This medication is usually given as one dose only.

Notes:

Do not share this medication with others.

To help prevent vaginal yeast infections, dry the genital area thoroughly after showering, bathing, or swimming. Avoid wearing tight jeans, nylon underwear, pantyhose, a wet bathing suit, or damp/sweaty exercise clothes for long periods. Wear cotton underwear, and change your underwear daily.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

If your sexual partner experiences symptoms, they should contact their doctor right away.