Terconazole 80 mg Vaginal 3-Suppositories

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TERCONAZOLE CREAM, SUPPOSITORY - VAGINAL

(ter-KONE-a-zole)

COMMON BRAND NAME(S): Terazol 3, Terazol 7

USES: This medication is used to treat vaginal yeast infections. Terconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using terconazole, 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 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 usually once daily at bedtime for 3 or 7 days (depending on product) or as directed by your doctor. The dosage and length of treatment is based on your medical condition and response to treatment. Learn all preparation and usage instructions in the product package. If using the cream, use the applicator. If using the suppository, you may use either the applicator or your finger to insert it. Unwrap the suppository before use. Follow the package instructions on how to fill the applicator with the cream or with a suppository. Lie on your back with your knees toward your chest. Insert the applicator or suppository into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator in to release the medication. Clean the applicator with warm soapy water, rinse well, and dry. If you have itching/burning around the outside of the vagina (vulva), you may also apply terconazole cream once daily to that area and rub in. Continue to use this medication every day until the full prescribed amount is finished, even if symptoms disappear after 1 to 2 days. Stopping the medication too soon may allow the yeast to continue to grow, which may result in a return of the infection. You may use this product during your menstrual period. 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.

SIDE EFFECTS: Headache, increased vaginal/urethral burning/itching/pain, or menstrual 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. The following may be side effects. However, they may also be symptoms of a different or more serious condition (bacterial vaginosis or Pelvic Inflammatory Disease-PID) that may require different treatment. Tell your doctor right away if any of these unlikely but serious effects occur: 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.

PRECAUTIONS: 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. The suppository (but not the cream form) may damage 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 the suppository form 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 or use the cream form of this product. 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. The manufacturer does not recommend using this product during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines 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).

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room 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.

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.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the cream or suppository at room temperature away from light and moisture. 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.

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.