Condylox 0.5% Gel- 3.5g

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.

PODOFILOX GEL - TOPICAL

(poe-DOF-il-ox)

COMMON BRAND NAME(S): Condylox

USES: This medication is used on the skin to treat external genital warts.

HOW TO USE: This medication is for topical use only. Apply it on the warts pointed out by your doctor. It is usually applied once in the morning and again in the evening for 3 days followed by a 4 day rest period. If the warts do not go away, then this cycle is repeated up to 4 times. Contact your doctor for other options if the warts do not go away after 4 weeks of treatment. To apply, use the provided applicator tip or your finger. Apply a small amount of medication to the wart to cover it. Allow the gel to dry. Wash your hands thoroughly afterwards. Be careful with this medication because it can irritate normal skin around the application site. Do not use large amounts, apply more often or use for a longer period than directed. Your condition will not clear faster, and the chance for side effects may be increased. Avoid contact with the eyes and mucous membranes. If contact occurs, immediately wash with plenty of water and contact your doctor. Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

SIDE EFFECTS: Swelling, pain, burning, itching, peeling skin, small sores, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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. Tell your doctor right away if this serious side effect occurs: bleeding. 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 taking podofilox, tell your doctor or pharmacist if you are allergic to it; 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: other skin problems (such as skin cancer). This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this drug passes into breast milk. Consult 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.

OVERDOSE: 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. This medicine may be harmful if swallowed. If accidentally swallowed, you may experience symptoms such as: nausea, vomiting, diarrhea, change in mental status, weakness or fatigue, unusually slowed breathing, and seizures.

NOTES: This medication is prescribed for your current condition only. Do not use it later for another skin problem unless directed by your doctor. A different medication may be necessary in those cases. Do not share this medication with others. This medication is not a cure. New warts or return of old warts may occur, especially in the first 3 months after treatment. Follow-up medical visits may be periodically necessary to monitor your progress or check for side effects. Consult your doctor for more details. Refrain from sexual intercourse on the days you apply this drug. Using condoms may help prevent the spread of genital warts to your partner.

MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from heat or open flame. Do not freeze. Replace the cap tightly after use. 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.

Information last revised April 2022. Copyright(c) 2022 First Databank, Inc.