Vivjoa

Read the Patient Information Leaflet if available from your pharmacist before you start taking oteseconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food exactly as directed by your doctor. Swallow the capsules whole. Do not crush, chew, dissolve, or open the capsules. The dosage and treatment schedule are based on whether this medication has been prescribed to be taken alone, or whether it has been prescribed to be taken with another antifungal medication (fluconazole). Carefully follow your doctor's directions.

If your doctor has prescribed this medication to be taken alone, it is usually taken for 2 days in a row. Then, starting on day 14 after the first dose, take it once a week (every 7 days) for 11 weeks.

If your doctor has prescribed this medication to be taken with fluconazole, first take fluconazole as directed by your doctor, usually on days 1, 4, and 7. After that, you will stop taking fluconazole. On day 14 after you started taking fluconazole, start taking oteseconazole. Take oteseconazole every day for 7 days. Starting on day 28, take oteseconazole once a week (every 7 days) for 11 weeks.

Take this medication regularly to get the most benefit from it. To help you remember, mark your calendar with reminders when to take your medication(s).

Tell your doctor if you develop symptoms of a vaginal yeast infection (such as vaginal pain, itching, thick/white discharge).

Headache or nausea may occur. If either of these effects lasts or gets 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.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 taking oteseconazole, 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: kidney disease, liver disease.

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

This medication must not be used if you are pregnant, able to become pregnant, or plan to become pregnant. You should not become pregnant while using oteseconazole. Oteseconazole may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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.

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.

Do not share this medication with others.

It is important to take each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.