Product Description:

• NUVESSA® is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older. It is not known if NUVESSA® is safe and effective in female children younger than 12 years of age.

What is the most important information I should know about NUVESSA® (metronidazole vaginal gel 1.3%)

Do not use NUVESSA® if you:

• Are allergic to metronidazole, parabens, nitroimidazole derivatives, or any of the ingredients in NUVESSA®.


• Take, or have taken in the last 2 weeks, a medicine called Antabuse® (disulfiram).


• Are not willing to or cannot abstain from alcohol. Do not drink alcohol while you use NUVESSA® and for at least 24 hours after you stop using it.

Before you use NUVESSA®, tell your doctor about all your medical conditions, including if you:

• Have or had central nervous system diseases.


• Are pregnant or plan to become pregnant. It is not known if NUVESSA® will harm your unborn baby. Tell your doctor if you become pregnant during treatment with NUVESSA®.


• Are breastfeeding or plan to breastfeed. NUVESSA® can pass into breast milk and may harm your baby. You should not breastfeed while using NUVESSA® and for 2 days after treatment. Talk with your doctor about the best way to feed your baby while using NUVESSA®.


• Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUVESSA and certain other medicines can affect each other, especially medicine that contains warfarin or other coumarin blood thinners, or lithium.

NUVESSA® may cause serious side effects, including:

• Convulsive seizures and weakness, numbness, or pain in the arms and legs. Tell your doctor right away if these symptoms or neurologic changes develop.


• Abnormal blood tests. NUVESSA® may cause changes in certain blood tests, such as those for liver enzymes, triglycerides, and blood sugar.

What are the possible side effects of NUVESSA®?

• In adults, the most common side effects of NUVESSA® were: yeast infection, headache, vaginal itching, nausea, diarrhea, and menstrual cramps.


• In patients 12 to less than 18 years old, the most common side effect was vulvovaginal discomfort.

What should I avoid while using NUVESSA®?

• Do not consume ethanol (alcohol) or propylene glycol during, and for at least 24 hours after, you stop using NUVESSA®.


• Do not have vaginal intercourse or use other vaginal products (such as tampons or douches). These are not all the side effects of NUVESSA®.


• To learn more, talk about NUVESSA® with your doctor or pharmacist.

Indication:

What is NUVESSA®?

• NUVESSA® is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older. It is not known if NUVESSA® is safe and effective in female children younger than 12 years of age.