Nuvessa

What is Nuvessa?

Nuvessa is a prescription medicine that is used to treat bacterial vaginosis in women who are not pregnant.

Description

NUVESSA contains 1.3% metronidazole, USP in a single-dose prefilled disposable applicator. It is intended for intravaginal use. Metronidazole is a nitroimidazole antimicrobial.

Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. Its structural formula is:

The molecular formula is C 6H 9N 3O 3 with a molecular weight of 171.16.

NUVESSA is an aqueous gel containing metronidazole at a concentration of 13 mg/g (1.3%). The gel is formulated at pH 4.0. The gel also contains benzyl alcohol, methylparaben, polycarbophil, polyethylene glycol 400, propylene glycol, propylparaben, and purified water.

Each applicator contains approximately 65 mg of metronidazole in 5 g of vaginal gel.

What is the most important information I should know about Nuvessa?

Nuvessa is for intravaginal use only. Do not use in the eyes, mouth or skin.

Who should not use Nuvessa?

Do not use Nuvessa if you:

• are allergic to metronidazole, parabens, nitroimidazole derivatives, or any of the ingredients in Nuvessa. See the end of this leaflet for a complete list of ingredients in Nuvessa.
• take or have taken a medicine called Antabuse (disulfiram) in the last 2 weeks.
• drink alcohol. Do not drink alcohol while you use Nuvessa and for at least 24 hours after you stop using it. It can increase your chances of getting serious side effects.

What should I tell my healthcare provider before using Nuvessa?

Before you use Nuvessa, tell your healthcare provider about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Nuvessa will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Nuvessa passes into breast milk and may harm your baby. You and your healthcare provider should decide if you will use Nuvessa or breastfeed.

Tell your healthcare provider all about the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

How should I use Nuvessa?

• See the Instructions for use at the end of this Patient Information leaflet for detailed instructions about how to use Nuvessa
• Use Nuvessa exactly as your healthcare provider tells you to.
• Nuvessa is used one time at bedtime.
• If you get Nuvessa in your eyes, rinse your eyes with cool tap water and call your healthcare provider.

What should I avoid while using Nuvessa?

Do not have vaginal intercourse or use other vaginal products (such as tampons or douches).

What are the possible side effects of Nuvessa?

The most common side effects of Nuvessa include yeast infections, headache, vaginal itching, nausea, diarrhea, and pain with menstrual cycle.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the side effects of Nuvessa. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General information about the safe and effective use of Nuvessa

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Nuvessa for a condition for which it was not prescribed. Do not give Nuvessa to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Nuvessa. If you would like more information, talk with your doctor. You can also ask your pharmacists or doctor for information about Nuvessa that is written for health professionals.

For more information call: Exeltis USA, Inc., at 1-877-324-9349.

How should I store Nuvessa?

Store Nuvessa at room temperature, 59°-86°F (15°-30°C).

Keep Nuvessa and all medicines out of the reach of children.

What are the ingredients in Nuvessa?

Active ingredient: metronidazole

Inactive ingredients: polyethylene glycol 400, propylene glycol, benzyl alcohol, methylparaben, propylparaben, purified water, and polycarbophil AA-1

Instructions for use for Nuvessa

Nuvessa

(metronidazole vaginal gel 1.3%)

For vaginal use only.

You will need the following supplies (See Figure A)

Figure A

Step 1: Remove the pre-filled applicator and plunger from the foil package (See Figure B)

Tear open the foil packet just before using

Remove the pre-filled applicator and plunger from the foil packaging

Figure B

Step 2: Insert the plunger into the open end of the pre-filled applicator (See Figure C)

With the pink cap still on, push the tip of the plunger into the open end of the pre-filled applicator

Figure C

Step 3: Remove the pink cap (See Figure D)

Pull the pink cap straight off the top of the pre-filled applicator.

Figure D

Step 4: Prepare to insert the pre-filled applicator (See Figure E)

The pre-filled applicator may be inserted while lying on your back with your knees bent or in any comfortable position.

Figure E

Step 5: Insert the pre-filled applicator (See Figure F)

Hold the pre-filled applicator by the barrel and gently insert the rounded tip into your vagina as far as it will comfortably go, then pull back slightly

Figure F

Step 6: Push the plunger (See Figure G)

While holding the barrel in place, slowly press the plunger until it stops to release the gel into your vagina

Figure G

Step 7: Remove the pre-filled applicator from your vagina and throw it away in your household trash.

How should I store Nuvessa?

Store Nuvessa at room temperature, 59°-86°F (15°-30°C).

Keep Nuvessa and all medicines out of the reach of children.

Label

PRINCIPAL DISPLAY PANEL – 5 G APPLICATOR CARTON