Patient information: uses, side effects, how to take - Nuvessa

What is NUVESSA?

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

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.

Before you use NUVESSA, tell your healthcare provider 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 healthcare provider if you become pregnant during treatment with NUVESSA.
are breastfeeding or plan to breastfeed. NUVESSA can pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby while using NUVESSA.

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 and vaginal pain or discomfort. 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 doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about NUVESSA

Medicines are sometimes prescribed for purposes other than those listed in a 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 that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NUVESSA that is written for health professionals.

What are the ingredients in NUVESSA?

Active ingredient: metronidazole

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

INSTRUCTIONS FOR USE

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 between 68°F to 77°F (20°-25°C).
Do not freeze.
Do not refrigerate.

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

This Patient Information and Instructions for Use have been approved by the US Food and Drug Administration.

Rx only

Distributed By:

Exeltis USA, Inc..

180 Park Ave., Florham Park, NJ 07932

NUVESSA ^®and its design are trademarks of Exeltis Healthcare S.L.

Revised: 04/2022