Nuvessa 1.3 % (65 mg/5 gram) vaginal gel

Generic name:
Metronidazole single dose gel - vaginal

Pronunciation
(MET-roe-NID-a-zole)

Brand name(s)
Nuvessa

This medication is used to treat a certain type of vaginal infection (bacterial vaginosis) in females 12 years of age and older. Metronidazole is an antibiotic that works by stopping the growth of bacteria.

Read the Patient Information Leaflet and the Instructions for Use that come with this product before you start using this medication. If you have any questions, ask your doctor or pharmacist.

This product is for vaginal use only. Wash your hands before and after use. Avoid getting this medication in your eyes. If it gets into your eyes, rinse them with cool water. Call your doctor if eye irritation lasts.

Insert the applicator filled with medication high into the vagina and press the plunger to release the medication. This product is given as a single dose at bedtime.

Tell your doctor if your condition does not get better after several days or if it gets worse.

Although uncommon, dizziness, headache, or mild stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Rarely, vaginal discomfort/itching/discharge may occur or worsen. These symptoms may be due to a new vaginal infection (such as a yeast/fungal infection). Contact your doctor if you notice a change in vaginal discharge or other new vaginal symptoms.

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.

Get medical help right away if you have any very serious side effects, including:

• numbness/tingling of the hands/feet
• seizures

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:

• fever that doesn't go away
• new or worsening lymph node swelling
• 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 using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (such as tinidazole); or if you have any other allergies. This product may contain inactive ingredients (such as paraben preservatives), 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:

• nervous system disorders (such as seizures, numbness/tingling of the hands/feet)

This drug may rarely make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

Do not drink alcohol while using this medication and for at least 24 hours after treatment. Drinking alcohol while using this medication may cause stomach cramps, flushing, nausea, vomiting, and headache.

Do not have vaginal sex or use tampons or douches while using this medication.

During pregnancy, this medication should be used only when clearly needed. Antibiotics taken by mouth have been used to treat vaginal infections during pregnancy, especially high-risk pregnancies (for example, if there is a risk of early childbirth). Consult your doctor for more details and to discuss the risks and benefits.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

See also Precautions section.

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.

Do not use this medication if you have taken disulfiram within the last 2 weeks.

Do not take products containing alcohol or propylene glycol while using this medication and for at least 24 hours after treatment. Ask your pharmacist for more details.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medicine may be harmful if swallowed. 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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Not applicable.

Store at room temperature. Do not refrigerate or freeze. 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.

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.