lactic acid 1.8 %-citric ac 1 %-potassium bitartate 0.4 % vaginal gel

Generic name:
Lactic acid/citric acid/potassium bitartrate - vaginal

Pronunciation
(LAK-tik AS-id/SIT-rik AS-id/poe-TAS-ee-um bye-TAR-trate)

Brand name(s)
Phexxi

This product is used to prevent pregnancy. It contains 3 medications: lactic acid, citric acid, and potassium bitartrate. It works mainly by lowering the acid-base balance (pH) of the vagina which prevents the sperm from reaching an egg (fertilization).

This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity.

This product must be used within 1 hour before vaginal intercourse to work well. It will not work if it is used after vaginal intercourse.

Read the Patient Information Leaflet and the Instructions for Use that come with this product before you start using this product. 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.

Use this product as directed by your doctor, usually within 1 hour before vaginal intercourse. Insert the applicator filled with medication into the vagina and press the plunger to release the product.

Use a new applicator each time you have vaginal intercourse. If you have vaginal intercourse more than 1 time within 1 hour, use a new applicator each time.

Vaginal burning or itching may occur. If this effect 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.

Tell your doctor right away if you have any serious side effects, including:

• signs of a vaginal infection (such as unusual vaginal discharge/odor)
• signs of a urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine, fever)

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 using this product, tell your doctor or pharmacist if you are allergic to lactic acid, citric acid, or potassium bitartrate; 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 product, tell your doctor or pharmacist your medical history, especially of:

• urinary tract problems (such as recurring urinary tract infections)

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

This product must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

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

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.

A product that may interact with this drug is:

• a certain birth control device (vaginal ring)

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. Keep the medication in the original foil pouch until ready to use. 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.