Potassium bitartrate

What it is used for

• PHEXX is a prescription medicine used to prevent pregnancy in females who can become pregnant and choose to use an on-demand method of birth control.
• PHEXX is not effective at preventing pregnancy when used after vaginal sex.

How to take it

• See the Instructions for Use that come with PHEXX for detailed instructions on the right way to use PHEXX.
• PHEXX exactly as your healthcare provider tells you to use it.
• PHEXX must be used before vaginal sex.
• PHEXX comes as a pre-filled single-dose vaginal applicator.
• Insert 1 PHEXX pre-filled applicator into your vagina and use PHEXX within 1 hour before each time you have vaginal sex. If you do not have vaginal sex within 1 hour of using PHEXX, you must insert a new PHEXX pre-filled applicator.
• If you have vaginal sex more than 1 time within 1 hour, you must use a new PHEXX pre-filled applicator.
• PHEXX may be used at any time during the menstrual cycle.
• PHEXX may be used as soon as your healthcare provider tells you it is safe for you to have vaginal sex after childbirth, abortion, or miscarriage.
• PHEXX may be used with hormonal contraceptives; and latex, polyurethane, and polyisoprene condoms. PHEXX may be used with a vaginal diaphragm. Avoid using PHEXX with contraceptive vaginal rings.
• PHEXX may be used with other medicines used in the vagina to treat infections including miconazole, metronidazole, and tioconazole.

Side effects, and when to stop

PHEXX may cause serious side effects, including:

• Bladder infection (cystitis) and acute kidney infection (pyelonephritis). Urinary tract infections are common but can also be serious. You should not use PHEXX if you have a history of urinary tract infections that keep coming back or other problems with your urinary tract. Call your healthcare provider if you have burning with urination or other signs and symptoms of a urinary tract infection such as: burning feeling when passing urine, urine that looks cloudy, pain in the pelvis, or back pain.
• Allergic reactions. Avoid using PHEXX if you are a female who can become pregnant and are allergic to lactic acid, citric acid, potassium bitartrate or any of the ingredients in PHEXX; or your sexual partners are allergic to any of the ingredients in PHEXX. Stop using PHEXX if you have a local vulvovaginal reaction.

The most common side effects of PHEXX include:

• vaginal burning
• vaginal itching
• vaginal yeast infection
• discomfort around the vaginal area
• bacterial vaginosis
• vaginal discharge
• discomfort in the genital area
• pain while passing urine

These are not all the possible side effects of PHEXX.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storing it

• Store PHEXX at room temperature between 68°F to 77°F (20°C to 25°C).
• Store PHEXX in the original foil pouch.

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

General information about the safe and effective use of PHEXX.

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

You can ask your healthcare provider or pharmacist for information about PHEXX that is written for health professionals.

How well does PHEXX work?

Your chance of getting pregnant depends on how well you follow the directions for using PHEXX. The better you follow the directions, the less chance you have of getting pregnant. It is very important that you follow the directions carefully each time you have vaginal sex.

PHEXX does not protect against HIV infection or other sexually transmitted infections (STIs).

Before using PHEXX, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or think you are pregnant. PHEXX is not for use in pregnant women.
• are breastfeeding or plan to breastfeed. It is not known if PHEXX passes into your breast milk.

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

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.