Uses of Progesterone Vaginal 4% Gel:

• It is used to treat females who do not have a monthly period cycle.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Progesterone Vaginal 4% Gel?

• If you have an allergy to progesterone or any other part of progesterone vaginal 4% gel.
• If you are allergic to progesterone vaginal 4% gel; any part of progesterone vaginal 4% gel; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had any of these health problems: Bleeding disorder; blood clots or risk of having a blood clot; breast cancer or other cancer; liver disease; heart attack; stroke; or tumor where estrogen or progesterone make it grow.
• If you have unexplained vaginal bleeding.
• If you have had a recent miscarriage.

This is not a list of all drugs or health problems that interact with progesterone vaginal 4% gel.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take progesterone vaginal 4% gel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Progesterone Vaginal 4% Gel?

• Tell all of your health care providers that you take progesterone vaginal 4% gel. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how progesterone vaginal 4% gel affects you.
• If you have an allergy to any type of nuts or seeds, talk with your doctor.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take progesterone vaginal 4% gel.
• Blood clots have happened with progesterone vaginal 4% gel. These clots have included heart attack, stroke, and clots in the leg, lung, or eye. Sometimes blood clots can be deadly. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• If you are 65 or older, use progesterone vaginal 4% gel with care. You could have more side effects.
• This medicine is not approved for use in children. Talk with the doctor.
• This medicine may stop you from having a period (menstrual bleeding) for some time. This is not a method of birth control.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Progesterone Vaginal 4% Gel) best taken?

Use progesterone vaginal 4% gel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take progesterone vaginal 4% gel by mouth. For vaginal use only. Keep out of your mouth, nose, and eyes (may burn).
• Wash hands before and after use.
• Do not use the applicators more than 1 time.
• Do not take other vaginal drugs within 6 hours of progesterone vaginal 4% gel.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Trouble walking.
• Very bad dizziness or passing out.
• Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Pain when passing urine.
• Passing urine more often.
• Depression or other mood changes.
• Memory problems or loss.
• Seizures.
• Flushing.
• Fast or abnormal heartbeat.
• This medicine may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Progesterone Vaginal 4% Gel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Trouble sleeping.
• More hungry.
• Headache.
• Pimples (acne).
• Hair loss.
• Hair growth.
• Diarrhea or constipation.
• Upset stomach or throwing up.
• Stomach pain or cramps.
• Bloating.
• Enlarged breasts.
• Tender breasts.
• Back, muscle, or joint pain.
• Weight gain or loss.
• Vaginal bleeding or spotting.
• Lowered interest in sex.
• Irritation where progesterone vaginal 4% gel is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Progesterone Vaginal 4% Gel?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about progesterone vaginal 4% gel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.