Progesterone Vaginal insert

What is this medicine?

PROGESTERONE (proe JES ter one) is a female hormone. This medicine is used to help women who are going through an assisted reproductive technology (ART) treatment program to become pregnant.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel disease, blood clotting disorder, or suffered a stroke
• breast, cervical or vaginal cancer
• heart disease
• kidney disease
• liver disease
• miscarriage or abortion
• vaginal bleeding
• an unusual or allergic reaction to progesterone, other hormones, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for vaginal use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

• carbamazepine
• rifampin

Do not use any other vaginal products without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for a regular check on your progress.

This medicine can cause swelling, tenderness, or bleeding of the gums. Be careful when brushing and flossing teeth. See your dentist regularly for routine dental care.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• abnormal vaginal bleeding
• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast tissue changes or discharge
• changes in vision
• chest pain
• confusion, trouble speaking or understanding
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite
• pain, swelling, warmth in the leg
• right upper belly pain
• severe headaches
• shortness of breath
• sudden numbness or weakness of the face, arm or leg
• trouble walking, dizziness, loss of balance or coordination
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• back pain
• depressed mood or mood swings
• increased appetite
• fluid retention and swelling
• nausea, vomiting
• stomach cramps or bloating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.