This medication is used to treat infertility in women who do not make enough of a certain natural hormone called progesterone. This hormone is needed to maintain pregnancy.

This medication is also used to restore menstrual cycles in women whose cycles have stopped. Progesterone is needed to keep menstrual periods regular.

Read the Patient Information Leaflet if available from your pharmacist before you start using progesterone gel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for vaginal use only. Remove the wrapper and prepare the applicator for use as shown in the instructions. There are additional instructions for preparing the applicator if you use this medication at altitudes above 2,500 feet (762 meters).

To treat infertility, use this medication as directed by your doctor, usually once or twice a day. If you become pregnant, continue to use this medication for 10-12 weeks as directed until your body is able to make its own progesterone.

If you are using this medication to restore your menstrual cycle, use it as directed by your doctor, usually every other day up to a total of 6 doses.

If you are directed to use any other vaginal products, separate their application from progesterone gel by at least 6 hours.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Bloating, cramps, stomach pain, constipation, diarrhea, nausea, breast swelling/pain, pain around the vaginal area, drowsiness, tiredness, decreased interest in sex, joint pain, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

You may develop a vaginal discharge containing little white balls of gel from using this medication. This is normal and harmless. However, if you develop any unusual vaginal discharge, itching, or odor, 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:

• mental/mood changes (such as depression, nervousness, mood swings)
• swelling of the hands/feet
• increased urination at night
• abnormal vaginal bleeding
• breast lumps
• yellowing of the eyes or skin

This medication, especially if used along with an estrogen product, may rarely cause very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

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 progesterone, tell your doctor or pharmacist if you are allergic to it; 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 medication, tell your doctor or pharmacist your medical history, especially of:

• vaginal bleeding of unknown cause
• personal or family history of cancer (especially breast or cervical cancer)
• a miscarriage with some tissue remaining in the womb
• blood clots
• seizures
• liver disease
• migraines
• asthma
• heart disease
• kidney disease
• depression
• diabetes

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

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). In general, alcohol is not recommended for pregnant or possibly pregnant women due to the increased risk of harm to the baby.

This medication may be used in pregnancy as directed by your doctor. Consult your doctor for more details.

This drug passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use 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.

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.

You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. 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.