This medication contains a hormone called progesterone. Progesterone and other hormones help you become and stay pregnant. This medication is used to increase the level of progesterone in women taking fertility treatments because these treatments tend to decrease progesterone levels.

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

This medication is for vaginal use only. Unwrap the suppository. Following the instructions, use the applicator to insert this medication into the vagina as directed by your doctor, usually 2 or 3 times a day. If you become pregnant, continue to use this medication for up to a total of 10 weeks or as directed by your doctor.

Dosage is based on your medical condition and response to treatment.

To get the most benefit from this medication, use it regularly at evenly spaced intervals. To help you remember, use it at the same times each day.

Bloating, stomach/abdominal pain, nausea, breast tenderness, headache, drowsiness, mood swings, irritability, or vaginal discomfort may occur. If any of these effects last or get 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:

• unusual vaginal bleeding
• severe mental/mood changes (such as depression)
• swelling ankles/feet
• yellowing eyes/skin
• breast lumps

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, legs, or eyes). Get medical help right away if you have:

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

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:

• blood clots
• liver disease
• cancer (especially of the breast or other female organs)
• vaginal bleeding of unknown cause
• a loss of pregnancy with some tissue remaining in the uterus ("missed abortion")
• an abnormal pregnancy where the fertilized egg is outside of the uterus (ectopic pregnancy)
• kidney disease
• heart disease (such as past heart attacks, heart failure)
• high blood pressure
• seizures
• migraine headaches
• asthma
• depression
• diabetes
• strokes
• high level of fats in the blood (high cholesterol/triglycerides)

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 or clear vision 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 increased risk of harm to the baby.

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

This medication may be used during pregnancy, but only as directed by your doctor. Discuss the risks and benefits with your doctor.

This drug 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.

Do not use other vaginal products during treatment with this medication unless otherwise directed by your doctor. Doing so may affect how well the drug is absorbed by your body.

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.

Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. However, do not use more doses in a day than prescribed. 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.