Progesterone is a type of hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (such as fibroids, cancer of the uterus).

Progesterone must not be used to test for pregnancy.

Progestins are not effective in preventing miscarriages.

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

This medication is given by injection into a muscle as directed by your doctor, usually once daily. This medication is usually given for 6 to 8 days. Dosage is based on your medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Before injecting each dose, the injection site should be cleaned with rubbing alcohol. It is important to change the location of the injection site daily to avoid problem areas in the muscle.

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

Tell your doctor if your condition lasts or gets worse.

Pain/swelling at injection site, breast tenderness, headache, weight gain/loss, acne, nausea, increased body/facial hair, loss of scalp hair, drowsiness, or dizziness 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:

• nausea/vomiting that doesn't stop
• unusual vaginal bleeding/discharge (such as breakthrough bleeding, spotting)
• stopped menstrual periods (amenorrhea)
• breast lumps
• swelling of the ankles/feet
• mental/mood changes (such as depression, nervousness)
• dark patches on the skin/face
• frequent/painful urination
• dark urine
• yellowing eyes/skin
• stomach/abdominal pain

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
• pain/swelling/warmth in the groin/calf
• shortness of breath/rapid breathing
• sudden/severe headaches
• sudden dizziness/fainting
• 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
• fever

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 (such as sesame oil), 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
• history of bleeding in the brain
• 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")
• migraine headaches
• seizures
• asthma
• heart disease (such as coronary artery disease, heart failure)
• kidney disease
• depression
• diabetes
• high blood levels of cholesterol/triglycerides

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or 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).

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 product 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 medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

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.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are using this medication. 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.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Consult the product instructions and your pharmacist for storage details. 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.