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Progesterone Micronized

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Warning

Progesterone is sometimes used with another medication (a type of estrogen) as combination hormone replacement therapy (HRT) in women after menopause. Combination HRT may rarely cause very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs), dementia, and breast cancer. Some of these risks appear to depend on the length of treatment and other factors. Combination HRT should be used for the shortest possible length of time at the lowest effective dose so you can obtain the benefits and minimize the chance of serious side effects from long-term treatment. Combination HRT should not be used to prevent heart disease or dementia. Discuss the risks and benefits of treatment and your personal health history with your doctor. If you take combination HRT, check with your doctor regularly (such as every 3-6 months) to see if you still need to take it.

If you use this medication for an extended period, you should have a complete physical exam at regular intervals (such as once a year) or as directed by your doctor. See also Notes section.

Precautions

See also Warning section.

Before taking 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 peanut 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, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), personal or family history of cancer (especially breast or other female organs), kidney disease, obesity, heart disease (such as past heart attacks, coronary artery disease, heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes, smoking, lupus.

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).

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 may be used during pregnancy 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.

Side Effects

See also Warning section.

Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, or drowsiness may occur. If any of these effects last or get worse, notify 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 (such as spotting, breakthrough bleeding), mental/mood changes (such as depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness.

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.