Progesterone Oral capsule

What is this medicine?

PROGESTERONE (proe JES ter one) is a female hormone. This medicine is used to prevent the overgrowth of the lining of the uterus in women who are taking estrogens for the symptoms of menopause. It is also used to treat secondary amenorrhea. This is when a woman stops getting menstrual periods due to low levels of progesterone.

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:

• autoimmune disease like systemic lupus erythematosus (SLE)
• blood vessel disease, blood clotting disorder, or suffered a stroke
• breast, cervical or vaginal cancer
• dementia
• diabetes
• kidney or liver disease
• heart disease, high blood pressure or recent heart attack
• high blood lipids or cholesterol
• hysterectomy
• recent miscarriage
• tobacco smoker
• vaginal bleeding
• an unusual or allergic reaction to progesterone, peanuts, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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.

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

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bosentan

This medicine may also interact with the following medications:

• barbiturate medicines for sleep or seizures
• bexarotene
• carbamazepine
• ethotoin
• ketoconazole
• phenytoin
• rifampin

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 regular checks 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.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast tissue changes or discharge
• changes in vaginal bleeding during your period or between your periods
• depression
• muscle or bone pain
• numbness or pain in the arm or leg
• pain in the chest, groin or leg
• seizures or tremors
• severe headache
• stomach pain
• sudden shortness of breath
• unusually weak or tired
• vision or speech problems
• yellowing of skin or eyes

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

• acne
• fluid retention and swelling
• increased in appetite
• mood changes, anxiety, depression, frustration, anger, or emotional outbursts
• nausea, vomiting
• sweating or hot flashes

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). Protect from light. Keep container tightly closed. 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.