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Brand Names: Premphase, Prempro

Generic Name: conjugated estrogens and medroxyprogesterone (Pronunciation: KON joo GAY ted ES troe jenz and me DOX ee proe JES ter one)

• What are conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
• What are the possible side effects of conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
• What is the most important information I should know about conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
• What should I discuss with my healthcare provider before taking conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
• How should I take conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
• What happens if I miss a dose (Prempro, Premphase)?
• What happens if I overdose (Prempro, Premphase)?
• What should I avoid while taking conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
• What other drugs will affect conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
• Where can I get more information?

What are conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?

Conjugated estrogens are a mixture of estrogen hormones. Estrogen is a female sex hormone produced by the ovaries that is necessary for many processes in the body.

Medroxyprogesterone is also a female hormone, usually called "progesterone." It is important for the regulation of ovulation and menstruation.

Together, conjugated estrogens and medroxyprogesterone are used to treat the symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation, and to prevent thinning of the bones (osteoporosis).

Conjugated estrogens and medroxyprogesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Conjugated estrogens and medroxyprogesterone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• pain or swelling in your lower leg;
• abnormal vaginal bleeding;
• migraine headache;
• pain, swelling, or tenderness in your stomach;
• confusion, problems with memory or concentration;
• jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet; or
• a breast lump.

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach pain;
• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin;
• acne, increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge;
• changes in your menstrual periods, decreased sex drive; or
• headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?

Do not use this medication if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer.

This medication can cause birth defects in an unborn baby. Do not use conjugated estrogens and medroxyprogesterone if you are pregnant.

Long-term treatment with conjugated estrogens and medroxyprogesterone may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using this medication long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using conjugated estrogens and medroxyprogesterone.

Conjugated estrogens and medroxyprogesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.