What is femhrt?
femhrt is a continuous combined hormone therapy (CCHT) for the treatment of menopause symptoms such as hot flashes/night sweats and the prevention of osteoporosis. femhrt is the only hormone therapy with the estrogen, ethinyl estradiol (EE) and the progestin, norethindrone acetate (NA). These are the same active ingredients found in many birth control pills. In fact, this particular combination has been used in birth control pills for over 40 years.

femhrt is now available in two dosages. Low-Dose femhrt 0.5/2.5 provides half the dose of estrogen and progestin found in femhrt 1/5, (that's one-eighth the estrogen found in the lowest-dose birth control pill.) Low-Dose femhrt 0.5/2.5 is the lowest effective dose approved by the FDA to treat menopausal symptoms with this combination of hormones.

How can it help me?
femhrt provides your body with estrogen, to help relieve your hot flashes and night sweats. The progestin NA in femhrt protects against the increased risk of cancer in the lining of the uterus from the use of estrogen.

femhrt can also help reduce your chances of developing osteoporosis by increasing bone mass. However, if you are using femhrt only to prevent osteoporosis, talk with your healthcare provider to discuss if an alternative treatment without estrogen may be right for you.

Who should not take femhrt?
Do not take femhrt if you have had your uterus removed (hysterectomy).

femhrt contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not take either dose of femhrt.

Do not start taking femhrt if you:

• have unusual vaginal bleeding
• currently have or have had certain cancers
  Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take femhrt.
• had a stroke or heart attack in the past year
• currently have or have had blood clots
• currently have or have had liver problems
• think you may be pregnant
• are allergic to femhrt or any of its ingredients.

How should I take femhrt?
One tablet should be taken each day at around the same time, regardless of whether or not you have eaten. Be sure to follow the specific directions provided by your healthcare provider.

Before you initiate any hormone therapy (HT), be sure to discuss with your healthcare provider your health history as well as the benefits and risks involved with HT. To help provide just the right amount of estrogen/progestin therapy your body needs, femhrt is available in two different doses; (0.5 mg/2.5 mcg and 1 mg/5 mcg). Low-Dose femhrt 0.5/2.5 offers the lowest effective dose of NA/EE to treat menopausal symptoms.

As with all HT, femhrt 1/5 and Low-Dose femhrt 0.5/2.5 should only be used as long as you need it. Be sure to review your treatment progress and goals with your healthcare provider regularly, every three to six months.

What are the possible side effects of femhrt 1/5 and Low-Dose femhrt 0.5/2.5?
Less common but serious side effects include: breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, ovarian cancer.

Common side effects of estrogens and progestins include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss

In clinical studies with femhrt the following side effects were observed:
headache, runny nose, abdominal pain, sinusitis, breast pain, viral infection, muscle pain, diarrhea, nausea and/or vomiting, upset stomach, and back pain. These are not all the possible side effects of femhrt. For more information, ask your healthcare provider or pharmacist.

Please see IMPORTANT SAFETY INFORMATION.

For more information, refer to the PATIENT PRODUCT INFORMATION.