Product Description.:
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Tablet , film-coated , white , round round
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Activella? 0.5 mg/0.1 mg is used after menopause in women who have a uterus to reduce moderate to severe hot flashes and help reduce your chances of getting osteoporosis (thin weak bones). If you use Activella? only to prevent osteoporosis, talk to your health care provider about whether a different treatment or medicine without estrogens might be better for you.
Important Safety Information
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ACTIVELLA? (a combination of estrogen and progestin hormones)?
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
Do not use estrogens with or without progestins to prevent dementia. Using estrogens with or without progestins may increase your risk of dementia.
You and your health care provider should talk regularly about whether you still need treatment with Activella?.
In women with a uterus, the use of estrogen alone may increase the chance of getting cancer of the tissue lining the uterus. Therefore, contact your doctor right away if you have unusual vaginal bleeding.
Do not take Activella? if you have had your uterus removed (hysterectomy). Do not start taking Activella? if you have unusual vaginal bleeding, currently have or have had certain cancers (including cancer of the breast or uterus), had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to Activella? 0.5 mg/0.1 mg or Activella? 1.0 mg/0.5 mg or any of their ingredients, think you may be pregnant, or are breast feeding.
In clinical trials, the most commonly reported adverse events (reported at a frequency of ��%) were back pain, pain in arms and legs, headache, nausea, diarrhea, upper respiratory tract infection, uterine thickening, vaginal bleeding, gastroenteritis, insomnia, weight gain, breast pain, uterine fibroid, ovarian cyst, viral infection, fungal infection, and accidental injury.
Estrogens and progestins should be used at the lowest dose possible for your treatment only as long as needed.
ACTIVELLA? is conveniently dosed as one tablet that you take once daily. ACTIVELLA? comes in a 28-day calendar dial pack designed to help you remember to take it every day.
It is very important to take ACTIVELLA? as directed by your health care provider. If you miss a dose, please contact your health care provider.
ACTIVELLA? is a hormone therapy (HT) that contains a combination of two plant-derived hormones?an estrogen and a progestin. ACTIVELLA? supplements the estrogen your body used to produce naturally, to:
* Relieve moderate to severe menopausal symptoms, such as hot flashes
* Relieve vaginal dryness and discomfort associated with menopause (ACTIVELLA? 1.0 mg/0.5 mg only)
* Prevent postmenopausal osteoporosis
How estrogen works
The term estrogen refers to a group of structurally similar hormones that have multiple effects on the female reproductive system. Hormones are chemical messengers that circulate throughout your body, where they can change the function of specific target cells.
Estrogen affects your body in many different ways. For example, estrogen is needed in order for the vagina, uterus, and other female organs to grow and mature during puberty. Estrogen, along with progestin, regulates the changes that occur with each monthly period during your reproductive years and prepares the uterus for pregnancy. Estrogen also stimulates skeletal growth and helps maintain healthy bones after you stop growing.
By supplementing the estrogen that is lost during menopause, ACTIVELLA? helps you treat the symptoms of hot flashes that may result due to insufficient estrogen levels. ACTIVELLA? also has been proven to prevent postmenopausal osteoporosis. If you use ACTIVELLA? only to prevent osteoporosis from menopause, talk with your doctor about whether a different treatment or medicine without estrogens might be better for you.
How progestin works
The term progestin refers to a group of hormones that have actions similar to progesterone. As with estrogen, most of the progesterone in your body is made by your ovaries. Progestins work in the female reproductive tract, breasts, pituitary gland, hypothalamus, and brain.
Progestins generally oppose the actions of estrogen. This is the primary reason that ACTIVELLA? combines a progestin with an estrogen to treat postmenopausal symptoms. For postmenopausal women with an intact uterus, taking estrogen alone (estrogen therapy, or ET) has been associated with increased risk of uterine cancer. Taking progestin in addition to estrogen (h
