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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Climara Pro^® (combination of estrogen and progestogen)?

Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (declines of brain function).

Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Using estrogens with progestogens may increase your chance of getting dementia based on a study of women 65 years of age and older.
Using estrogen-alone may increase your chance of getting cancer of the uterus (womb) or breast cancer.
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia.
Using estrogen-alone may increase your chances of getting strokes or blood clots.
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia.
Because other products and doses have not been studied in the same way, it is not known how the use of Climara Pro will affect your chances of these conditions.
You and your healthcare provider should talk regularly about whether you still need treatment with Climara Pro.

Who should not use Climara Pro?

Do not use Climara Pro if you have had your uterus (womb) removed (hysterectomy). Climara Pro contains a progestogen to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and should not use Climara Pro.

Do not start using Climara Pro if you:

Have any unusual vaginal bleeding; have been diagnosed with a bleeding disorder; currently have or have had certain cancers, such as cancer of the breast or uterus (womb); had a stroke or heart attack; currently have or have had blood clots or liver problems; or are allergic to Climara Pro or any of the ingredients in it.

Before using Climara Pro, tell your healthcare provider if you:

Have any unusual vaginal bleeding, have any other medical conditions that may become worse while you are using Climara Pro, are going to have surgery or will be on bed rest, are pregnant or think you may be pregnant or are breastfeeding.

What are possible side effects of Climara Pro?

Serious, but less common side effects of Climara Pro include heart attack, stroke, blood clots, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, dementia, high or low blood calcium, gallbladder disease, visual abnormalities, high blood pressure, cancer changes of endometriosis, high levels of fat (triglyceride) in your blood, liver problems, changes in your thyroid hormone levels, fluid retention, enlargement of benign tumors of the uterus (“fibroids”) and worsening of swelling of face and tongue (angioedema) in women with a history of angioedema.

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

New breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches and severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Common side effects of Climara Pro include:

Headache, breast pain, irregular vaginal bleeding or spotting, stomach or abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, vaginal yeast infection and redness and/or irritation at the patch placement site.

These are not all the possible side effects of Climara Pro. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.

What is Climara Pro^® Used For?

Climara Pro^® contains two kinds of hormones, an estrogen and a progestogen. Climara Pro is used after menopause in women with uterus for:

• Reduce moderate to severe hot flashes.

• Help reduce your chances of getting osteoporosis (thin weak bones) from menopause.

- If you use Climara Pro to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

Climara Pro is available by prescription only.

For important risk and use information, including boxed warning, about Climara Pro, please see the full prescribing information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

For Bayer products, you can report these directly to Bayer by clicking here.

BAYER, the Bayer Cross, and Climara Pro are registered trademarks of Bayer.

All other trademarks are the property of their respective owners.

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