Patient information: uses, side effects, how to take - Climara Pro

What is the most important information I should know about Climara Pro (a 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).
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.

What is Climara Pro?

Climara Pro is a prescription medicine patch (transdermal system) that contains two kinds of hormones, an estrogen and a progestogen.

What is Climara Pro used for?

Climara Pro is used after menopause to:

Reduce moderate to severe hot flashes
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause."
When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe.
Help reduce your chances of getting osteoporosis (thin weak bones)
Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. 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.
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 progestogen and you should not use Climara Pro.

Do not start using Climara Pro if you:

have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
have been diagnosed with a bleeding disorder
currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use Climara Pro.
had a stroke or heart attack
currently have or have had blood clots
currently have or have had liver problems
are allergic to Climara Pro or any of the ingredients in it.
See the list of ingredients in Climara Pro at the end of this leaflet.

Before you use Climara Pro, tell your healthcare provider about all of your medical conditions, including if you:

have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
have any other medical conditions that may become worse while you are using Climara
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop using Climara Pro.
are pregnant or think you may be pregnant.
Climara is not for pregnant women.
are breastfeeding
The hormones in Climara Pro can pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Climara Pro works. Climara Pro may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Climara Pro?

For detailed instructions, see the step-by-step instructions for using Climara Pro at the end of this Patient Information.

Use Climara Pro exactly as your healthcare provider tells you to use it.
Climara Pro is for skin use only.
Change your Climara Pro patch 1 time each week or every 7 days.
Apply your Climara Pro patch to a clean, dry area on your lower abdomen or buttocks. This area must be clean, dry, and free of powder, oil or lotion for your patch to stick to your skin.
Apply your Climara Pro patch to a different area of your abdomen or your buttocks each time. Do not use the same application site 2 times in the same week.
Do not apply Climara Pro to your breasts.
If you forget to apply a new Climara Pro, apply a new patch as soon as possible.
You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are using and whether you still need treatment with Climara Pro.

How do I change Climara Pro?

When changing Climara Pro, peel off the used patch slowly from the skin.
After removal of Climara Pro, if any adhesive residue remains on your skin after removing the patch, allow the area to dry for 15 minutes. Then, gently rub the area with an oil-based cream or lotion to remove the adhesive from your skin.
Apply the new patch to a different skin area of your lower abdomen or buttocks. This area must be clean, dry, and free of powder, oil or lotion. Do not use the same site again for at least 1 week after removal of the patch.

What are the possible side effects of Climara Pro?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

heart attack
stroke
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

blood clots
breast cancer
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")
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
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
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.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937.

What can I do to lower my chances of a serious side effect with Climara Pro?

Talk with your healthcare provider regularly about whether you should continue using Climara Pro.
If you have a uterus, talk with your healthcare provider about whether Climara Pro is right for you. In general, the addition of a progestogen is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
See your healthcare provider right away if you get vaginal bleeding while using Climara Pro.
Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease.

How should I store and throw away used Climara Pro?

Store at room temperature between 68°F to 77°F (20°C to 25°C).
Do not store Climara Pro patches outside of their pouches. Apply immediately after removal from the protective pouch.
Used patches still contain estrogen. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet.

KEEP CLIMARA PRO and all medicines out of the reach of children.

General information about the safe and effective use of Climara Pro.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Climara Pro for conditions for which it was not prescribed. Do not give Climara Pro to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Climara Pro that is written for health professionals. For more information, go to www.climara-us.com or call Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937.

What are the ingredients in Climara Pro?

Active ingredient: estradiol and levonorgestrel

Inactive ingredient: acrylate copolymer adhesive, and polyvinylpyrrolidone/vinyl acetate copolymer.

Instructions for Use

Climara Pro (Klī-mâr-uh prō)

(estradiol transdermal system)

Read this Patient Information before you start using Climara Pro and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

You will need the following supplies: See Figure A

Figure A

Step 1: Pick the days you will change your Climara Pro.

You will need to change your patch 1 time each week or every 7 days.

Step 2. Remove the Climara Pro patch from the pouch.

Remove patch from its protective pouch by tearing at the notch (do not use scissors). See Figure B
Do not remove your patch from the protective pouch until you are ready to apply it.

Figure B

Step 3. Remove the adhesive liner. See Figure C

You will see that Climara Pro is an oval shaped clear patch that is attached to a thick, hard-plastic adhesive liner and covered by a clear, plastic film. See Figure C
To apply your patch you must first remove the protective, clear plastic film that is attached to the clear thicker plastic backing. See Figure D


Figure C	Figure D

Step 4. Placing the patch on your skin.

Apply the sticky side of the patch to one of the areas of skin shown below. See Figure E and Figure F
Do not touch the sticky side of the patch with your fingers.


Figure E	Figure F

Note:

Avoid the waistline, since clothing and belts may cause the patch to be rubbed off.
Do not apply Climara Pro to your breasts.
Only apply Climara Pro to skin that is clean, dry, and free of any powder, oil, or lotion.
You should not apply the patch to injured, burned, or irritated skin, or areas with skin conditions (such as birth marks, tattoos, or that is very hairy).

Step 5. Press the patch firmly onto your skin.

Press the patch firmly in place with your fingers for at least 10 seconds
Rub the edges of the patch to make sure that it will stick to your skin. See Figure G

Figure G

Note:

Contact with water while you are swimming, using a sauna, bathing, or showering may cause the patch to fall off.
If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area (See Figures E and F ) and continue to follow your original application schedule.
If you stop using your Climara Pro or forget to apply a new patch as scheduled, you may have spotting, or bleeding, and your symptoms may come back.

Step 6: Throwing away your used patch.

When it is time to change your patch, remove the old patch before you apply a new patch.
To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Do not flush used patches in the toilet.

This Patient Information and Instructions for Use have been approved by the U.S Food and Drug Administration.

Revised: 3/2023

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.

Whippany, NJ 07981

Manufactured by:

Kindeva Drug Delivery L.P.

Northridge CA, 91324

Climara Pro: Uses, Side Effects and Dosage