Uses of Climara Pro:

• It is used to put off soft, brittle bones (osteoporosis) in women after change of life.
• It is used to prevent or lower the signs of the change of life (menopause).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Climara Pro?

For all patients taking Climara Pro (estradiol and levonorgestrel):

• If you have an allergy to estradiol, levonorgestrel, or any other part of Climara Pro (estradiol and levonorgestrel).
• If you are allergic to Climara Pro (estradiol and levonorgestrel); any part of Climara Pro (estradiol and levonorgestrel); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had any of these health problems: Bleeding disorder, blood clots, a higher risk of having a blood clot, breast cancer, liver problems or liver tumor, heart attack, stroke, or a tumor where estrogen makes it grow.
• If you have ever had a cancer where hormones make it grow.
• If you have unexplained vaginal bleeding.
• If you are pregnant or may be pregnant. Do not take Climara Pro (estradiol and levonorgestrel) if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

Children:

• If the patient is a child. This medicine is not approved for use in children.

This is not a list of all drugs or health problems that interact with Climara Pro (estradiol and levonorgestrel).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Climara Pro (estradiol and levonorgestrel) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Climara Pro?

For all uses of Climara Pro (estradiol and levonorgestrel):

• Tell all of your health care providers that you take Climara Pro (estradiol and levonorgestrel). This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If Climara Pro (estradiol and levonorgestrel) is stopped, your doctor will tell you when to start taking Climara Pro (estradiol and levonorgestrel) again after your surgery or procedure.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• High triglyceride levels have happened with Climara Pro (estradiol and levonorgestrel). Tell your doctor if you have ever had high triglyceride levels.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Climara Pro (estradiol and levonorgestrel).
• Avoid cigarette smoking. Smoking raises the chance of heart disease. Talk with your doctor.
• Limit your drinking of alcohol.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Protect patch from the sun.
• If you are 65 or older, use Climara Pro (estradiol and levonorgestrel) with care. You could have more side effects.

Soft, brittle bones (osteoporosis):

• This medicine works best when used with calcium/vitamin D and weight-bearing workouts like walking or PT (physical therapy).
• Follow the diet and workout plan that your doctor told you about.

How is this medicine (Climara Pro) best taken?

Use Climara Pro (estradiol and levonorgestrel) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Put patch on clean, dry, healthy skin on the lower belly or upper buttocks. Move the site with each new patch.
• Do not put on the breast.
• Do not put the patch on the waistline.
• Do not put on skin that is irritated or damaged. Do not put on an area with skin folds or skin that will be rubbed by tight clothes.
• Do not put on skin where you have just used creams, oils, lotions, powder, or other skin products. The patch may not stick as well.
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
• It is not known how swimming, bathing, or using a sauna affects Climara Pro (estradiol and levonorgestrel). Doing any of these things may affect how well Climara Pro (estradiol and levonorgestrel) works.

What do I do if I miss a dose?

• Put on a missed patch as soon as you think about it after taking off the old one.
• Do not put on more than 1 patch at a time.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• Change in eyesight, eye pain, or very bad eye irritation.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Memory problems or loss.
• Swelling in the arms or legs.
• Very bad irritation where Climara Pro (estradiol and levonorgestrel) is used.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Climara Pro?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Hair loss.
• Back pain.
• Upset stomach or throwing up.
• Cramps.
• Bloating.
• Tender breasts.
• Vaginal bleeding or spotting.
• Irritation where Climara Pro (estradiol and levonorgestrel) is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Climara Pro?

• Store at room temperature.
• Store in pouch until ready for use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Climara Pro (estradiol and levonorgestrel), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.