August 3, 2015
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CombiPatch

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CombiPatch

PATIENT INFORMATION

CombiPatch®
(kam-be `pach)
(estradiol/norethindrone acetate transdermal system)

Read this Patient Information before you start using CombiPatch 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.

What is the most important information I should know about CombiPatch (a combination of estrogen and progestin hormones)?

  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia.
  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • Using estrogen-alone may increase your chances of getting stroke or blood clots.
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.

You and your healthcare provider should talk regularly about whether you still need treatment with CombiPatch.

What is CombiPatch?

CombiPatch is a prescription medicine patch (Transdermal System) that contains 2 kinds of hormones, estrogen and progestin.

What is CombiPatch used for?

CombiPatch 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 estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest or sudden strong 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.
  • Treat moderate to severe menopausal changes in and around your vagina
    You and your healthcare provider should talk regularly about whether you still need treatment with CombiPatch to control these problems. If you use CombiPatch only to treat menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
  • Treat certain conditions in women before menopause if their ovaries do not make enough estrogens naturally.
    You and your healthcare provider should talk regularly about whether you still need treatment with CombiPatch.

Who should not use CombiPatch?

Do not use CombiPatch if you have had your uterus (womb) removed (hysterectomy).

CombiPatch contains a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use CombiPatch.

Do not start using CombiPatch if you:

  • have 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.
  • 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. If you have or have had cancer, talk with your health care provider about whether you should use CombiPatch.
  • had a stroke or heart attack
  • currently have or have had blood clots
  • currently have or have had liver problems
  • have been diagnosed with a bleeding disorder
  • are allergic to CombiPatch or any of its ingredients
    See the list of ingredients in CombiPatch at the end of this leaflet.
  • think you may be pregnant
    CombiPatch is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use CombiPatch if the test result is positive and talk to your healthcare provider.

What should I tell my healthcare provider before I use CombiPatch?

Before you use CombiPatch, tell your healthcare provider 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
    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 CombiPatch.
  • are breastfeeding
    The hormones in CombiPatch can pass into your breast milk.

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

How should I use CombiPatch?

  • For detailed instructions, see the step-by-step instructions for using CombiPatch at the end of this Patient Information.
  • Use CombiPatch exactly as your healthcare provider tells you to use it.
  • CombiPatch is for skin use only.
  • Change your CombiPatch 2 times each week or every 3 to 4 days.
  • Apply your CombiPatch to a clean, dry area on your lower abdomen. This area must be clean, dry, and free of powder, oil or lotion for your CombiPatch to stick to your skin.
  • Apply your CombiPatch to a different area of your lower abdomen each time. Do not use the same application site 2 times in the same week.
  • Do not apply CombiPatch to or near your breasts.
  • If you forget to apply a new CombiPatch, you should apply a new CombiPatch as soon as possible.
  • Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time.
  • You and your healthcare provider should talk regularly (every 3 to 6 months) about your dose and whether you still need treatment with CombiPatch.

How do I change CombiPatch?

  • When changing CombiPatch, slowly peel away the used CombiPatch from your skin.
  • After you remove CombiPatch, you may have a small amount of stickiness (adhesive) left on your skin. If you have any adhesive left on your skin after you remove CombiPatch, allow the area to dry for 15 minutes. Gently rub the sticky area of your skin with oil or lotion to remove the adhesive.
  • The new CombiPatch must be applied to a different area of your lower abdomen. This area must be clean, dry, cool and free of powder, oil or lotion. The same site should not be used again for at least 1 week after removal of CombiPatch.

What are the possible side effects of CombiPatch?

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:

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

Less serious, but common side effects include:

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

You may report side effects to Noven at 1-800-455-8070 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with CombiPatch?

  • Talk with your healthcare provider regularly about whether you should continue using CombiPatch.
  • See your healthcare provider right away if you get vaginal bleeding while using CombiPatch.
  • 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 for getting heart disease.

How should I store and throw away used CombiPatch?

  • Store CombiPatch at room temperature between 68°F to 77°F (20°C to 25°C) for up to 6 months.
  • Do not store CombiPatch outside of its pouch.
  • Apply immediately upon removal from the protective pouch.
  • Used patches still contain estrogen and progestin. To throw away the patch, fold the sticky side of the patch together, place in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet.

Keep CombiPatch and all medicines out of the reach of children. General information about the safe and effective use of CombiPatch.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use CombiPatch for conditions for which it was not prescribed. Do not give CombiPatch to other people, even if they have the same symptoms you have. It may harm them.

This leaflet provides a summary of the most important information about CombiPatch. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about CombiPatch that is written for health professionals. You can get more information by calling 1-800-455-8070

What are the ingredients in CombiPatch?

Active Ingredients: estradiol and norethindrone acetate

Inactive Ingredients: acrylic adhesive, silicone adhesive, oleic acid NF, povidone USP, dipropylene glycol, polyester release protective liner and a translucent polyolefin film backing

Instructions for Use

CombiPatch
(kam-be `pach)
(estradiol/norethindrone acetate transdermal system)

Step 1. Pick the days you will change your CombiPatch.

  • You will need to change your patch every 3 to 4 days (twice weekly).

Step 2. Remove CombiPatch from the pouch.

  • Tear open the protective pouch at the slit (do not use scissors) and remove the patch. See Figure A.
  • The pouch should not be opened until you are ready to put the patch on.

Figure A

Tear open the protective pouch - Illustration

Step 3. Remove the adhesive liner.

  • Peel off one side of the protective liner. See Figure B.
  • Do not touch the sticky part of the patch with your fingers. See Figure B.

Figure B

Remove the adhesive liner - Illustration

Step 4. Placing the CombiPatch on your skin.

  • Put the sticky side of the patch on the lower abdomen (below the panty line). See Figure C.
  • Peel off the second side of the protective liner. See Figure C.
  • Press the patch firmly in place with your hand for about 10 seconds. See Figure D.

Figure C

Put the sticky side of the patch on the lower abdomen - Illustration

Figure D

Press the patch firmly - Illustration

Note:

  • Avoid the waistline, since clothing and belts may cause the CombiPatch to be rubbed off.
  • Do not apply the CombiPatch to or near your breasts.
  • Only apply the CombiPatch to skin that is clean, dry, and free of any powder, oil, or lotion.
  • You should not apply the CombiPatch 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 CombiPatch firmly onto your skin.

  • Rub the edges of the CombiPatch with your fingers to make sure that it will stick to your skin. See Figure E.

Figure E

Press the CombiPatch firmly - Illustration

Note:

  • Bathing, swimming, or showering will not affect the CombiPatch.
  • Once in place, the patch should not be exposed to the sun for prolonged periods of time.
  • If your CombiPatch falls off reapply it. If you cannot reapply the CombiPatch, apply a new CombiPatch to another area (See Figures C, D and E) and continue to follow your original placement schedule.
  • If you stop using your CombiPatch or forget to apply a new CombiPatch as scheduled you may have spotting, or bleeding, and your symptoms may come back.

Step 6. Throwing away your used CombiPatch.

  • When it is time to change your CombiPatch, remove the old CombiPatch before you apply a new one.
  • 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.

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

Last reviewed on RxList: 5/27/2015
This monograph has been modified to include the generic and brand name in many instances.

CombiPatch - User Reviews

CombiPatch User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication CombiPatch sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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