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ALORA- estradiol transdermal system patch


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Alora (an Estrogen Hormone)?
  3. Alora Is Used After Menopause To:
  4. Less Common But Serious Side Effects Include:
  5. These Are Some Of The Warning Signs Of Serious Side Effects:
  6. Common Side Effects Include:
  7. Other Side Effects Include:
  8. What Can I Do To Lower My Chances Of Getting A Serious Side Effect With Alora?
  9. Step 2. Before You Apply The Patch Make Sure The Skin At The Spot Is:

Patient Information 

Read this PATIENT INFORMATION before you start usingAlora(ah-LORE-ah) and read what you get each time you refillAlora. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What Is The Most Important Information I Should Know About Alora (an Estrogen Hormone)? 

  • Estrogens increase the chances of getting cancer of the uterus.

    Report any unusual vaginal bleeding right away while you are taking estrogens. 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.
  • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.

    Using estrogens with or without progestins may increase your chances of getting heart attack, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment withAlora.

What isAlora?

Alorais a patch that contains the estrogen hormone estradiol. When applied to the skin as directed below, theAlorapatch releases estrogen through the skin into the abdomen.

Alora Is Used After Menopause To: 

  • Reduce moderate or severe hot flashes.
    Estrogens are hormones made by a woman s ovaries. Between ages 45 and 55, the ovaries normally stop making estrogens. 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 develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating ( hot flashes or hot flushes ). In some women the symptoms are mild and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment withAlora.
  • Treat moderate to severe dryness, itching, and burning in and around the vagina.
    You and your healthcare provider should talk regularly about whether you still need treatment withAlorato control these problems. If you useAloraonly to treat your dryness, itching, and burning 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 which a young woman s ovaries do not produce enough estrogen naturally.
  • Help reduce your chances of getting osteoporosis (thin weak bones).
    Osteoporosis from menopause is a thinning of the bones that makes them weaker and allows them to break more easily. If you useAloraonly to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

    Weight-bearing exercise like walking and running, and taking calcium and vitamin D supplements may lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your healthcare provider before starting them.

Who Should Not Use Alora

Do not useAloraif you:

  • Have unusual vaginal bleeding.
  • Currently have or have had certain cancers.
    Estrogens may increase the risk of certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk to your healthcare provider about whether you should useAlora.
  • 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 Alora or any of the ingredients in it.

Less Common But Serious Side Effects Include: 

  • Breast cancer
  • Cancer of the uterus
  • Stroke
  • Heart attack
  • Blood clots
  • Gallbladder disease
  • Ovarian cancer
  • Dementia

These Are Some Of The Warning Signs Of Serious Side Effects: 

  • Breast lumps
  • Unusual vaginal bleeding
  • Dizziness and faintness
  • Changes in speech
  • Severe headaches
  • Chest pain
  • Shortness of breath
  • Pains in your legs
  • Changes in vision
  • Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common Side Effects Include: 

  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps, bloating
  • Nausea and vomiting
  • Hair loss

Other Side Effects Include: 

  • High blood pressure
  • Liver problems
  • High blood sugar
  • Fluid retention
  • Enlargement of benign tumors of the uterus ( fibroids )
  • Vaginal yeast infection

These are not all the possible side effects ofAlora. For more information, ask your healthcare provider or pharmacist.

What Can I Do To Lower My Chances Of Getting A Serious Side Effect With Alora? 

  • Talk with your healthcare provider regularly about whether you should continue usingAlora.
  • If you have a uterus, talk to your healthcare provider right away about whether the addition of a progestin is right for you. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
  • Before you begin, readallthe information in these 5 steps.

    Step 1. Choose your schedule for twice-a-week application.

    Patch Dosing Schedule

    Put on a new patch twice a week. Use one of the schedules on thebackof thepatch box.

    For example, if you apply your first patch on Sunday, take that patch off on Wednesday and put on a new one. Stay on this schedule as long as you useAlora. To help remind yourself, mark the schedule on the back panel of the patch box. Put a check next to the first day you apply the patch. When you change your patch, don t put the new one in the same place. To help reduce the chance of skin redness or irritation, wait at least 1 week before you reuse a spot.

Step 2. Before You Apply The Patch Make Sure The Skin At The Spot Is: 

  • Freshly washed, butdry and cool(wait a few minutes after taking a hot bath or shower).
  • Free of body powder or lotion.
  • Free of cuts, rashes, or any other skin problem.

Step 3. Choose a spot for the patch

  • Place the patch on the lower abdomen (below the panty line) when you first start using Alora.

    Choose a spot for the patch.
  • As you get used to applyingAlora, you may want to try the hips or buttocks to

    Store at 20-25 C (68-77 F). [

    Each patch contains estradiol, USP as the active component. Inactive components of each patch include sorbitan monooleate, NF; acrylic adhesive; polyethylene film; and siliconized polyester film.

    Keep out of reach of children.

    For all medical inquiries contact:
    Allergan
    Medical Communications
    1-800-678-1605

    Distributed by:
    Allergan USA, Inc.
    Madison, NJ 07940

    Rev. 11/2018

    2018 Allergan. All rights reserved.

    ALORA is a registered trademark of Allergan Sales, LLC

    V1.0MG5885



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