What Alora is used for and how to use it
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Alora – Consumer Medicine Information

Manufacture: Actavis
Country: United States
Condition: Atrophic Urethritis, Atrophic Vaginitis, Hypoestrogenism, Postmenopausal Symptoms
Class: Estrogens
Form: Skin patch (transdermal)
Ingredients: estradiol, sorbitan monooleate, NF, acrylic adhesive, polyethylene film, siliconized polyester film

(Estradiol transdermal system)

PATIENT INFORMATION before you start using Alora (ah-LORE-ah) and read what you get each time you refill Alora. 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 an 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, or 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 with Alora

What is Alora?

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

What is Alora used for?

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 with Alora.

  • 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 with Alora to control these problems. If you use Alora only 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 use Alora only 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 use Alora if 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 use Alora.
  • had a stroke or heart attach 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. See the end of this leaflet for a list of ingredients in Alora.
  • think you may be pregnant. Tell your healthcare provider:
  • if you are breastfeeding. The hormone in Alora may pass into your milk.
  • about all of your medical problems. Your healthcare provider may need to check you more carefully in you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Alora works. Alora may also affect how your other medicines work.
  • if you are going to have surgery or will be on bed rest. You may need to stop estrogens.

What Are the Possible Side Effects of Alora?

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 you 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 of Alora. 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 Alora.
  • 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.
  • See your healthcare provider right away if you get vaginal bleeding while using Alora.
  • Have a 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 use Alora?

Before you begin, read all he information in these 5 steps. Step

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

Put on a new patch twice a week. Use one of the schedules on the inside flap of the patch 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 use Alora. To help remind yourself, mark the schedule on the inside flap 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 one week before you reuse a spot.

Step 2. Before you apply the patch

  • Make sure the skin at the spot is:
  • Freshly washed, but dry 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.
  • As you get used to applying Alora, you may want to try the hips or buttocks to see which area works best for you.
  • Do not apply Alora to your breasts or any other parts of your body.

Step 4. How to apply the patch

  • Open the pouch that contains the patch.
  • Locate the notch on the top left or right corner of the pouch.
  • Hold the pouch at the notch and tear off the top edge. Do not cut the pouch with scissors, which might damage the patch inside.
  • Pull the patch out.
  • Apply one half of the patch to your skin.
  • Remove half of the liner, which covers the sticky surface of the patch. To find the liner, bend the patch in half. Then grab the clear straight edge of the liner and pull that piece off.
  • Without touching the sticky surface, press the sticky half of the patch onto your skin. (If you touch the sticky surface, the patch may not stay on as well.)
  • Rub the sticky half firmly to ensure full contact with your skin.
  • Apply the second half of the patch to your skin.
  • Bend the patch back over itself. Press down on the liner firmly.
  • Push the liner forward a little to loosen the edge.
  • Grab the loose edge at either corner and peel off the second piece of the liner. Try not to touch the sticky surface of the patch.
  • Press the entire patch firmly onto the skin with your finger tips.

Press for at least 10 seconds to make sure the patch will stay in place. Be sure all of it sticks to your skin, even around the edges.

To help the patch stay in place:

  • Try not to disturb the patch while putting on and removing clothes. It may help to place the patch where your underwear will cover it at all times.
  • Be careful while changing clothes, washing or drying off, so that you do not catch the patch with your clothes or the towel.
  • Try different sites on the lower abdomen, hips, or buttocks area to see what works well with your body and your clothing.
  • If the patch starts to lift, simply press it back in place.

Step 5. Removing the patch

  • Take off the old patch.
  • Fold it in half (sticky sides together) and throw it away out of the reach of children and pets.

The skin under the old patch may look pink, but the color should fade away soon. In some cases, the skin may itch or look red; this may last from a couple of hours to a couple of days. Most of the time this is minor, and goes away by itself. But if it bothers you a lot or lasts longer than a few days, call your healthcare provider.

For Best Results, Stay with Your Patch Program /p>

  • Replace your patch twice each week, on the two days you have chosen. Until it becomes a habit, try:
    • Marking your schedule on the inside flap of the patch box;
    • Marking the days on your calendar;
    • Linking the days you change your patch to other things that always happen on those days (e.g., an exercise class, meetings, etc.)
  • Handle each patch with care.
    • Make sure the skin is clean, dry, and free of lotion and powder.
    • Try to avoid touching the sticky surface when applying the patch.
    • Be careful while changing clothes, washing or drying off, so that you do not catch the patch with your clothes or the towel.
    • If the patch starts to lift, simply press it back in place.
  • Keep working with your healthcare provider, pharmacist, or other healthcare professional. Ask questions. If you have concerns, talk them over - don't just stop using the patch on your own. Remember, it may take a little time and some experience to get accustomed to using a patch. Estrogens should be used only as long as needed. Start with the lowest dose and talk to your healthcare provider about how well that dose is working for you. You and your health care healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with Alora.
  • Get your refills of the Alora patch before your supply runs out.

How should I store Alora?

Store at 59° - 86° F (15° - 30° C). Do not store patches outside of their pouches. Apply the patch as soon as you take it out of the protective pouch.

General Information about the safe and effective use of Alora

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Alora for conditions for which it was not prescribed. Your healthcare provider has prescribed this drug for you and you alone. Do not give the drug to anyone else. It may harm them. Keep Alora out of the reach of children.

This leaflet provides a summary of the most important information about Alora. If you would like more information, talk with your healthcare provider. You can ask for information about Alora that is written for health professionals. You can also get more information by calling the toll free numbers 1-888-ALORA-4-U (1-888-256-7248).

What are the ingredients in Alora?

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.