ESTALIS: ESTALIS packs contain 8 patches. ESTALIS (NETA/17β-estradiol) patches are available in two strengths, called ESTALIS 140/50 and ESTALIS 250/50, each containing and releasing different amounts of estradiol and norethindrone acetate, as follows:

• ESTALIS 140/50: 9 cm² patch, containing 0.620 mg estradiol and 2.70 mg NETA, and releasing around 50 µg estradiol and 140 µg NETA per day.

• ESTALIS 250/50: 16 cm² patch, containing 0.512 mg estradiol and 4.80 mg NETA, and releasing around 50 µg estradiol and 250 µg NETA per day.

  Your doctor will prescribe the patches in a continuous regimen.

  Continuous regimen:

  The ESTALIS patch is worn continuously for the 4 weeks of the cycle. The ESTALIS patches are applied twice weekly on the same days of each week. Each patch should be worn continuously for 3-4 days.

  The next treatment cycle is started immediately after removal of the last ESTALIS patch. Irregular uterine bleeding may occur particularly in the first 6 months, but generally decreases with time.

  It is important that you take your medication as your physician has prescribed. Do not discontinue or change your therapy without consulting your physician first.

  How and where to apply ESTALIS:

  It is recommended that you change the site of application each time the patch is applied. In other words, each time you apply a patch, place it on a different area of your abdomen or buttocks than used before. The same area should not be used again for at least one week. However, each time you apply a patch you should always apply it to the same area of your body (i.e., if the patch is applied to the buttocks, move the patch from right side to left side, twice a week or more if there is any redness under the patch).

  Apply whole patches.

  1. Preparing the skin: In order for the patch to stick, the skin should be clean, dry, cool and free of any powder, moisturizer, lotions or oils. If you wish, you may use body lotion after the patch has been properly applied to the skin. The skin should not be irritated or broken, since this may alter the amount of hormone you get. Contact with water (bath, pool, or shower) should not affect the patch (see Helpful Hints:).

  2. Where to apply the ESTALIS patches: The patches may be applied to the buttocks or abdomen (see Figure 3). Change the site of application each time you put a patch on. A one week period should elapse before applying the patch to a previously used spot.

     Avoid areas of the skin where clothing may rub the patch off or areas where the skin is very hairy or folded. Also avoid areas where the patch is likely to be exposed to the sun since this may affect how the patch works.

     DO NOT APPLY THE PATCHES TO YOUR BREAST, since this may cause unwanted effects and discomfort.

  3. Opening the pouch: The patches contained in ESTALIS are individually sealed in a protective pouch. Tear open this pouch at the indented notch and remove the patch (see Figure 4). Do not use scissors, as you may accidentally cut and destroy the patch.

  4. Removing the liner: One side of the patch has the adhesive that sticks to your skin. The adhesive is covered by a protective liner that must be removed.

     To separate the patch from the liner, hold the patch with the protective liner facing you. Peel off one side of the protective backing and discard it (see Figure 5). Try to avoid touching the sticky side of the patch with your fingers.

     Using the other half of the backing as a handle, apply the sticky side of the system to a dry area of your abdomen or buttocks. Press the sticky side on the skin and smooth down.

     Fold back the remaining side of the patch. Grasp the straight edge of the protective backing and pull it off the patch (see Figure 6). Avoid touching the adhesive.

  5. Applying the ESTALIS patches: Apply the adhesive side to the spot you have chosen. Press it firmly in place with the palm of your hand for about 10 seconds, then run your finger around the edge, making sure there is good contact with the skin. Apply the patch soon after opening the pouch and removing the protective backing.

     ESTALIS should be worn continuously until it is time to replace it with a new patch. You may wish to experiment with different locations when applying a new patch, to find sites that are most comfortable for you, where clothing will not rub against the patch.

  6. When and how to remove the patch: Continuous regimen: The ESTALIS patch should be changed twice weekly. Always change it on the same 2 days of the week. If you forget to change it at the scheduled time, there is no cause for alarm. Just change it as soon as possible and continue to follow your usual schedule.

     After you remove the patch fold it in half with the adhesive sides inwards. Throw it away, safely out of the reach of children or pets.

     Any adhesive left on your skin should rub off easily. You can also use mineral oil, baby oil or rubbing alcohol to remove adhesive from the skin. Apply a new ESTALIS patch on a different spot of clean, dry skin.

     The drug in your patch is contained in the adhesive and not in a special reservoir.

  Helpful Hints:

  What to do if the patch falls off: Should a patch fall off in a very hot bath or shower, shake the water off the patch. Dry your skin completely and reapply the patch as soon as possible (to a different area of skin) and continue your regular schedule. Make sure you choose a clean, dry, lotion-free area of skin. If it still does not stick completely to your skin, then use a new patch. No matter what day this happens, go back to changing this patch on the same days as the initial schedule.

  If hot baths, saunas or whirlpools are something you enjoy and you find that the patch is falling off, you may consider removing the patch temporarily while you are in the water. If you do remove the patch temporarily, the adhesive side of the patch should be placed on the protective liner that was removed when originally applying the patch. Wax paper may be used as an alternate to the liner. This prevents the contents of the patch from emptying by evaporation while you are not wearing it.

  In addition to exposure to very hot water, there are some other causes for the patch failing to stick. If you are having patches fall off regularly, this could be happening as a result of:

  • using any type of bath oil

  • using soaps with a high cream content

  • using skin moisturizers before applying the patch

  Patch adhesion may be improved if you avoid using these products, and by cleansing the site of application with rubbing alcohol before you apply the patch.

  What to do if your skin becomes red or irritated under or around the patch: As with any product that covers the skin for a period of time (such as bandages), the ESTALIS patches can produce some skin irritation in some women. This varies according to the sensitivity of each woman.

  Usually this redness does not pose any health concern to you, but to reduce this problem, you may change the site of application of the ESTALIS patches every time a new patch is applied.

  Experience with another patch, VIVELLE, has shown that if you allow the patch to be exposed to the air for approximately 10 seconds after the protective liner has been removed, skin redness may not occur.

  If redness and/or itching continues, you should consult your physician.

  Always Remember:

  Your doctor has prescribed ESTALIS for you after a careful review of your medical needs. Use it only as directed and do not give it to anyone else.

  Use ESTALIS within 6 months of purchase or before the expiry date shown on the pack, whichever comes first.

  Do not use any ESTALIS pack that is damaged or shows signs of tampering.

  Do not expose the patch to direct sunlight.

  Overdose:

  Symptoms:

  Overdosage with estrogen may cause nausea, breast discomfort, fluid retention, bloating or vaginal bleeding in women.

  Progestin (norethindrone acetate) overdosage may cause depressed mood, tiredness, acne and hirsutism.

  If you suspect an overdose, remove the patch, contact either your doctor, or emergency department of the nearest hospital, or your regional poison control center immediately.

  Missed dose:

  If you forget to change a patch, replace it with another patch as soon as you remember. No matter when this happens, go back to changing this patch on the day as specified on your initial schedule.

  All medicines can have side effects. Sometimes they are serious, most of the time they are not.

  Check with your doctor as soon as possible if any of the following occur:

  Most Common Adverse Drug Reactions (≥1%):

  • back pain or menstrual period-like pain,

  • breast tenderness and excessive vaginal secretions (may be a sign that too much estrogen is taken), vaginal thrush (vaginal fungal infection with severe itching, vaginal discharge),

  • change in weight,

  • headache,

  • intolerable breast tenderness,

  • itching under the patch, reddening of the skin after the patch has been removed (signs of application site reaction includes bleeding, bruising, burning, discomfort, dryness, skin boils, edema, erythema, inflammation, irritation, pain, tiny solid skin bumps, rash, skin discolouration, skin pigmentation, swelling, hives, and blisters),

  • nervousness,

  • pain in extremity,

  • pelvic pain,

  • persistent or severe skin irritation,

  • rash, itching, acne, dryness

  Less Common Adverse Drug Reactions (<1%):

  • breast cancer, abnormal tumour growth related to estrogens (e.g. cancer of the lining of the womb—endometrial cancer),

  • change in your sex drive,

  • gall bladder disease (tendency to form gall stones),

  • painful and/or heavy periods (may be signs of growth of fibroids in uterus),

  • or discoloration of the skin, purple skin patches,

  • swelling of the lower legs, ankles, fingers or abdomen due to fluid retention (oedema) persisting for more than 6 weeks,

  • tingling or numbness

  Adverse Drug Reactions with unknown frequency:

  • tender, red nodules under the skin (most common on the shins),

  • spotty darkening of the skin, particularly on the face or abdomen (chloasma),

  • easy bruising,

  • excessive nose bleeds,

  • sudden contraction of the womb,

  • hair loss,

  • excessive hairiness,

  • decline of memory or mental ability,

  • rapid change in mood,

  • difficulty sleeping,

  • contact lens discomfort,

  • dry eyes,

  • hearing loss,

  • itchy rash

  Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products.

  This particularly includes the following:

  • acetaminophen,

  • aminoglutethimide with medroxyprogesterone acetate (MPA),

  • anti-anxiety medicines (meprobamate, temazepam),

  • cyclosporin,

  • anti-epileptic medicines (e.g. phenobarbital, phenytoin or carbamazepine),

  • an anti-inflammatory medicine called phenylbutazone,

  • antibiotics and other anti-infective medicines (e.g. ketoconazole, erythromycin, rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir), and

  • herbal medicines (e.g. St John’s wort),

  • morphine,

  • prednisone,

  • salicylic acid,

  • theophylline,

  • vitamin C

  These medicines may be affected by ESTALIS or, conversely, they may affect how well ESTALIS works. Your doctor may need to adjust the dose of your treatment.

  Tell your doctor that you are on treatment with ESTALIS if you are going to have laboratory tests. Some laboratory tests, such as tests for glucose tolerance or thyroid function, may be affected by ESTALIS therapy.