Sandoz Estradiol Derm 50: Uses, Side Effects and Dosage

Serious warnings and precautions box

The Women’s Health Initiative (WHI) trial is a large clinical study that assessed the benefits and risks of oral combined estrogen plus progestin therapy and oral estrogen-alone therapy compared with placebo (a pill with no active ingredients) in postmenopausal women.

The WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women taking oral combined estrogen plus progestin.

The WHI trial indicated an increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) taking oral estrogen-alone.

Therefore, you should highly consider the following:

• There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.
• There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.
• Estrogens with or without progestins should not be used for the prevention of heart disease or stroke.
• Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of time possible. Regular medical follow-up is advised.

What SANDOZ ESTRADIOL DERM is used for:

• The relief of menopausal and postmenopausal symptoms.
• The prevention of osteoporosis due to a lack of estrogens occurring naturally or caused by a surgery (removal of uterus). In postmenopausal women already diagnosed as having osteoporosis and vertebral fractures, treatment with SANDOZ ESTRADIOL DERM may delay further bone loss.

SANDOZ ESTRADIOL DERM should not be used in women who still have their uterus unless it is taken with a progestin. Some women are more likely to develop osteoporosis after menopause than others. If you have been prescribed SANDOZ ESTRADIOL DERM only for the prevention of osteoporosis you should discuss other alternative therapies with your healthcare professional. These include adequate diet, calcium and vitamin D intake, cessation of smoking and regular physical weight-bearing exercise.

You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your healthcare professional. You should regularly talk with your healthcare professional about whether you still need treatment with HRT.

How SANDOZ ESTRADIOL DERM works:

The main estrogen produced by your ovaries prior to menopause is estradiol, and this is the same estrogen that is in SANDOZ ESTRADIOL DERM. When applied to the skin, the SANDOZ ESTRADIOL DERM patch continually releases small, controlled quantities of estradiol, which pass through your skin and into your bloodstream. This offers relief from menopausal symptoms. It also slows down bone loss and may prevent bones from breaking. The amount of estrogen prescribed depends on your body's needs. Your healthcare professional can adjust the amount you get by prescribing different patch sizes.

Your body normally makes estrogens and progesterone (female hormones) mainly in the ovaries. Between ages 45 and 55, the ovaries gradually stop making estrogens. This leads to a decrease in body estrogen levels and a natural menopause (the end of monthly menstrual periods). If both ovaries are removed during an operation before natural menopause takes place, the sudden decrease in estrogen levels causes “surgical menopause”.

Menopause is not a disease - it is a natural life event and different women experience menopause and its symptoms differently. Not all women suffer obvious symptoms of estrogen deficiency. When the estrogen levels begin decreasing, 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”). Using estrogen drugs can help the body adjust to lower estrogen levels and reduce these symptoms.

Osteoporosis: The bones of both men and women start to thin after about age 40, but women lose bone faster after menopause. Using estrogens after menopause slows down bone thinning and may prevent bones from breaking.

The ingredients in SANDOZ ESTRADIOL DERM are:

Medicinal ingredient: estradiol-17β (as estradiol hemihydrate)

Non-medicinal ingredients: acrylic copolymers and tocopherol contained on a polyethylene terephthalate film.

SANDOZ ESTRADIOL DERM comes in the following dosage forms:

SANDOZ ESTRADIOL DERM is a patch that is applied to the skin. It is available in three sizes, each containing and releasing different amount of estradiol as follows:

• SANDOZ ESTRADIOL DERM 50: oval, transparent 20 cm² patch, containing 4 mg of estradiol (as hemihydrate), which delivers 50 mcg of estradiol per day.
• SANDOZ ESTRADIOL DERM 75: oval, transparent 30 cm² patch, containing 6 mg of estradiol (as hemihydrate), which delivers 75 mcg of estradiol per day.
• SANDOZ ESTRADIOL DERM 100: oval, transparent 40 cm² patch, containing 8 mg of estradiol (as hemihydrate), which delivers 100 mcg of estradiol per day.

Do not use SANDOZ ESTRADIOL DERM if:

• you are allergic to estradiol or any of the non-medicinal ingredients in SANDOZ ESTRADIOL DERM or a component of the container (see What are the ingredients in SANDOZ ESTRADIOL DERM?)

• you are pregnant or think you may be pregnant. Since pregnancy may be possible early in menopause while you are still having spontaneous periods, you should talk to your healthcare professional about using non-hormonal birth control. If you take estrogen during pregnancy, there is a small risk of your unborn child having birth defects.

• you are breastfeeding. Talk to your healthcare professional about how to feed your baby.
• you have or have a history of cancer of the breast, uterus or endometrium (lining of the womb) or any other cancer which is sensitive to estrogens.
• you have been diagnosed with an overgrowth of the lining of the uterus (endometrial hyperplasia).
• you have unusual vaginal bleeding without a known reason.
• you have inflamed varicose veins (thrombophlebitis).
• you have or have a history of blood clots in the legs or somewhere else in your body.
• you have or have a history of heart attack, stroke or coronary heart disease (including angina pectoris).
• you have serious liver disease.
• you have or have a history of migraines.
• you have had partial or complete loss of vision due to blood vessel disease of the eye.
• you have a disease of blood pigment called porphyria.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SANDOZ ESTRADIOL DERM. Talk about any health conditions or problems you may have, including if you:

• have a history of severe allergic reaction or intolerance to any medications or other substances;
• have been told that you have a condition called hereditary or acquired angioedema or if you have had episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage) or digestive tract;
• have a history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer;
• have uterine fibroids or endometriosis;
• have or have a history of liver disease or liver tumours, jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy;
• have high blood pressure;
• have a family history of blood clots, heart disease or stroke;
• have inflamed varicose veins (phlebitis);
• have kidney problems;
• have asthma;
• have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus);
• have or have a family history of diabetes;
• have systemic lupus erythematous. This is a disease of the immune system that affects the joints, skin, kidneys, blood cells, brain, heart and lungs.
• have gall bladder disease;
• have a history of depression;
• have hearing loss due to otosclerosis. This is a condition caused by abnormal bone growth in the middle ear.
• have a history of epilepsy (seizures) or other neurological disorders;
• have high cholesterol or high triglycerides;
• have had a hysterectomy (surgical removal of the uterus);
• smoke;
• are undergoing surgery or need long bed rest;
• have had several miscarriages;
• have hypothyroidism. This is a condition in which your thyroid gland does not produce enough thyroid hormone.

Other warnings you should know about:

Cancer:

• Breast cancer:

  There is an increased risk for breast cancer in women taking menopausal hormone therapy (MHT) for many years. The risk increases the longer you take MHT and persists for more than 10 years after stopping treatment with both estrogen plus progestin therapy and estrogen-alone therapy.

  The results of the WHI trial indicated an increased risk of breast cancer in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

  The results of the WHI trial indicated no difference in the risk of breast cancer in postmenopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

  Estrogens should not be taken by women who have a personal history of breast cancer.

  In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies or abnormal mammograms (breast x-rays) should talk to their healthcare professional before starting hormone replacement therapy (HRT).

  Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their healthcare professional.

  Regular breast examinations by a healthcare professional and regular breast self-examinations are recommended for all women. You should review techniques for breast self-examination with your healthcare professional.

• Ovarian cancer:

  In some studies, the use of estrogen-alone and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer.

Overgrowth of the lining of the uterus and cancer of the uterus:

The use of estrogen-alone therapy by postmenopausal women who still have a uterus increases the risk of developing endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the uterus).

If you still have your uterus, you should take a progestin medication (another hormone drug) regularly for a certain number of days of each month to reduce the risk of endometrial hyperplasia.

You should discuss progestin therapy and risk factors for endometrial hyperplasia and endometrial carcinoma with your healthcare professional. You should also report any unexpected or unusual vaginal bleeding to your healthcare professional.

If you have had your uterus removed, you are not at risk of developing endometrial hyperplasia or endometrial carcinoma. Progestin therapy is therefore not generally required in women who have had a hysterectomy.

Heart disease and Stroke:

The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

Abnormal blood clotting:

The results of the WHI trial indicated an increased risk of blood clots in the lungs and large veins in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated an increased risk of blood clots in the large veins, but no difference in the risk of blood clots in the lungs in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

The risk of blood clots also increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your healthcare professional since blood clots can be life-threatening or cause serious disability.

Gallbladder disease:

The use of estrogens by postmenopausal women has been associated with an increased risk of gallbladder disease requiring surgery.

Dementia:

The Women’s Health Initiative Memory Study (WHIMS) was a sub-study of the WHI trial and indicated an increased risk of dementia (loss of memory and intellectual function) in post-menopausal women age 65 and over taking oral combined estrogen plus progestin compared to women taking placebo.

The WHIMS indicated no difference in the risk of dementia in post-menopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

Check-ups and Tests:

SANDOZ ESTRADIOL DERM should be used only under the supervision of a healthcare professional, with regular follow-up visits, at least once a year, to check for side effects associated with its use. Your first follow-up visit should be within 3 to 6 months of starting treatment. Your visit may include a blood pressure check, a breast exam, a Pap smear and pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your healthcare professional. Your healthcare professional may recommend some blood tests.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SANDOZ ESTRADIOL DERM:

• medicines used to help you relax or sleep such as barbiturates, meprobamate, temazepam;
• medicines used for the treatment of epilepsy such as phenobarbital, phenytoin, carbamazepine, lamotrigine;
• medicines used to treat fever, pain or inflammation such as phenylbutazone, acetaminophen, salicylic acid;
• medicines used to treat bacterial infections such as erythromycin;
• medicines used in the treatment of tuberculosis such as rifampicin, rifabutin;
• herbal products containing St John’s wort (Hypericum perforatum) used to treat depression and other conditions;
• medicines used to treat fungal infections such as ketoconazole;
• medicines used for the treatment of HIV and AIDS such as nevirapine, efavirenz, ritonavir;
• some nutritional supplements such as vitamin C;
• aminoglutethimide with medroxyprogesterone acetate (MPA), often used together for the treatment of breast cancer;
• medicines used to lower cholesterol such as atorvastatin, clofibric acid;
• medicines used to prevent organ rejection such as cyclosporin;
• morphine, used for the treatment of severe pain;
• prednisolone, a corticosteroid used to treat a variety of conditions including allergies and inflammation;
• medicines used to treat lung and breathing problems such as theophylline;
• insulin and other medicines used to treat diabetes such as troglitazone;
• medicines used to thin the blood and prevent blood clots;
• medicines used to lower high blood pressure;

• alcohol.

Tell your healthcare professional that you are being treated with SANDOZ ESTRADIOL DERM if you are going to have laboratory tests. Some laboratory tests, such as tests for glucose tolerance or thyroid function, may be affected by SANDOZ ESTRADIOL DERM therapy.

How to use SANDOZ ESTRADIOL DERM:

1. 1. Preparing the Skin

In order for the patch to stick, the skin should be clean, dry and free of creams, 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) won't affect the patch, although very hot water or steam may loosen it and therefore should be avoided (see Helpful Hints).

1. 2. Where to Apply the SANDOZ ESTRADIOL DERM Patch

The buttock is the preferred place to apply the patch. The patches may also be applied to the sides, hip, lower back or lower abdomen (see Figure 1). Change the site of application each time you put a patch on. You can use the same spot more than once but not twice in a row.

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 often if there is any redness under the patch).

Figure 1

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 SANDOZ ESTRADIOL DERM TO YOUR BREAST, since this may cause unwanted effects and discomfort.

1. 3. Opening the Pouch

Each SANDOZ ESTRADIOL DERM patch is individually sealed in a protective pouch. Tear open this pouch at the indented notch and remove the patch (see Figure 2). Do not use scissors, as you may accidentally cut and destroy the patch. There may or may not be bubbles in the patch, this is normal.

Figure 2

1. 4. Removing the Liner

Make sure that you have removed your old patch before applying the new one.

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 liner and discard it (see Figure 3). Try to avoid touching the sticky side of the patch with your fingers.

Figure 3

Using the other half of the liner as a handle, apply the sticky side of the patch to a dry area of intact skin on the trunk of the body. 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 4). Avoid touching the adhesive.

Figure 4

Don't worry if the patch buckles slightly. You can flatten it out after the liner has been removed. Apply the patch soon after opening the pouch and removing the liner.

1. 5. Applying the SANDOZ ESTRADIOL DERM Patch

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. The patch should be worn continuously until it is time to remove it or 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.

1. 6. When and How to Remove the Patch

The SANDOZ ESTRADIOL DERM 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 and sight 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 SANDOZ ESTRADIOL DERM patch on a different spot of clean, dry skin.

The medicine 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 (to a new area of skin) and continue your regular schedule. Make sure you choose a clean, lotion-free area of the 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 the 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; or
• 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 SANDOZ ESTRADIOL DERM patch can produce some skin irritation. This varies according to the sensitivity of your skin.

Usually this redness does not pose any health concern to you, but to reduce this problem, there are some things that you may do:

• choose the buttock as the site of application;
• change the site of application of the SANDOZ ESTRADIOL DERM patch every time a new patch is applied, usually twice weekly.

Experience with estradiol-17β matrix patch 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 talk to your healthcare professional.

Usual dose:

Follow all instructions given to you by your healthcare professional carefully. Your healthcare professional will explain when to start using SANDOZ ESTRADIOL DERM.

The SANDOZ ESTRADIOL DERM patches are applied twice weekly on the same days of each week. Each patch should be worn continuously for 3 to 4 days.

The dose of SANDOZ ESTRADIOL DERM will be based on the reason for its use, as determined by your healthcare professional. Your healthcare professional may adjust the dosage based on your response to treatment.

Estrogen is usually taken in a cyclic fashion (although your physician's instructions may be different depending upon your personal situation). This means that you would apply SANDOZ ESTRADIOL DERM patch on the first 21 or 25 days of the cycle, followed by 5 to 7 days without. Your next cycle starts with the next patch application. Irregular uterine bleeding may occur particularly in the first 6 months, but generally decreases with time.

Each box contains eight SANDOZ ESTRADIOL DERM patches. If your treatment is for less than 28 days of estrogen (cyclical therapy), you will have one or two patches left over which can be used for the next month.

It is important that you use SANDOZ ESTRADIOL DERM as your healthcare professional has prescribed. Do not discontinue or change your therapy without talking to your healthcare professional.

Overdose:

If you think you, or a person you are caring for, have used too much SANDOZ ESTRADIOL DERM, remove the patch and contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

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

Possible side effects from using SANDOZ ESTRADIOL DERM:

These are not all the possible side effects you may have when taking SANDOZ ESTRADIOL DERM. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• change in weight;
• vaginal bleeding or spotting, changes in vaginal discharge;
• vaginal infection;
• menstrual cramps;
• headache;
• dizziness;
• nausea, abdominal pain and swelling, vomiting;
• diarrhea;
• tender breasts, breast enlargement;
• change in your sex drive;
• hair loss or excessive hairiness;
• fibroids (benign growths in the uterus, may have painful and/or heavy periods);
• easy bruising, excessive nose bleeds;
• darkening of the skin, particularly on the face or abdomen (chloasma), purple skin patches;
• acne;
• decline of memory or mental ability;
• rapid mood changes, nervousness;
• contact lens discomfort, dry eyes;
• back pain, pain in the extremities;
• uncontrollable jerky movements (chorea);
• varicose veins.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

SANDOZ ESTRADIOL DERM should be stored between 15 and 30°C. Protect from freezing. Store in the original package. Do not store it out of the pouch.

SANDOZ ESTRADIOL DERM patches should be kept out of the reach and sight of children and pets before use and when disposing of used patches.

Do not use SANDOZ ESTRADIOL DERM after the expiry date shown on the pack.

Do not use any SANDOZ ESTRADIOL DERM pack that is damaged or shows signs of tampering.

If you want more information about SANDOZ ESTRADIOL DERM:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sandoz.ca; or by calling 1-800-361-3062.

Date of Authorization: 2026-03-18