Patient Medication Information: uses, side effects, how to take - Oesclim
What is OESCLIM® used for?
OESCLIM® is used to relieve menopausal and postmenopausal symptoms.
Serious Warnings and Precautions
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:
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These occur when your body does not produce enough estrogen, such as:
- Naturally;
- Following surgery.
If you have a uterus, OESCLIM® must be taken with a progestin. Your doctor will prescribe this to you. It is important to take them together as this will help prevent problems with the lining of the uterus such as cell overgrowth (endometrial hyperplasia) and cancer.
OESCLIM® should be used only under the supervision of a doctor, with regular follow-up at least once a year to identify 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 a pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your doctor, and check your breasts regularly for lumps. Your doctor may recommend some blood tests.
You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your doctor. You should talk regularly with your doctor about whether you still need treatment with HRT.
How does OESCLIM® work?
Estradiol is the main estrogen produced by your ovaries prior to the menopause, and is the same estrogen that is in OESCLIM®. When applied to the skin, the OESCLIM® patch continuously releases small, controlled quantities of estradiol, which passes through your skin and into your bloodstream. The amount of estrogen prescribed depends on your body’s needs. Your doctor may adjust the amount you get by prescribing another (different) patch size.
By providing estradiol, OESCLIM® offers relief from menopausal symptoms.
Estrogens
- 1.
Estrogens are used to reduce moderate or severe menopausal symptoms. Your body normally makes estrogens and progestins (female hormones) mainly in the ovaries. Between the ages of 45-55, 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 experience the 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 flushes" or "hot flashes"). Using estrogen drugs can help the body adjust to lower estrogen levels and reduce these symptoms.
- 2. Estrogens are used to treat vulval and vaginal atrophy. Some women may also develop vulval or vaginal atrophy (itching, burning or dryness in or around the vagina, difficulty or burning on urination) in association with menopause. These changes may be improved by estrogen therapy.
Progestins
Progestins used in hormone replacement therapy are similar to the female sex hormone progesterone. During the childbearing years, progesterone is responsible for the regulation of the menstrual cycle. The estradiol delivered by OESCLIM® not only relieves your menopausal symptoms, but like estrogens produced by your body, may also stimulate growth of the inner lining of the uterus, the endometrium. In menopausal and post-menopausal women with an intact uterus, stimulation of growth of the endometrium may result in irregular bleeding. In some cases, this may progress into a disorder of the uterus known as endometrial hyperplasia (overgrowth of the lining of the uterus). Endometrial hyperplasia increases the risk of developing endometrial cancer (cancer of the lining of the uterus).
The development of estrogen-mediated disorders of the uterus can be reduced if a progestin is given regularly for a certain number of days with your estrogen replacement therapy. Each cycle of progestin administration should include a periodic bleeding, whereby the inner lining of the uterus is regularly shed, thus protecting against endometrial hyperplasia.
If your uterus has been surgically removed, endometrial hyperplasia cannot occur and cyclic administration of a progestin is not necessary.
What are the ingredients in OESCLIM®?
Medicinal ingredients: estradiol
Non-medicinal ingredients: Ethylene/vinyl acetate copolymer, dipropylene glycol, octyl dodecanol, ethylcellulose.
OESCLIM® comes in the following dosage forms:
Transdermal patch:
25 mcg / 24 hours as a 5 mg patch
37.5 mcg / 24 hours as a 7.5 mg patch
50 mcg / 24 hours as a 10 mg patch
75 mcg / 24 hours as a 15 mg patch
100 mcg / 24 hours as a 20 mg patch
Do not use OESCLIM® if:
You are pregnant
- You are breast-feeding
- You are allergic or have unusual reaction to any of the ingredients of OESCLIM® (see the list of ingredients above)
- You have or had active liver disease
- You have a personal history of breast cancer or endometrial cancer (cancer of the lining of the uterus)
- You have or had undiagnosed or unusual vaginal bleeding
- You have or had stroke, a heart attack, or a coronary heart disease
- You have or had migraine headaches
- You have active or personal history of venous thromboembolism (blood clots in the large veins or lungs) or thrombophlebitis (inflammation of the veins)
- You have or had partial or complete loss of vision due to blood vessel disease of the eye
- You have or had porphyria (a disease of blood pigment)
- You have or had endometrial hyperplasia (overgrowth of the lining of the uterus)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OESCLIM®. Talk about any health conditions or problems you may have, including if you:
- are taking any non-prescription medicines, including herbal products (St. John’s Wort)
- have a history of allergy or intolerance to any medications or other substances
- have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer
- have experienced any unusual or undiagnosed vaginal bleeding
- have a history of uterine fibroids or endometriosis
- have a history of liver disease, jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy
- have a history of gallbladder disease
drink alcohol
- smoke
- have a history of migraine headache
- have a history of high blood pressure
- have a personal or family history of blood clots, or a personal history of heart disease or stroke
- have a history of kidney disease, asthma or epilepsy (seizures)
- have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus)
- have been diagnosed with diabetes
- have a history of high cholesterol or high triglycerides (blood lipids)
- are pregnant or may be pregnant
- have had a hysterectomy (surgical removal of the uterus)
- have a history of depression
- are undergoing surgery or need long bed rest
- have been diagnosed with porphyria (a disease of blood pigment)
Other warnings you should know about:
Breast cancer
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 post-menopausal 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 consult with their doctor before starting hormone replacement therapy.
Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor.
Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women. You should review technique for breast self-examination with your doctor.
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 post menopausal 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 doctor. You should also report any unexpected or unusual vaginal bleeding to your doctor.
If you have had your uterus removed, you are not at risk of developing endometrial hyperplasia or endometrial carcinoma. Progestin therapy is therefore not required as part of hormone replacement therapy 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 postmenopausal 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 postmenopausal 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 postmenopausal 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 doctor since blood clots can be life-threatening or cause serious disability.
Blood pressure
Women using hormonal replacement therapy (HRT) may experience high blood pressure (hypertension). Your doctor will monitor your blood pressure while you are taking OESCLIM.
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 substudy of the WHI trial involving women aged 65 and older. This study indicated an increased risk of dementia (loss of memory and intellectual function) in postmenopausal 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 postmenopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.
Hepatic
Benign liver tumours have been associated with the use of combined estrogen and progestagen oral contraceptives. Although benign and rare, these tumours may rupture and cause death from internal abdominal bleeding. Such lesions have not yet been reported in association with other estrogen or progestagen preparations, but they should be considered if abdominal pain and tenderness, abdominal mass, or shock due to abnormal decrease in the volume of circulating blood occurs in patients receiving estrogen. Liver cell cancerous tumour has also been reported in women taking estrogen-containing oral contraceptives.
Interactions with this medication
The following may interact with OESCLIM®:
- anticoagulant agents;
- antidiabetic agents;
- antihypertensive agents;
- herbal and natural products, like St. John’s wort.
Tell your doctor or pharmacist if you are taking any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products.
How and where to apply OESCLIM®:
The site of application should be changed each time the patch is applied. However, each time you apply the 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 the right side to the left side).
- 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) will not affect the patch, although very hot water or steam may loosen it and therefore should be avoided (see Helpful Hints).
- 2. Where to Apply the OESCLIM® Patch: The patch may be applied to the buttock, the torso (area under the arms at the elbow level, abdomen) or the upper part of the arm or thigh (see Fig. 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.
Do not apply OESCLIM® to your abdomen, if a dose of OESCLIM® has been previously adjusted by your doctor with the patch applied to other sites of your body, as this might change the amount of hormone delivered.
Fig. 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 OESCLIM® to your breast, since this may cause unwanted effects and discomfort.
- 3. Opening the Pouch: Each OESCLIM® patch is individually sealed in a protective pouch. Tear open this pouch and remove the patch. Do not use scissors, as you may accidentally cut and destroy the patch.
- 4.
Removing the Liner: The patch is made up of an adhesive part containing the active substance and a transparent protective film. The protective liner must be removed.
To separate the patch from the protective liner, lift a corner of the liner and peel it off the patch. Discard the protective liner. Avoid touching the adhesive. Press the sticky side on the skin and smooth down.
Apply the patch immediately after opening the pouch and removing the liner.
- 5. Applying the OESCLIM® Patch: Apply the adhesive side to the spot you have chosen. Check that the OESCLIM® system is sticking correctly: press firmly in place for about 10 seconds with the palm of your hand over its entire surface area.
- 6.
When and How to Remove the Patch: To remove OESCLIM®, simply lift up one edge and pull. The OESCLIM® 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 side inwards. Throw it away out of the reach of children and pets.
Apply a new OESCLIM® patch on a different spot of clean, dry skin.
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. If it does not stick, then apply a new patch and continue your regular 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 alternative 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 OESCLIM® patch 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 there are some things you may do:
- choose the buttock as the site of application
- change the site of application of the OESCLIM® patch every time a new patch is applied, usually twice weekly
Experience with OESCLIM® 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.
Usual dose:
The OESCLIM® patch contains estradiol. When applied to the skin as directed above, OESCLIM® releases estradiol which passes through the skin and into the bloodstream.
Your doctor will explain when to start using OESCLIM®. The OESCLIM® patches are applied twice weekly on the same day of each week. You will apply one patch for a three day period and the next patch for a four day period. Therefore, the patch is changed every 3 or every 4 days.
OESCLIM® is usually applied for 24 to 28 days followed by 2 to 7 treatment-free days. Your next 24 to 28 day patch treatment cycle starts after your last treatment-free day.
If you still have your uterus, your doctor should prescribe another hormone drug (a progestogen) at the same time as the patch for at least the last 12 days of each treatment cycle with OESCLIM®.
Bleeding similar to menstrual bleeding may occur during the treatment-free period. This bleeding should be normal and slight.
Your doctor may prescribe the treatment using a different schedule that is better adapted to your condition. The system may be applied continuously with no treatment-free days.
It is important that you take your medication as your doctor has prescribed. Do not discontinue or change your therapy without consulting your doctor.
Remember: Your doctor has prescribed OESCLIM® for you after a careful review of your medical needs. Use it only as directed and do not give it to anyone else. Your doctor should re-examine you at least once a year.
Overdose:
Overdosage with estrogen may cause nausea, breast discomfort, fluid retention, bloating or vaginal bleeding in women.
In the case of overdosage, immediately remove the patch.
| If you think you have taken too much OESCLIM®, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
What are possible side effects from using OESCLIM®?
These are not all the possible side effects you may feel when taking OESCLIM®. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Redness, irritation, itching, discoloration, burning and swelling of skin under or around the patch application site
- Nausea and vomiting
- Abdominal cramps or pain, bloating
- Joint and muscle pain
- Fatigue
- Change in appetite
- Change in weight (increase or decrease)
- Change in libido
- Nervousness and irritability
- Breast pain, breast swelling, vaginal itching, excessive vaginal secretions, irregular bleeding between periods and spotting, painful sexual intercourse
- Lower abdominal pain or swelling and painful and/or heavy periods which may be signs of fibroids in the uterus
- Hair loss, excessive growth of hair on the face or body (hirsutism), acne, skin rash
- Fluid retention
- Melasma: darkening of the skin of the face especially when exposed to the sun
- Intolerance to contact lenses
OESCLIM® can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Gallbladder disease: Persistent abdominal pain, abdominal tenderness, nausea and vomiting | ✓ | ||
| Breast cancer: Breast lump | ✓ | ||
| Crushing chest pain or chest heaviness | ✓ | ||
| Edema: Swelling of the hand and / or feet | ✓ | ||
| Thromboembolism / Blood clot: Pain, redness or swelling in the leg or feet that may be warm to the touch | ✓ | ||
| Depression: Persistent sad mood | ✓ | ||
| Blood clot in the lung: Sharp pain in the chest, coughing blood or sudden shortness of breath | ✓ | ||
| Sudden partial or complete loss of vision | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Stroke: Sudden severe headache or worsening of headache, vomiting, dizziness, fainting, disturbance of vision or speech, paralysis or weakness or numbness in an arm or a leg | ✓ | ||
| Unexpected vaginal bleeding | ✓ | ||
| Jaundice: Yellowing of the skin or eyes | ✓ | ||
| Fluid retention or bloating persisting for more than 6 weeks | ✓ | ||
| Palpitations: Irregular heart beat | ✓ | ||
| High blood pressure (hypertension) | ✓ | ||
| Severe headache or migraine headache | ✓ | ||
| Dizziness | ✓ | ||
| Persistent or severe skin infection | ✓ | ||
| Tender or painful vein inflammation | ✓ | ||
| Rapid swelling of the throat (airway blockage) | ✓ | ||
| Abnormal clotting: Easy bruising, excessive nose bleeding or excessively heavy periods | ✓ | ||
| Liver tumour: Upper abdominal pain or swelling | ✓ | ||
| Nerve inflammation: Muscle weakness, numbness, pain or tingling | ✓ | ||
| Painful or difficult urination | ✓ | ||
High blood sugar: Frequent urination, thirst, fatigue | ✓ | ||
| Aggravation of epilepsy: Seizures occurring more often than usual or more severe seizures | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
OESCLIM® should be stored at room temperature (15–25°C). Avoid freezing. Do not store unpouched. Apply immediately upon removal from the protective pouch. OESCLIM® patches should be kept out of the reach of children and pets before and after use. After removal of the patch fold it in half, with the adhesive side inwards, before discarding.
Keep out of reach and sight of children.
If you want more information about OESCLIM®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; Searchlight Pharma website (http://searchlightpharma.com), or by calling 514-613-1513.
Searchlight Pharma Inc.
Montréal, Québec H3J 1M1
1-855-331-0830