0.75 mg / dose transdermal gel
estradiol
1. What Estrogel is and what it is used for
Estrogel is a hormone replacement therapy ( HRT ). It contains the female sex hormone estradiol. When you apply the gel to the skin, the hormone is absorbed and absorbed into the bloodstream.
Estrogel is used for menopausal symptoms in women who had their last natural menstrual period at least 6 months ago.
Estrogel is used for:
Relief of symptoms occurring after menopause a
During menopause, the estrogen content that the female body produces decreases. This can cause symptoms such as heat over the face, neck, and chest (“hot flashes”). Estrogel relieves these symptoms after menopause. Estrogel will only be prescribed to you if your symptoms are a serious limitation of your daily life.
Prevention of osteoporosis
After menopause, some women develop osteoporosis ( osteoporosis ). You should discuss all available options with your doctor.
If you are at increased risk of fracture due to osteoporosis and other medicines are not suitable for you, you can use Estrogel to prevent post-menopausal osteoporosis.
Estradiol contained in Estrogel may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Estrogel
Medical history and regular check-ups
The use of HRT entails risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.
Experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have premature menopause, the risks of HRT may be different. Talk to your doctor.
Before you start (or resume) HRT, your doctor will ask you about your own and your family’s medical history. Your doctor may decide to perform an examination. This examination may include an examination of the breasts and/or a gynecological examination, if necessary.
Once you have started using Estrogel, go to your doctor for regular check-ups (at least once a year). Discuss the benefits and risks of continuing to use Estrogel with your doctor during these check-ups.
Get regular breast screening according to your doctor’s or nurse’s recommendations.
Do not use Estrogel:
If any of the following applies to you. If you are not sure about any of the things below, talk to your doctor before using Estrogel.
- if you have or have had breast cancer, or suspect you may have breast cancer,
- if you have cancer that is estrogen sensitive e.g. endometrial cancer, or if you suspect you have it,
- if you have unexpected genital bleeding,
- if you have severe thickening of the uterine lining ( endometrial hyperplasia ) and are not treated for it,
- if you have or have had a blood clot in a vein ( thrombosis ), for example in the leg (deep vein thrombosis ) or the lungs ( pulmonary embolism ),
- if you have a blood clotting disorder (eg protein C, protein S or antithrombin deficiency)
- if you have or have recently had a disease caused by blood clots in an artery, e.g. myocardial infarction (heart attack), stroke or angina,
- if you have or have had liver disease and your liver function tests have not returned to normal,
- if you have a rare blood disorder called “porphyria”, which runs in the family (hereditary).
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
If any of the conditions occur for the first time when you use Estrogel, stop using it immediately and see your doctor immediately.
When to take special care with Estrogel
Tell your doctor if you have, or have had, any of the following problems before starting treatment, as these may recur or worsen with treatment with Estrogel.
You should see your doctor more often at check-ups if any of these situations apply to you:
- fibroids (muscle knots) in the uterus,
- growth of the uterine lining outside the uterus ( endometriosis ) or a previous strong growth of the uterine lining ( endometrial hyperplasia ),
- increased risk of developing blood clots (see “Blood clots in a vein ( thrombosis )”),
- increased risk of estrogen-sensitive cancer (eg a mother, sister, or grandmother who has had breast cancer),
- high blood pressure,
- liver disease, such as a benign liver tumor,
- diabetes,
- gallstones,
- migraine or severe headache,
- a disease of the immune system that affects several organs in the body ( SLE ),
- epilepsy,
- asthma,
- a disease affecting the eardrum and hearing (otosclerosis),
- very high level of fat in the blood ( triglycerides )
- fluid retention in the body due to heart or kidney problems.
Stop using Estrogel and contact a doctor immediately
If you notice any of the following during treatment with HRT:
- any of the conditions listed in the section “Do not use Estrogel”,
- yellowing of the skin or whites of the eyes (jaundice). This may be a sign of liver disease,
- that blood pressure rises sharply (symptoms may include headache, fatigue, dizziness),
- migraine-like headaches that occur for the first time,
- if you become pregnant,
- if you notice signs of a blood clot, for example:
- painful swelling and redness of the legs,
- sudden chest pain,
- breathing difficulties,
For more information, see “Blood clots in a vein ( thrombosis )”
Note! Estrogel is not a contraceptive. If it is less than 12 months since your last menstrual period or if you are under 50, you may need additional contraception to prevent pregnancy. Talk to your doctor if you need advice.
HRT and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
The use of estrogen-only HRT increases the risk of severe thickening of the uterine lining( endometrial hyperplasia ) and uterine lining cancer (endometrial cancer).
Using a corpus luteum hormone ( progestin ) in addition to estrogen for at least 12 days in each 28-day cycle protects you from this extra risk. Your doctor will prescribe a corpus luteum hormone ( progestin ) separately if you have the uterus left. If your uterus has undergone surgery ( hysterectomy ), you should consult your doctor about the safety of the product when used without corpus luteum hormone ( progestogen ).
In women who have the uterus left and do not use HRT, on average,
5 out of 1,000 are diagnosed with endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who have the uterus left and who take HRT with estrogen alone, between 10 and 60 out of 1,000 women are diagnosed with endometrial cancer (ie between 5 and 55 extra cases), depending on dose one and for how long it tas.
Estrogel contains a higher dose of estrogen than other estrogen-only HRT products. The risk of endometrial cancer when using Estrogel with a corpus luteum hormone ( progestin ) is not known.
Irregular bleeding
You may experience irregular bleeding or spotting during the first 3 to 6 months of treatment with Estrogel. About irregular bleeding:
- continues for more than 6 months,
- starts after using Estrogel for more than 6 months,
- continue after stopping using Estrogel, see
your doctor as soon as possible.
Unexpected bleeding
If you use Estrogel with a progestogen (ie progesterone ) you will have bleeding once a month (so-called dropout bleeding). But if you get unexpected small spotting ( spotting ) in addition to your monthly bleeding such as:
- continues longer than in the first 6 months,
- starts after using Estrogel for more than 6 months,
- continues after you stop using Estrogel.
See your doctor as soon as possible.
Breast cancer
Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.
Comparison
Of 1,000 women aged 50 to 54 who do not take HRT, an average of 13 to 17 will be diagnosed with breast cancer over a 5-year period.
In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1,000 users (ie 0-3 extra cases) will occur.
In women who are 50 years old and start taking HRT with estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (ie 4-8 extra cases).
Among women aged 50-59 who do not use HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over a 10-year period.
In women who are 50 years old and start taking HRT with estrogen alone for 10 years, 34 cases per 1,000 users (ie 7 extra cases will occur).
In women who are 50 years old and start taking HRT with estrogen-progestogen for 10 years, 48 cases per 1,000 users (ie 21 extra cases) will occur.
- Check your breasts regularly. Contact your doctor if you notice any changes such as:
- pits in the skin,
- changes in the nipple,
- nodules that you can see or feel.
It is also recommended that you participate in screening programs with mammography when they are offered to you. During mammography screening, you must inform the nurse/healthcare professional performing the X-ray examination that you are using HRT as this medicine may increase the density (density) of the breasts and this may affect the results of the mammogram. If the density of your breasts increases, it is possible that mammography will not detect all the lumps.
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare – much less common than breast cancer. Use of HRT with only estrogen or HRT with combined estrogen-progestin has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. Of, for example, women aged 50 to 54 who do not take HRT, approximately 2 women out of 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have used HRT for 5 years, 3 cases per 2,000 users have been reported (ie approximately 1 extra case).
How HRT affects the heart and blood circulation
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is about 1.3 to 3 times greater for those who use HRT than for those who do not use it, especially during the first year of treatment.
Blood clots can be serious and if a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, lead to fainting or even death.
You are more likely to get a blood clot if you are older and if any of the following apply to you. Tell your doctor if any of these situations apply to you:
- you can not walk for a long time due to a major operation, injury or illness (see also section 3, If you need surgery)
- you are severely overweight ( BMI > 30 kg / m 2 ),
- you have a coagulation disorder that requires long-term treatment with drugs to prevent blood clots,
- if you or any of your close relatives have had a blood clot in a bone, lung, or another organ,
- you have systemic lupus erythematosus ( SLE ),
- you have cancer.
For signs of a blood clot, see “Stop using Estrogel and contact a doctor immediately”
For women in their 50s who do not use HRT, an average of 4 to 7 per 1,000 people are expected to have a blood clot in a vein over a 5-year period.
For women in their 50s who have used HRT with estrogen-progestogen for more than 5 years, there will be 9 to 12 cases per 1,000 users (ie 5 extra cases).
For women in their 50s who have had their uterus operated on and have used HRT with estrogen alone for more than 5 years, there will be 5 to 8 cases per 1,000 users (ie 1 extra case).
Heart disease (heart attack/heart attack)
There is no evidence that HRT can prevent a heart attack.
For women over the age of 60 who take HRT with estrogen-progestogen, the probability of developing heart disease is slightly greater than for those who do not take HRT.
For women who have had their uterus operated on and who use estrogen-only treatment, there is no increased risk of heart disease.
Stroke
The risk of stroke is about 1.5 times higher for those who use HRT than for those who do not use it. The number of extra cases of stroke due to the use of HRT increases with age.
If you look at women in their 50s who do not take HRT, an average of 8 women out of 1,000 are expected to have a stroke during a 5-year period.
For women in their 50s who take HRT, there will be 11 cases per 1,000 users during a 5-year period (ie 3 extra cases).
Other conditions
- The use of Estrogel may lead to fluid retention in the body. Therefore, if you have impaired cardiac or renal function, you must be closely monitored when using Estrogel.
- HRT does not prevent memory loss. There is some evidence that there is a higher risk of memory loss in women who start taking HRT after the age of 65. Consult your doctor.
Other medicines and Estrogel
Some medicines may affect the effect of Estrogel. This can lead to irregular bleeding. This applies to the following medicines:
- Other medicines for topical use (for example, cancer drugs)
- antiepileptic drugs (eg phenobarbital, phenytoin and carbamazepine);
- tuberculosis drugs (eg rifampicin and rifabutin),
- drugs against HIV – infection (for example, nevirapine, efavirenz, ritonavir, and nelfinavir),
- (traditional) herbal medicines containing St. John’s wort (Hypericum perforatum).
Tell your doctor or pharmacist if you are taking or using, or have recently taken or used, or might take or take any other medicines, including medicines obtained without a prescription, (traditional) herbal and herbal medicines, other natural products, or medical skincare products containing alcohol or skin cleanser.
Laboratory tests
If you need to take blood samples, tell your doctor or laboratory staff that you are taking Estrogel, as this medicine may affect the results of some tests.
Pregnancy and breastfeeding
Estrogel is for use in postmenopausal women only.
If you become pregnant, stop using Estrogel and contact your doctor.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Estrogel contains ethanol
Each dose of 1.25 g of this medicine contains 500 mg of alcohol ( ethanol ), equivalent to 400 mg / g (40% (w / w)). It can cause a burning sensation on damaged skin.
3. How to use Estrogel
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will strive to prescribe the lowest dose to treat your symptoms in as short a time as possible. Talk to your doctor if you think your dose is too high or too low.
Estrogel is a gel that contains the female sex hormone estradiol. When you apply a gel to the skin, it dries within 5 minutes and the hormone is quickly absorbed and absorbed by the bloodstream.
Apply as thin a layer of gel as possible over the entire surface of the inside and outside of the arm from the wrist to the shoulder, and/or the inside of the thighs. Spread it out as much as possible.
DO NOT apply it to the breasts or any mucous membranes, especially not to the mucous membranes of the labia or vagina.
When starting a new bottle of gel, first activate the pump by depressing the pump and discarding the first dose.
Each pump pressure gives 1.25 g of gel (one measure) containing 0.75 mg of estradiol.
Where to apply Estrogel
- The usual dose is ONE measure (1.25 g gel ) which is applied to the arm from the wrist to the shoulder and/or the inside of the thigh.
Each vial contains 60 dose s (measure) gel.
Apply one measure of Estrogel from the pump bottle every day for 21 days (3 weeks) and then stop using the gel for 7 days (1 week) – (see ‘Estrogel must be applied’ below).
Estrogel must be applied:
- by the woman herself,
- in the evening or morning, preferably after washing, at the same time each day.
- Skin contact with other adults and children should be avoided for one hour after application
Spread the gel as MUCH as possible over your arms and shoulders, and/or the inside of the thighs, over a large area of undamaged healthy skin.
If the skin is still sticky five minutes after the application of the gel, this means that you have probably not spread it enough on the skin. Spread the gel over a wider surface, on your arms and shoulders, and/or the inside of the thighs, the next time you apply it.
Always wash your hands thoroughly with soap and water after applying gel to your skin.
- Women who have a uterus:
Your doctor will prescribe the lowest effective dose you need.
Apply one dose of Estrogel every day for 21 days (3 weeks) and then stop using Estrogel for 7 days (1 week).
Prolonged use of estrogen without the addition of a progestogen (eg progesterone ) increases the risk of endometrial cancer in women who have the uterus left. To counteract this, estrogen must be used with a progestogen for at least 12 to 14 days a month. Your doctor will probably give you progesterone treatment. You must take progesterone for at least 12 to 14 days during your monthly cycle.
During the 4th week, when you are not taking any estrogen, you will not use any drug that contains progesterone either. Bleeding (“menstruation”) may occur during this treatment-free period.
- Women without uterus:
If you have no uterus and do not have endometriosis, estrogen treatment should not be combined with progestogen.
If you are taking Estrogel to treat postmenopausal symptoms and you notice that the effect of Estrogel is too strong or too weak, talk to your doctor.
Duration of treatment
Your doctor will tell you how long to use Estrogel. It is important to follow this. Do not stop treatment prematurely, discuss this with your doctor first.
If you use more Estrogel than you should
An unpleasant feeling in the breasts (chest tension), bleeding, or nervousness can be a sign of overdose, which usually disappears when the amount of gel applied is reduced.
In such cases, reduce the amount you apply with your doctor’s consent.
If you use more Estrogel than you should, contact your doctor or pharmacist immediately.
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Estrogel
Do not take a double dose the following day to make up for a forgotten dose. If it is time for your next dose within 12 hours, wait for the next application. If it is time for your next dose in more than 12 hours, apply the missed dose immediately and apply the next dose as usual.
If you need surgery
Tell your surgeon that you are using Estrogel if you are going to have surgery. You may need to stop using Estrogel approximately 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Estrogel again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases have been reported more frequently for women using HRT compared to women not using HRT:
- breast cancer,
- abnormal growth of cancer or cancer of the uterine mucosa ( endometrial hyperplasia or cancer);
- cancer of the ovaries
- blood clots in the bones or lungs (venous thromboembolism ),
- heart disease, stroke,
- probable memory loss if HRT begins after age 65.
For more information on these side effects, see section 2.
Common: may affect up to 1 in 10 people: painful menstruation ( dysmenorrhea ), heavy menstruation ( menorrhagia ), small bleeding ( spotting ), menstrual problems, discharge, unexpected abdominal bleeding, abnormal thickening of cells in the uterus ( endometrial hyperplasia ) abdominal pain and cramps, bloated stomach, feeling sick, headache, muscle cramps, pain in arms/legs, nervousness and depression.
Uncommon: may affect up to 1 in 100 people: benign breast, polyp s in the uterus, the increase of uterine fibroids (fibroids) in the uterus, a condition that means that cells from the uterus grows outside and causes pain ( endometriosis ), pain in breasts (mastodynia), worsening of estrogen-dependent tumors, migraine, dizziness, drowsiness, joint pain ( arthralgia ), superficial or deep vein thrombosis, pain and swelling in the veins ( thrombophlebitis ), swelling of the hands, feet, and ankles (peripheral edema ), itching ( pruritus ), too much sodium in the body, feeling of swelling, weight change, rash, itching, brown spots on the skin (chloasma), altered liver values, liver tumors, gallstones.
Rare: may affect up to 1 in 1,000 people: contact lens intolerance, severe allergic (life-threatening) reactions, liver problems, yellowing of the skin or whites of the eyes that indicate you have liver disease, glucose intolerance (especially if you have diabetes ), skeletal pain, worsening of epilepsy (seizures), changes in your sex drive, discoloration of the skin, acne, high blood pressure.
The following side effects may occur during treatment with HRT:
- benign or malignant tumors that are affected by estrogen hormones, e.g. endometrial cancer
- heart attack (heart attack) and stroke,
- gallbladder diseases,
- skin diseases, e.g. vascular purpura (small blood spots under the skin)
- dementia symptoms,
- Venous thrombosis and pulmonary embolism are more common in HRT users than in non- HRT users. For more information, see “Do not use Estrogel” and “HRT and thrombosis” in section 2.
- The risk of breast cancer is slightly higher in users of HRT and increases with the number of years of use of HRT. It is estimated that among 1,000 non-users of HRT, approximately 32 aged 50-64 will get breast cancer. It is estimated that among 1,000 women who use HRT for 5 years or who have recently used it, there will be approximately 2 to 6 additional cases of breast cancer. If HRT is used for 10 years, this increase can amount to approximately 5 to 19 extra cases per 1,000 users. The number of extra cases of breast cancer does not depend on how old you were when you started using HRT (provided you started using HRTbetween 45 and 65 years of age). For more information, see “Do not use Estrogel” and “HRT and breast cancer” in section 2.
- in women who still have the uterus and who use HRT with only estrogen, the risk of cancer of the uterine lining increases with the number of years of using HRT. It is estimated that among 1,000 non-users of HRT, approximately 5 women aged 50-65 will get cancer of the uterus. Depending on the size and duration of the dose, it is estimated that among 1,000 women who use estrogen alone, there are approximately 10-60 extra cases of cancer of the uterine lining. If a progestogen is used at the same time, this risk is largely avoided.
The following side effects have been reported with the use of other HRTs:
- gallbladder diseases,
- various skin diseases:
- pigmentation of the skin especially on the face or neck, so-called “pregnancy spots” (chloasma),
- tender reddish-purple bumps on the skin (erythema nodosum),
- rash with red dots or circular wounds (erythema multiforme).
5. How to store Estrogel
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration Estrogel
- The active substance is estradiol
- The other ingredients are ethanol, carbomer, trolamine, and purified water.
Estrogel appearance and pack sizes
Estrogel is available in packs containing 1, 2, or 3 multidose vial (s). Each 80 g package consists of a bottle fitted with a metering valve. A pump pressure gives 1.25 g of gel containing 0.75 mg of estradiol. Each container contains 80 g of gel and gives at least 60 doses of 1.25 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Besins Healthcare SA
Avenue Louise, 287 1050 Brussels – Belgium
Manufacturer
Delpharm Drogenbos SA
Groot-Bijgaardenstraat, 128 – B-1620 Drogenbos – Belgium
Or
Laboratories Besins International
13 Rue Perrier
92120 Montrouge
France