ESTRADERM 25 MCG Трансдермальный пластырь

Содержание инструкции

1. Estraderm MX 25 mcg/day transdermal patch, 50 mcg/day transdermal patch, 100 mcg/day transdermal patch
   1. What is Estraderm MX and what is it used for
   2. Cosa deve sapere prima di usare Estraderm MX
   3. How to use Estraderm MX
   4. Possible side effects
   5. How to store Estraderm MX
   6. Package Contents and Other Information

Estraderm MX 25 mcg/day transdermal patch, 50 mcg/day transdermal patch, 100 mcg/day transdermal patch

estradiol

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Estraderm MX is and what it is used for
• 2. What you need to know before you use Estraderm MX
• 3. How to use Estraderm MX
• 4. Possible side effects
• 5. How to store Estraderm MX
• 6. Contents of the pack and other information

1. What is Estraderm MX and what is it used for

Estraderm MX is a hormone replacement therapy (HRT). It contains the active ingredient estradiol, which
belongs to the class of estrogens (female sex hormones). Estradiol is produced
naturally by the body and mainly by the ovaries.
The estradiol contained in Estraderm MX is identical to the estradiol produced by the body.
Estraderm MX is used for:

Relief of symptoms that appear after menopause
During menopause, the amount of estrogen produced by a woman's body decreases.
This can cause symptoms such as hot flushes on the face, neck and chest. Estraderm MX alleviates
these symptoms after menopause. Estraderm MX will only be prescribed to you if your symptoms
seriously interfere with your daily life.
Menopause occurs naturally in all women, generally between the ages of 45 and 55. It also occurs in
younger women who have undergone surgical removal of the ovaries.

Prevention of osteoporosis
After menopause, some women may develop fragile bones (osteoporosis). Consult your
doctor about all available options.
If you are at increased risk of fractures due to osteoporosis and other medications are not
suitable for you, you can use Estraderm MX to prevent osteoporosis after menopause.

2. Cosa deve sapere prima di usare Estraderm MX

Medical history and regular check-ups
The use of HRT involves risks that must be assessed when deciding whether to start or continue therapy.
Experience in treating women with premature menopause (due to ovarian insufficiency or surgery) is limited. In the case of premature menopause, the risks of using HRT may be different. Inform your doctor in this case.
Before starting (or restarting) HRT, your doctor will ask you about your personal and family medical history. Your doctor may decide to perform a check-up. This may include a breast exam and/or a pelvic exam, if necessary.
Once you have started taking Estraderm MX, see your doctor for regular check-ups (at least once a year). During these check-ups, talk to your doctor about the benefits and risks of continuing therapy with Estraderm MX.
Undergo regular breast screenings, as directed by your doctor.

Do not use EstradermMX
If any of the following conditions apply to you. If you are unsure about any of the points listed, consult your doctorbefore using Estraderm MX.
Do not use Estraderm MX:

• if you have, have had, or your doctor suspects you have breast cancer
• if you have or your doctor suspects you have a hormone-sensitive cancer, such as cancer of the uterine lining (endometrium)
• if you have experienced vaginal bleeding of unknown origin
• if you have an excessive thickening of the uterine lining(endometrial hyperplasia) and are not receiving any treatment
• if you have or have had a blood clot in a vein(thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have a blood clotting disorder(e.g., protein C, protein S, or antithrombin deficiency)
• if you have or have recently had a disease caused by blood clots in the arteries, such as heart attack, stroke, or angina pectoris(chest pain)
• if you have severe liver problems
• if you have or have had a liver diseaseand if liver function tests have not returned to normal values
• if you have a rare blood disease called "porphyria" that is inherited (familial)
• if you are allergic (hypersensitive) to estradiol or any of the other ingredients of this medicine (listed in section 6)

If any of the following conditions occur for the first time while taking Estraderm MX, stop taking it immediately and inform your doctor immediately.

Warnings and precautions
Tell your doctor if you have ever had any of the following conditions before starting treatment, as these conditions may recur or worsen during treatment with Estraderm MX. If this happens, you should see your doctor more often for check-ups:

• benign tumors of the uterus (fibroids inside the uterus)
• growth of the uterine lining outside the uterus itself (endometriosis) or a history of excessive growth of the uterine lining (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
• increased risk of developing hormone-sensitive cancers (e.g., if your mother, sister, or grandmother has had breast cancer)
• high blood pressure
• liver problems, such as a benign liver tumor
• diabetes
• gallstones
• migraine or severe headache
• an autoimmune disease that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary or acquired angioedema, an inherited disease characterized by sudden swelling attacks, because it may occur or worsen with treatment.
• if you have risk factors for the formation of a blood clot in a vein, for example: you or someone in your family has had a blood clot in blood vessels, or you are severely overweight (body mass index >30 kg/m2) or you have an autoimmune disease called systemic lupus erythematosus (SLE) or you have a blood clotting disorder or you or someone in your family has had frequent miscarriages or you have to lie down for a long time, have undergone surgery or have suffered trauma
• if you are taking medicines to thin the blood (anticoagulants)
• if you have kidney problems and in particular if you have end-stage renal failure
• if you have heart problems
• if you have high levels of fats in the blood (hypertriglyceridemia)
• if you have thyroid problems or are taking medicines for the thyroid.

Stop treatment with Estraderm MX and contact your doctor immediately
If you notice any of the following symptoms while taking HRT:

• any of the conditions mentioned in the “Do not use Estraderm MX” section
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, along with difficulty breathing suggestive of angioedema
• marked increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• headache similar to migraine that occurs for the first time
• if you become pregnant
• if you notice signs of a blood clot such as:
• painful and red swelling in the legs,
• sudden chest pain,
• difficulty breathing. For more information, see section “Blood clots in a vein (thrombosis)”.

Note:Estraderm MX is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you need to use additional contraception to prevent possible pregnancies. Ask your doctor for advice.

HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
Taking HRT based on estrogen alone will increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer).
Taking a progestin in addition to estrogen for at least 12 days for every 28 days of the cycle protects against an additional risk. Therefore, if you still have a uterus, your doctor will prescribe you a progestin separately. If your uterus has been removed (by hysterectomy), discuss with your doctor whether you can safely take this product without associating it with progestin.
Among women who have a uterus not treated with HRT, an average of 5 cases of endometrial carcinoma will be diagnosed per 1000 women in the age group between 50-65 years.
In women with a uterus between the ages of 50 and 65 who use HRT based on estrogen alone, depending on the duration of use and the dose of estrogen taken, between 10 and 60 cases of endometrial cancer will be diagnosed per 1000 women (between 5 and 55 additional cases).
Estraderm MX 100 micrograms contains a high dose of estrogen compared to other estrogen-only products used for HRT. A risk of endometrial cancer is not known when Estraderm MX 100 micrograms is associated with a progestin.

Unexpected bleeding
During therapy with Estraderm MX, you will have a bleeding (so-called "withdrawal bleeding") once a month. However, if in addition to the monthly bleeding you observe unexpected bleeding or spotting (drops of blood) that:

• lasts longer than the first 6 months,
• occurs after more than 6 months from the start of taking Estraderm MX,
• continues even after stopping Estraderm MX, consult your doctor as soon as possible.

Breast cancer
Evidence shows that taking hormone replacement therapy (HRT) based on estrogen and progestins combined or based on estrogen alone increases the risk of breast cancer. The additional risk depends on the duration of HRT use. This additional risk manifests within 3 years of use.
After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT is used for more than 5 years.

Comparison
In women between the ages of 50 and 54 who are not following HRT, breast cancer will be diagnosed in an average of about 13-17 women out of 1000 in a period of 5 years.
In women aged 50 who start following HRT based on estrogen alone for a period of 5 years, 16-17 cases will occur in 1000 users (i.e. 0-3 additional cases).
In women aged 50 who start following HRT based on estrogen and progestins combined for 5 years, there will be 21 cases per 1000 women treated (i.e. 4 to 8 additional cases).
In women between the ages of 50 and 59 who do not follow HRT, breast cancer will be diagnosed in an average of 27 women out of 1000 in a period of 10 years.
In women aged 50 who start following HRT based on estrogen alone for 10 years, 34 cases will occur in 1000 users (i.e. 7 additional cases).
In women aged 50 who start following HRT based on estrogen and progestins combined for 10 years, 48 cases will occur in 1000 users (i.e. 21 additional cases).

Check your breasts regularly. See your doctor if you notice any changes such as:

• skin depressions,
• changes in the nipples,
• any visible or palpable lumps.

In addition, it is recommended to participate in mammography screening programs when they are offered to you. For mammography screening, it is important that you inform the nurse/healthcare professional performing the X-ray that you are taking HRT, as this medicine may increase breast density, which may affect the outcome of the mammography. When breast density is increased, mammography may not detect all nodules.

Ovarian cancer
Ovarian cancer is rare - much rarer than breast cancer. The use of estrogen-only or estrogen-progestin-based therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women between the ages of 50 and 54 who are not following HRT, about 2 women out of 2,000 will be diagnosed with ovarian cancer within 5 years. For women who are taking HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e., about 1 additional case).

Effects of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veinsis 1.3 to 3 times higher in users of HRT compared to non-users, especially during the first year of use.
Blood clots can be dangerous and if one of them reaches the lungs it can cause chest pain, sudden shortness of breath, fainting or even death.
The risk of having a blood clot in the veins increases with age and if any of the following conditions apply to you. Tell your doctor if any of the following conditions apply to you:

• you are unable to walk for a long time due to major surgery, accident or illness (see also “If you are going to have surgery”),
• you are severely overweight (BMI>30 kg/m2),
• you have any blood clotting disorder that requires long-term treatment with a medicine that prevents blood clots,
• a close relative of yours has had a blood clot in the leg, lung or another organ,
• you have systemic lupus erythematosus (SLE),
• you have cancer. For signs of a blood clot, see “Stop treatment with Estraderm MX and contact your doctor immediately”.

Comparison
For women around the age of 50 who are not taking HRT, on average, in a time span of 5 years, 4-7 cases out of 1000 are expected to have a blood clot in a vein.
For women around the age of 50 who are taking estroprogestinic HRT for more than 5 years, there will be 9-12 cases per 1000 users (i.e. an increase of 5 cases).
For women around the age of 50 whose uterus has been removed and who are taking estrogen-only HRT for more than 5 years, there will be 5-8 cases per 1000 (i.e. an increase of 1 case).

Heart disease (heart attack)
There is no evidence that HRT can prevent a heart attack.
Women over the age of 60 who use HRT containing estrogen and progestin hormones are slightly more likely to develop heart disease than those who do not use HRT.
Women who have had their uterus removed who take estrogen-only HRT are not at increased risk of heart disease.

Stroke
The risk of having a stroke is approximately 1.5 times higher in women who take HRT compared
to those who do not use it. The number of additional stroke cases due to the use of HRT
increases with advancing age.

Comparison
Considering women around 50 years of age who do not take HRT, on average, 8 out of 1000
may have a stroke over a period of 5 years. Considering fifty-year-old women
who take HRT, 11 cases out of 1000 will occur over 5 years (that is, 3 more cases).

Other conditions
HRT does not prevent memory loss. There is some evidence of an increased risk of
memory loss in women who start using HRT after the age of 65. Consult your
doctor.

Children and adolescents
Estraderm MX should not be used in children.

Other medicines and Estraderm MX
Some medicines can interfere with the effects of Estraderm MX. This can cause irregular
bleeding. This may occur with the following medicines:

• sedatives (medicines that relax),
• medicines for epilepsy(such as phenobarbital, phenytoin and carbamazepine),
• medicines for tuberculosis(such as rifampicin, rifabutin),
• medicines for HIV infections(such as nevirapine, efavirenz, ritonavir and nelfinavir),
• medicine to fight fungal infections (ketoconazole),
• antibiotic used for the treatment of bacterial infections (erythromycin),
• herbal preparations such as St. John's Wort(Hypericum perforatum),
• medicines for hepatitis C virus (HCV) (such as the ombitasvir/paritaprevir/ritonavir combination regimen with or without dasabuvir and the glecaprevir/pibrentasvir regimen) can cause increases in blood test values of liver function (increase of the liver enzyme ALT) in women using combined hormonal contraceptives containing ethinylestradiol. Estraderm MX contains estradiol instead of ethinylestradiol. Therefore, it is not known whether an increase in the liver enzyme ALT may occur when Estraderm MX is taken with this HCV combination regimen. Your doctor will advise you.

Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription, herbal products or other natural
products.

Laboratory tests
If you are to undergo a blood test, tell your doctor or laboratory personnel that you are
taking Estraderm MX, as this medicine may alter the results of some tests.

Pregnancy and breastfeeding
Estraderm MX is intended for use exclusively by postmenopausal women. If you become
pregnant, stop taking Estraderm MX and contact your doctor.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Estraderm MX does not impair the ability to drive vehicles and use machines.

3. How to use Estraderm MX

Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor.
Your doctor will tend to prescribe the lowest dose to treat the symptoms you suffer from for the
shortest possible period of time. Consult your doctor if you think this dose is too
high or insufficient.
You must apply the Estraderm MX patch twice a week, which means you must
change it every 3-4 days, to ensure a continuous hormonal supply to the body.
For example, if you start therapy on Monday or Thursday, you must always change the patch on Thursday or
Monday.
You will find a series of adhesive labels in the package, indicating the days of the week, which will serve as a
reminder. Choose the one that on the left shows the day you applied the first
patch. Stick this label inside the opening of the package, in the indicated place and throw
away the other labels.
Your doctor will tell you whether to use Estraderm MX continuously, that is, applying the patch twice
a week uninterruptedly, or cyclically, that is, applying the patches twice a week
for a period of 21 days followed by 7 days of suspension.
Your doctor may also prescribe a treatment with a progestin, a female hormone, in addition.

Use in patients with liver failure
Estraderm MX should not be used in patients with severe liver problems (e.g. severe
hepatic insufficiency).
Estraderm MX should not be used in patients who have or have had acute liver problems: your doctor will not prescribe Estraderm MX until liver function returns to
normal.

How to apply the Estraderm MX patch
The package contains 8 sealed sachets, each containing a transdermal patch.

• Tear open a sachet
• open the sachet by tearing it from the marked notch, do not use scissors to avoid risking damage to the patch
• remove the patch
• remove the smaller part of the transparent film and then the larger part; touch the adhesive part as little as possible
• apply the patch immediately: either to a clean, dry, and unoily area of skin or cream.

Never apply the patch immediately after taking a hot bath or shower, wait until
the skin is completely cool and dry.
or to an area of skin without redness, lesions or irritation
or to an area of the body where only small folds of skin form during the
movement (e.g. buttocks, hips or abdomen) and not exposed to direct sunlight (e.g. the
areas normally covered by clothing).
or Do not apply the patch to the breast or in its vicinity.

• press firmly on the entire surface of the patch for about 10-20 seconds
• run your finger along the edges again to ensure good adhesion. Do not check the adhesion of the patch by trying to peel it off
• do not apply the patch twice in a row to the same area of skin.

Each time you change the patch, apply it to an area of skin different from the previous one. After
a week has passed since the application in a specific area of the body, you can
reapply the patch to that point.
If you have applied the patch correctly, it will adhere to the skin without problems for a period of
4 days, you can also safely take a bath, shower, swim or do sports.
However, if you notice that the patch has come off, replace it with a new one. Then proceed with the
regular application of a new patch respecting the previously established dates.
If you have to be exposed to sunlight, even through tanning beds, make sure that
the patch is covered by clothing or a swimsuit.

If you use more Estraderm MX than you should
In case of accidental overdose of Estraderm MX, immediately inform your
doctor or go to the nearest hospital.
An overdose of estradiol is unlikely when administered via
transdermally, i.e. by applying a patch. However, if this were to occur, the situation can be resolved quickly
by removing the patch.
The symptoms caused by an overdose of estradiol are represented by breast tension, unexpected vaginal bleeding, fluid retention and/or abdominal swelling.

If you forget to use Estraderm MX
If you forget to replace the patch on the scheduled day, do not worry, but change it as soon as possible.
Then replace it on the day previously scheduled.
If you forget to apply the patch one or more times, it may increase the likelihood that
symptoms reappear or that vaginal bleeding occurs.
Do not use a double dose to make up for the missed dose.

If you stop treatment with Estraderm MX
Do not stop treatment with Estraderm MX without first consulting your doctor, unless
you develop serious side effects.
The patch may come off inadvertently. If you have applied the patch correctly, this
will adhere to the skin without problems for a period of 4 days, but if you notice that the patch is
off, replace it with a new one. Then proceed with the regular application of a new patch
respecting the previously established dates.

If you are going to have surgery
If you are going to have surgery, inform the surgeon that you are taking Estraderm MX.
You may need to stop taking Estraderm MX about 4-6 weeks before
surgery to reduce the risk of a blood clot (see paragraph 2 “Blood clots in a vein (thrombosis)”). Ask your doctor when you can start using Estraderm MX again.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following effects are reported more frequently in women taking hormone replacement therapy (HRT) than
in those who do not use it:

• breast cancer
• abnormal growth or cancer of the uterine lining (hyperplasia or endometrial cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started after the age of 65. For further information on these side effects, see paragraph 2.

Very common side effects (may affect more than 1 in 10 people)

• breast discomfort
• irregular vaginal bleeding
• reactions at the site where the patch is applied: such as bleeding, bruising or burning, discomfort, dryness or skin reactions e.g. eczema, erythema, edema, inflammation, irritation, appearance of papules, rash, changes in skin color, formation of spots on the skin, hives and appearance of blisters or itching or swelling or pain or tingling.

Common side effects (may affect up to 1 in 10 people)

• headache
• nausea
• abdominal pain, abdominal distension

Uncommon side effects (may affect up to 1 in 100 people)

• breast tumor

Rare side effects (may affect up to 1 in 1,000 people)

• dizziness
• pain in the extremities (hands, legs, ankles and feet)
• edema, increase or decrease in body weight

Very rare side effects (may affect up to 1 in 10,000 people)

• serious allergic reactions even after the first dose
• blockage of a blood vessel
• high blood pressure
• formation or worsening of varicose veins
• changes in liver function parameters
• yellowing of the skin, mucous membranes and eyes due to bile stagnation
• skin reactions such as contact dermatitis, changes in skin color, widespread itching, widespread rash

Side effects with unknown frequency (frequency cannot be estimated on the basis of
available data)

• serious allergic reactions (anaphylaxis) and angioedema (for a list of symptoms see paragraph “Tell your doctor immediately if during treatment with Estraderm MX”)
• depression
• nervousness, emotional instability
• changes in sexual desire
• migraine
• gallstones (cholelithiasis)
• vomiting
• diarrhea
• problems with the gallbladder
• hair loss
• skin patches of dark brown color with defined edges, located on the face usually on the forehead, temples (cloasma)
• urticaria
• back pain
• uterine lining too thick (endometrial hyperplasia)
• benign uterine tumor (leiomyoma)
• chest pain
• feeling of tension in the breasts
• painful menstruation
• fibrocystic breast disease
• breast enlargement
• nipple discharge.

The following side effects have been reported with other HRT:

• estrogen-dependent tumors, benign and malignant, e.g. endometrial carcinoma
• formation of a blood clot in a vein of the legs and pelvic area (deep vein thrombosis) and the lungs (pulmonary embolism)
• stroke
• myocardial infarction
• gallbladder diseases
• various skin conditions:
• alteration of skin color, especially of the face or neck, known as “pregnancy spots” (cloasma)
• painful reddish nodules (erythema nodosum)
• rash with target-like redness or lesions (erythema multiforme)
• dry eyes, changes in the tear film
• dementia

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Estraderm MX

Do not store at a temperature above 25 °C. Do not expose the patches to direct sunlight.
Keep this medicine out of the sight and reach of children.
The Estraderm MX patches must be stored packaged in their sachets.
Do not use this medicine after the expiry date which is reported on the packaging after “Expires”.
The expiry date refers to the last day of that month.
The patches, once used, should be folded with the adhesive side inwards and thrown into the appropriate
containers.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how to
dispose of medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What EstradermMX contains
Estraderm MX 25 mcg/day transdermal patch

• The active ingredient is estradiol. Each transdermal patch contains 0.75 mg of estradiol hemihydrate and releases 25 mcg of estradiol over 24 hours.
• The other ingredients are acrylate-methacrylate copolymer, isopropyl palmitate, polyethylene terephthalate, ethylene-vinyl acetate. The protective film, which is removed before applying the transdermal patch, is siliconized on the inner side.

Estraderm MX 50 mcg/day transdermal patch

• The active ingredient is estradiol. Each transdermal patch contains 1.5 mg of estradiol hemihydrate and releases 50 mcg of estradiol over 24 hours.
• The other ingredients are acrylate-methacrylate copolymer, isopropyl palmitate, polyethylene terephthalate, ethylene-vinyl acetate. The protective film, which is removed before applying the transdermal patch, is siliconized on the inner side.

Estraderm MX 100 mcg/day transdermal patch

• The active ingredient is estradiol. Each transdermal patch contains 3 mg of estradiol hemihydrate and releases 100 mcg of estradiol over 24 hours.
• The other ingredients are acrylate-methacrylate copolymer, isopropyl palmitate, polyethylene terephthalate, ethylene-vinyl acetate. The protective film, which is removed before applying the transdermal patch, is siliconized on the inner side.

Description of the appearance of EstradermMX and package contents
Each pack of Estraderm MX 25 mcg/day transdermal patch contains 8 sealed sachets,
each containing one transdermal patch.
Each pack of Estraderm MX 50 mcg/day transdermal patch contains 8 sealed sachets,
each containing one transdermal patch.
Each pack of Estraderm MX 100 mcg/day transdermal patch contains 8 sealed sachets,
each containing one transdermal patch.

Marketing Authorisation Holder and Manufacturer
Merus Labs Luxco II S.à.R.L.
26-28, rue Edward Steichen
L-2540 Luxembourg

Manufacturer
Norgine B. V.,
Antonio Vivaldistraat 150,
1083 HP Amsterdam,
Netherlands