Prospect: information for the patient

Estradiol Meriestra 2 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Estradiol Meriestra is a hormone replacement therapy (HRT) that contains the female hormone estrogen.

Estradiol Meriestra is used for:

Relief of symptoms that appear after menopause.

Menopause occurs naturally in all women, usually between the ages of 45 and 55. It can also occur in younger women who have undergone an ovary removal. During menopause, the amount of estrogen produced by the woman's body drops sharply. This can result in symptoms such as a feeling of heat in the face, neck, and chest (“hot flashes”). Estradiol Meriestra relieves these symptoms after menopause. Your doctor will only prescribe Estradiol Meriestra if the symptoms you are experiencing severely affect your daily life.

Estradiol Meriestra only contains estrogens, which is specifically indicated for women without a uterus who do not need to take progestogens in addition. If you have not had your uterus removed, you should take progestogens in addition to Estradiol Meriestra, following your doctor's instructions.

Prevention of osteoporosis

After menopause, some women develop bone weakness (osteoporosis). You should discuss all available options with your doctor.

If you have a higher risk of fractures due to osteoporosis and other medications that are not suitable for you, you may take Estradiol Meriestra to prevent osteoporosis after menopause.

There is limited experience in treating women over 65 years old with Estradiol Meriestra.

Medical History and Regular Reviews

The use of THS involves a series of risks that must be weighed when deciding whether to take or continue taking it.

The experience in treating women with premature menopause (due to failure or removal of the ovaries) is limited. If you have premature menopause, the risks of using a THS may be different. Consult your doctor.

Before starting (or restarting) THS, your doctor will ask you questions about your medical history and that of your family. Your doctor may need to perform a medical examination that may include a breast examination and/or an internal examination, if necessary.

Once you have started taking Estradiol Meriestra, you should undergo regular medical check-ups (at least once a year). In these reviews, consult with your doctor about the benefits and risks of continuing Estradiol Meriestra treatment.

Undergo frequent mammograms, as determined by your doctor.

Do Not Take Estradiol Meriestra

If you have any of the following cases. If you are unsure about any of the following points, consult your doctor before taking Estradiol Meriestra.

Do Not Take Estradiol Meriestra

• if you have or have had breast cancer, or if you suspect you may have it,
• if you have any cancer sensitive to estrogens, such as endometrial cancer, or if you suspect you may have it,
• if you have unexplained vaginal bleeding,
• if you have an excessive thickening of the inner wall of the uterus (endometrial hyperplasia) that is not being treated,
• if you have or have had a blood clot in a vein (thrombosis) in any location, such as the legs (deep vein thrombosis) or lungs (pulmonary embolism),
• if you have any bleeding disorder (such as a deficiency of protein C, protein S, or antithrombin),
• if you have or have had a recent arterial disease caused by blood clots, such as a heart attack, stroke, or angina pectoris,
• if you have or have had previously liver disease and liver function tests have not returned to normal,
• if you have a rare blood disorder called "porphyria" that is inherited,
• if you are allergic to estradiol or to any of the other components of this medication (including those listed in section 6).

If any of these situations appear for the first time while taking Estradiol Meriestra, stop taking the medication and consult your doctor immediately.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Estradiol Meriestra.

Before starting treatment, inform your doctor if you have ever had any of the following problems, as they may recur or worsen during Estradiol Meriestra treatment. If this happens, you should visit your doctor more frequently for check-ups:

• fibroids within the uterus,
• growth of the uterine wall outside of it (endometriosis) or a history of excessive growth of the uterine wall (endometrial hyperplasia),
• increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)")
• increased risk of developing estrogen-sensitive cancer (e.g., having a mother, sister, or grandmother who has had breast cancer),
• high blood pressure,
• liver disorders, such as benign liver tumors,
• diabetes,
• gallstones,
• migraines or severe headaches,
• a disease of the autoimmune system that affects many organs in the body (systemic lupus erythematosus, SLE),
• epilepsy,
• asthma,
• a disease that affects the eardrum and hearing (otosclerosis),
• very high levels of fat in the blood (triglycerides),
• fluid retention due to heart or kidney problems,
• hypothyroidism (a disease in which the thyroid gland does not produce enough thyroid hormone and for which you are treated with hormone replacement therapy),
• hereditary and acquired angioedema (episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat, or digestive tract).

Stop taking Estradiol Meriestra and visit your doctor immediately.

If you experience any of the following events while taking the THS:

• any of the conditions mentioned in the "Do Not Take Estradiol Meriestra" section,
• yellowing of the skin or white of the eyes (jaundice). This may be a sign of liver disease,
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness),
• migraine-type headaches that appear for the first time,
• if you become pregnant,
• swelling of the face, tongue, or throat and difficulty swallowing or urticaria accompanied by difficulty breathing, which suggests angioedema,
• if you notice symptoms of blood clots such as:
• • painful and swollen legs,
  • sudden chest pain,
  • difficulty breathing

For more information, see "Blood clots in a vein (thrombosis)".

Note:Estradiol Meriestra is not a contraceptive. If you have had a period in the last 12 months or are under 50 years old, you may still need to use an additional contraceptive method to avoid becoming pregnant. Consult your doctor.

THS and Cancer

Excessive thickening of the inner wall of the uterus (endometrial hyperplasia) and uterine cancer (endometrial cancer)

The use of THS with estrogens alone increases the risk of excessive thickening of the inner wall of the uterus (endometrial hyperplasia) and uterine cancer (endometrial cancer).

Taking progestogens in addition to estrogens for at least 12 days each cycle of 28 days helps protect against this additional risk. Therefore, if you still have a uterus, your doctor will prescribe progestogens as well. If you have had a hysterectomy, consult your doctor if you can take this medication without progestogens.

In women with a uterus who do not receive THS, on average, 5 out of 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

In women aged 50 to 65 who still have a uterus and take a THS containing estrogens only, between 10 and 60 women out of 1,000 will be diagnosed with endometrial cancer (i.e., between 5 and 55 cases more), depending on the dose and duration of treatment.

Unexpected Bleeding

You will experience bleeding once a month (also called bleeding due to deprivation) while taking Estradiol Meriestra. However, if you have unexpected bleeding or spotting outside of your monthly bleeding that:

• lasts beyond the first 6 months,
• starts after taking Estradiol Meriestra for more than 6 months,
• continues after stopping Estradiol Meriestra,

Visit your doctor as soon as possible

Breast Cancer

The available data show that the use of hormone replacement therapy (HRT) with estrogens-progestogens or estrogens alone increases the risk of breast cancer. The additional risk depends on the duration of use. The additional risk becomes apparent after about 3 years of use. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.

Comparison

In women aged 50 to 54 who are not using HRT, on average, 13 to 17 out of 1,000 will be diagnosed with breast cancer over a 5-year period.

In women aged 50 who start HRT with estrogens only for 5 years, there will be between 16 and 17 cases per 1,000 users (i.e., between 0 and 3 additional cases).

In women aged 50 who start HRT with estrogens-progestogens for 5 years, there will be 21 cases per 1,000 users (i.e., between 4 and 8 additional cases).

Examine your breasts regularly. Consult your doctor if you notice any of the following changes:

• small depressions in the skin,
• changes in the nipple,
• visible lumps or palpable lumps.

Ovarian Cancer

Ovarian cancer is relatively rare (much less common than breast cancer). The use of HRT with estrogens alone or with a combination of estrogens-progestogens has been associated with a slight increase in the risk of developing ovarian cancer.

The risk of developing ovarian cancer varies with age. For example, in women aged 50 to 54 who are not receiving HRT, about 2 out of 2,000 will be diagnosed with ovarian cancer over a 5-year period. In women receiving HRT for 5 years, there will be about 3 cases per 2,000 users (i.e., about 1 additional case).

Effect of HRT on the Heart and Circulation

Blood Clots in a Vein (Thrombosis)

The risk of blood clots in veins is approximately 1.3 to 3 times higher in HRT users compared to non-users, especially during the first year of treatment.

Blood clots can be serious, and if they reach the lungs, they can cause chest pain, difficulty breathing, dizziness, and even death.

You are more likely to have a blood clot in a vein if you have any of the following conditions. Inform your doctor if you have any of these conditions:

• you cannot walk for a long time due to major surgery, injury, or illness (see also section 3, "If you need to undergo a surgical procedure"),
• you have severe obesity (BMI > 30 kg/m2),
• you have a bleeding disorder that requires long-term treatment with a medication to prevent blood clots,
• any of your close relatives have had a blood clot in a vein, lung, or other organ,
• pregnancy and postpartum,
• you have systemic lupus erythematosus (SLE),
• you have cancer.

For signs of blood clots, see "Stop taking Estradiol Meriestra and visit your doctor immediately".

Comparison

In women aged 50 who are not taking HRT, on average, 4 to 7 out of 1,000 will have a blood clot in a vein over a 5-year period.

In women aged 50 who have been taking HRT with estrogens-progestogens for 5 years, there will be 9 to 12 cases per 1,000 users (i.e., 5 additional cases).

Additional warning for estrogen-only products: In women aged 50 who have had a hysterectomy and have been taking HRT with estrogens only for 5 years, there will be 5 to 8 cases per 1,000 users (i.e., 1 additional case).

Cardiovascular Diseases (Heart Attack)

There is no evidence that HRT will prevent a heart attack.

Women over 60 who take HRT with estrogens-progestogens are slightly more susceptible to developing cardiovascular diseases than those who do not take any type of HRT.

In women who have had a hysterectomy and are taking estrogen-only treatment, there is no increased risk of developing cardiovascular diseases.

Stroke

The risk of stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional stroke cases due to HRT use increases with age.

Comparison

In women aged 50 who are not taking HRT, on average, 8 out of 1,000 will have a stroke over a 5-year period. In women aged 50 who receive HRT, there will be 11 cases per 1,000 users over a 5-year period (i.e., 3 additional cases).

HRT and Other Disorders

HRT will not prevent memory loss. Some studies suggest that there may be an increased risk of memory loss in women who start HRT after the age of 65. Consult your doctor.

Estradiol can cause fluid retention in the body. If you have kidney or heart problems, you should be monitored by your doctor while taking estradiol.

In some cases, the use of estrogens can significantly increase the level of lipids in the blood, and in rare cases, produce pancreatitis. If you have very high levels of triglycerides in your blood (hypertriglyceridemia), you should be monitored while taking estradiol.

Consult your doctor if you identify with any of the previous warnings, or if you have had them in the past.

Other Medications and Estradiol Meriestra

Some medications may reduce the effectiveness of Estradiol Meriestra. This may result in irregular bleeding. This can occur with the following medications:

• antiepileptic medications (such as phenobarbital, phenytoin, and carbamazepine),
• antituberculosis medications (rifampicin, rifabutin),
• antiviral medications (nevirapine, efavirenz, ritonavir, nelfinavir),
• herbal preparations containing St. John's Wort (Hypericum perforatum),

HRT may affect the functioning of other medications:

• a medication for epilepsy (lamotrigine), which may increase the frequency of seizures,
• medications for hepatitis C virus (HCV) (e.g., combination regimen for HCV or ombitasvir/paritaprevir/ritonavir with or without dasabuvir or glecaprevir/pibrentasvir) may cause elevated liver function test results (increased ALT enzyme) in women using HCV therapy with ethinylestradiol. Estradiol Meriestra contains estradiol instead of ethinylestradiol. It is unknown whether an increase in ALT enzyme can occur when using Estradiol Meriestra with this HCV combination regimen. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor will advise you accordingly.

Laboratory Tests

If you need to have blood tests, inform your doctor or laboratory staff that you are taking estradiol, as this medication may affect the results of some tests.

Pregnancy and Lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Estradiol Meriestra should only be used in postmenopausal women. If you become pregnant, stop taking this medication and contact your doctor.

Pregnancy

If you are pregnant, do not take Estradiol Meriestra. If you become pregnant while taking Estradiol Meriestra, stop taking the medication immediately.

Lactation

You should not take Estradiol Meriestra during lactation.

Driving and Operating Machinery

Estradiol Meriestra will not affect your ability to drive or operate machinery.

Estradiol Meriestra contains lactose

If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will prescribe the lowest possible dose to treat symptoms for the minimum time. Consult your doctor if you think the prescribed dose is too high or too low.

The recommended dose is:

Treatment for symptoms of estrogen deficiency in postmenopausal women:

Generally, your doctor will prescribe half a tablet of Estradiol Meriestra once a day at the beginning of treatment. If necessary (for example, if desired results are not obtained after 3 months), your doctor may adjust the dose.

Women with uterus:

The prolonged use of estrogens without the incorporation of progestogens increases the risk of endometrial cancer in women with a uterus. Estrogens should be taken with progestogen tablets for at least 12 days a month to reduce this risk.

Two different treatments may be prescribed:

Cyclic treatment:

Take half or 1 tablet of Estradiol Meriestra once a day for 21 days (3 weeks), followed by a 7-day break.

Generally, your doctor will also prescribe a treatment with a hormone called progestogen. You should take the progestogen tablets during the last 12-14 days of the 21-day estrogen cycle. In the fourth week, when you are not taking any medication, you will not take progestogen either. During the break from treatment, you may experience withdrawal bleeding (menstruation).

Continuous treatment:

Take half or 1 tablet of Estradiol Meriestra every day without interruption.

Generally, your doctor will also prescribe another hormone called progestogen.

You should take the progestogen tablets during the last 12-14 days of the month. You may experience withdrawal bleeding during treatment when estrogens are taken in combination with progestogens.

Women without uterus:

Unless you have a condition in which cells from the lining of the uterus come out (endometriosis), treatment with estrogens should not be administered with progestogens if you have had your uterus removed. Take half or 1 tablet of Estradiol Meriestra once a day without interruption.

The tablet can be divided into equal doses by placing the tablet on a firm surface with the marks facing down and pressing it.

If you use Estradiol Meriestra for the treatment of menopausal symptoms and observe that the effects of Estradiol Meriestra are too strong or too weak, consult your doctor.

If you have taken other HRTs previously, consult your doctor or pharmacist when you should start taking Estradiol Meriestra.

Prevention of osteoporosis:

1 tablet of Estradiol Meriestra per day, as determined by your doctor.

Take the tablet with a sufficient amount of liquid (for example, a glass of water).

How long should you take Estradiol Meriestra?

At regular intervals, you should discuss the possible risks associated with Estradiol Meriestra with your doctor, and whether you need to continue treatment. It is essential to take the minimum effective dose and only for as long as necessary.

If you take more Estradiol Meriestra than you should:

If you have taken more Estradiol Meriestra than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.Among the symptoms that may occur are nausea, vomiting, and withdrawal bleeding.

If you forget to take Estradiol Meriestra:

If you have forgotten to take a tablet, take it as soon as possible. If more than 12 hours have passed, continue treatment normally without taking the forgotten tablet.Do not take a double dose to compensate for the missed doses.If you have already forgotten to take a previous tablet, you may experience withdrawal bleeding.

If you need surgery:

If you are to undergo surgery, you should inform the surgeon that you are taking Estradiol Meriestra. You may need to stop taking Estradiol Meriestra between 4 and 6 weeks before the operation to avoid the risk of blood clots (see section 2, "Blood clots in a vein (thrombosis)"). Consult your doctor when you can restart treatment with Estradiol Meriestra.

If you interrupt treatment with Estradiol Meriestra:

Stopping Estradiol Meriestra 2 mg may increase the risk of bleeding or spotting. If this occurs after stopping treatment, contact your doctor immediately. Your doctor should investigate the reason for this.After a prolonged interruption of treatment, consult your doctor before resuming Estradiol Meriestra.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following diseases have been reported to occur more frequently in women using THS:

• Breast cancer.
• Abnormal growth or cancer of the inner wall of the uterus (endometrial hyperplasia or cancer).
• Ovarian cancer.
• Clots in the veins of the legs or lungs (venous thromboembolism).
• Heart disease.
• Stroke.
• Probable memory loss if THS has been started after the age of 65.

For more information on side effects, see Section 2.

Other serious side effects:

• Swelling of the face, lips, mouth, tongue, or throat (angioneurotic edema).

If you experience any of the symptoms mentioned, stop taking Estradiol Meriestra immediately and seek medical help as soon as possible.

Breast tenderness is the side effect that has been reported most frequently with estradiol treatment.

The following side effects have been reported with estradiol:

Frequent: may affect more than 1 in 10 people

• Weight gain or loss.
• Sleep disorders, headaches.
• Nausea, abdominal pain.
• Skin eruptions, pruritus.
• Uterine or vaginal bleeding, including spotting, irregular vaginal bleeding, abnormal and prolonged menstrual bleeding.
• Viscous, whitish, yellowish, or greenish vaginal secretions (leucorrhea).

Rare: may affect up to 1 in 100 people

• Hypersensitivity.
• Depression, depressed mood.
• Dizziness.
• Vision disorders.
• Sensation of agitation in the chest (palpitations).
• Obstruction of veins by a blood clot.
• Flatulence, indigestion.
• Erythema nodosum (a type of skin eruption with painful blue and red nodules), hives.
• Breast tenderness, breast pain.
• Vaginal candidiasis.
• Fluid retention.

Rare: may affect up to 1 in 1,000 people

• Increased blood glucose levels (glucose intolerance).
• Anxiety.
• Changes in sexual desire.
• Migraine.
• Lens intolerance.
• Increased blood pressure.
• Vomiting, sensation of fullness in the upper abdomen.
• Gallstones, gallbladder disease, liver function abnormalities.
• Excessive hair growth, acne.
• Muscle cramps.
• Painful menstruation, vaginal discharge, premenstrual-like syndrome, breast enlargement.
• Fatigue.

Other side effects that may occur during estradiol treatment are:

• Hair loss
• Fibroids (benign growth of tissue within the uterus).
• Pain in the limbs.
• Tachycardia or other cardiac symptoms.
• Weak or painful veins.
• Nasal bleeding.

Other side effects that appear with hormone replacement therapies are:

• Skin or subcutaneous disorders such as:

• Chloasma (brown-yellow patches of pigmentation, also known as "pregnancy patches").
• Erythema multiforme (a type of skin eruption with blisters, vesicles, and fluid accumulation).
• Purpura vascular (small points of bleeding in the skin).

• Cholestatic jaundice.
• Dyspepsia.
• Dry eyes.
• Changes in tear film composition.

Please consult your doctor if you do not feel well or experience any unusual symptoms that you do not understand.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after“CAD/EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Estradiol Meriestra

• The active ingredient is estradiol.
• Each film-coated tablet contains 2 mg of estradiol (as hemihydrate). The other components are:

Tablet core:microcrystalline cellulose, lactose monohydrate, magnesium stearate, cornstarch, anhydrous colloidal silica.

Tablet coating:aluminum hydroxide, hypromellose, indigotin (E132), lactose monohydrate, macrogol 4000, titanium dioxide (E171).

Appearance of the product and contents of the packaging

EstradiolMeriestraare round, blue, scored tablets with a notch on one face.

EstradiolMeriestrais available in aluminum/polyvinylchloride blisters containing 28, 3 x 28, 30, 60, 90 or 100 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Sandoz Farmacéutica, S.A

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

Last review date of this leaflet:july 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/