ESTRADIOL MERIESTRA 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Estradiol Meriestra 2 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Estradiol Meriestra and what is it used for
2. What you need to know before taking Estradiol Meriestra
3. How to take Estradiol Meriestra
4. Possible side effects
5. Storage of Estradiol Meriestra
6. Package Contents and Additional Information

1. What is Estradiol Meriestra and what is it used for

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

Estradiol Meriestra is used for:

Relief of symptoms that occur after menopause.

Menopause occurs naturally in all women, usually between the ages of 45 and 55. It also occurs in younger women who have had their ovaries removed. During menopause, the amount of estrogen produced by the woman's body decreases 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 estrogen, which is specifically indicated for women without a uterus who do not need to take progestogens as well. If you have not had a hysterectomy, you should also take progestogens with Estradiol Meriestra, following your doctor's instructions.

Prevention of osteoporosis

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

If you are at increased risk of fractures due to osteoporosis and other medications are not suitable for you, you can take Estradiol Meriestra to prevent osteoporosis after menopause.

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

2. What you need to know before starting to take Estradiol Meriestra

Medical history and periodic reviews

The use of Hormone Replacement Therapy (HRT) involves a series of risks that must be weighed when deciding whether to take it or continue taking it.

Experience in treating women with premature menopause (due to ovarian failure or removal) is limited. If you have premature menopause, the risks of using HRT may be different. Consult your doctor.

Before starting (or restarting) HRT, 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). During these check-ups, discuss the benefits and risks of continuing Estradiol Meriestra treatment with your doctor.

Undergo frequent mammograms, as determined by your doctor.

Do not take Estradiol Meriestra

If you have any of the following conditions. If you are unsure about any of the following points, consult your doctorbefore taking Estradiol Meriestra.

Do not take Estradiol Meriestra

• if you have or have had breast cancer,or if it is suspected that you may have it,
• if you have any estrogen-sensitive cancer, such as cancer of the uterine lining (endometrium), or if it is suspected that you may have it,
• if you have vaginal bleeding of unknown origin,
• if you have excessive thickening of the uterine lining(endometrial hyperplasia) that is not being treated,
• if you have or have had a blood clot in a vein(thrombosis) in a place such as the legs (deep vein thrombosis) or lungs (pulmonary embolism),
• if you have a blood coagulation disorder(such as a deficiency of protein C, protein S, or antithrombin),
• if you have or have recently had a disease caused by blood clots in an artery, such as a heart attack,stroke,or angina pectoris,
• if you have or have had liver disease in the past and liver function tests have not returned to normal,
• if you have a rare blood disorder called "porphyria" that is inherited from parents to children (hereditary),
• if you are allergicto estradiol or any of the other components of this medication (included in section 6).

If any of these situations occur for the first time while you are 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 treatment with Estradiol Meriestra. If that happens, you should visit your doctor more frequently for check-ups:

• fibroids in the uterus,
• growth of the uterine lining outside the uterus (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 an 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 of the body (systemic lupus erythematosus, SLE),
• epilepsy,
• asthma,
• a disease that affects the eardrum and hearing (otosclerosis),
• a very high level of fats in the blood (triglycerides),
• fluid retention due to heart or kidney problems,
• hypothyroidism (a disease in which your thyroid gland does not produce enough thyroid hormone and for which you are being 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 these events while taking HRT:

• any of the disorders mentioned in the section "Do not take Estradiol Meriestra",
• yellowing of the skin or whites of the eyes (jaundice). These can be symptoms of liver disease,
• a significant increase in blood pressure (symptoms may be headache, fatigue, dizziness),
• migraine-like 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 suggest angioedema,
• • painful swelling and redness of the legs,
  • sudden chest pain,
  • difficulty breathing

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

Note:Estradiol Meriestra is not a contraceptive. If it has been less than 12 months since your last period or you are under 50 years old, you may still need to use an additional contraceptive method to avoid becoming pregnant. 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 with only estrogens increases the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer).

Taking progestogens in addition to estrogens for at least 12 days every 28-day cycle helps protect against this additional risk. Therefore, if you have a uterus, your doctor will also prescribe progestogens. If you have had a hysterectomy (removal of the uterus), consult your doctor to see if you can take this medication without progestogens.

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

In women between the ages of 50 and 65 who have a uterus and take HRT that contains only estrogens, between 10 and 60 women out of 1,000 will be diagnosed with endometrial cancer (i.e., between 5 and 55 additional cases), depending on the dose and duration of treatment.

Unexpected bleeding

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

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

see your doctor as soon as possible

Breast cancer

Existing data show that the use of Hormone Replacement Therapy (HRT) with combined estrogen-progestogen or only estrogen increases the risk of breast cancer. The additional risk depends on the length of time you use HRT. 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 between the ages of 50 and 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 estrogen-only HRT 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 estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (i.e., between 4 and 8 cases).

In women between the ages of 50 and 59 who are not taking HRT, on average, 27 cases of breast cancer will be diagnosed per 1,000 women over a 10-year period. In women aged 50 who start estrogen-only HRT for more than 10 years, there will be 34 cases per 1,000 users (i.e., 7 additional cases). In women aged 50 who start HRT with estrogen-progestogen for 10 years, there will be 48 cases per 1,000 users (i.e., 21 additional cases).

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

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

Ovarian cancer

Ovarian cancer is uncommon (much less common than breast cancer). The use of HRT with only estrogens or combined estrogen-progestogen 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 receiving HRT, about 2 out of 2,000 will be diagnosed with ovarian cancer over a 5-year period. In women treated with 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 the veinsis approximately 1.3 to 3 times higher among HRT users compared to non-users, especially during the first year of treatment.

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

You are more likely to have a blood clot in the veins with age and if any of the following apply to you. Inform your doctor if any of these situations apply to you:

• you are unable to walk for a long time due to major surgery, injury, or illness (see also section 3, "If you need to undergo surgery"),
• you are severely overweight (BMI >30 kg/m2),
• you have a blood coagulation disorder that requires long-term treatment with a medication to prevent blood clots,
• any of your close relatives have had a blood clot in the leg, 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 in their fifties 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 in their fifties who have been taking HRT with estrogen-progestogen 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 in their fifties who have had a hysterectomy and have been taking HRT with estrogen only for 5 years, there will be between 5 and 8 cases per 1,000 users (i.e., 1 additional case).

Heart disease (heart attack)

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

Women over 60 who take HRT with estrogen-progestogen are slightly more likely to develop heart disease than those who do not take any HRT.

In women who have had a hysterectomy and are taking estrogen-only therapy, there is no increased risk of developing heart disease.

Stroke

The risk of having a stroke is about 1.5 times higher among HRT users compared to non-users. The number of additional stroke cases due to HRT use increases with age.

Comparison

In women in their fifties who do not take HRT, on average, 8 out of 1,000 will have a stroke. In women in their fifties 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 tests suggest that there may be a higher risk of memory loss among women who start using HRT after the age of 65. Consult your doctor.

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

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

Consult your doctor if you identify with any of the above warnings or if they have occurred 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:

• medications for epilepsy (such as phenobarbital, phenytoin, and carbamazepine),
• medications for tuberculosis (rifampicin, rifabutin),
• anti-infective 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), as it may increase the frequency of seizures,
• medications for hepatitis C virus (HCV) (e.g., combination regimen for HCV ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevations in blood test results for liver function (increase in liver enzyme ALT) in women using HRT that contains ethinylestradiol. Estradiol Meriestra contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT can occur when using Estradiol Meriestra with this combination regimen for HCV.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication. Your doctor will inform you about this.

Lab tests

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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, you should not take Estradiol Meriestra. If you become pregnant while taking Estradiol Meriestra, you should stop treatment immediately.

Breastfeeding

You should not take Estradiol Meriestra during breastfeeding.

Driving and using machines

Estradiol Meriestra does not affect your ability to drive or use machines.

Estradiol Meriestra contains lactose

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

3. How to take Estradiol Meriestra

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 start of treatment. If necessary (e.g., desired results are not obtained after 3 months), your doctor may adjust the dose.

Women with a uterus:

Long-term use of estrogens without the inclusion of progestogens increases the risk of endometrial cancer in women with a uterus. Estrogens should be taken along 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 per day for 21 days (3 weeks), followed by a 7-day break.

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

Continuous treatment:

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

Usually, your doctor will also prescribe another hormone called progestogens.

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

Women without a uterus:

Unless you have a condition where uterine wall cells come out of the uterus (endometriosis), estrogen treatment 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 notice that the effects of Estradiol Meriestra are too strong or too weak, consult your doctor.

If you have previously taken other HRTs, 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 (e.g., a glass of water).

How long should you take Estradiol Meriestra?

From time to time, you should talk to your doctor about the possible risks associated with Estradiol Meriestra and whether you need to continue treatment. It is essential that you take the minimum effective dose and only for the necessary time.

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 Toxicology 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 with the treatment as usual without taking the missed tablet. Do not take a double dose to make up for missed doses. If you have already forgotten to take a tablet previously, you may experience withdrawal bleeding.

If you need surgery

If you are going to undergo surgery, you should inform the surgeon that you are taking Estradiol Meriestra. You may need to stop taking Estradiol Meriestra 4 to 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 stop 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 determine the reason for this. After a prolonged interruption of treatment, consult your doctor before taking Estradiol Meriestra again.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Breast cancer.
• Abnormal growth or cancer of the uterine lining (endometrial hyperplasia or 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 65 years of age.

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 mentioned symptoms, stop taking Estradiol Meriestra immediately and seek medical help as soon as possible.

Breast tenderness is the most frequently reported side effect 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 rashes, itching.
• Uterine/vaginal bleeding, including spotting, irregular vaginal bleeding, abnormal and prolonged menstrual bleeding.
• Viscous white, yellowish, or greenish vaginal discharge (leucorrhea).

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity.
• Depression, depressed mood.
• Dizziness.
• Vision disorders.
• Palpitations.
• Venous obstruction by a blood clot.
• Flatulence, indigestion.
• Erythema nodosum (a form of skin rash with painful red and blue 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.
• Intolerance to contact lenses.
• Increased blood pressure.
• Vomiting, feeling of fullness in the upper abdomen.
• Gallstones, gallbladder disease, changes in liver function tests.
• Excessive hair growth, acne.
• Muscle cramps.
• Painful menstruation, vaginal discharge, premenstrual syndrome, breast enlargement.
• Fatigue.

Other side effects that may occur during estradiol treatment are:

• Hair loss
• Fibroids (benign growth of tissue inside the uterus).
• Pain in the limbs.
• Tachycardia or other cardiac symptoms.
• Brittle or painful veins.
• Nosebleeds.

Other side effects that occur with hormone replacement therapy are:

• Skin or subcutaneous disorders such as:

• Chloasma (brown-yellowish pigmentation spots, also called "pregnancy spots").
• Erythema multiforme (a form of skin rash with blisters, bumps, and fluid accumulation).
• Vascular purpura (small bleeding points on the skin).

• Cholestatic jaundice.
• Diarrhea.
• Dry eyes.
• Changes in the composition of the tear film.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Estradiol Meriestra

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after "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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Estradiol Meriestra

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

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

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

Appearance and package contents

Estradiol Meriestra is a film-coated, round, blue tablet with a score line on one side.

Estradiol Meriestra is available in aluminum/polyvinyl chloride blister packs of 28, 3 x 28, 30, 60, 90, or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

Date of last revision of this leaflet:April 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/