Estradiol Meriestra 2 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Estradiol Meriestra 2 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Estradiol Meriestra is and what it is used for
2. What you need to know before taking Estradiol Meriestra
3. How to take Estradiol Meriestra
4. Possible side effects
5. How to store Estradiol Meriestra
6. Contents of the pack and other information

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

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

Estradiol Meriestra is used for:

Relief of symptoms occurring after menopause.

Menopause occurs naturally in all women, usually between the ages of 45 and 55. It also occurs in younger women who have undergone surgical removal of the ovaries. During menopause, the amount of estrogen produced by a woman's body decreases sharply. This may result in symptoms such as a feeling of warmth in the face, neck, and chest ("hot flashes"). Estradiol Meriestra relieves these postmenopausal symptoms. Your doctor will prescribe Estradiol Meriestra only if your symptoms significantly affect your daily life.

Estradiol Meriestra contains only estrogens and is specifically indicated for women without a uterus who do not need to take progestogens. If your uterus has not been removed, you must also take a progestogen along with Estradiol Meriestra, as directed by your doctor.

Prevention of osteoporosis

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

If you are at increased risk of fractures due to osteoporosis and other medications are not suitable for you, Estradiol Meriestra may be prescribed to prevent postmenopausal osteoporosis.

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

2. What you need to know before starting Estradiol Meriestra

Medical history and regular check-ups

Hormone replacement therapy (HRT) involves certain risks that must be weighed when deciding whether to start or continue treatment.

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

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

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

Have mammograms regularly, as recommended by your doctor.

Do not take Estradiol Meriestra

If any of the following apply to you. 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 breast cancer is suspected,
• if you have any estrogen-sensitive cancer, such as cancer of the uterine lining (endometrium), or if such cancer is suspected,
• if you have vaginal bleeding of unknown origin,
• if you have excessive thickening of the inner lining of the uterus (endometrial hyperplasia) that is not being treated,
• if you have or have had a blood clot in a vein (thrombosis), such as in the legs (deep vein thrombosis) or lungs (pulmonary embolism),
• if you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency),
• if you have or have recently had a disease caused by blood clots in an artery, such as heart attack, stroke, or angina pectoris,
• if you have or have previously had a liver disease and liver function tests have not returned to normal,
• if you have a rare inherited blood disorder called “porphyria”,
• if you are allergic to estradiol or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions occur for the first time while you are taking Estradiol Meriestra, stop taking the medicine immediately and consult your doctor.

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 conditions, as they may recur or worsen during treatment with Estradiol Meriestra. If this occurs, you should visit your doctor more frequently for check-ups:

• fibroids in the uterus,
• growth of the uterine lining outside the uterus (endometriosis) or 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., if your mother, sister, or grandmother had breast cancer),
• high blood pressure,
• liver disorders, such as benign liver tumours,
• diabetes,
• gallstones,
• migraine or severe headaches,
• an autoimmune disease affecting multiple organs (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,
• hypothyroidism (a condition in which your thyroid gland does not produce enough thyroid hormone, and for which you are receiving thyroid hormone replacement therapy),
• hereditary or acquired angioedema (episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat, or digestive tract).

Stop taking Estradiol Meriestra and see your doctor immediately

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

• any of the conditions listed in the section “Do not take Estradiol Meriestra”,
• yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disease,
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness),
• new-onset migraine-type headaches,
• if you become pregnant,
• swelling of the face, tongue, or throat, difficulty swallowing, or hives accompanied by difficulty breathing, suggesting angioedema,
• if you notice symptoms of blood clots such as:
  • painful swelling and redness in 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 less than 12 months have passed since your last period, or if you are under 50 years of age, you may still need to use an additional contraceptive method to avoid pregnancy. Seek advice from your doctor.

HRT and cancer

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

Taking HRT with estrogens alone increases the risk of thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer).

Taking progestogens in addition to estrogens for at least 12 days of each 28-day cycle helps protect against this additional risk. Therefore, if you still have your uterus, your doctor will prescribe progestogens along with the estrogen. If you have had your uterus removed (hysterectomy), consult your doctor to determine whether you can take this medicine without progestogens.

Among 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.

Among women aged 50 to 65 who still have their uterus and who take HRT containing estrogens only, between 10 and 60 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 monthly bleeding (also called withdrawal bleeding) while taking Estradiol Meriestra. However, if you experience unexpected bleeding or spotting outside your monthly bleed that:

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

see your doctor as soon as possible.

Breast cancer

Available data show that the use of combined estrogen-progestogen HRT or estrogen-only HRT increases the risk of breast cancer. The additional risk depends on how long you use HRT. The additional risk becomes apparent after about 3 years of use. After stopping HRT, the additional risk decreases over time, but may persist for 10 years or more if you have used HRT for more than 5 years.

Comparison

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

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

Among women aged 50 who start estrogen-progestogen HRT for 5 years, there will be 21 cases per 1,000 women (i.e., between 4 and 8 additional cases).

Among women aged 50 to 59 who are not taking HRT, an average of 27 cases of breast cancer will be diagnosed per 1,000 women over a 10-year period. Among women aged 50 who start estrogen-only HRT for more than 10 years, there will be 34 cases per 1,000 women (i.e., 7 additional cases). Among women aged 50 who start estrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 women (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 lumps or lumps that can be felt.

Ovarian cancer

Ovarian cancer is uncommon (much less common than breast cancer). The use of HRT with estrogens alone or combined estrogen-progestogen HRT has been associated with a slight increase in the risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, among 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. Among women receiving HRT for 5 years, about 3 cases per 2,000 users will occur (i.e., about one 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 among HRT users compared to non-users, especially during the first year of treatment.

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

Your risk of developing a blood clot in a vein increases with age and if any of the following apply to you. Inform your doctor if any of these situations affect you:

• inability to walk for long periods due to major surgery, injury, or illness (see also section 3, “If you need to undergo surgery”),
• severe obesity (BMI >30 kg/m²),
• a clotting disorder requiring long-term treatment with blood-thinning medication,
• a close relative who has ever had a blood clot in the leg, lung, or another organ,
• pregnancy and postpartum,
• systemic lupus erythematosus (SLE),
• cancer.

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

Comparison

Among women in their fifties who are not taking HRT, an average of 4 to 7 out of 1,000 are expected to have a blood clot in a vein over a 5-year period.

Among women in their fifties who have been taking estrogen-progestogen HRT 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: Among women in their fifties who have had their uterus removed and have been taking estrogen-only HRT for 5 years, there will be 5 to 8 cases per 1,000 users (i.e., 1 additional case).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.

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

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

Stroke

The risk of 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

Among women in their fifties who do not take HRT, an average of 8 out of 1,000 are expected to have a stroke. Among women in their fifties receiving 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 does not prevent memory loss. Some evidence suggests an increased risk of memory loss in women who start HRT after age 65. Consult your doctor.

The use of estradiol 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, the use of estrogens may significantly increase blood lipid levels, and rarely, may cause pancreatitis. If you have very high triglyceride levels in the blood (hypertriglyceridemia), you should be monitored while taking estradiol.

Consult your doctor if any of the above warnings apply to you, or if they have occurred in the past.

Other medicines and Estradiol Meriestra

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

• epilepsy medications (such as phenobarbital, phenytoin, and carbamazepine),
• tuberculosis medications (rifampicin, rifabutin),
• antiviral medications (nevirapine, efavirenz, ritonavir, nelfinavir),
• herbal remedies containing St. John’s wort (Hypericum perforatum).

HRT may affect the function of other medicines:

• an epilepsy medication (lamotrigine), as it may increase the frequency of seizures,
• hepatitis C virus (HCV) medications (e.g., the HCV combination regimen ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevations in liver function blood tests (increased ALT liver enzyme) in women using HRT containing ethinylestradiol. Estradiol Meriestra contains estradiol instead of ethinylestradiol. It is unknown whether an increase in ALT liver enzyme may occur when Estradiol Meriestra is used with this HCV combination regimen.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor will advise you accordingly.

Laboratory tests

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

Estradiol Meriestra is only intended for use in postmenopausal women. If you become pregnant, stop taking this medicine and contact your doctor.

Pregnancy

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

Breastfeeding

Do not take Estradiol Meriestra while breastfeeding.

Driving and use of machines

Estradiol Meriestra does not affect the ability to drive or use machinery.

Estradiol Meriestra contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Estradiol Meriestra

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will prescribe the lowest possible dose to treat your symptoms for the shortest necessary duration. Consult your doctor if you think the prescribed dose is too high or too low.

The recommended dose is:

Treatment of estrogen deficiency symptoms in postmenopausal women:

In general, your doctor will initially prescribe half a tablet of Estradiol Meriestra once daily. If necessary (for example, if desired results are not achieved after 3 months), your doctor may adjust the dose.

Women with a uterus:

Long-term use of estrogens without the addition of progestogens increases the risk of endometrial cancer in women with a uterus. Estrogens should be taken together with progestogen tablets for at least 12 days per month to reduce this risk.

Two different treatment regimens may be prescribed:

Cyclic treatment:

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

Usually, your doctor will also prescribe treatment with a hormone called a progestogen. You should take the 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 treatment break, withdrawal bleeding (menstruation-like bleeding) may occur.

Continuous treatment:

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

Usually, your doctor will also prescribe a progestogen hormone.

You should take the progestogen tablets for the last 12–14 days of each month. Withdrawal bleeding (menstruation-like bleeding) may occur during treatment when estrogens are administered in combination with progestogens.

Women without a uterus:

Unless you have a condition in which cells from the uterine lining grow outside the uterus (endometriosis), estrogen therapy does not need to be combined with progestogens if your uterus has been removed. Take half or 1 tablet of Estradiol Meriestra once daily without interruption.

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

If you are using Estradiol Meriestra to treat menopausal symptoms and notice that the effects are too strong or too weak, consult your doctor.

If you have previously used other HRT treatments, consult your doctor or pharmacist about when to start taking Estradiol Meriestra.

Prevention of osteoporosis

1 tablet of Estradiol Meriestra daily, 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?

You should regularly discuss with your doctor the potential risks associated with Estradiol Meriestra and whether you still need to continue treatment. It is important to take the lowest effective dose for only as long as necessary.

If you take more Estradiol Meriestra than you should

If you have taken more Estradiol Meriestra than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, stating the name of the medicine and the amount ingested. Possible symptoms include nausea, vomiting, and withdrawal bleeding.

If you forget to take Estradiol Meriestra

If you forget to take a tablet, take it as soon as possible. If more than 12 hours have passed, continue your treatment as normal and do not take the missed tablet. Do not take a double dose to make up for a missed dose. If you have previously missed taking tablets, you may experience withdrawal bleeding.

If you need surgery

If you are scheduled for surgery, inform your surgeon that you are taking Estradiol Meriestra. You may need to stop taking Estradiol Meriestra 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, “Blood clots in a vein (thrombosis)”). Consult your doctor about when you can restart treatment with Estradiol Meriestra.

If you stop taking 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 must determine the cause of this occurrence. After a prolonged interruption of treatment, consult your doctor before resuming Estradiol Meriestra.

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

4. Possible adverse effects

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

The following conditions have been reported more frequently in women using HRT (hormone replacement therapy):

• Breast cancer.
• Abnormal growth or cancer of the inner lining of the uterus (endometrial hyperplasia or cancer).
• Ovarian cancer.
• Blood clots in the veins of the legs or lungs (venous thromboembolism).
• Heart disease.
• Stroke.
• Possible memory loss if HRT is started after the age of 65.

For more information about adverse 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 listed above, stop taking Estradiol Meriestra immediately and seek medical help as soon as possible.

Breast tenderness is the most frequently reported adverse effect associated with estradiol treatment.

The following adverse effects have been reported with estradiol:

Frequent: may affect more than 1 in 10 people

• Weight gain or weight loss.
• Sleep disorders, headaches.
• Nausea, abdominal pain.
• Skin rashes, pruritus (itching).
• Uterine/vaginal bleeding, including spotting, irregular vaginal bleeding, and abnormally heavy or prolonged menstrual bleeding.
• White, yellowish, or greenish sticky vaginal discharge (leucorrhoea).

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity.
• Depression, depressed mood.
• Dizziness.
• Visual disturbances.
• Sensation of pounding in the chest (palpitations).
• Venous obstruction due to a blood clot.
• Flatulence, indigestion.
• Erythema nodosum (a type of skin rash 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.
• 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-like syndrome, breast enlargement.
• Fatigue.

Other side effects that may occur during treatment with estradiol include:

• Hair loss.
• Fibroids (benign growths of tissue within the uterus).
• Limb pain.
• Tachycardia or other cardiac symptoms.
• Fragile or painful veins.
• Nosebleeds.

Other side effects associated with hormone replacement therapies include:

• Skin or subcutaneous disorders such as:

• Chloasma (brown-yellowish pigmentation patches, also known as "pregnancy mask").

• Erythema multiforme (a type of skin rash with sores, blisters, and fluid accumulation).

• Vascular purpura (small bleeding spots on the skin).

• Cholestatic jaundice.

• Diarrhea.

• Dry eyes.

• Changes in the composition of the tear film.

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

Reporting of adverse effects

If you experience any adverse effects, talk to 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Estradiol Meriestra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging after “CAD/EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Estradiol Meriestra

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

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

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

Appearance of the product and contents of the pack

Estradiol Meriestra are round, blue, film-coated tablets, scored on one side (notch).

Estradiol Meriestra is available in aluminium/polyvinyl chloride blisters containing 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
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben
Germany

Date of the most recent review of this leaflet: April 2025

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