FEMOSTON 1 mg/5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Femoston 1mg/5mg film-coated tablets

Active substances: estradiol/dydrogesterone

The full name of this medicine is Femoston 1 mg/5 mg film-coated tablets. In this leaflet, it will be referred to as Femoston.

Contents of the pack and other information

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

1. What is Femoston and what is it used for

This medicine is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen called estradiol and a progestogen called dydrogesterone. This medicine is given to postmenopausal women at least 12 months after their last natural period.

What Femoston is used for

Relief of symptoms occurring after menopause

During menopause, the amount of estrogen produced by the woman's body decreases. This can lead to symptoms such as hot flushes (flushes to the face, neck, and chest). This medicine relieves these symptoms after menopause. You will only be prescribed this medicine if your symptoms are severely affecting your daily life.

Prevention of osteoporosis

After menopause, the bones of some women may become fragile (osteoporosis). You should discuss all available options with your doctor.

If you are at increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you may use this medicine to prevent osteoporosis after menopause.

2. What you need to know before you take Femoston

Medical history and regular check-ups

Taking HRT involves risks that need to be considered when deciding whether to start or continue treatment.

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

Before starting (or restarting) HRT, your doctor will ask about your medical history and that of your family. Your doctor may decide to perform a physical examination, which may include a breast and internal examination, if necessary.

Once you have started treatment with estradiol/dydrogesterone, your doctor will need to perform regular check-ups (at least once a year). During these check-ups, your doctor will discuss the benefits and risks of continuing treatment with this medicine.

Have breast screenings as recommended by your doctor.

Do not take Femostonif you are in any of the following situations. If you are unsure about any of the following points, talk to your doctorbefore taking this medicine.

Do not take Femoston

• If you have or have had breast cancer, or if you suspect you may have it.
• If you have cancer that is sensitive to estrogens, such as cancer of the uterus (endometrium), or if you suspect you may have it.
• If you have unexplained vaginal bleeding.
• If you have excessive thickening of the uterus lining(endometrial hyperplasia) that is not being treated.
• If you have or have had a blood clot in a vein(thrombosis) of 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 the arteries, such as a heart attack, stroke, or angina.
• If you have or have had liver diseaseand your liver function tests have not returned to normal.
• If you have a rare blood disorder called porphyriathat is inherited.
• If you are allergic(hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of this medicine (listed in section 6).
• If you have a meningiomaor have ever been diagnosed with a meningioma (a usually benign tumor that forms in the tissue layer between the brain and the skull).

If any of the above conditions appear for the first time while taking estradiol/dydrogesterone, stop taking it and consult your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before taking estradiol/dydrogesterone if you have had any of the following problems, as you may need to be kept under closer supervision:

• Fibroids in the uterus
• Growth of the uterine lining outward (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 estrogen-sensitive cancer (such as having a mother, sister, or grandmother who has had breast cancer)
• High blood pressure
• Liver disease, such as a benign liver tumor
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic immune disease that affects many organs of the body (systemic lupus erythematosus, SLE)
• Epilepsy
• Asthma
• Disease affecting the eardrum and hearing (otosclerosis)
• Very high levels of lipids in the blood (triglycerides)
• Fluid retention due to heart or kidney problems
• Hereditary and acquired angioedema

Meningioma

The use of estradiol/dydrogesterone has been associated with the development of a usually benign tumor that forms in the tissue layer between the brain and the skull (meningioma). If you are diagnosed with a meningioma, your doctor will stop treatment with Femoston (see "Do not take..."). If you notice any symptoms, such as changes in vision (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, headaches that worsen over time, memory loss, seizures, or weakness in the arms or legs, you should inform your doctor immediately.

Stop taking Femoston and consult your doctor immediately

If you notice any of the following symptoms while taking HRT:

• Any of the conditions mentioned in the "Do not take Femoston" section
• Yellowing of the skin or the whites of the eyes (jaundice). These symptoms could be signs of liver disease
• Signs of angioedema, such as swelling of the face, tongue, or throat, or difficulty swallowing, or hives, accompanied by difficulty breathing
• A significant increase in blood pressure (symptoms may be headache, fatigue, dizziness)
• Migraine-type headaches that you have not had before
• If you become pregnant
• If you notice symptoms of a blood clot, such as:
• Painful swelling and redness of the legs
• Sudden chest pain
• Difficulty breathing

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

Note:This medicine is not a contraceptive. If it has been less than 12 months since your last menstrual period or you are under 50 years old, you may need to use an additional contraceptive method to prevent pregnancy. Talk to your doctor for advice.

HRT and cancer

Excessive thickening of the uterine lining (endometrial hyperplasia) and uterine cancer (endometrial cancer)

Taking HRT that only contains estrogen will increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and uterine cancer (endometrial cancer).

The progestogen in estradiol/dydrogesterone protects you from this additional risk.

Irregular bleeding

You may experience irregular bleeding or spotting during the first 3-6 months of taking estradiol/dydrogesterone. However, if irregular bleeding:

• Continues for longer than the first 6 months
• Starts after you have been taking this medicine for more than 6 months
• Continues after you have stopped taking this medicine

consult your doctor as soon as possible.

Breast cancer

Evidence shows that taking combined estrogen-progestogen or estrogen-only HRT increases the risk of breast cancer. The additional risk depends on how long you take HRT and becomes apparent within 3 years of use. After stopping HRT, the additional risk will decrease over time but may persist for 10 years or more if you have used HRT for more than 5 years.

Comparison

In women aged 50-54 who are not taking HRT, about 13-17 in every 1,000 will be diagnosed with breast cancer over a 5-year period. In women aged 50 who start taking estrogen-only HRT for 5 years, there will be between 16 and 17 cases per 1,000 users (i.e., 0-3 additional cases).

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

In women aged 50-59 who are not taking HRT, about 27 cases of breast cancer per 1,000 women will be diagnosed over a 10-year period. In women aged 50 who start taking 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 taking combined estrogen-progestogen HRT 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:

• Depression of the skin
• Changes in the nipple
• Any lump you can see or feel

Additionally, it is recommended that you participate in breast screening programs that are offered to you. When having a mammogram, it is important to inform the nurse or healthcare professional performing the X-ray that you are taking HRT, as this medicine may increase the density of the breast and make the mammogram less effective. As the density of the breast increases, it is possible that the mammogram may not detect all lumps.

Ovarian cancer

Ovarian cancer is much less common than breast cancer. Taking HRT that only contains estrogen 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 aged 50-54 who are not taking HRT, about 2 women in every 2,000 will be diagnosed with ovarian cancer over a 5-year period. In women who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (i.e., 1 additional case).

Effects of HRT on the heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veinsis about 1.3 to 3 times higher in patients taking HRT than in those not taking it, especially during the first year of treatment.

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

You are more likely to get a blood clot in your veins if you are older and if any of the following apply to you. Tell your doctor if you are in any of the following situations:

• You are unable to walk for a long time due to a major operation, injury, or illness (see also section 3, If you need to have surgery)
• You are seriously overweight (BMI >30 kg/m²)
• You have a blood clotting disorder that needs long-term treatment with a medicine used to prevent blood clots
• A close relative has had a blood clot in the leg, lung, or other organ
• You have systemic lupus erythematosus (SLE)
• You have cancer

To find out the symptoms of a blood clot, see "Stop taking Femoston and consult your doctor immediately".

Comparison

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

In women in their 50s who are taking combined estrogen-progestogen HRT for 5 years, there will be 9 to 12 cases per 1,000 users (i.e., 5 additional cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks. Women over 60 years old who take combined estrogen-progestogen HRT have a slightly higher risk of developing heart disease than those not taking HRT.

Stroke

The risk of having a stroke is about 1.5 times higher in patients taking HRT than in those not taking it. The number of additional stroke cases due to HRT will increase with age.

Comparison

Considering women in their 50s who are not taking HRT, on average, over a 5-year period, 8 in every 1,000 will have a stroke. In women in their 50s who are taking HRT, over 5 years, there will be 11 cases per 1,000 users (i.e., 3 additional cases).

Other diseases

HRT does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start HRT after the age of 65. Talk to your doctor for advice.

Tell your doctor if you have or have had any of the following medical conditions so that they can monitor you more closely:

• Heart disease
• Kidney failure
• Higher than normal levels of certain lipids in the blood(hypertriglyceridemia)

Children

This medicine is not intended for use in children.

Taking Femoston with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may interfere with the effect of this medicine. This combination may cause irregular bleeding. These medicines include:

• Medicines for epilepsy(such as phenobarbital, carbamazepine, phenytoin)
• Medicines for tuberculosis(such as rifampicin, rifabutin)
• Medicines for HIV infection(such as ritonavir, nelfinavir, nevirapine, efavirenz)
• Herbal remedies containing St. John's Wort(Hypericum perforatum)

HRT may affect the performance of some medicines:

• A medicine for epilepsy (lamotrigine), as it may increase the frequency of seizures
• The combined treatment for hepatitis C virus (HCV) ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the treatment glecaprevir/pibrentasvir, may cause elevations in blood test results for liver function (increase in liver enzyme ALT) in women using HRT that contains ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT can occur when using Femoston with this combined treatment for HCV. Your doctor will inform you about this.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Lab tests

If you need to have a blood test, tell your doctor or the laboratory staff that you are taking estradiol/dydrogesterone, as this medicine may affect the results of some tests.

Taking Femoston with food and drink

This medicine can be taken with or without food.

Pregnancy and breastfeeding

This medicine should only be taken by postmenopausal women.

If you become pregnant

• stop taking Femoston and consult your doctor.

This medicine is not intended for use during breastfeeding.

Driving and using machines

The effect of estradiol/dydrogesterone on the ability to drive or use machines has not been studied. It is unlikely to have any effect.

Femoston tablets containlactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Femoston

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

When to start taking Femoston

Do not start taking estradiol/didrogesterona until at least 12 months have passed since your last natural period.

You can start taking estradiol/didrogesterona any day if:

• You are not currently taking any other HRT product.
• You are switching from a "continuous combined" HRT product. That is, when you take a tablet or apply a patch every day that contains an estrogen and a progestogen.

You can start taking estradiol/didrogesterona the day after finishing the 28-day cycle if:

• You are switching from a "cyclic" or "sequential" HRT product. That is, when you take a tablet or apply a patch that contains estrogens for the first part of your cycle. Then you take a tablet or apply a patch that contains an estrogen and a progestogen for a maximum of 14 days.

How to take this medication

• Swallow the tablet whole with water.
• You can take the tablet with or without food.
• Try to take the tablet every day at the same time. This will ensure that there is a constant amount of the product in your body, and it will also help you remember to take the tablets.
• Take one tablet every day, without a break between packs. The blisters are marked with the days of the week, which will help you remember when to take the tablets.

How much to take

• Your doctor will try to prescribe you the minimum dose to treat your symptoms for the shortest necessary time. Consult your doctor if you think the dose is too strong or not strong enough.
• If you are taking this medication to prevent osteoporosis, your doctor will adjust the dose according to your needs based on your bone mass.
• Take one salmon-colored tablet per day for a 28-day cycle.

If you need to have surgery

If you are going to have surgery, inform the surgeon that you are taking this medication. You may need to stop taking this medication approximately 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking this medication again.

If you take more Femoston than you should

If you (or someone else) have taken too many estradiol/didrogesterona tablets, it is unlikely that you will suffer any harm. You may experience nausea or vomiting, have breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or breakthrough bleeding. No treatment is necessary. But if you are concerned, ask your doctor for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Femoston

Take the missed tablet as soon as you remember. If more than 12 hours have passed since you should have taken the tablet, take the next dose at the usual time. Do not take the missed tablet, nor a double dose. If you miss a dose, you may experience bleeding or spotting.

If you stop taking Femoston

Do not stop taking estradiol/didrogesterona without first discussing it with your doctor.

• 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 more frequently in women taking HRT compared to women who do not take them:

• Breast cancer
• Abnormal growth of the uterine lining or uterine cancer (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 the age of 65

For more information on these side effects, see section 2.

The following side effects can occur with this medication:

Very common (may affect more than 1 in 10 patients):

• Headache
• Abdominal pain
• Back pain
• Breast tenderness or pain

Common (may affect up to 1 in 10 patients):

• Vaginal candidiasis (a vaginal infection caused by a fungus called Candida albicans)
• Depression, nervousness
• Migraine. If you experience a migraine-type headache for the first time, stop taking this medication and consult your doctor immediately
• Dizziness
• Nausea, vomiting, abdominal bloating, flatulence
• Allergic skin reactions (such as rash, intense itching [pruritus] or hives)
• Menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavier or lighter bleeding
• Pelvic pain
• Vaginal discharge
• Weakness, fatigue, or malaise
• Swelling of the ankles, feet, or fingers (peripheral edema)
• Weight gain

Uncommon (may affect up to 1 in 100 patients):

• Pseudocystitis syndrome
• Uterine tumors (fibroids) become larger
• Hypersensitivity reactions such as shortness of breath (allergic asthma)
• Change in sexual desire
• Blood clots in the legs or lungs (venous thromboembolism or pulmonary embolism)
• High blood pressure
• Circulatory problems (peripheral vascular disease)
• Varicose veins
• Indigestion
• Liver disorders, sometimes with yellowing of the skin (jaundice), feeling of weakness (asthenia), or general malaise and abdominal pain. If you notice yellowing of the skin or the whites of the eyes, stop taking this medication and consult your doctor immediately.
• Gallbladder disease
• Breast swelling
• Pre-menstrual syndrome
• Weight loss

Rare (may affect up to 1 in 1,000 patients):

(*Adverse reactions from the market not observed in clinical trials have been assigned the frequency "Rare").

• Disease resulting from the destruction of red blood cells (hemolytic anemia)*
• Meningioma (a brain tumor)*
• Changes in the surface of the eye (increased corneal curvature)*, inability to wear contact lenses (intolerance to contact lenses)*
• Heart attack (myocardial infarction)
• Stroke*
• Swelling of the skin around the face and throat. This can cause difficulty breathing (angioedema)
• Purpura (purple spots or patches on the skin)
• Red and painful skin nodules (erythema nodosum)*, skin discoloration especially on the face or neck known as "pregnancy patches" (chloasma or melasma)*
• Leg cramps*

The following side effects have been observed with other HRTs:

• Benign or malignant tumors that can be affected by estrogen levels, such as uterine or ovarian cancer (see section 2 for more information)
• Increased size of tumors that can be affected by progestogen levels (such as meningioma)
• Disease of the immune system that abnormally attacks many organs of the body (systemic lupus erythematosus)
• Probable dementia
• Worsening of seizures (epilepsy)
• Uncontrolled muscle twitching (chorea)
• Blood clots in the arteries (arterial thromboembolism)
• Pancreatitis in women with pre-existing high levels of certain lipids in the blood (hypertriglyceridemia)
• Rash with a target-like appearance or blisters (erythema multiforme)
• Urinary incontinence
• Pain or nodules in the breasts (fibrocystic breast disease)
• Erosion of the cervix (cervical erosion)
• Worsening of a rare disorder of blood pigments (porphyria)
• High levels of certain lipids in the blood (hypertriglyceridemia)
• Increased total thyroid hormones

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Femoston

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not take this medication after the expiration date shown on the blister pack and carton. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

What Femoston contains

• The active ingredients are estradiol in the form of estradiol hemihydrate and didrogesterona.
• Each tablet contains 1 mg of estradiol and 5 mg of didrogesterona.

• The other ingredients of the tablet core are lactose monohydrate, hypromellose, cornstarch, colloidal anhydrous silica, and magnesium stearate.

• The other ingredients of the coating are:
• Titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), hypromellose, macrogol.

Appearance of the product and package contents

• This medication is a film-coated tablet. The tablet is round, biconvex, and marked with 379 on one side (7 mm).

• Each blister pack contains 28 tablets.

• The tablets are salmon-colored.

• The tablets are packaged in PVC film with an aluminum foil cover.

• The blister packs contain 28, 84 (3 x 28), or 280 (10 x 28) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

Abbott Biologicals B.V.

Veerweg 12

8121 AA Olst

Netherlands

You can request more information about this medication from the local representative of the marketing authorization holder:

–

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this leaflet: October 2024.

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