Femoston

Package Leaflet: Information for the Patient

Femoston

2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets
Estradiol, Estradiol + Dydrogesterone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Femoston and what is it used for
• 2. Important information before taking Femoston
• 3. How to take Femoston
• 4. Possible side effects
• 5. How to store Femoston
• 6. Contents of the pack and other information

1. What is Femoston and what is it used for

Femoston is a medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen called estradiol and a progestogen called dydrogesterone.
Femoston is indicated for use in women who have symptoms of estrogen deficiency and who have been post-menopausal for at least 6 months.

Femoston is used for the following purpose:

Treatment of post-menopausal symptoms

During menopause, the amount of estrogen produced in a woman's body decreases. This can cause symptoms such as hot flashes in the face, neck, and chest. Femoston alleviates symptoms in post-menopausal women. Femoston is prescribed if these symptoms significantly disrupt daily life.

Prevention of osteoporosis

In some post-menopausal women, bone fragility (osteoporosis) may occur. All available treatment options should be discussed with a doctor.
In cases of increased risk of fractures due to osteoporosis and when the patient cannot take other medicines, Femoston may be used to prevent osteoporosis in post-menopausal women.

2. Important information before taking Femoston

Medical history and regular check-ups

HRT use involves risks that should be considered when deciding to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or after ovarian surgery) is limited. In the case of premature menopause, the risk of HRT may be different. Consult a doctor.
Before starting (or re-starting) HRT, the doctor should conduct a medical history with the patient, including a family history. The doctor may decide to perform additional tests, including breast and/or gynecological examinations, if deemed necessary.
After starting Femoston, regular check-ups with a doctor should be scheduled (at least once a year). During these check-ups, the benefits and risks associated with continuing Femoston should be discussed with the doctor.
Regular breast screening should be performed in accordance with the doctor's recommendations.
DO NOT TAKE FEMOSTONif any of the following conditions or symptoms are present or have occurred. In case of doubts about the following conditions or symptoms before taking Femoston, consult a doctor.

When not to take Femoston

• if breast cancer has been diagnosed, has occurred in the past, or is suspected by the doctor
• if there is or is suspected to be a tumor that grows in response to estrogen, such as endometrial cancer (cancer of the endometrium)
• if there is or is suspected to be a tumor that grows in response to progestogens
• if the patient has or has ever been diagnosed with a meningioma (usually a benign brain tumor)
• if there is vaginal bleeding of unknown cause
• if there is untreated endometrial hyperplasia(thickening of the uterine lining)
• if blood clots in the veins (thrombosis) have occurred or are present, such as deep vein thrombosis or pulmonary embolism
• if there is a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if a blood clot-related disease has occurred, such as heart attack, stroke, or coronary artery disease
• if liver disease has occurred and liver function tests have not returned to normal
• if the patient has a rare, inherited blood disorder called porphyria
• if the patient is allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of Femoston (listed in section 6).

If any of the above conditions occur for the first time while taking Femoston, the medicine should be stopped immediately and a doctor consulted.

Warnings and precautions

Before starting treatment, inform the doctor if any of the following problems have occurred, as they may recur or worsen while taking Femoston. If any of the following problems have occurred, more frequent medical check-ups should be performed:

• uterine fibroids
• endometriosis (growth of uterine lining outside the uterus) or previous endometrial hyperplasia
• blood clot risk factors (see "Blood clots in veins (thrombosis)")
• increased risk of estrogen-dependent cancer (family history of breast cancer)
• high blood pressure
• liver disease, such as benign liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• systemic immune system disease (systemic lupus erythematosus)
• epilepsy
• asthma
• otosclerosis (a condition that affects the middle ear and causes hearing loss)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary and acquired angioedema.

STOP TAKING FEMOSTON AND CONSULT A DOCTOR IMMEDIATELYif any of the following symptoms occur while taking HRT:

• any of the conditions listed in "When not to take Femoston"
• jaundice (yellowing of the skin or eyes) - may be a sign of liver disease
• facial, tongue, and/or throat swelling and difficulty swallowing or hives, along with difficulty breathing - may be signs of angioedema
• significant increase in blood pressure (symptoms may include headaches, fatigue, dizziness)
• migraine headaches that occur for the first time
• pregnancy
• symptoms of blood clots, such as painful swelling and redness of the legs, sudden chest pain, or difficulty breathing. See "Blood clots in veins (thrombosis)".

NOTE:Femoston does not have a contraceptive effect. If it has been less than 12 months since the last menstrual period and the patient is under 50 years old, additional contraception may be necessary to prevent pregnancy. Consult a doctor.

HRT and cancer

Estrogen-only HRT increases the risk of endometrial hyperplasiaand endometrial cancer.
The progestogen in Femoston protects against this additional risk.

Unexpected bleeding

While taking Femoston, withdrawal bleeding will occur once a month. However, if unexpected bleeding or spotting occurs, which:

• lasts longer than the first 6 months of treatment
• starts after 6 months of treatment
• continues after stopping Femoston, consult a doctor as soon as possible.

Breast cancer

Data confirms that taking combined estrogen-progestogen HRT or estrogen-only HRT increases the risk of breast cancer. The additional risk depends on how long HRT is taken. This additional risk becomes apparent after 3 years of HRT. After stopping HRT, the additional risk will decrease over time but may persist for 10 years or more if HRT lasted more than 5 years.
Comparison
In women aged 50-54 who do not take HRT, breast cancer will be diagnosed in approximately 13-17 out of 1000 women over 5 years.
In women aged 50 who start 5-year estrogen-only HRT, the number of cases will be 16-17 out of 1000 patients (i.e., 0-3 additional cases).
In women aged 50 who start 5-year combined estrogen-progestogen HRT, the number of cases will be 21 out of 1000 patients (i.e., 4-8 additional cases).
In women aged 50-59 who do not take HRT, breast cancer will be diagnosed in approximately 27 out of 1000 women over 10 years.
In women aged 50 who start 10-year estrogen-only HRT, the number of cases will be 34 out of 1000 patients (i.e., 7 additional cases).
In women aged 50 who start 10-year combined estrogen-progestogen HRT, the number of cases will be 48 out of 1000 patients (i.e., 21 additional cases).

• Regular breast exams should be performed. Consult a doctor if any changes are noticed, such as:
• indentation of the breast skin
• changes in the nipple area
• any visible or palpable lumps

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT that includes only estrogen or a combination of estrogen and progestogen is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not take HRT, ovarian cancer will be diagnosed in approximately 2 out of 2000 women over 5 years. In women who have taken HRT for 5 years, it will occur in approximately 3 out of 2000 women (i.e., approximately 1 additional case).

Effect of HRT on the heart and blood vessels

Blood clots in veins (thrombosis)

The risk of blood clots in veins is 1.3-3 times higher in women taking HRT than in those not taking HRT, especially during the first year of treatment.
Blood clot formation can have serious consequences. If they travel to the lungs, they can cause chest pain, shortness of breath, fainting, or even death.
The risk of blood clots in veins increases with age and if the patient has any of the following conditions. Inform the doctor if any of the following apply:

• prolonged immobilization due to major surgery, injury, or illness (see also section 3 "Planned surgery")
• the patient is severely overweight (BMI >30 kg/m)
• there are blood clotting problems that require long-term treatment with anticoagulant medicines
• any close relatives have had blood clots in the veins of the legs, lungs, or other organs
• the patient has systemic lupus erythematosus
• the patient has cancer.

Symptoms of blood clots, see "Stop taking Femoston and consult a doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in veins will occur in approximately 4-7 out of 1000 women over 5 years.
In women aged 50-60 who take combined estrogen-progestogen HRT for more than 5 years, 9-12 cases will occur out of 1000 women (i.e., 5 additional cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.
In women over 60 taking combined estrogen-progestogen HRT, there is a slightly increased risk of heart disease compared to those not taking HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in women taking HRT than in those not taking HRT.
The number of additional stroke cases due to HRT increases with age.
Comparison
In women aged 50-60 who do not take HRT, stroke will occur in approximately 8 out of 1000 women over 5 years. In women aged 50-60 who take HRT for more than 5 years, 11 cases will occur out of 1000 women (i.e., 3 additional cases).

Meningioma

Taking Femoston is associated with the development of usually benign brain tumors (meningioma). If a meningioma is diagnosed, the doctor will stop Femoston treatment (see "When not to take Femoston"). If the patient experiences any symptoms such as vision disturbances (e.g., double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, weakness in the arms or legs, they should inform their doctor immediately.

Other conditions

HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start HRT over the age of 65. Consult a doctor.

Children

Femoston is indicated only for women with symptoms of estrogen deficiency, who have been post-menopausal for at least 6 months.

Femoston and other medicines

Some medicines may affect the action of Femoston. This may cause irregular bleeding. These include:

• medicines for epilepsy (such as phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (such as rifampicin, rifabutin)
• medicines for HIV (AIDS) (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal medicines containing St. John's Wort ( Hypericum perforatum) HRT may affect the action of other medicines:
• the anti-epileptic medicine lamotrigine, as it may increase the frequency of seizures
• the treatment regimen for chronic hepatitis C virus (HCV) infection (e.g., ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and the treatment regimen with glecaprevir/pibrentasvir) may increase liver function test results in the blood (increased ALT enzyme activity) in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether increased ALT enzyme activity may occur when taking Femoston with such a treatment regimen.

During Femoston treatment, high levels of the following medicines may occur in the blood:

• tacrolimus, cyclosporin - used, for example, after organ transplantation
• fentanyl - a pain reliever
• theophylline - used in asthma and other breathing problems.

Therefore, careful monitoring of the medicine level and possible dose reduction may be necessary.
Tell the doctor or pharmacist about all other medicines currently being taken, including those available without a prescription, herbal medicines, or other natural products (e.g., dietary supplements). The doctor will provide guidance.

Blood tests

Before a blood test, inform the doctor or laboratory staff that Femoston is being taken, as it may affect the results of some laboratory tests.

Femoston with food and drink

Femoston can be taken with or without food.

Pregnancy and breastfeeding

Femoston is indicated only for women with symptoms of estrogen deficiency, who have been post-menopausal for at least 6 months.

• In case of pregnancy, stop taking Femoston and consult a doctor. Femoston is not indicated during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of Femoston on driving or using machines. Such an effect is unlikely.

Femoston contains lactose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking Femoston.

3. How to take Femoston

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

When to start taking Femoston

Do not start Femoston treatment before at least 6 months have passed since the last natural menstrual period.
Femoston treatment can be started on any day if:

• the patient is not currently taking HRT
• the patient is switching from another HRT medication to a continuous combined regimen. This regimen involves taking a tablet or applying a patch that contains both estrogen and progestogen every day.

Femoston treatment can be started after completing a 28-day menstrual cycle if:

• the patient is switching from a cyclic or sequential HRT regimen. This regimen involves taking a tablet or applying a patch that contains estrogen for the first part of the cycle, followed by a tablet or patch that contains both estrogen and progestogen for the next 14 days.

Taking Femoston

• Swallow the tablet with water.
• Tablets can be taken with or without food.
• Try to take the tablet at the same time every day. This will help keep a constant level of the medicine in the body and make it easier to remember to take the tablet.
• Take one tablet every day without interruption between packs. The blister pack is marked with the days of the week to help remember when to take the tablet.

How much to take

• The doctor will prescribe the smallest effective dose for the shortest necessary time to treat the symptoms. Consult a doctor if the dose seems too strong or too weak.
• When taking Femoston to prevent osteoporosis, the doctor will adjust the dose individually according to the patient's bone mass.
• Take one brick-red tablet every day for the first 14 days, followed by one yellow tablet every day for the remaining 14 days. The 28-day treatment cycle is indicated on the calendar included in the package.

Planned surgery

• In case of planned surgery, inform the surgeon about taking Femoston. It may be necessary to stop taking Femoston about 4-6 weeks before the planned surgery to reduce the risk of blood clots (see "Blood clots in veins (thrombosis)"). Ask the doctor when it is possible to restart Femoston.

Taking more Femoston than prescribed

If the patient (or someone else) takes too many Femoston tablets, it is unlikely to cause harm. Nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or withdrawal bleeding may occur. No additional treatment is necessary, but in case of doubts, consult a doctor.

Missing a dose of Femoston

Take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet should have been taken, take the next tablet at the scheduled time without taking the missed tablet. Do not take a double dose to make up for the missed dose. Bleeding or spotting may occur.

Stopping Femoston treatment

Do not stop taking Femoston without consulting a doctor.

• In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Femoston can cause side effects, although not everybody gets them.
The following conditions have been reported to occur more frequently in women taking HRT than in women not taking HRT:

• breast cancer
• endometrial hyperplasiaor endometrial cancer
• ovarian cancer
• blood clots in the veins (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started over the age of 65.

See section 2 for more information on these side effects.
The following side effects may occur while taking Femoston:

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

• headaches
• abdominal pain
• back pain
• breast tenderness or pain.

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

• vaginal candidiasis (yeast infection)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, stop taking Femoston and consult a doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (gas)
• skin allergic reactions (such as rash, severe itching, hives)
• bleeding disturbances, such as irregular bleeding or spotting, painful periods, heavy or light bleeding
• pelvic pain
• vaginal discharge
• feeling weak, tired, and unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain.

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

• uterine fibroids may increase in size
• allergic reactions, such as difficulty breathing (asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• changes in libido
• blood clots that cause blockages in the legs or lungs (venous thromboembolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If jaundice occurs, stop taking Femoston and consult a doctor immediately
• gallbladder disease
• breast swelling (breast edema)
• premenstrual syndrome
• weight loss.

Rare (may affect up to 1 in 1000 people):

• heart attack
• swelling of the face, throat, and/or tongue, making it difficult to breathe (angioedema)
• purple spots and patches on the skin (purpura).

Other side effects have been reported during HRT treatment, including Femoston, with unknown frequency:

• benign or malignant tumors that may be estrogen-dependent, such as endometrial cancer(cancer of the endometrium), ovarian cancer (see section 2 for more information)
• tumors that may be progestogen-dependent (such as meningioma)
• a disease in which red blood cells are broken down (hemolytic anemia)
• an immune system disease that can affect many organs (systemic lupus erythematosus)
• seizure frequency may increase (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in arteries (arterial thrombosis)
• pancreatitis, especially in women with previous high levels of certain fats in the blood (hypertriglyceridemia)
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma), painful red skin lumps (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• breast pain/lumps (fibrocystic breast changes)
• cervical erosion
• worsening of a rare blood disorder (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• changes in the cornea of the eye (corneal degeneration), inability to wear contact lenses (intolerance to contact lenses)
• increased total thyroid hormone levels.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Femoston

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the package after: Expiry date. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Femoston contains

• The active substances are estradiol (as estradiol hemihydrate) and dydrogesterone
• each brick-red tablet contains 2 mg of estradiol
• each yellow tablet contains 2 mg of estradiol and 10 mg of dydrogesterone
• Other ingredients are lactose monohydrate, hypromellose, cornstarch, colloidal anhydrous silica, magnesium stearate. Coating: titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), hypromellose, Macrogol 400, talc.

What Femoston looks like and contents of the pack

• The film-coated tablets are round, biconvex, and marked with "379" on one side. Each pack contains 28 tablets.
• Femoston contains tablets in two colors. Each pack contains 14 brick-red tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the next 14 days of the cycle).
• The tablets are packaged in PVC/Al blisters.
• The pack contains 28 or 84 film-coated tablets.

Marketing authorization holder

Theramex Ireland Limited
3rd Floor, Kilmore House
Spencer Dock, Park Lane
Dublin 1, D01 YE64
Ireland

Manufacturer

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst, Netherlands
For more information, contact the local representative of the marketing authorization holder at phone number: 22 307 71 66.

Date of last revision of the leaflet: