Femoston

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Femoston

2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets
Estradiolum, Estradiolum + Dydrogesteronum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 any not listed in this leaflet, they should tell 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. You should discuss all available treatment options with your doctor.
If there is an increased risk of fractures due to osteoporosis and the patient cannot take other medicines, Femoston can be used to prevent osteoporosis in post-menopausal women.

2. Important information before taking 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 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 taking HRT may be different. You should 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 a breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston, you should visit your doctor for regular check-ups (at least once a year). During these check-ups, you should discuss the benefits and risks of continuing to take Femoston with your doctor.
You should have regular breast screening tests as recommended by your doctor.
DO NOT take Femostonif you have or have had any of the following conditions or symptoms. If you are unsure about any of the conditions or symptoms listed below, consult your doctor before taking Femoston.

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 the doctor suspects the presence of a tumor that is estrogen-dependent, such as endometrial cancer (cancer of the lining of the uterus)
• if there is or the doctor suspects the presence of a tumor that is progestogen-dependent, such as a brain tumor (meningioma)
• if there is vaginal bleeding of unknown cause
• if there is untreated endometrial hyperplasia (thickening of the lining of the uterus)
• if there have been or are blood clots in the veins (thrombosis), 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 there has been or recently been a blood clot-related disease, such as a heart attack, stroke, or coronary artery disease
• if there is or has been liver disease, and liver function tests have not returned to normal
• if there is 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, you should stop taking it and consult a doctor immediately.

Warnings and precautions

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

• uterine fibroids
• endometriosis (growth of uterine lining outside the uterus) or a history of endometrial hyperplasia
• risk factors for blood clots (see "Blood clots in the 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 lupus erythematosus (an immune system disease that affects multiple organs)
• epilepsy
• asthma
• otosclerosis (a disease that affects the eardrum and impairs hearing)
• very high levels of triglycerides in the blood
• fluid retention due to heart or kidney problems
• hereditary and acquired angioedema.

YOU SHOULD STOP TAKING FEMOSTON AND CONSULT A DOCTOR IMMEDIATELYif you experience any of the following symptoms while taking HRT:

• any of the conditions listed in "When not to take Femoston"
• yellowing of the skin or whites of the eyes (jaundice) - this may be a sign of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, with difficulty breathing - these 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, difficulty breathing. See "Blood clots in the veins (thrombosis)" for more information.

NOTE:Femoston does not have a contraceptive effect. If it has been less than 12 months since your last menstrual period and you are under 50 years old, you may need to use additional contraception to prevent pregnancy. You should consult a doctor.

HRT and cancer

Estrogen-only HRT increases the risk of endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer.
The progestogen in Femoston protects against this additional risk.

Unexpected bleeding

While taking Femoston, you will experience monthly bleeding (so-called withdrawal bleeding). However, if you experience unexpected bleeding or spotting that:

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

Breast cancer

Data confirm that taking combined estrogen-progestogen HRT increases the risk of breast cancer. The additional risk depends on how long you take HRT. 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.
Comparative data
In women aged 50-54 who do not take HRT, breast cancer will be diagnosed in approximately 13-17 out of 1000 women over a 5-year period.
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 a 10-year period.
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).

• YOU SHOULD HAVE REGULAR BREAST EXAMINATIONS. YOU SHOULD CONSULT A DOCTOR IF YOU NOTICE ANY CHANGES, 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 contains only estrogen or combined 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 over a 5-year period in approximately 2 out of 2000 women. 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 circulation

Blood clots in the veins (thrombosis)

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

• inability to walk for an extended period due to major surgery, injury, or illness (see also section 3 "Planned surgery")
• the patient is severely overweight (BMI >30 kg/m2)
• there are any blood clotting problems that require long-term treatment with anticoagulant drugs
• any of the patient's 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 "You should stop taking Femoston and consult a doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in the veins will occur in approximately 4-7 out of 1000 women over a 5-year period.
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 years old 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 it.
The number of additional stroke cases due to HRT increases with age.
Comparative data
In women aged 50-60 who do not take HRT, stroke will occur in approximately 8 out of 1000 women over a 5-year period. 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).

Other conditions

HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start HRT at an age over 65. You should 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. This applies to the following medicines:

• medicines for epilepsy (such as phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (such as rifampicin, rifabutin)
• medicines used in HIV infection (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:
• epilepsy medicine (lamotrigine), as it may increase the frequency of seizures
• combined treatment for hepatitis C virus (HCV) infection (e.g., using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or using glecaprevir/pibrentasvir) may increase liver function test results in the blood in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether increased liver function test results may occur when using Femoston with this type of combined HCV treatment.

While taking Femoston, the following medicines may have dangerously high blood levels:

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

Therefore, it may be necessary to carefully monitor the level of the medicine and may be necessary to reduce the dose of the medicine.
You should tell your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including those available without a prescription, herbal medicines, or other natural remedies (e.g., dietary supplements). Your doctor will provide you with appropriate guidance.

Blood tests

Before a planned blood test, you should inform your doctor or laboratory staff that you are taking Femoston, as this medicine 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.

• If pregnancy is suspected, you should stop taking Femoston and consult a doctor.

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 monohydrate.

If you have been diagnosed with an intolerance to some sugars, you should consult a doctor before taking Femoston.

3. How to take Femoston

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

When to start taking Femoston

You should not start Femoston before 6 months have passed since your last natural menstrual period.
Treatment with Femoston can be started on any day if:

• you are not currently taking hormone replacement therapy
• you are switching from another HRT medicine to a continuous combined HRT. This method involves taking a tablet or applying a patch that contains both estrogen and progestogen every day.

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

• you are switching from a cyclical or sequential HRT. This method involves taking a tablet or applying a patch that contains estrogen for the first part of the cycle, and then taking a tablet or applying a patch that contains estrogen and progestogen for the next 14 days.

Taking Femoston

• Swallow the tablet with water.
• Tablets can be taken with or without food.
• You should try to take the tablet at the same time every day. This will help keep a constant amount of medicine in your body. It will also help you remember to take the tablet.
• You should take 1 tablet every day, without interruption between packs. The blister pack is marked with the days of the week to help you remember when to take the tablet.

(The translation of the day symbols on the packaging is at the end of the leaflet and on the insert in the packaging).

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest necessary period to treat your symptoms. You should consult your doctor if the dose seems too strong or too weak for you.
• If you are taking Femoston to prevent osteoporosis, your doctor will adjust the dose individually according to your bone mass.
• You should take 1 brick-red tablet every day for the first 14 days, and then 1 yellow tablet every day for the remaining 14 days. The 28-day treatment cycle is shown on the blister pack (see also the translation of the day symbols on the packaging).

Planned surgery

• If you are having surgery, you should inform the surgeon that you are 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 section 2 "Blood clots in the veins (thrombosis)"). You should ask your doctor when you can start taking Femoston again.

Overdose

If you (or someone else) have taken too many Femoston tablets, it is unlikely to cause harm. You may experience nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, or withdrawal bleeding. No additional treatment is necessary, but if you are concerned, you should consult a doctor.

Missed dose

You should take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet was due to be taken, you should take the next tablet at the scheduled time without taking the missed tablet. You should not take a double dose to make up for the missed dose. You may experience bleeding or spotting.

Stopping treatment

You should not stop taking Femoston without consulting a doctor.

• IF YOU HAVE ANY FURTHER QUESTIONS ABOUT THE USE OF THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.

4. Possible side effects

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

• breast cancer
• endometrial hyperplasia or cancer (thickening or cancer of the uterine lining)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism, pulmonary embolism)
• heart disease
• stroke
• possible memory loss if HRT is started at an age over 65.

For more information on these side effects, see section 2.
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 you experience migraine headaches for the first time, you should stop taking Femoston and consult a doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (gas)
• allergic skin reactions (such as rash, severe itching, hives)
• bleeding disturbances, such as irregular bleeding or spotting, painful periods, heavy or light bleeding
• pelvic pain
• 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 asthma (allergic 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 blood vessels of the legs or lungs (venous thromboembolism or pulmonary embolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or whites of the eyes, you should stop taking Femoston and consult a doctor immediately
• gallbladder disease
• breast swelling
• premenstrual syndrome
• weight loss.

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

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

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

• benign or malignant tumors that may be estrogen-dependent, such as endometrial cancer (cancer of the uterine lining), ovarian cancer (more information in section 2)
• increased size of 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 affects multiple organs (systemic lupus erythematosus)
• increased frequency of epileptic seizures
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, especially in women with high levels of triglycerides in the blood
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma), painful red lumps on the skin (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• breast pain or lumps (fibrocystic breast changes)
• cervical erosion
• worsening of porphyria (a rare blood disorder)
• high levels of triglycerides in the blood (hypertriglyceridemia)
• changes in the cornea of the eye (corneal edema), inability to wear contact lenses (intolerance to contact lenses)
• increased levels of thyroid hormones.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Femoston

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Femoston contains

• The active substances of Femoston are estradiol (in the form of 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. The pink coating Opadry OY-6957 (brick-red tablets): titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, macrogol 400, talc. The yellow coating Opadry OY-02B2264 (yellow tablets): titanium dioxide (E 171), iron oxide yellow (E 172), hypromellose, macrogol 400, talc.

What Femoston looks like and contents of the pack

• The tablets are round, biconvex, and have "379" embossed on one side. Each blister pack contains 28 tablets.
• Femoston contains tablets in two colors. Each blister 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 packaging includes a cardboard carton in which the blister pack should be placed.
• The pack contains 28 or 84 film-coated tablets.

For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

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

Manufacturer:

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
Netherlands

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:1-21632
Parallel import authorization number:354/24
Translation of the day symbols on the packaging:

MO –Monday
DI –Tuesday
MI– Wednesday
DO– Thursday
FR– Friday
SA– Saturday
SO –Sunday.

Date of approval of the leaflet: 07.10.2024

[Information about the trademark]