Femoston

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Femoston (Femoston 2/10)

2 mg (brick-red), 2 mg + 10 mg (yellow), film-coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Femoston and Femoston 2/10 are different trade names for the same drug.

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 necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging 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 female sex hormone deficiency (estrogen) and who have had their last menstrual period at least 6 months ago.

Femoston is used for the following purpose:

Treatment of postmenopausal 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 postmenopausal women.
Femoston is prescribed if these symptoms significantly interfere with daily life.

Prevention of osteoporosis

In some postmenopausal women, bone fragility (osteoporosis) may occur. All available treatment methods should be discussed with the doctor.
In the case of increased risk of fractures due to osteoporosis and when the patient cannot take other medicines, Femoston can be used to prevent osteoporosis in postmenopausal women.

2. Important information before taking Femoston

Medical history and regular check-ups

Taking HRT 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 taking HRT may be different. You should consult a doctor.
Before starting (or re-introducing) 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 associated with continuing to take Femoston with your doctor.
Regular breast screening tests should be performed in accordance with the doctor's recommendations.
DO NOT TAKE FEMOSTONif you have or have had any of the following conditions or symptoms. If you are unsure about any of the following conditions or symptoms before taking Femoston, you should consult your 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 the doctor suspects the presence of a tumor whose growth is dependent on estrogen, such as endometrial cancer (cancer of the endometrium);
• if there is or the doctor suspects the presence of a tumor whose growth is dependent on progestogens, 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 are or have been 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 is or has recently been a blood clot-related disease, such as 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 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 in mother, sister, grandmother);
• high blood pressure;
• liver disease, such as benign liver tumors;
• diabetes;
• gallstones;
• migraine or severe headaches;
• an immune system disease that affects many organs (systemic lupus erythematosus);
• epilepsy;
• asthma;
• a disease that damages the eardrum and impairs hearing (otosclerosis);
• very high levels of fats in the blood (triglycerides);
• fluid retention in the body due to heart or kidney problems;
• inherited and acquired angioedema.

Stop taking Femoston and consult your doctor immediately

if 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) - these may be signs of liver disease;
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, along 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; For more information, see "Blood clots in the veins (thrombosis)".

Warning: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 your doctor.

HRT and cancer

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

Taking HRT with only estrogens increases the risk of excessive thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of the uterus (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 in addition to your monthly bleeding, and:

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

Breast cancer

Data confirms that taking combined estrogen and progestogen HRT or estrogen-only 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 taking HRT. After stopping HRT, the additional risk will decrease over time, but the risk 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 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 exams. You should consult your 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 includes only estrogens or a combination of estrogens and progestogens 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 veinsis 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 conditions:

• inability to walk for a long 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 blood clotting problems that require long-term treatment with anticoagulant medications,
• 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 "Stop taking Femoston and consult your doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, it is expected that 4-7 out of 1000 women will experience blood clots in the veins over a 5-year period.
In women aged 50-60 who take combined estrogen-progestogen HRT for more than 5 years, 9-12 cases out of 1000 women will occur (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 tendency to develop heart disease compared to women 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.
Comparison
In women aged 50-60 who do not take HRT, it is expected that 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 out of 1000 women will occur (i.e., 3 additional cases).

Other conditions

HRT does not prevent memory loss. There is evidence of increased risk of memory loss in women who start HRT at the age of 65 or older. You should consult your doctor.

Children

Femoston is indicated only for women with symptoms of female sex hormone deficiency (estrogen), who have had their last menstrual period at least 6 months ago.

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:
• an antiepileptic drug (lamotrigine), as it may increase the frequency of seizures,
• a combination treatment for hepatitis C virus (HCV) infection (e.g., ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and a combination treatment with glecaprevir/pibrentasvir) may increase liver function test results in the blood (increased ALT enzyme activity) in women taking combined hormonal contraceptives containing ethinyl estradiol. Femoston contains estradiol instead of ethinyl estradiol. It is not known whether increased ALT enzyme activity may occur when taking Femoston with this type of combination treatment for HCV.

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.

For this reason, careful monitoring of drug levels may be necessary for a period, and it may be necessary to reduce the dose of the given drug.
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 instructions.

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 female sex hormone deficiency (estrogen), who have had their last menstrual period at least 6 months ago.

• If pregnancy is detected, Femoston should be stopped and a doctor consulted.

Driving and using machines

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

Femoston contains lactose monohydrate

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

3. How to take Femoston

This medicine should always be taken 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 at least 6 months have passed since your last natural menstrual period.
Treatment with Femoston may be started on any day if:

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

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

• you are switching from cyclic 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 ensure that there is a constant amount of medicine in your body. This 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.

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.
• When taking Femoston to prevent osteoporosis, your doctor will adjust the dose individually according to your needs. It will depend on your bone mass.
• You should take 1 brick-red tablet every day for the first 14 days, and then 1 yellow tablet once a day for the remaining 14 days. The 28-day cycle of taking Femoston is indicated on the calendar included in the packaging.

Planned surgery

• In the case of planned 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.

Taking more Femoston than prescribed

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

Missing a dose of Femoston

You should take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet should have been 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 Femoston

You should not stop taking Femoston without consulting your doctor.

If you have any further doubts about taking this medicine, you should consult 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 compared to women not taking HRT:

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

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 thrush (infection of the vagina with Candida albicansfungus);
• depression, nervousness;
• migraine. If migraine headaches occur for the first time, you should stop taking Femoston and consult your doctor immediately;
• dizziness;
• nausea (nausea), vomiting, gas (bloating);
• skin allergic reactions (such as rash, severe itching, hives);
• bleeding disorders, such as irregular bleeding or spotting, painful periods, heavy or light bleeding;
• pelvic pain;
• discharge;
• feeling of weakness, tiredness, and general malaise;
• 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 shortness of breath (asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure;
• change in libido;
• blood clots causing blockages in the veins 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 your doctor immediately;
• gallbladder disease;
• breast swelling;
• premenstrual syndrome;
• weight loss.

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

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

Other side effects reported during the use of HRT, including Femoston, with an unknown frequency:

• benign or malignant tumors that may be dependent on estrogen levels, such as endometrial cancer (endometrial cancer), ovarian cancer (see section 2 for more information);
• increased size of tumors that may be dependent on progestogen levels (such as meningioma);
• a disease in which red blood cells are broken down (hemolytic anemia);
• an immune system disease that affects many organs (systemic lupus erythematosus);
• worsening of epilepsy (epilepsy) seizures;
• involuntary muscle contractions (chorea);
• blood clots in the arteries (arterial thrombosis);
• pancreatitis, especially in women with previously elevated levels of certain fats in the blood (hypertriglyceridemia);
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy spots" (chloasma), painful red skin lumps (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme);
• leg cramps;
• urinary incontinence;
• painful/lumpy breasts (fibrocystic breast changes);
• cervical erosion;
• worsening of porphyria symptoms;
• high levels of certain fats 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 any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 stated.
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 packaging 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.

Coating:

• brick-red tablets: Opadry OY-6957 Pink (titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), hypromellose, macrogol 400, talc);
• yellow tablets: Opadry OY-02B22764 Yellow (titanium dioxide (E 171), iron oxide yellow (E 172), hypromellose, macrogol 400, talc).

What Femoston looks like and contents of the pack

• The film-coated tablets are round, biconvex, with "379" embossed on one side.
• 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 packaging contains 28 film-coated tablets or 84 film-coated tablets.

A cardboard wallet is included with the packaging, which should be placed in the blister pack.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin, Ireland

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 15178/2023/01

Parallel import authorization number: 244/24

Translation of day of the week symbols on the packaging:

Luni

• Monday Mar
• Tuesday Mie
• Wednesday Joi
• Thursday Vin
• Friday Sȃm
• Saturday Dum
• Sunday

Date of leaflet approval: 18.06.2024

[Information about the trademark]