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

Estradiol, Estradiol + Dydrogesterone

You should carefully read the contents of this 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 postmenopausal for at least 6 months.

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 options should be discussed with a doctor. In cases of increased risk of fractures due to osteoporosis and when the patient cannot take other medications, Femoston may be used to prevent osteoporosis in postmenopausal women.

2. Important information before taking Femoston

Medical history and regular check-ups

HRT use involves risks that need to 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-initiating) 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, 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 Femoston with your doctor. Regular breast screening 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, 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 estrogen-dependent tumors are present or suspected, such as endometrial cancer (endometrium cancer);
• if progestogen-dependent tumors are present or suspected, such as brain tumors (meningioma);
• if there is vaginal bleeding of unknown cause;
• if there is untreated endometrial hyperplasia (endometrial hyperplasia);
• if blood clots in the veins (thrombosis) have occurred or are present;
• if there is a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency);
• if arterial thromboembolic diseases have occurred or are present, such as heart attack, stroke, or coronary artery disease;
• if liver disease has occurred or is present and liver function tests have not returned to normal;
• if a rare, inherited blood disorder called porphyria is present;
• 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 during Femoston treatment. 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 thrombosis (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;
• 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 fats in the blood (triglycerides);
• fluid retention due to heart or kidney problems.

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

• any of the conditions listed in "When not to take Femoston";
• jaundice (yellowing of the skin or whites of the eyes) - this may be a sign of liver disease;
• 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. Consult your doctor.

HRT and cancer

Estrogen-only HRT increases the risk of endometrial hyperplasia (thickening of the lining of the uterus) 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 your 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 you take HRT. This additional risk becomes apparent after 3 years of 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 REGULARLY EXAMINE YOUR BREASTS. 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 estrogen-only or combined estrogen-progestogen HRT 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., about 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 HRT, 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 you have any of the following conditions. You should inform your doctor if you have any of the following:

• inability to walk for a long period due to major surgery, injury, or illness (see also section 3 "Planned surgery");
• you are significantly overweight (BMI > 30 kg/m2);
• you have any blood clotting problems that require long-term treatment with anticoagulant medications;
• any of your close relatives have had blood clots in the veins of the legs or lungs;
• you have systemic lupus erythematosus;
• you have had cancer.

Symptoms of blood clots, see "You should stop taking Femoston and consult your doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in the veins will occur over a 5-year period in approximately 4-7 out of 1000 women.
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 tendency to develop 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 over a 5-year period in approximately 8 out of 1000 women.
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. Consult your doctor.

Children

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

Femoston and other medicines

Certain 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 used in HIV infection (AIDS) (such as nevirapine, efavirenz, ritonavir, and nelfinavir);
• herbal medicines containing St. John's Wort (Hypericum perforatum).

While taking Femoston, high levels of the following medicines may occur in the blood:

• tacrolimus, cyclosporin - used 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 of the medicine may be necessary. 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).

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 postmenopausal for at least 6 months.

• If pregnancy is detected, you should stop taking Femoston and consult your 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 intolerance to some sugars, you should consult your 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. Femoston treatment can be started on any day if:

• you are not currently taking hormone replacement therapy,
• you are switching from another HRT product to combined continuous HRT. This method 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:

• 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, followed by a tablet or patch that contains both estrogen and progestogen for the next 14 days.

How to take 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 level of the 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 (translation of the day symbols on the packaging is at the end of the leaflet and on the package insert).

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest duration necessary 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 bone mass.
• You should take 1 brick-red tablet every day for the first 14 days, followed by 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 - at the end of the leaflet and on the package insert).

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 restart Femoston.

Overdose

If you (or someone else) have taken too many Femoston tablets, it is unlikely to cause harmful effects. Nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding may occur. No additional treatment is necessary, but if you are concerned, you should consult your 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. Do not take a double dose to make up for the missed dose. Bleeding or spotting may occur.

Stopping treatment

You should not stop taking Femoston without consulting your doctor.

If you have any further questions 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 conditions have been reported more frequently in women taking HRT compared to those not taking HRT:

• breast cancer;
• endometrial hyperplasia or cancer (endometrial hyperplasia or cancer);
• 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.

More information on these side effects can be found in section 2. While taking Femoston, the following side effects may occur:

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 (vaginal infection with Candida albicans fungus);
• depression, nervousness;
• migraine. If migraine headaches occur for the first time, you should stop taking Femoston and consult your doctor immediately;
• dizziness;
• nausea (feeling sick), vomiting, bloating (gas);
• 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 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 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 face and neck, making it difficult to breathe (angioedema);
• purple spots and patches on the skin (purpura).

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

• benign or malignant tumors that may be estrogen-dependent, such as endometrial cancer (endometrial cancer), ovarian cancer (more information in section 2);
• tumors that may be progestogen-dependent, such as meningioma;
• a disease in which red blood cells break down (hemolytic anemia);
• an immune system disease that affects multiple organs (systemic lupus erythematosus);
• seizure frequency may increase (epilepsy);
• 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 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;
• painful/lumpy breasts (fibrocystic breast changes);
• cervical erosion;
• worsening of a rare blood disorder (porphyria);
• high levels of certain fats in the blood (hypertriglyceridemia);
• corneal changes (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. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 kept out of the 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 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. Coating: 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; 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/Aluminum blisters in a cardboard box. A cardboard wallet is included with the packaging.
• 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 Ireland, the country of export:

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Manufacturer:

Abbott Biologicals BV, 8121 AA Olst, Netherlands

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warszawa Ireland export license number:PA 2010/12/2

Parallel import license number: 20/22

Translation of the day symbols on the packaging:
MON- Monday
TUE- Tuesday
WED- Wednesday
THU- Thursday
FRI- Friday
SAT- Saturday
SUN- Sunday
Leaflet approval date: 05.01.2022
[Information about the trademark]