Patient Information Leaflet

Caution! Keep this leaflet. The packaging information in a foreign language.
Femoston (Femoston 2/10)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and Femoston 2/10 are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Femoston is and what it is used for
Important information before taking Femoston
How to take Femoston
Possible side effects
How to store Femoston
Contents of the pack and other information

1. What Femoston is and what it is used for

Femoston is a medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones: an oestrogen called estradiol and a progestagen called dydrogesterone.
Femoston is indicated for use in women who have symptoms of oestrogen deficiency and who have had their last menstrual period at least 6 months ago.

Femoston is used for the following purposes:

Treatment of postmenopausal symptoms
During menopause, the amount of oestrogen produced by a woman's body decreases. This may lead to symptoms such as hot flushes affecting the face, neck, and chest. Femoston helps relieve symptoms occurring after menopause.
Femoston is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
Some women after menopause may develop brittle bones (osteoporosis). Please discuss all available treatment options with your doctor.
Femoston may be used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and for whom other treatment options are unsuitable.

2. Important information before using Femoston

Medical history and regular check-ups
Hormone replacement therapy (HRT) carries risks that should be considered when deciding whether to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or surgical removal of ovaries) is limited. In cases of premature menopause, the risks associated with HRT may differ. Please consult your doctor.
Before starting (or restarting) HRT, your doctor should take a full medical history, including family medical history. Your doctor may decide to perform additional tests, including breast examination and/or gynecological examination, if considered necessary.
Once you have started taking Femoston, you should have regular check-ups with your doctor (at least once a year). During these visits, you and your doctor should discuss together the benefits and risks of continuing treatment with Femoston.
You should undergo regular breast screening as recommended by your doctor.

DO NOT take Femoston if any of the following symptoms or medical conditions are present or have occurred previously. If you have any doubts about the conditions listed below before taking Femoston, you should contact your doctor.

When not to take Femoston

if you have been diagnosed with, have had previously, or your doctor suspects breast cancer;
if you currently have or your doctor suspects a tumour whose growth is dependent on estrogens, e.g. endometrial cancer (endometrium cancer);
if you currently have or your doctor suspects a tumour whose growth is dependent on progestogens;
if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the membrane between the brain and skull);
if you have vaginal bleeding of unknown cause;
if you have untreated abnormal thickening of the lining of the womb (endometrial hyperplasia);
if you currently have or have previously had blood clots in the veins (thrombosis), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
if you have a blood clotting disorder (such as protein C deficiency, protein S deficiency, or antithrombin deficiency);
if you currently have or have recently had an arterial disease caused by blood clots, e.g. heart attack, stroke, or coronary heart disease;
if you have liver disease and liver function test results have not returned to normal;
if you have a rare inherited blood disorder called porphyria;
if you are 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, stop taking the medicine immediately and consult your doctor.

Warnings and precautions
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Femoston. If you have ever had any of the conditions listed below, you should have more frequent medical check-ups:

uterine fibroids;
endometriosis (presence of endometrial tissue outside the uterus) or previous history of abnormal thickening of the endometrium (endometrial hyperplasia);
risk factors for venous blood clots (see "Blood clots in the veins (thrombosis)");
increased risk of estrogen-dependent cancer (e.g. history of breast cancer in close relatives such as mother, sister, or grandmother);
high blood pressure;
liver diseases, such as benign liver tumours;
diabetes;
gallstones;
migraine or severe headaches;
an autoimmune disease affecting multiple organs (systemic lupus erythematosus);
epilepsy;
asthma;
a disease affecting the middle ear membrane and causing hearing impairment (otosclerosis);
very high levels of blood fats (triglycerides);
fluid retention due to heart or kidney problems;
hereditary or acquired angioedema.

You should stop taking Femoston and contact your doctor immediately if you notice any of the following symptoms while taking HRT:

any of the conditions listed under "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 combined with breathing difficulties – these may be symptoms of angioedema;
a significant increase in blood pressure (symptoms may include: headaches, fatigue, dizziness);
new-onset migraine headaches;
pregnancy;
symptoms of blood clots such as: painful swelling and redness in the legs, sudden chest pain, difficulty breathing. See more information under "Blood clots in the veins (thrombosis)".

Note: Femoston does not have contraceptive effects. If less than 12 months have passed since your last menstrual period and you are under 50 years of age, additional contraception may be necessary to prevent pregnancy. Please consult your doctor.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Using HRT with estrogen alone increases the risk of abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer. The progestogen contained in Femoston protects against this additional risk.

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

persists for longer than the first 6 months of treatment;
starts after 6 months of taking Femoston;
continues after stopping Femoston,
you should contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking combined estrogen-progestagen HRT or estrogen-only HRT increases the risk of developing breast cancer. The additional risk depends on how long you take HRT. This additional risk becomes apparent after 3 years of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT was taken for more than 5 years.

Comparison
Among women aged 50 to 54 who do not use HRT, breast cancer will be diagnosed in an average of 13 to 17 per 1,000 women over a 5-year period.
Among women aged 50 who start a 5-year course of estrogen-only HRT, the number of cases will be 16–17 per 1,000 women (i.e. 0 to 3 additional cases).
Among women aged 50 who start a 5-year course of estrogen-progestagen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 who do not use HRT, breast cancer will be diagnosed in an average of 27 per 1,000 women over a 10-year period.
Among women aged 50 who start a 10-year course of estrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e. 7 additional cases).
Among women aged 50 who start a 10-year course of estrogen-progestagen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).

You should regularly examine your breasts. Contact your doctor if you notice any changes such as:
- skin indentation of the breast,
- changes around the nipple,
- any visible or palpable lumps.

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. Using HRT containing only estrogens or a combination of estrogens and progestagens is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 per 2,000 women over 5 years. Among women who have used HRT for 5 years, it will occur in about 3 per 2,000 women (i.e. about 1 additional case).

Effects of HRT on the heart and circulation

Blood clots in the veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women using HRT than in those not using it, especially during the first year of treatment.
Blood clots can have serious consequences. If they travel to the lungs, they may cause chest pain, shortness of breath, fainting, or even death.
The risk of venous blood clots increases with age and if any of the following conditions apply to you. Inform your doctor if you have any of the following:

inability to walk for a prolonged period due to major surgery, injury, or illness (see also section 3 "Planned surgery"),
significant overweight (BMI > 30 kg/m²),
any blood clotting disorders requiring long-term anticoagulant treatment,
history of venous blood clots in legs, lungs, or other organs in any close relatives,
systemic lupus erythematosus,
cancer.

Symptoms of blood clots: see "Stop taking Femoston and contact your doctor immediately".

Comparative data
Among women aged 50–60 who do not use HRT, venous blood clots are expected to occur in 4 to 7 per 1,000 over 5 years.
Among women aged 50–60 who use estrogen-progestagen HRT for more than 5 years, 9 to 12 cases per 1,000 women will occur (i.e. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
Women over 60 years of age using combined estrogen-progestagen HRT have a slightly higher tendency to develop heart disease compared to women not using HRT.

Stroke
The risk of stroke is about 1.5 times higher in women using HRT than in those not using it. The number of additional stroke cases due to HRT use increases with age.

Comparison
Among women aged 50 to 60 who do not use HRT, stroke is expected to occur in an average of 8 per 1,000 women over 5 years. Among women aged 50 to 60 who use HRT for more than 5 years, 11 cases per 1,000 women will occur (i.e. 3 additional cases).

Meningioma
Using Femoston is associated with the development of usually benign tumours of the membrane between the brain and skull (meningioma). If meningioma is diagnosed in you, your doctor will discontinue treatment with Femoston (see section "When not to take Femoston"). If you notice any symptoms such as visual disturbances (e.g. double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in arms or legs, you should inform your doctor immediately.

Other conditions
HRT does not prevent memory loss. There is evidence of increased risk of memory loss in women who start HRT after age 65. Please consult your doctor.

Children
Femoston is indicated only for women with symptoms of estrogen deficiency who have not had a menstrual period for at least 6 months.

Femoston and other medicines
Some medicines may affect the action of Femoston, possibly causing irregular bleeding. These include:

The following medicines may reduce the effectiveness of Femoston, leading to bleeding or spotting:

antiepileptic drugs (such as: phenobarbital, carbamazepine, phenytoin),
tuberculosis drugs (such as: rifampicin, rifabutin),
HIV (AIDS) medications (such as: nevirapine, efavirenz, ritonavir, and nelfinavir),
herbal remedies containing St. John’s wort (Hypericum perforatum).

HRT may affect the action of other medicines:

the antiepileptic drug lamotrigine, which may increase seizure frequency;
combination treatment regimens for hepatitis C virus (HCV) infection (e.g. ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir regimens) may increase liver function parameters in blood tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether elevated AlAT liver enzyme activity may occur when Femoston is used concurrently with such HCV combination therapies.

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

tacrolimus, cyclosporine – used, for example, after organ transplantation,
fentanyl – a painkiller,
theophylline – used in asthma and other breathing problems. Therefore, careful monitoring of drug levels may be necessary for a period of time, and dose reduction of the affected drug may be required.

You should tell your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including over-the-counter medicines, herbal remedies, or other natural medicinal products (e.g. dietary supplements). Your doctor will provide appropriate advice.

Blood tests
Before any planned blood test, inform your doctor or laboratory staff that you are taking Femoston, as this medicine may affect the results of certain 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 not had a menstrual period for at least 6 months.

If pregnancy occurs, stop taking Femoston immediately and contact your doctor. Femoston is not indicated during breastfeeding.

Driving and operating machinery
No studies on the effect of Femoston on the ability to drive or operate machinery have been conducted. Such effects are unlikely.

Femoston contains monohydrate lactose
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to use Femoston

This medicine should always be used exactly as your doctor has told you. If you are unsure, please
consult your doctor or pharmacist.
When to start taking Femoston
Do not start treatment with Femoston until at least 6 months have passed since your last natural
menstrual period.
Treatment with Femoston may be started on any day if:

the patient is not currently using any hormonal replacement therapy,
the patient is switching from another HRT product used in a "continuous combined" regimen. This regimen involves taking a tablet or applying a patch daily containing both an estrogen and a progestagen.

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

the patient is switching from HRT used in a "cyclic" or "sequential" regimen. This regimen involves taking or applying an estrogen-only tablet or patch during the first part of the cycle, followed by 14 days of taking a tablet or applying a patch containing both an estrogen and a progestagen.

How to take Femoston

Swallow the tablet with water.
Tablets may be taken with or without food.
Try to take the tablet at the same time each day. This helps maintain a constant level of medicine in your body and also helps you remember to take it.
Take one tablet every day without interruption between packs. The blister pack is marked with days of the week to help you remember when to take your tablet.

Dosage

Your doctor will prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. If you feel the dose is too strong or too weak, consult your doctor.
If Femoston is being taken to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on your bone mass.
Take one brick-red tablet daily for the first 14 days, followed by one yellow tablet daily for the next 14 days. The 28-day treatment schedule is indicated on the calendar provided in the packaging.

Planned surgery

If you are scheduled for surgery, inform your surgeon that you are taking Femoston. It may be necessary to stop taking Femoston approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2 "Venous thromboembolism (blood clots in the veins)"). Ask your doctor when you can resume taking Femoston.

Accidental overdose of Femoston
If a patient (or another person) takes too many Femoston tablets, it is unlikely to cause harmful effects.
Possible symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain,
drowsiness/fatigue, or withdrawal bleeding. No additional treatment is usually required, but if in
doubt, consult your doctor.
Missed dose of Femoston
Take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet was due, take the next tablet at the usual time and do not take the missed tablet. Do not take a double dose to make up for a missed dose. Breakthrough bleeding or spotting may occur.
Stopping Femoston
Do not stop taking Femoston without consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following diseases have been reported more frequently in women using hormone replacement therapy (HRT) compared to women not using HRT:

breast cancer,
abnormal growth or cancer of the uterine lining (endometrial hyperplasia or cancer of the endometrium),
ovarian cancer,
blood clots in the legs or lungs (venous thromboembolism, pulmonary embolism),
heart diseases,
stroke,
probable memory loss if HRT is initiated after the age of 65. For more information on the above adverse reactions, see section 2.

The following adverse reactions may occur during treatment with Femoston:
Very common (may affect more than 1 in 10 women):

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

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

vaginal thrush (vaginal infection caused by fungi called Candida albicans);
depression, nervousness;
migraine. If migraine-type headaches occur for the first time, treatment with Femoston should be discontinued and you should contact your doctor immediately;
dizziness;
nausea, vomiting, flatulence (bloating);
skin allergic reactions (such as rash, severe itching, urticaria);
bleeding disorders, such as irregular bleeding or spotting, painful menstruation, excessive or scanty bleeding;
pelvic pain;
hot flushes;
feeling of weakness, fatigue, and general malaise;
swelling of ankles, feet, or fingers (peripheral edema);
weight gain.

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

benign growths in the pelvis (e.g. fibroids) may increase in size;
hypersensitivity reactions, such as shortness of breath (allergic asthma) or other systemic reactions such as nausea, vomiting, diarrhea, or hypotension;
change in libido;
blood clots causing embolism in vessels of legs or lungs (venous thromboembolic disease or pulmonary embolism);
liver function disorders, sometimes with jaundice, feeling of weakness or general malaise, and abdominal pain. If yellowing of the skin or whites of the eyes occurs, treatment with Femoston should be discontinued and you should contact your doctor immediately;
gallbladder diseases;
breast swelling;
premenstrual syndrome;
weight loss.

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

heart attack;
swelling of tissues in the face and neck causing breathing difficulties (angioedema);
purplish spots or patches on the skin (purpura).

Other adverse reactions reported during HRT use, including Femoston, with unknown frequency:

benign or malignant tumours which may be hormone-dependent, such as cancer of the endometrium (cancer of the endometrium), ovarian cancer (see section 2 for more information);
increase in size of tumours which may be progestogen-dependent (e.g. meningioma);
condition involving destruction of red blood cells (haemolytic anaemia);
autoimmune disease which may affect multiple organs (systemic lupus erythematosus);
worsening of epileptic seizures (epilepsy);
involuntary muscle spasms (chorea);
arterial blood clots (arterial thrombosis);
pancreatitis in women with previously existing high levels of certain blood fats (hypertriglyceridaemia);
various skin disorders: skin pigmentation, especially on face and neck known as "pregnancy mask" (chloasma), painful red skin nodules (erythema nodosum), rash in the form of red rings or blisters (erythema multiforme);
leg cramps;
urinary incontinence;
painful/lumpy breasts (fibrocystic breast changes);
cervical erosion;
worsening of symptoms of a rare disease affecting blood pigment (porphyria);
high levels of certain fats in the blood (hypertriglyceridaemia);
changes in the cornea of the eye (corneal opacity), inability to wear contact lenses (contact lens intolerance);
increased total concentration of thyroid hormones.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Femoston

Keep the medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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: monohydrate lactose, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate. Coating:
- brick-red tablets: Opadry OY-6957 Pink (titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), hypromellose, polyethylene glycol 400, talc);
- yellow tablets: Opadry OY-02B22764 Yellow (titanium dioxide (E 171), yellow iron oxide (E 172), hypromellose, polyethylene glycol 400, talc).

What Femoston looks like and contents of the pack

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

A cardboard sachet is included with the pack, in which the blister should be placed.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Romania, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane
Spencer Dock, Dublin 1
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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Romania, country of export: 15178/2023/01
Parallel import authorization number: 244/24
Translation of weekday symbols located next to each tablet in the immediate packaging:
Luni - Monday
Mar - Tuesday
Mie - Wednesday
Joi - Thursday
Vin - Friday
Sȃm - Saturday
Dum - Sunday