Femoston

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Femoston (Climaston 2 mg/10 mg)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston and Climaston 2 mg/10 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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 or pharmacist. See section 4.

Table of Contents

1. What Femoston is and what it is 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 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 in whom at least 6 months have passed since their last menstrual period.

Femoston is used for the following purpose:

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 in postmenopausal women. Femoston is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
Some postmenopausal women 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 not suitable.

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. The risks associated with HRT in cases of premature menopause may differ. 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 gynaecological examination, if considered necessary.
Once you start 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 Femoston treatment.
You should undergo regular breast screening according to your doctor's recommendations.

DO NOT take Femoston if any of the following conditions are present or have occurred in the past. If you are uncertain about any of the conditions listed below, you should consult your doctor before taking Femoston.

When not to take Femoston

• if you have been diagnosed with, have had in the past, or your doctor suspects breast cancer;
• if you currently have or your doctor suspects the presence of a tumour dependent on oestrogens, such as cancer of the lining of the womb (endometrial cancer);
• if you currently have or your doctor suspects the presence of a tumour dependent on progestogens, such as a brain tumour (meningioma);
• 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 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, protein S 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 any of the following conditions apply to you, you should have more frequent medical check-ups:

• fibroids (uterine myomas);
• presence of endometrial tissue outside the uterus (endometriosis) or history of abnormal thickening of the endometrium (endometrial hyperplasia);
• risk factors for developing blood clots (see "Blood clots in the veins (thrombosis)");
• increased risk of oestrogen-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 hearing disorder affecting the middle ear and causing hearing loss (otosclerosis);
• very high levels of fats in the blood (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 experience any of the following symptoms while on 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, together with breathing difficulties – these may be symptoms of angioedema;
• 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 "Blood clots in the veins (thrombosis)" for more information.

Note: Femoston does not have a contraceptive effect. If less than 12 months have passed since your last period and you are under 50 years of age, additional contraception may be needed to prevent pregnancy. Consult your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking oestrogen-only HRT 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 a monthly bleed (known as a withdrawal bleed). However, if in addition to these monthly bleeds, you experience unexpected bleeding or spotting that:

• continues 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 oestrogen-progestogen HRT or oestrogen-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 over time, but may persist for 10 years or longer if HRT was taken for more than 5 years.

Comparison
Among women aged 50 to 54 years who do not take HRT, an average of 13 to 17 out of 1,000 women will be diagnosed with breast cancer over a 5-year period.
Among women aged 50 who start a 5-year course of oestrogen-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 oestrogen-progestogen 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 take HRT, an average of 27 out of 1,000 women will be diagnosed with breast cancer over a 10-year period.
Among women aged 50 who start a 10-year course of oestrogen-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 oestrogen-progestogen 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:
• dimpling of the breast skin;
• changes around the nipple area;
• any visible or palpable lumps.

Ovarian cancer
Ovarian cancer is rare – significantly less common than breast cancer. Taking oestrogen-only HRT or combined oestrogen-progestogen HRT 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 take HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 women over a 5-year period. Among women who have taken HRT for 5 years, it will occur in about 3 out of 2,000 women (i.e. about 1 additional case).

Effects of HRT on the heart and circulatory system

Blood clots in veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women taking HRT than in those not taking HRT, 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 apply to you. Inform your doctor if any of the following apply:

• inability to walk for a prolonged 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 disorders requiring long-term anticoagulant treatment;
• a close relative has ever had venous blood clots in the legs, lungs or other organs;
• you have systemic lupus erythematosus;
• you have cancer.

Symptoms of blood clots are described under "Stop taking Femoston and contact your doctor immediately".

Comparison
Among women aged 50–60 who do not take HRT, an average of 4 to 7 out of 1,000 will develop venous blood clots over 5 years.
Among women aged 50–60 who take combined oestrogen-progestogen HRT for more than 5 years, there will be 9 to 12 cases per 1,000 women (i.e. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
In women over 60 years of age taking combined oestrogen-progestogen HRT, there is a slightly increased tendency to develop heart disease compared to women not taking HRT.

Stroke
The risk of stroke is about 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
Among women aged 50 to 60 who do not take HRT, an average of 8 out of 1,000 will have a stroke over 5 years. Among women aged 50 to 60 who take HRT for more than 5 years, there will be 11 cases per 1,000 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 after the age of 65. Consult your doctor for advice.

Children
Femoston is indicated only for women with symptoms of oestrogen 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, which may cause irregular bleeding. These include:

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

• epilepsy medicines (such as: phenobarbital, carbamazepine, phenytoin);
• tuberculosis medicines (such as: rifampicin, rifabutin);
• medicines used to treat HIV (AIDS) (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 epilepsy medicine lamotrigine, which may increase the frequency of seizures;
• combination therapy for hepatitis C virus (HCV) infection (e.g. using ombitasvir/paritaprevir/ritonavir with or without dasabuvir, or glecaprevir/pibrentasvir therapy) may increase liver function parameters in blood tests (increased liver enzyme AlAT activity) in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether increased AlAT liver enzyme activity may occur when Femoston is taken concurrently with such combination HCV treatments.

While taking 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 a dose reduction of the affected medicine may be required.
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 a 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 may be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only for women with symptoms of oestrogen deficiency who have not had a menstrual period for at least 6 months.

• If pregnancy is detected, stop taking Femoston immediately and contact your doctor.

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

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

3. How to use Femoston

This medicine should always be used as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
When to start using 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 hormone replacement therapy (HRT),
• the patient is switching from another HRT product administered using a "continuous combined" regimen. This regimen involves taking a tablet or applying a patch daily containing both an oestrogen and a progestagen.

Treatment with Femoston may be started the day after completion of a 28-day menstrual cycle if:

• the patient is switching from HRT administered using a "cyclical" or "sequential" regimen. This regimen involves taking a tablet or applying a patch containing oestrogen alone during the first part of the cycle, followed by taking a tablet or applying a patch containing both oestrogen and a progestagen for the next 14 days.

Taking 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 the body and also helps you remember to take it.
• Take 1 tablet daily without interruption between packs. The days of the week are marked on the blister pack to help you remember when to take each tablet (see translation of weekday symbols located next to each tablet on the immediate packaging – provided at the end of this leaflet and on the sachet included in the package).

How much medicine to take

• Your doctor will choose the lowest effective dose to be used for the shortest necessary duration to treat your symptoms. Consult your doctor if the dose seems too strong or too weak for you.

• 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 shown on the blister pack (see also translation of weekday symbols located next to each tablet on the immediate packaging – provided at the end of this leaflet and on the sachet included in the package).

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 the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in the veins (venous thromboembolism)"). Ask your doctor when you can restart taking Femoston.

Taking more Femoston than prescribed
If you (or someone else) take too many Femoston tablets, it is unlikely to cause harmful effects. Symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. Additional treatment is not usually required; however, if in doubt, seek medical advice.

Missed dose of Femoston
Take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet should have been taken, take the next tablet at the usual time and do not take the missed tablet. Do not take a double dose to make up for a missed dose. Spotting or bleeding 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following diseases have been reported more frequently in women using 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 effects, see section 2.
The following adverse effects may occur during treatment with Femoston:

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

• headache
• abdominal pain
• back pain
• breast tenderness or pain

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

• vaginal thrush (yeast infection caused by 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
• 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 oedema)
• weight gain

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

• growth of pelvic tissue (e.g. fibroids) may increase
• hypersensitivity reactions, such as shortness of breath (allergic asthma) or other systemic reactions such as nausea, vomiting, diarrhoea, or hypotension
• change in libido
• blood clots causing embolism in blood vessels of legs or lungs (venous thromboembolism 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 (breast oedema)
• 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)
• purple spots and skin lesions (purpura)

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

• benign or malignant tumours that may be hormone-dependent, such as cancer of the uterine lining (cancer of the endometrium), ovarian cancer (see section 2 for more information)
• growth of tumours that may be progestogen-dependent (such as meningioma)
• condition involving destruction of red blood cells (haemolytic anaemia)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• worsening of epileptic seizures (epilepsy)
• involuntary muscle contractions (chorea)
• arterial blood clots (arterial thrombosis)
• pancreatitis in women with previously elevated levels of certain blood fats (hypertriglyceridaemia)
• various skin disorders: skin discolouration, 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 pigments (porphyria)
• high levels of certain fats in the blood (hypertriglyceridaemia)
• changes in the cornea of the eye (corneal oedema), inability to wear contact lenses (contact lens intolerance)
• increased total concentration of thyroid hormones

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Femoston

Keep the medicine out of the sight and reach of children.
No special storage conditions are required.
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, maize starch, colloidal anhydrous silica, magnesium stearate.

Coating (brick-red tablet): titanium dioxide (E 171), red iron oxide (E 172),
black iron oxide (E 172), yellow iron oxide (E 172), hypromellose, polyethylene glycol 400, talc.
Coating (yellow tablet): 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. Each blister contains 28 tablets.
• Femoston contains tablets of two colours. 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/aluminum blisters, placed in a cardboard box.
• The pack contains either 28 or 84 coated tablets.

A cardboard pouch is included in the packaging, in which the blister should be placed.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in France, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin, D01YE64
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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in France, country of export: 3400934385247
Parallel Import Authorisation Number: 415/24
Translation of the weekday symbols printed next to each tablet in the immediate packaging:
LUN – Monday
MAR – Tuesday
MER – Wednesday
JEU – Thursday
VEN – Friday
SAM – Saturday
DIM – Sunday