Femoston

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Femoston (Climaston)
2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets
Estradiolum, Estradiolum + Dydrogesteronum
Femoston and Climaston 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 doubts, 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 another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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 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 oestrogen called estradiol and a progestagen called dydrogesterone.
Femoston is indicated for use in women who have symptoms caused by a lack of female sex hormones (oestrogens) and in whom at least 6 months have passed since their last menstrual period.

Femoston is used for the following purposes:

Treatment of postmenopausal symptoms
During menopause, the amount of oestrogens 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 impair daily life.

Prevention of osteoporosis
In some women after menopause, bone fragility (osteoporosis) may occur. All available treatment options should be discussed with your doctor.
Femoston may be used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and who cannot take other medicines.

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.
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Experience in treating women with premature menopause (due to ovarian dysfunction or after surgical removal of ovaries) is limited. The risks associated with HRT may differ in cases of premature menopause. Consult your doctor.
Before starting (or reinitiating) HRT, your doctor should take a full medical history, including family history. The doctor may decide to perform additional tests, including breast examination and/or gynaecological examination, if deemed necessary.
After starting Femoston, you should have regular check-ups with your doctor (at least once a year). During these visits, you and your doctor should discuss the benefits and risks of continuing Femoston treatment.
Regular breast screening should be performed according to your doctor's recommendations.
DO NOT take Femoston if any of the following symptoms or medical conditions are present or have occurred in the past. 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 in the past, or your doctor suspects breast cancer;
• if you currently have or your doctor suspects a tumour dependent on oestrogens, e.g. endometrial cancer (endometrium cancer);
• if you currently have or your doctor suspects a tumour 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 endometrium (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 recently had an arterial disease caused by blood clots, e.g. myocardial infarction, stroke or coronary heart disease;
• if you have liver disease and liver function tests 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 veins (thrombosis)");

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• increased risk of oestrogen-dependent cancer (e.g. family history of breast cancer in 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 impairing hearing (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 during 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, possibly with difficulty breathing – these may be symptoms of angioedema;
• significantly increased 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 veins (thrombosis)" for more information.

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. Consult your doctor.
HRT and cancer
Excessive thickening of the endometrium (endometrial hyperplasia) and endometrial cancer
HRT using oestrogen 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, withdrawal bleeding will occur once a month. However, if in addition to monthly bleeding, unexpected bleeding or spotting occurs that:

• persists beyond 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. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT lasted 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 1000 women over 5 years.
Among women aged 50 who start 5-year oestrogen-only HRT, the number of cases will be 16–17 per 1000 women (i.e. 0 to 3 additional cases).
Among women aged 50 who start 5-year oestrogen-progestogen HRT, the number of cases will be 21 per 1000 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 1000 women over 10 years.
Among women aged 50 who start 10-year oestrogen-only HRT, the number of cases will be 34 per 1000 women (i.e. 7 additional cases).
Among women aged 50 who start 10-year oestrogen-progestogen HRT, the number of cases will be 48 per 1000 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. HRT using oestrogen alone or combined oestrogen-progestogen therapy 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 2000 women over 5 years. Among women who have used HRT for 5 years, it will occur in about 3 per 2000 women (i.e. about 1 additional case).
Effect 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 using HRT than in those not using it, especially during the first year of treatment.
Venous 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 prolonged periods 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 therapy,
• history of venous blood clots in legs, lungs or other organs in close relatives,
• systemic lupus erythematosus,
• cancer.

Symptoms of venous blood clots: see "Stop taking Femoston and contact your doctor immediately".
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Comparative data
Among women aged 50–60 who do not use HRT, venous blood clots are expected in 4 to 7 per 1000 over 5 years.
Among women aged 50–60 who use combined oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases per 1000 women (i.e. 5 additional cases).
Heart disease (myocardial infarction)
There is no evidence that HRT prevents heart attacks.
Women over 60 years of age using combined oestrogen-progestogen 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 increases with age.
Comparison
Among women aged 50 to 60 who do not use HRT, stroke is expected in an average of 8 per 1000 women over 5 years. Among women aged 50 to 60 who use HRT for over 5 years, there will be 11 cases per 1000 women (i.e. 3 additional cases).
Meningioma
Use of Femoston is associated with the development of usually benign tumours of the membrane between the brain and skull (meningioma). If meningioma is diagnosed, your doctor will discontinue Femoston treatment (see section "When not to take Femoston"). If you notice any symptoms such as vision 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. Evidence suggests an increased risk of memory loss in women who start HRT after age 65. Consult your doctor.
Children
Femoston is indicated only for women with symptoms of oestrogen deficiency who have had no menstrual period for at least 6 months.
Femoston and other medicines
Some medicines may affect the action of Femoston, potentially causing irregular bleeding. These include:

The following medicines may inhibit the effect of Femoston, leading to bleeding or spotting:

• antiepileptic drugs (such as: phenobarbital, carbamazepine, phenytoin),
• tuberculosis medications (such as: rifampicin, rifabutin),
• HIV (AIDS) medications (such as: nevirapine, efavirenz, ritonavir and nelfinavir),
• herbal products 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) using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir 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.

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Dangerously high blood levels of the following medicines may occur during Femoston treatment:

• tacrolimus, cyclosporine – used, for example, after organ transplantation,
• fentanyl – a painkiller,
• theophylline – used for asthma and other breathing problems.

For this reason, careful monitoring of drug levels may be necessary for a period of time, and dose reduction of the affected medicine may be required.
Inform 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 can be taken with or without food.
Pregnancy and breastfeeding
Femoston is indicated only for women with symptoms of oestrogen deficiency who have had no menstrual period for at least 6 months.
➢ If pregnancy is confirmed, stop taking Femoston and contact your doctor.
Femoston is not indicated during breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of Femoston on driving or operating machinery. 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 Femoston.

3. How to use Femoston

This medicine should always be used as directed by the physician. 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 the 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 the "continuous combined" regimen. This regimen involves taking a tablet or applying a patch daily, both containing estrogen and progestagen.

Treatment with Femoston may be started the day after completion of a 28-day menstrual cycle pack if:
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• the patient is switching from HRT administered using the "cyclical" or "sequential" regimen. This regimen involves taking a tablet or applying a patch containing estrogen alone during the first part of the cycle, followed by 14 days of taking a tablet or applying a patch containing both estrogen and 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 the body and also helps you remember to take it.
• Take one tablet every day without interruption between packs. The days of the week are marked on the blister pack to help you remember when to take each tablet (the translation of the day symbols next to each tablet on the immediate packaging can be found at the end of this leaflet and on the sachet included in the package).

Dosage

• Your doctor will prescribe the lowest effective dose for the shortest necessary duration to treat your symptoms. Consult your doctor if the dose seems too strong or too weak.
• When Femoston is used 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 cycle is clearly indicated on the blister pack.

Planned surgery

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

Accidental overdose of Femoston
If a patient (or another person) takes more tablets than recommended, 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 necessary, but if in doubt, consult a doctor.

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. Breakthrough bleeding or spotting may occur.

Stopping Femoston
Do not stop taking Femoston without consulting your doctor.
➢ If you have any further questions about how to use 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.
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The following diseases have been reported more frequently in women using HRT compared to women not using HHTZ:

• breast cancer,
• abnormal growth or cancer of the lining of the uterus (endometrial hyperplasia or cancer of the endometrium),
• ovarian cancer,
• blood clots in the legs or lungs (venous thromboembolism, pulmonary embolism),
• heart disease,
• stroke,
• possible memory loss if HRT is started at age over 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):

• headache;
• 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 stopped and you should contact your doctor immediately;
• dizziness;
• nausea, vomiting, flatulence (bloating);
• allergic skin reactions (such as rash, severe itching, hives);
• bleeding disorders, such as irregular bleeding or spotting, painful periods, excessive or scanty bleeding;
• pelvic pain;
• vaginal discharge;
• 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):

• pelvic growths (fibroids) may increase in size;
• 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 blockages 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 stopped and you should contact your doctor immediately;
• gallbladder disease;
• breast swelling (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 patches on the skin (purpura).

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

• benign or malignant tumours which may be oestrogen-dependent, such as cancer of the lining of the uterus (cancer of the endometrium), ovarian cancer (for more information see section 2);
• increase in size of tumours which may be progestogen-dependent (such as meningioma);
• disease involving destruction of red blood cells (haemolytic anaemia);
• autoimmune disease (immunological disease) which may attack multiple organs (systemic lupus erythematosus);
• worsening of epileptic seizures (epilepsy);
• involuntary muscle spasms (chorea);
• blood clots in arteries (arterial thrombosis);
• pancreatitis in women with previously existing increased levels of certain fats in the blood (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 oedema), inability to wear contact lenses (contact lens intolerance);
• increased total concentration of thyroid hormones.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Femoston

Keep this medicine out of 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
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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 are: monohydrate lactose, hypromellose, maize starch, anhydrous colloidal 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" imprinted on one side.
• Femoston contains tablets in two colours. Each pack 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 either 28 coated tablets or 84 coated tablets.

A cardboard sleeve is included with the pack, in which the blister should be placed.
For more detailed information, please contact the responsible party 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 BV
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 Authorisation number in France, country of export: 34009 343 852 4 7
Parallel Import Authorisation number: 17/26
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
LUN - Monday
MAR - Tuesday
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MER - Wednesday
JEU - Thursday
VEN - Friday
SAM - Saturday
DIM - Sunday
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