FEMOSTON 10-14 Coated tablets

Зміст інструкції

1. Femoston 1/10 film-coated tablets
   1. What is Femoston and what is it used for
   2. Cosa deve sapere prima di prendere Femoston
   3. How to take Femoston
   4. Possible side effects
   5. How to store Femoston
   6. Package contents and other information
2. Femoston 2/10 film-coated tablets 2 mg/10 mg
   1. What is Femoston and what is it used for
   2. Cosa deve sapere prima di prendere Femoston
   3. How to take Femoston
   4. Possible side effects
   5. How to Store Femoston
   6. Package Contents and Other Information
3. Femoston 0.5 mg/2.5 mg film-coated tablets
   1. What is Femoston and what is it used for
   2. What you need to know 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
4. Femoston 1/5 Conti film-coated tablets 1mg, 5mg
   1. What is Femoston and what is it used for
   2. Cosa deve sapere prima di prendere Femoston
   3. How to take Femoston
   4. Possible side effects
   5. How to store Femoston
   6. Package Contents and Other Information

Femoston 1/10 film-coated tablets

Active ingredients: estradiol + estradiol/dihydrogesterone

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if theirsymptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 1/10 film-coated tablets. In this
leaflet the abbreviated name Femoston is used.

Contents of this leaflet:

• 1. What Femoston is and what it is used for
• 2. What you need to know before you take 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 Hormone Replacement Therapy (HRT). It contains two types of female hormones, an
estrogen called estradiol and a progestin called didrogesterone. Femoston is used
in women who have been postmenopausal for at least 6 months.

Femoston is used for
Relieving symptoms that occur after menopause
During menopause, the amount of estrogen produced by the female body decreases.
This can cause symptoms such as flushing of the face, neck and chest (“hot flushes”).
Femoston relieves these symptoms after menopause. Femoston should only be prescribed if the
symptoms seriously interfere with daily life.

Preventing osteoporosis
After menopause, some women may develop fragile bones (osteoporosis). You should discuss
all available options with your doctor.
If you are at high risk of fractures due to osteoporosis and other medicines are not suitable, Femoston can
be used to prevent osteoporosis after menopause.

2. Cosa deve sapere prima di prendere Femoston

Medical history and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue treatment.
Experience in women treated with early menopause (due to ovarian damage or surgery) is limited. In the case of early menopause, the risks due to HRT treatment may be different. Talk to your doctor.
Before starting (or restarting) HRT, your doctor will ask you about your personal and family medical history. Your doctor may perform a breast and/or pelvic (lower abdomen) examination if necessary.
Once HRT has started, regular medical check-ups (at least annually) must still be carried out for an accurate assessment of the risks and benefits in relation to continuing therapy.
Undergo regular breast screenings as recommended by your doctor.

Do not take Femostonif you are in any of the following conditions. If you are unsure about any of the points below, inform your doctor before starting therapy with Femoston.

Do not take Femoston:

• if you have, have had, or there is suspicion of breast cancer
• if you have or there is suspicion of a cancer whose growth is sensitive to estrogens, such as endometrial cancer (uterine lining)
• if you have vaginal bleeding of unknown origin
• if you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
• if you have or have been treated in the past for blood clots in the veins (thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have diseases caused by blood clots (such as protein C, protein S, or antithrombin deficiency)
• if you have or have had diseases caused by blood clots in the arteries, such as myocardial infarction, stroke, or angina (severe chest pain)
• if you have or have had liver disease and liver function tests have not returned to normal levels
• if you have porphyria (hereditary metabolic disease due to an alteration in the metabolism of blood pigments)
• if you are allergic (hypersensitive) to estradiol, dihydrogesterone, or any of the other ingredients of this medicine (listed in section 6).

During treatment with Femoston, if any of the above conditions should occur for the first time, stop taking it and consult your doctor immediately.

Warnings and precautions

Tell your doctor or pharmacist before taking Femoston if you have had any of the following in the past

problems, as they may recur or worsen during treatment with Femoston.

If so, your doctor may require more frequent check-ups:

• uterine fibroids
• growth of the uterine wall outside the uterus (endometriosis) or previous excessive thickening of the uterine wall (endometrial hyperplasia)
• brain tumor that may be related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “Blood clots in the veins (thrombosis)”)
• increased risk of having a cancer whose growth is sensitive to estrogens (having a first-degree relative, such as mother, sister, or grandmother, who has had breast cancer)
• hypertension (high blood pressure)
• liver disorders such as benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (autoimmune disease)
• epilepsy
• asthma
• otosclerosis (hereditary predisposition to middle ear disease)
• hypertriglyceridemia (elevated increase in triglycerides in the blood)
• fluid retention due to heart or kidney failure
• hereditary and acquired angioedema

Stop taking Femoston and consult your doctor immediately
If you notice any of the following conditions when starting HRT:

• any of the conditions mentioned in the “Do not use Femoston” section
• 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 with difficulty breathing, symptoms indicative of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine headache that occurs for the first time
• if you are pregnant
• if you notice signs of blood clots such as: o painful swelling and redness of the legs o sudden chest pain o difficulty breathing

For more information, see the “Blood clots in the veins (thrombosis)” section.

Note:Femoston is not a contraceptive. If you are under 50 years of age or if your last menstrual period was less than 12 months ago, you may need additional contraception to prevent pregnancy. Consult your doctor.

HRT and cancer
Excessive thickening of the uterine wall (endometrial hyperplasia) and uterine cancer (endometrial cancer)
Taking HRT based on estrogens alone may increase the risk of excessive thickening of the uterine wall (endometrial hyperplasia) and uterine cancer (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.

Unexpected vaginal bleeding
During the intake of Femoston you will have one bleeding per month (defined as withdrawal bleeding). But if you experience unexpected bleeding or spotting (drops of blood) outside of your monthly bleeding, which:

• occurs for more than 6 months
• starts after you have been taking Femoston for more than 6 months
• occurs after stopping Femoston therapy

contact your doctor as soon as possible.
Breast cancer
Evidence suggests that the risk of breast cancer increases with hormone replacement therapy (HRT) based on combined estrogens and progestins or based on estrogens alone. The additional risk depends on how long HRT is used and becomes apparent within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT is used for more than 5 years.

Comparative data
Among women aged between 50 and 54 who do not use HRT for more than 5 years, an average of 13 to 17 breast cancers are diagnosed per 1,000 women.
In women aged 50 who start to follow HRT based on estrogen alone for 5 years, 16-17 cases will occur per 1,000 users (i.e. 0-3 additional cases).
In women aged 50 who start to follow HRT based on estrogens and progestins for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (4 to 8 additional cases).
In women aged between 50 and 59 who do not follow HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 in a period of 10 years.
In women aged 50 who start to follow HRT based on estrogen alone for 10 years, 34 cases will occur per 1,000 users (i.e. 7 additional cases).
In women aged 50 who start to follow HRT based on estrogens and combined progestins for 10 years, 48 cases will occur per 1,000 users (i.e. 21 additional cases).

Check your breasts regularly. See your doctor if you notice any changes in your breasts such as:

• small depressions on the skin
• changes in the nipple
• any visible or palpable hardening.

Also, participate in breast screening programs when they are offered to you. For breast screening, it is important that you inform the healthcare provider that you are taking HRT, as this medicine may increase breast density impacting the mammogram result. If breast density increases, mammography may not detect all hardening.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer.
The use of estrogen-only or estrogen-progestin therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged between 50 and 54 who do not follow HRT, about 2 women out of 2,000 will receive a diagnosis of ovarian cancer within 5 years. For women who are taking HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e., about 1 additional case).

Effects of HRT on the heart and circulation
Blood clots in the veins (thrombosis)
The risk of blood clots in the veins is approximately 1.3 – 3 times higher in HRT users, especially during the first year of taking it.
Blood clots can be serious, and if one of these reaches the lungs, it can cause chest pain, shortness of breath, fainting, and even death.
As you get older, you are more likely to develop blood clots in the veins and if you experience any of the following conditions, talk to your doctor:

• if you have to be immobilized for a long time due to major surgery, trauma or illness (see also paragraph 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m)
• if you have coagulation problems requiring prolonged treatment with anticoagulants
• if one of your first-degree relatives has had blood clots in the legs, lungs or other organ in the past
• if you suffer from a rare condition such as systemic lupus erythematosus (SLE)
• if you have cancer.

For symptoms of a blood clot, see “Stop taking Femoston and consult your doctor immediately”.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 4 – 7 women per 1,000 can expect to have a venous thrombosis.
In women around 50 years of age who have taken HRT based on estrogens and progestins for more than 5 years, there will be 9 – 12 cases per 1,000 (e.g. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attack. Women over 60 years of age who use HRT based on estrogens and progestins are slightly more likely to develop heart disease than those women who are not taking any HRT.

Stroke
The risk of having a stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional cases of stroke due to HRT use may increase with age.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 women per 1,000 can expect to have a stroke.
In women around 50 years of age who are taking HRT for more than 5 years, there will be 11 cases per 1,000 (e.g. 3 additional cases).

Other conditions
HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after the age of 65. Ask your doctor for advice.
Tell your doctor if you have or have had any of the following medical conditions as you will need to be checked more frequently:

• heart disease
• kidney failure
• higher than normal levels of some fats in the blood (hypertriglyceridemia).

Children
Femoston is not intended for use in children.

Other medicines and Femoston
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can interfere with the effectiveness of Femoston. This can lead to irregular bleeding and occurs with the following medicines:

• medicines for epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g. rifampicin, rifabutin)
• medicines for HIV [AIDS] infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John's wort (Hypericum perforatum).

HRT may affect how some other medicines work:

• a medicine for epilepsy (lamotrigine), as it may increase the frequency of seizures
• The combination regimen against the hepatitis C virus (HCV) consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV combination regimen.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription, herbal medicines or other natural products. Your doctor will give you the necessary instructions.

Laboratory tests
If you need to have a blood test, tell your doctor or nurse that you are taking Femoston because this medicine may interfere with the results of some tests.

Femoston with food and drink
Femoston can be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.

Driving and operating machinery
The effect of Femoston on driving or operating machinery has not been studied. An effect is
unlikely.

Femoston tablets contain lactose.
If you are intolerant to some sugars, contact your doctor before taking this medicine.

3. How to take Femoston

Take this medicinealways following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
When to start treatment with Femoston
Do not start treatment with Femoston until at least 6 months after your last menstrual period.
You can start taking Femoston on any day if:

• you are not currently taking any HRT
• you are switching from a continuous combined HRT. That is when you take a tablet or apply a patch every day that contains both, an estrogen and a progestin.

Start taking Femoston the day after you finish day 28 of your cycle if:

• you are switching from a cyclical or sequential HRT. That is when you take a tablet or use a patch that contains an estrogen for the first part of your cycle. Afterwards, take a tablet or use a patch containing both an estrogen and a progestin for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you can take the tablet with or without food
• try to take the tablet at the same time each day. This will ensure that there is a constant amount of product in your body. It will also help you remember to take the tablet
• take one tablet every day, without interruption between one pack and the next. The days of the week are highlighted on the blisters. This will make it easier to remember when to take the tablet.

For how long

• your doctor will prescribe the minimum dose to treat your symptoms for a period that is as short as possible. If you feel that this dose is too strong or too weak, consult your doctor.
• If you are taking Femoston to prevent osteoporosis, your doctor will adjust your dose. It will depend on your bone mass.
• Take one white tablet every day for the first 14 days followed by one grey tablet per day for the next 14 days. The 28 days are printed on the blister.

If you need surgery
If you are going to have surgery, tell your doctor that you are taking Femoston. You may
need to stop taking Femoston about 4 – 6 weeks before the surgery in
order to reduce the risk of blood clots (see section 2, “Blood clots inside the veins”). Ask your
doctor when you can start taking Femoston again.

If you take more Femoston than you should
If you have taken too many Femoston tablets (or someone else has), it is unlikely that they will
harm you. You may feel nauseous, or feel sick (vomiting), you may have breast pain/tension, dizziness, abdominal pain, drowsiness/fatigue, or breakthrough bleeding.
No treatment is necessary, but if you are concerned, contact your doctor for advice.

If you forget to take Femoston
Take the forgotten tablet as soon as you remember. If more than 12 hours have passed after
you should have taken the tablet, take the next dose at the usual time. Do not take the
forgotten tablet. Do not double the dose. If you forget a dose, irregular bleeding or spotting may occur.

If you stop taking Femoston
Do not stop Femoston without the advice of your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following disorders are more frequently observed in women using Hormone Replacement Therapy (HRT) than
in women who are not:

• breast cancer
• abnormal growth or cancer of the uterine lining (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots inside the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65.

For more information on these side effects, see Section 2.
The following side effects may occur with this medicine:

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

• headache
• abdominal pain
• back pain
• breast pain/tension

Common(may affect up to 1 in 10 treated patients):

• vaginal candidiasis (infection caused by a fungus called Candida albicans)
• feeling depressed, nervousness
• migraine. If a migraine headache occurs for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling sick (nausea), vomiting, bloating (abdominal distension), including gas (flatulence)
• allergic skin reactions (rash, intense itching or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavy or light bleeding
• pelvic pain
• vaginal discharge
• feeling weak, tired or unwell
• swelling of the ankles, feet or toes (peripheral edema)
• weight gain

Uncommon(may affect up to 1 in 100 treated patients):

• disorders that mimic cystitis
• increase in the size of uterine fibroids
• hypersensitivity reactions such as dyspnea (allergic asthma)
• changes in sexual desire
• blood clots inside the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged or tortuous veins (varicose veins)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia) or generally unwell (malaise) and abdominal pain. If you notice yellowing of the skin or whites of the eyes, stop treatment with Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms that mimic premenstrual syndrome
• weight loss

Rare(may affect up to 1 in 1,000 treated patients):
(* side effects reported post-marketing not observed in clinical studies to which the frequency
“rare” has been attributed)

• disease characterized by the destruction of red blood cells (hemolytic anemia)*
• meningioma (brain tumor)*
• change in the surface of the eye (increased corneal curvature)*, which prevents wearing contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat. This can cause difficulty breathing (angioedema)
• purple or pinpoint spots on the skin (vascular purpura)
• painful, reddish skin nodules (erythema nodosum)*, discoloration of the skin, especially on the face or neck, known as “chloasma” or “melasma”*
• leg cramps*

The following side effects have been associated with the use of other HRTs:

• estrogen-dependent tumors (both benign and malignant), such as cancer of the uterine lining, ovarian cancer (for more information see section 2)
• increase in the size of progestin-dependent tumors (such as meningioma)
• immune system disease that affects many organs of the body (systemic lupus erythematosus)
• worsening of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots inside the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain fats in the blood (hypertriglyceridemia)
• skin rash with red or irritated target lesions (erythema multiforme)
• urinary incontinence
• nodular, painful breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare disease of blood pigments (porphyria)
• elevated levels of certain fats in the blood (hypertriglyceridemia)
• increased total thyroid hormones

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Femoston

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Package contents and other information

What Femoston contains

• The active ingredients are estradiol as estradiol hemihydrate and didrogesterone or each white tablet contains 1 mg of estradiol or each grey tablet contains 1 mg of estradiol and 10 mg of didrogesterone
• The other components of the tablet core are lactose monohydrate, hypromellose, corn starch, anhydrous colloidal silica and magnesium stearate
• The other components of the tablet coating are: o titanium dioxide (E171), black iron oxide (E 172), polyvinyl alcohol, macrogol, talc, and hypromellose.

Description of the appearance of Femoston and package contents

• The film-coated tablets are round, biconvex and bear “379” on one side
• Each blister contains 28 tablets.
• Femoston contains two different coloured tablets. Each pack contains 14 white tablets (for the first 14 days of the cycle) and 14 grey tablets (for the next 14 days of the cycle).
• The tablets are packaged in PVC/aluminium blisters.
• The packs contain 28, 84 (3x28) or 280 (10x28) film-coated tablets in blisters.

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

Femoston 2/10 film-coated tablets 2 mg/10 mg

Active substances: estradiol + estradiol/dihydrogesterone

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their
  symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 2/10 film-coated tablets 2 mg/10 mg. In
this leaflet the abbreviated name Femoston is used.

Contents of this leaflet:

• 1. What Femoston is and what it is used for
• 2. What you need to know before you take 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 Hormone Replacement Therapy (HRT). It contains two types of female hormones, an
estrogen called estradiol and a progestin called didrogesterone. Femoston is used
in women who have been postmenopausal for at least 6 months.

Femoston is used for
Relieving symptoms that occur after menopause
During menopause, the amount of estrogen produced by the female body decreases.
This can cause symptoms such as flushing of the face, neck and chest (“hot flushes”).
Femoston relieves these symptoms after menopause. Femoston should only be prescribed if the
symptoms seriously interfere with daily life.

Preventing osteoporosis
After menopause, some women may develop fragile bones (osteoporosis). You should discuss
all available options with your doctor.
If you are at high risk of fractures due to osteoporosis and other medicines are not suitable, Femoston can
be used to prevent osteoporosis after menopause.

2. Cosa deve sapere prima di prendere Femoston

Storia medica e controlli regolari
The use of HRT involves risks that must be considered when deciding whether to start or continue treatment.
Experience in women treated with early menopause (due to ovarian damage or surgery) is limited. In the case of early menopause, the risks due to HRT treatment may be different. Talk to your doctor.
Before starting (or restarting) HRT, your doctor will ask you about your personal and family medical history. Your doctor may perform a breast and/or pelvic (lower abdomen) examination if necessary.
Once HRT has started, regular medical check-ups (at least annually) must still be carried out for an accurate assessment of the risks and benefits in relation to continuing therapy.
Undergo regular breast screening as recommended by your doctor.

Non prenda Femostonif you are in any of the following conditions. If you are unsure about any of the points below, inform your doctor before starting therapy with Femoston.

Non prenda Femoston:

• if you have, have had, or there is a suspicion that you have breast cancer
• if you have or there is a suspicion that you have a cancer whose growth is sensitive to estrogens, for example, in the endometrium (lining of the uterus)
• if you have vaginal bleeding of unknown origin
• if you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
• if you have or have been treated in the past for the presence of blood clots inside the veins (thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have diseases caused by blood clots (such as protein C, protein S, or antithrombin deficiency)
• if you have or have had diseases caused by blood clots inside the arteries, such as myocardial infarction, stroke, or angina (severe chest pain)
• if you have or have had a liver disease and liver function tests have not returned to normal levels
• if you have porphyria (inherited metabolic disease due to an alteration in the metabolism of blood pigments)
• if you are allergic (hypersensitive) to estradiol, dihydrogesterone, or any of the other ingredients of this medicine (listed in section 6).

During treatment with Femoston, if any of the above conditions should occur for the first time, stop taking it and consult your doctor immediately.

Avvertenze e precauzioni

Informi il medico o il farmacista prima di assumere Femoston se ha avuto in passato uno dei seguenti

problemi, poiché possono manifestarsi di nuovo o peggiorare durante il trattamento con Femoston.

Se è così, il medico curante potrebbe richiedere controlli più frequenti:

• uterine fibroids
• growth of the uterine wall outside the uterus (endometriosis) or previous excessive thickening of the uterine wall (endometrial hyperplasia)
• brain tumor that may be related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “Blood clots inside the veins (thrombosis)”)
• increased risk of having a cancer whose growth is sensitive to estrogens (having a first-degree relative, such as mother, sister, or grandmother, who has had breast cancer)
• hypertension (high blood pressure)
• liver disorders such as benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (autoimmune disease)
• epilepsy
• asthma
• otosclerosis (hereditary predisposition to middle ear disease)
• hypertriglyceridemia (high increase in triglycerides in the blood)
• fluid retention due to heart or kidney failure
• a hereditary and acquired angioedema

Interrompa la terapia con Femoston e consulti il medico immediatamente
If you notice any of the following conditions when you start HRT:

• any of the conditions mentioned in the “Do not take Femoston” section
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with difficulty breathing, symptoms indicative of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine headache that occurs for the first time
• if you are pregnant
• if you notice signs of blood clots such as: o painful swelling and redness of the legs o sudden chest pain o difficulty breathing

For more information, see the section “Blood clots inside the veins (thrombosis)”.

Nota:Femoston is not a contraceptive. If you are under 50 years of age or if your last menstrual period was less than 12 months ago, you may need additional contraception to prevent pregnancy. Consult your doctor.

TOS e cancro
Eccessivo ispessimento della parete uterina (iperplasia endometriale) e cancro della parete uterina
(cancro endometriale)
Taking HRT based on estrogens alone may increase the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and uterine cancer (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.

Sanguinamenti vaginali inaspettati
During the intake of Femoston you will have a bleeding once a month (defined as withdrawal bleeding). But if you should have unexpected bleeding or spotting (drops of blood) outside the monthly bleeding, which:

• occurs for more than 6 months
• starts after Femoston has been taken for more than 6 months
• occurs after stopping Femoston therapy contact your doctor as soon as possible.

Carcinoma mammario
Evidence shows that the risk of breast cancer increases with hormone replacement therapy (HRT) based on combined estrogens and progestogens or estrogens alone. The additional risk depends on how long HRT is used and becomes apparent within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT is used for more than 5 years.

Comparative data
Among women aged between 50 and 54 who do not use HRT for a period of more than 5 years, an average of 13 to 17 breast cancers are diagnosed per 1,000 women.
In women aged 50 who start following HRT based on estrogen alone for a period of 5 years, 16-17 cases will occur per 1,000 users (i.e. 0-3 additional cases).
In women aged 50 who start following HRT based on estrogens and progestogens for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (4 to 8 additional cases).
In women aged between 50 and 59 who do not follow HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 in a period of 10 years.
In women aged 50 who start following HRT based on estrogen alone for 10 years, 34 cases will occur per 1,000 users (i.e. 7 additional cases).
In women aged 50 who start following HRT based on combined estrogens and progestogens for 10 years, 48 cases will occur per 1,000 users (i.e. 21 additional cases).

Controlli regolarmente il suo seno. Si faccia visitare dal medico in caso di comparsa di cambiamenti
del seno come:

• small depressions on the skin
• changes in the nipple
• any visible or palpable hardening.

Also, participate in breast screening programs when they are offered to you. For breast screening, it is important that you inform the healthcare professional performing the X-ray that you are taking HRT, as this medicine may increase breast density impacting the mammography result. If breast density is increased, mammography may not detect all hardening.

Cancro dell’ovaio
Ovarian cancer is rare – much rarer than breast cancer.
The use of estrogen-only or estrogen-progestogen therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged between 50 and 54 who do not follow HRT, about 2 women out of 2,000 will receive a diagnosis of ovarian cancer over a 5-year period. For women who are taking HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e., about 1 additional case).

Effetti della TOS sul cuore e sulla circolazione
Trombi all’interno delle vene (trombosi)
The risk of blood clots inside the veins is approximately 1.3 – 3 times higher in users of HRT, especially during the first year of intake.
Blood clots can be serious, and if one of these reaches the lungs, it can cause chest pain, shortness of breath, fainting, and even death.
As you get older, you are more likely to develop blood clots inside the veins, and if one of the following conditions occurs, talk to your doctor:

• if you need to be immobilized for a long time due to major surgery, trauma, or illness (see also section 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m)
• if you have coagulation problems requiring prolonged treatment with anticoagulants
• if a first-degree relative of yours has had blood clots in the legs, lungs, or other organs in the past
• if you suffer from a rare condition such as systemic lupus erythematosus (SLE)
• if you have a tumor.

For the symptoms of a blood clot, see “Stop taking Femoston and consult your doctor immediately”.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 4 – 7 women per 1,000 can expect to have a venous thrombosis.
In women around 50 years of age who have taken HRT based on estrogens and progestogens for more than 5 years, there will be 9 – 12 cases per 1,000 (e.g. 5 additional cases).

Malattie cardiache (infarto)
There is no evidence that HRT prevents a heart attack. Women over 60 years of age who use HRT based on estrogens and progestogens are slightly more likely to develop heart disease compared to those women who are not taking HRT.

Ictus
The risk of having a stroke is approximately 1.5 times higher in users of HRT compared to non-users. The number of additional cases of stroke due to the use of HRT may increase with age.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 women per 1,000 can expect to have a stroke.
In women around 50 years of age who are taking HRT for more than 5 years, there will be 11 cases per 1,000 (e.g. 3 additional cases).

Altre condizioni
HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after the age of 65. Ask your doctor for advice.
Inform your doctor if you have or have had any of the following medical conditions as you will need to be checked more frequently:

• heart disease
• kidney failure
• higher than normal levels of some fats in the blood (hypertriglyceridemia).

Bambini
Femoston is not intended for use in children.

Altri medicinali e Femoston
Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.
Some medicines may interfere with the effectiveness of Femoston. This can lead to irregular bleeding and occurs with the following medicines:

• medicines for epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g. rifampicin, rifabutin)
• medicines for HIV [AIDS] infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John's wort (Hypericum perforatum)

HRT may affect how some other medicines work:

• a medicine for epilepsy (lamotrigine), as it may increase the frequency of seizures
• The combination regimen against the hepatitis C [HCV] virus consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV combination regimen.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines, or other natural products. Your doctor will give you the necessary instructions.

Analisi di laboratorio
If you need to have a blood test, inform your doctor or nurse that you are taking Femoston because this medicine may interfere with the results of some tests.

Femoston with food and beverages
Femoston can be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If a pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.

Driving and operating machinery
The effect of Femoston on driving or operating machinery has not been studied. An effect is
unlikely.

Femoston tablets contain lactose.
If you are intolerant to certain sugars, contact your doctor before taking this medicine.

3. How to take Femoston

Take this medicinealways following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
When to start treatment with Femoston
Do not start treatment with Femoston until at least 6 months after your last menstrual period.
You can start taking Femoston on any day if:

• you are not currently taking any HRT
• you are switching from a continuous combined HRT. That is when you take a tablet or apply a patch every day that contains both, an estrogen and a progestin.

Start taking Femoston the day after you finish day 28 of your cycle if:

• you are switching from a cyclical or sequential HRT. That is when you take a tablet or use a patch that contains an estrogen for the first part of your cycle. After that, take a tablet or use a patch containing both an estrogen and a progestin for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you can take the tablet with or without food
• try to take the tablet at the same time each day. This will ensure that there is a constant amount of product in your body. It will also help you remember to take the tablet
• take one tablet every day, without interruption between one pack and the next. The days of the week are highlighted on the blisters. This will make it easier to remember

when to take the tablet.

For how long

• your doctor will prescribe the minimum dose to treat your symptoms for a period that is as short as possible. If you feel that this dose is too strong or too weak, consult your doctor.
• If you are taking Femoston to prevent osteoporosis, your doctor will adjust your dose. It will depend on your bone mass.
• Take one brick-red tablet every day for the first 14 days followed by one yellow tablet per day for the next 14 days. The 28 days are printed on the blister.

If you need surgery
If you are going to have surgery, tell your doctor that you are taking Femoston. You may
need to stop taking Femoston about 4 – 6 weeks before the surgery to
reduce the risk of blood clots (see section 2, “Blood clots inside the veins”). Ask your
doctor when you can start taking Femoston again.

If you take more Femoston than you should
If you have taken too many tablets of Femoston (or someone else has), it is unlikely to harm you.
You may feel nauseous, or sick (vomiting), you may have breast pain/tenderness, dizziness, abdominal pain, drowsiness/fatigue, or breakthrough bleeding.
No treatment is necessary, but if you are worried contact your doctor for advice.

If you forget to take Femoston
Take the forgotten tablet as soon as you remember. If more than 12 hours have passed after
you were supposed to take the tablet, take the next dose at the usual time. Do not take the
forgotten tablet. Do not double the dose. If you forget a dose, irregular bleeding or spotting may occur.

If you stop taking Femoston
Do not stop Femostonwithout the advice of your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The disorders listed below are more common in women using HRT than in women who are not:

• breast cancer
• abnormal growth or cancer of the uterine walls (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots inside the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65.

For more information on these side effects, see Section 2.
The following side effects may occur with this medicine:

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

• headache
• abdominal pain
• back pain
• breast pain/tension

Common(may affect up to 1 in 10 treated patients):

• vaginal candidiasis (infection caused by a fungus called Candida albicans)
• feeling depressed, nervousness
• migraine. If a migraine headache occurs for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling sick (nausea), vomiting, bloating (abdominal distension), including air (flatulence)
• skin allergic reactions (rash, severe itching or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavy or light bleeding
• pelvic pain
• vaginal discharge
• feeling weak, tired or unwell
• swelling of the ankles, feet or fingers (peripheral edema)
• weight gain

Uncommon(may affect up to 1 in 100 treated patients):

• disorders that mimic cystitis
• increase in size of uterine fibroids
• hypersensitivity reactions such as dyspnea (allergic asthma)
• changes in sexual desire
• blood clots inside the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged and tortuous veins (varicose veins)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia) or generally unwell (malaise) and abdominal pain. If you notice yellowing of the skin or whites of the eyes, stop treatment with Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms that mimic premenstrual syndrome
• weight loss

Rare(may affect up to 1 in 1,000 treated patients):
(*side effects reported post-marketing not observed in clinical studies to which the frequency “rare” has been attributed)

• disease characterized by the destruction of red blood cells (hemolytic anemia)*
• meningioma (brain tumor)*
• change in the surface of the eye (increased corneal curvature)*, which prevents wearing contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat. This can cause difficulty breathing (angioedema)
• purple or pinpoint spots on the skin (vascular purpura)
• painful, reddish skin nodules (erythema nodosum)*, discoloration of the skin especially on the face or neck, known as “pregnancy spots” (cloasma or melasma)*
• leg cramps*

The following side effects have been associated with the use of other HRTs:

• estrogen-dependent tumors (both benign and malignant), such as cancer of the uterine walls, ovarian cancer (for more information see section 2)
• increase in the size of progestin-dependent tumors (such as meningioma)
• immune system disease that affects many organs of the body (systemic lupus erythematosus)
• possible dementia
• worsening of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots inside the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain fats in the blood (hypertriglyceridemia)
• skin rash with reddish or irritated target lesions (erythema multiforme)
• urinary incontinence
• nodular, painful breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare disease of blood pigments (porphyria)
• elevated levels of certain fats in the blood (hypertriglyceridemia)
• increased total thyroid hormones

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please

tell your doctor or pharmacist. Side effects can also be reported directly

through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

By reporting side effects you can help provide more information on the safety of

this medicine.

5. How to Store Femoston

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Femoston Contains

• The active ingredients are estradiol as estradiol hemihydrate and didrogesterone or each brick-red tablet contains 2 mg of estradiol or each yellow tablet contains 2 mg of estradiol and 10 mg of didrogesterone
• The other components of the tablet core are lactose monohydrate, hypromellose, corn starch, anhydrous colloidal silica and magnesium stearate
• The other components of the tablet coating are: or titanium dioxide (E171), yellow iron oxide (E 172), hypromellose, macrogol, talc, red iron oxide (E 172), black iron oxide (E 172).

Description of the Appearance of Femoston and Package Contents

• The film-coated tablets are round, biconvex and bear “379” on one side
• Each blister contains 28 tablets.
• Femoston contains two different colored tablets. 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 packaged in PVC/aluminum blisters.
• The packs contain 28, 84 (3x28) or 280 (10x28) film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

Femoston 0.5 mg/2.5 mg film-coated tablets

Active substances: estradiol/didrogesterone

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their
  symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 0.5 mg/2.5 mg film-coated tablets. In
this leaflet the abbreviated name Femoston is used.

Contents of this leaflet:

• 1. What Femoston is and what it is used for
• 2. What you need to know before you take 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 Hormone Replacement Therapy (HRT). It contains two types of female hormones, an
estrogen called estradiol and a progestin called didrogesterone. Femoston is used
in women who have been postmenopausal for at least 12 months.

Femoston is used for
Relieving symptoms that occur after menopause
During menopause, the amount of estrogen produced by the female body decreases.
This can cause symptoms such as flushing of the face, neck and chest (“hot flushes”).
Femoston relieves these symptoms after menopause. Femoston should only be prescribed if the
symptoms seriously interfere with daily life.

2. What you need to know before taking Femoston

Medical history and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue treatment.
Experience in women treated with early menopause (due to ovarian damage or surgery) is limited. In the case of early menopause, the risks due to HRT treatment may be different. Talk to your doctor.
Before starting (or restarting) HRT, your doctor will ask you about your personal and family medical history. Your doctor may decide to have you undergo a check-up. This may include a breast check and/or a gynecological examination, if necessary.
Once HRT has started, regular medical check-ups (at least annually) must still be performed. During these check-ups, discuss the risks and benefits of continuing Femoston therapy with your doctor.
Undergo regular breast screenings as recommended by your doctor.

Do not take Femostonif you are in any of the conditions listed below. If you are unsure about any of the points below, consult your doctor before starting Femoston therapy.

Do not take Femoston:

• if you have, have had, or there is suspicion of breast cancer
• if you have or there is suspicion of a cancer whose growth is sensitive to estrogens, such as that of the endometrium (uterine lining)
• if you have vaginal bleedingof unknown origin
• if you have excessive thickening of the uterine lining(endometrial hyperplasia) that has not been treated
• if you have or have been treated in the past for the presence of blood clots inside the veins(thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have diseases caused by blood clots(such as protein C deficiency, protein S deficiency, or antithrombin deficiency)
• if you have or have recently had a disease caused by blood clots in the arteries, such as myocardial infarction, stroke, or angina
• if you have or have had in the past liver diseaseand liver function tests have not returned to normal levels
• if you have a rare blood disorder called “porphyria” (which is hereditary if you are allergic (hypersensitive) to estradiol, dihydrogesterone or any of the other components of this medicine (listed in paragraph 6)

If you experience any of the conditions listed above for the first time during treatment with Femoston, stop taking it and consult your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before taking Femoston if you have had any of the following problems in the past, as they may reappear or worsen during treatment with Femoston. If so, your doctor may require more frequent check-ups:

• fibroids inside the uterus
• growth of the uterine wall outside the uterus (endometriosis) or previous excessive thickening of the uterine wall (endometrial hyperplasia)
• brain tumor that may be related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “blood clots inside the veins (thrombosis)”)
• increased risk of having a cancer whose growth is sensitive to estrogens (such as having a mother, sister or grandmother who has had breast cancer)
• high blood pressure
• liver disorders such as benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• an autoimmune disease that affects many organs of the body (systemic lupus erythematosus)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• high increase of triglycerides in the blood (hypertriglyceridemia)
• fluid retention due to heart or kidney failure
• a hereditary and acquired angioedema

Stop taking Femoston and consult your doctor immediately
If you notice any of the following conditions when you start HRT:

• any of the conditions mentioned in the “Do not use Femoston” paragraph
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with difficulty breathing, symptoms indicative of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine headache that occurs for the first time
• if you are pregnant
• if you notice signs of blood clots such as: o painful swelling and redness of the legs o sudden chest pain o difficulty breathing

For more information, see the “Blood clots inside the veins (thrombosis)” section.

Note:Femoston is not a contraceptive. If you are under 50 years of age or if your last menstrual period was less than 12 months ago, you may need additional contraception to prevent pregnancy. Talk to your doctor for advice.

HRT and cancer
Excessive thickening of the uterine wall (endometrial hyperplasia) and cancer of the uterine wall (endometrial cancer)
Taking HRT based on estrogens alone may increase the risk of excessive thickening of the uterine wall (endometrial hyperplasia) and cancer of the uterine wall (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.

Irregular bleeding
During the first 3-6 months of therapy with Femoston you may experience irregular bleeding or spotting. However, if irregular bleeding:

• lasts for more than 6 months
• occurs after Femoston has been taken for more than 6 months
• occurs after stopping Femoston therapy contact your doctor as soon as possible

Breast cancer
Evidence shows that the risk of breast cancer increases with hormone replacement therapy (HRT) based on combined estrogens and progestins or estrogens alone. The additional risk depends on how long HRT is used and becomes evident within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT is used for more than 5 years.

Comparative data
Among women aged between 50 and 54 who do not use HRT for more than 5 years, an average of 13 to 17 breast cancers are diagnosed per 1,000 women.
In women aged 50 who start using estrogen-only HRT for 5 years, 16-17 cases will occur per 1,000 users (i.e. 0-3 additional cases). In women aged 50 who start using estrogen-progestin HRT for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (e.g. 4 to 8 additional cases).
In women aged between 50 and 59 who do not use HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 over a 10-year period.
In women aged 50 who start using estrogen-only HRT for 10 years, 34 cases will occur per 1,000 users (i.e. 7 additional cases).
In women aged 50 who start using combined estrogen and progestin HRT for 10 years, 48 cases will occur per 1,000 users (i.e. 21 additional cases).

Check your breasts regularly. See your doctor if you notice any changes in your breasts, such as:

• small depressions on the skin
• changes in the nipple
• any visible or palpable hardening

Also, participate in breast screening programs when they are offered to you. For breast screening, it is important that you inform the healthcare provider who is performing the X-ray that you are taking HRT, as this medicine may increase breast density impacting the mammography result. If breast density increases, mammography may not detect all hardening.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer.
The use of estrogen-only or estrogen-progestin therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged between 50 and 54 who do not use HRT, about 2 women out of 2,000 will be diagnosed with ovarian cancer within 5 years. For women who are using HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e. about 1 additional case).

Effects of HRT on the heart and circulation
Blood clots inside the veins (thrombosis)
The risk of blood clots inside the veins is approximately 1.3 – 3 times higher in HRT users compared to non-users, especially during the first year of use.
Blood clots can be serious, and if one of these reaches the lungs, it can cause chest pain, shortness of breath, fainting and even death.
As you get older, blood clots inside the veins are more likely to occur and if any of the following conditions occur, talk to your doctor:

• if you have to be immobilized for a long time due to major surgery, trauma or illness (see also paragraph 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m)
• if you have coagulation problems that require prolonged treatment with anticoagulants
• if a family member of first degree has had blood clots in the legs, lungs or other organs in the past
• if you suffer from a rare condition such as systemic lupus erythematosus (SLE)
• if you have cancer

For the symptoms of a blood clot, see “Stop taking Femoston and consult your doctor immediately”.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 4 – 7 women per 1,000 can expect to have a venous thrombosis.
In women around 50 years of age who have taken estrogen-progestin HRT for more than 5 years, there will be 9 – 12 cases per 1,000 (i.e. 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attack. Women over 60 years of age who use estrogen-progestin HRT are slightly more likely to develop heart disease than those who are not taking HRT.

Stroke
The risk of having a stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional cases of stroke due to HRT use may increase with age.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 women per 1,000 can expect to have a stroke.
In women around 50 years of age who have been taking HRT for more than 5 years, there will be 11 cases per 1,000 (e.g. 3 additional cases).

Other conditions
HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after 65 years of age. Ask your doctor for advice.
Tell your doctor if you have or have had any of the following medical conditions as you will need to be checked more frequently:

• heart disease
• kidney failure
• higher than normal levels of some fats in the blood (hypertriglyceridemia)

Children
Femoston is not intended for use in children.

Other medicines and Femoston
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Some medicines can interfere with the effectiveness of Femoston. This can lead to irregular bleeding and occurs with the following medicines:

• medicines for epilepsy(e.g. phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis(e.g. rifampicin, rifabutin)
• medicines for HIV [AIDS] infection(e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John's wort(Hypericum perforatum)

HRT may affect how some other medicines work:

• a medicine for epilepsy (lamotrigine), as it may increase the frequency of seizures
• The combination regimen against hepatitis C virus (HCV) consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV combination regimen.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines or other natural products. Your doctor will give you the necessary instructions.

Laboratory analysis
If you need to have a blood test, inform your doctor or nurse that you are
taking Femoston, because this medicine may interfere with the results of some tests.

Femoston with food and drinks
Femoston can be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If a pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.

Driving and operating machinery
The effect of Femoston on driving or operating machinery has not been studied. An effect is
unlikely.

Femoston tablets containlactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Femoston

Take this medicinealways following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
When to start treatment with Femoston
Do not start treatment with Femoston until at least 12 months after your last menstruation. You can
start taking Femoston any day if:

• you are not currently taking any HRT
• you are switching from a continuous combined HRT. That is, when you take a tablet or apply a patch every day that contains both, an estrogen and a progestin.

Start taking Femoston the day after you finish day 28 of your cycle if:

• you are switching from a ‘cyclic’ or ‘sequential’ HRT. That is, when you take a tablet or use a patch that contains an estrogen for the first part of your cycle. After that, take a tablet or use a patch containing both an estrogen and a progestin for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you can take the tablet with or without food
• try to take the tablet at the same time each day. This will ensure that there is a constant amount of product in your body. It will also help you remember to take the tablet.
• Take one tablet every day, without interruption between one pack and the next. The days of the week are highlighted on the blisters. This will make it easier to remember when to take the tablet.

For how long

• your doctor will prescribe the minimum dose to treat your symptoms for a period that is as short as possible. If you feel that this dose is too strong or too weak, consult your doctor.
• Take one yellow tablet every day for a 28-day cycle.

If you need surgery
If you are going to have surgery, tell your doctor that you are taking Femoston. You may
need to stop taking Femoston about 4 – 6 weeks before the surgery to reduce the risk of
thrombi (see section 2, “Thrombi inside the veins”). Ask your doctor when you can start taking
Femoston again.

If you take more Femoston than you should
If you have taken too many Femoston tablets (or someone else has), it is unlikely to harm you.
You may feel nauseous, or feel sick (vomiting), you may have breast pain/tension, dizziness,
abdominal pain, drowsiness/fatigue, or breakthrough bleeding. No
treatment is necessary. But if you are worried, contact your doctor for advice.

If you forget to take Femoston
Take the forgotten tablet as soon as you remember. If more than 12 hours have passed
since you were supposed to take the tablet, take the next dose at the usual time. Do not take the
forgotten tablet. Do not double the dose. If you forget a dose, irregular bleeding or spotting may occur.

If you stop taking Femoston
Do not stop Femoston without your doctor’s advice.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The disorders listed below are more common in women using HRT than in women who are not:

• breast cancer
• abnormal growth or cancer of the uterine lining (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots inside the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65

For more information on these side effects, see Section 2.
The following side effects may occur with this medicine:

Very common(may affect more than 1 in 10 treated patients)

• headache
• abdominal pain
• back pain
• breast pain/tension

Common(may affect up to 1 in 10 treated patients):

• vaginal candidiasis (infection caused by a fungus called Candida albicans)
• feeling depressed, nervousness
• migraine. If a migraine headache occurs for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling sick (nausea), vomiting, bloating (abdominal distension), including air (flatulence)
• allergic skin reactions (rash, severe itching or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavy or light bleeding.
• pelvic pain
• vaginal discharge
• feeling weak, tired or unwell
• swelling of the ankles, feet or fingers (peripheral edema)
• weight gain

Uncommon(may affect up to 1 in 100 treated patients):

• disorders that mimic cystitis
• increase in size of uterine fibroids
• hypersensitivity reactions such as dyspnea (allergic asthma)
• changes in sex drive
• blood clots inside the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged and twisted veins (varicose)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia) or generally unwell (malaise) and abdominal pain. If you notice yellowing of the skin or whites of the eyes, stop treatment with Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms that mimic premenstrual syndrome
• weight loss

Rare(may affect up to 1 in 1,000 treated patients):
(*side effects reported post-marketing not observed in clinical studies to which the frequency “rare” has been attributed)

• disease characterized by the destruction of red blood cells (hemolytic anemia)*
• meningioma (brain tumor)*
• change in the surface of the eye (increased corneal curvature)*, which does not allow you to wear contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat. This can cause difficulty breathing (angioedema)
• purple or pinpoint spots on the skin (vascular purpura)
• painful, reddish skin nodules (erythema nodosum)*, discoloration of the skin especially of the face or neck, known as "pregnancy spots" (cloasma or melasma)* leg cramps*

The following side effects have been reported with the use of other HRT:

• estrogen-dependent tumors both benign and malignant, such as cancer of the uterine lining, ovarian cancer (for more information see section 2)
• increase in the size of tumors dependent on progesterone levels (such as meningioma)
• disease where the immune system abnormally attacks many organs of the body (systemic lupus erythematosus)
• possible dementia
• worsening of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots inside the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain blood fats (hypertriglyceridemia)
• skin rash with reddish or irritated target lesions (erythema multiforme)
• urinary incontinence
• nodular/painful breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare disease of blood pigments (porphyria)
• elevated levels of certain blood fats (hypertriglyceridemia)
• increased total thyroid hormones

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store FEMOSTON

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Femoston contains
➢ The active ingredients are estradiol as estradiol hemihydrate and didrogesterone.
➢ Each tablet contains 0.5 mg of estradiol and 2.5 mg of didrogesterone.
➢ The other components of the tablet core are lactose monohydrate, hypromellose, corn starch,
anhydrous colloidal silica and magnesium stearate.
➢ The other components of the tablet coating are:
titanium dioxide (E171), yellow iron oxide (E172), polyvinyl alcohol, macrogol, talc

Description of the appearance of Femoston and contents of the pack
➢ This medicinal product is constituted by a film-coated tablet. The tablet is round,
biconvex and bears ‘379’ on one side. Each blister contains 28 tablets.
➢ The tablets are yellow in colour.
➢ The tablets are packaged in PVC blisters with an aluminium foil covering.
➢ The packs contain 28, 84 (3 x 28) or 280 (10 x 28) film-coated tablets in blisters.
It is possible that not all pack sizes are marketed

Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

Femoston 1/5 Conti film-coated tablets 1mg, 5mg

Active substances: estradiol/dihydrogesterone

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if theirsymptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The full name of this medicine is Femoston 1/5 Conti film-coated tablets 1mg, 5 mg.
The abbreviated name Femoston is used in this leaflet.

Contents of this leaflet:

• 1. What Femoston is and what it is used for
• 2. What you need to know before you take 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 Hormone Replacement Therapy (HRT). It contains two types of female hormones, an
estrogen called estradiol and a progestin called didrogesterone. Femoston is used
in women who have been postmenopausal for at least 12 months.

Femoston is used for
Relieving symptoms that occur after menopause
During menopause, the amount of estrogen produced by the female body decreases.
This can cause symptoms such as flushing of the face, neck and chest (“hot flushes”).
Femoston relieves these symptoms after menopause. Femoston should only be prescribed if the
symptoms seriously interfere with daily life.

Preventing osteoporosis
After menopause, some women may develop fragile bones (osteoporosis). You should discuss
all available options with your doctor.
If you are at high risk of fractures due to osteoporosis and other medicines are not suitable, Femoston can
be used to prevent osteoporosis after menopause.

2. Cosa deve sapere prima di prendere Femoston

Medical history and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue treatment.
Experience in women treated with early menopause (due to ovarian damage or surgery) is limited. In the case of early menopause, the risks due to HRT treatment may be different. Talk to your doctor.
Before starting (or restarting) HRT, your doctor will ask you about your personal and family medical history. Your doctor may perform a breast and/or pelvic (lower abdomen) examination if necessary.
Once HRT has started, regular medical check-ups (at least annually) must still be carried out for an accurate assessment of the risks and benefits in relation to continuing therapy.
Undergo regular breast screenings as recommended by your doctor.

Do not take Femostonif you are in any of the following conditions. If you are unsure about any of the points below, inform your doctor before starting therapy with Femoston.

Do not take Femoston:

• if you have, have had, or there is a suspicion that you have breast cancer
• if you have or there is a suspicion that you have a cancer whose growth is sensitive to estrogens, for example, in the endometrium (uterine lining)
• if you have vaginal bleeding of unknown origin
• if you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
• if you have or have been treated in the past for the presence of blood clots inside the veins (thrombosis), such as in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)
• if you have diseases caused by blood clots (such as protein C deficiency, protein S deficiency, or antithrombin deficiency)
• if you have or have had diseases caused by blood clots inside the arteries, such as myocardial infarction, stroke, or angina (severe chest pain)
• if you have or have had liver disease and liver function tests have not returned to normal levels
• if you have porphyria (inherited metabolic disease due to an alteration in the metabolism of blood pigments)
• if you are allergic (hypersensitive) to estradiol, dihydrogesterone, or any of the other ingredients of this medicine (listed in section 6).

During treatment with Femoston, if any of the above conditions should occur for the first time, stop taking it and consult your doctor immediately.

Warnings and precautions

Tell your doctor or pharmacist before taking Femoston if you have had any of the following in the past

problems, as they may recur or worsen during treatment with Femoston.

If so, your doctor may require more frequent checks:

• uterine fibroids
• growth of the uterine wall outside the uterus (endometriosis) or previous excessive thickening of the uterine wall (endometrial hyperplasia)
• brain tumor that may be related to progesterone levels (meningioma)
• increased risk of developing blood clots (see “Blood clots inside the veins (thrombosis)”)
• increased risk of having a cancer whose growth is sensitive to estrogens (having a first-degree relative, such as mother, sister, or grandmother, who has had breast cancer)
• hypertension (high blood pressure)
• liver disorders such as benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (autoimmune disease)
• epilepsy
• asthma
• otosclerosis (hereditary predisposition to middle ear disease)
• hypertriglyceridemia (high increase in triglycerides in the blood)
• fluid retention due to heart or kidney failure
• a hereditary and acquired angioedema

Stop therapy with Femoston and consult your doctor immediately
If you notice any of the following conditions when you start HRT:

• any of the conditions mentioned in the “Do not use Femoston” section
• 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 with difficulty breathing, symptoms indicative of angioedema
• increased blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine headache that occurs for the first time
• if you are pregnant
• if you notice signs of blood clots such as: o painful swelling and redness of the legs o sudden chest pain o difficulty breathing

For more information, see the “Blood clots inside the veins (thrombosis)” section.

Note:Femoston is not a contraceptive. If you are under 50 years of age or if your last menstrual period was less than 12 months ago, you may need additional contraception to prevent pregnancy. Consult your doctor.

HRT and cancer
Excessive thickening of the uterine wall (endometrial hyperplasia) and uterine cancer (endometrial cancer)
Taking HRT based on estrogens alone may increase the risk of excessive thickening of the uterine wall (endometrial hyperplasia) and uterine cancer (endometrial cancer).
The progesterone contained in Femoston prevents this additional risk.

Irregular bleeding
During the first 3-6 months of therapy with Femoston, you may experience irregular bleeding or spotting (drops of blood). However, contact your doctor as soon as possible if the irregular bleeding:

• lasts more than 6 months
• starts after you have been taking Femoston for more than 6 months
• occurs after stopping Femoston therapy

Breast cancer
Evidence suggests that the risk of breast cancer increases with hormone replacement therapy (HRT) based on combined estrogens and progestins or estrogens alone. The additional risk depends on how long HRT is used and becomes evident within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT is used for more than 5 years.

Comparative data
Among women aged between 50 and 54 who do not use HRT for more than 5 years, an average of 13 to 17 breast cancers are diagnosed per 1,000 women.
In women aged 50 who start HRT based on estrogen alone for 5 years, 16-17 cases will occur per 1,000 users (i.e., 0-3 additional cases).
In women aged 50 who start HRT based on estrogens and progestins for 5 years, there will be 21 cases of breast cancer diagnosed per 1,000 users (4 to 8 additional cases).
In women aged between 50 and 59 who do not follow HRT, breast cancer will be diagnosed in an average of 27 women per 1,000 in a period of 10 years.
In women aged 50 who start HRT based on estrogen alone for 10 years, 34 cases will occur per 1,000 users (i.e., 7 additional cases).
In women aged 50 who start HRT based on combined estrogens and progestins for 10 years, 48 cases will occur per 1,000 users (i.e., 21 additional cases).

Check your breasts regularly. See your doctor if you notice any changes in your breasts such as:

• small depressions on the skin
• changes in the nipple
• any visible or palpable hardening.

Also, participate in breast screening programs when they are offered to you. For breast screening, it is important that you inform the healthcare professional performing the X-ray that you are taking HRT, as this medicine may increase breast density impacting the mammography result. If breast density is increased, mammography may not detect all hardening.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer.
The use of estrogen-only or estrogen-progestin-based therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged between 50 and 54 who do not follow HRT, about 2 women out of 2,000 will receive a diagnosis of ovarian cancer within 5 years. For women who are taking HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e., about 1 additional case).

Effects of HRT on the heart and circulation
Blood clots inside the veins (thrombosis)
The risk of blood clots inside the veins is approximately 1.3 – 3 times higher in HRT users, especially during the first year of use.
Blood clots can be serious, and if one of these reaches the lungs, it can cause chest pain, shortness of breath, fainting, and even death.
As you get older, blood clots inside the veins are more likely to occur, and if you experience any of the following conditions, talk to your doctor:

• if you are to be immobilized for a long time due to major surgery, trauma, or illness (see also section 3 - If you need surgery)
• if you are severely obese (body mass index >30 kg/m)
• if you have coagulation problems requiring prolonged treatment with anticoagulants
• if one of your first-degree relatives has had blood clots in the legs, lungs, or other organs in the past
• if you suffer from a rare condition such as systemic lupus erythematosus (SLE)
• if you have cancer.

For symptoms of a blood clot, see “Stop Femoston therapy and consult your doctor immediately.”

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 4 – 7 women per 1,000 can expect to have a venous thrombosis.
In women around 50 years of age who have taken HRT based on estrogens and progestins for more than 5 years, there will be 9 – 12 cases per 1,000 (e.g., 5 additional cases).

Heart disease (heart attack)
There is no evidence that HRT prevents heart attack. Women over 60 years of age who use HRT based on estrogens and progestins are slightly more likely to develop heart disease than those who are not taking any HRT.

Stroke
The risk of having a stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional strokes due to HRT use may increase with age.

Comparative data
In women around 50 years of age who have not taken HRT for more than 5 years, an average of 8 women per 1,000 can expect to have a stroke.
In women around 50 years of age who are taking HRT for more than 5 years, there will be 11 cases per 1,000 (e.g., 3 additional cases).

Other conditions
HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after age 65. Ask your doctor for advice.
Tell your doctor if you have or have had any of the following medical conditions as you will need to be checked more frequently:

• heart disease
• kidney failure
• higher than normal levels of some fats in the blood (hypertriglyceridemia).

Children
Femoston is not intended for use in children.

Other medicines and Femoston
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can interfere with the effectiveness of Femoston. This can lead to irregular bleeding and occurs with the following medicines:

• medicines for epilepsy (e.g., phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g., rifampicin, rifabutin)
• medicines for HIV [AIDS] infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz)
• herbal preparations containing St. John's wort (Hypericum perforatum)

HRT can affect how some other medicines work:

• a medicine for epilepsy (lamotrigine), as it may increase the frequency of seizures
• The combination regimen against the hepatitis C virus (HCV) consisting of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen based on glecaprevir/pibrentasvir, may cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Femoston with this HCV combination regimen.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription, herbal medicines, or other natural products. Your doctor will give you the necessary instructions.

Laboratory tests
If you need to have a blood test, tell your doctor or nurse that you are taking Femoston because this medicine may interfere with the results of some tests.

Femoston with food and drink
Femoston can be taken with or without food.

Pregnancy and breastfeeding
Femoston is indicated only in postmenopausal women.
If pregnancy occurs,

• stop taking Femoston and consult your doctor.

Femoston is not indicated during breastfeeding.

Driving and operating machinery
The effect of Femoston on driving or operating machinery has not been studied. An effect is
unlikely.

Femoston tablets contain lactose.
If you are intolerant to certain sugars, contact your doctor before taking this medicine.

3. How to take Femoston

Take this medicinealways following exactly the doctor's instructions. If you have doubts
consult your doctor or pharmacist.
When to start treatment with Femoston
Do not start treatment with Femoston until at least 12 months after your last menstrual period.
You can start taking Femoston on any day if:

• you are not currently taking any HRT
• you are switching from a continuous combined HRT. That is, when you take a tablet or apply a patch every day containing both, an estrogen and a progestin.

Start taking Femoston the day after you finish day 28 of your cycle if:

• you are switching from a cyclical or sequential HRT. That is, when you take a tablet or use a patch containing an estrogen for the first part of your cycle. Afterwards, take a tablet or use a patch containing both an estrogen and a progestin for up to 14 days.

Taking the medicine

• swallow the tablet with water
• you can take the tablet with or without food
• try to take the tablet at the same time each day. This will ensure that there is a constant amount of product in your body. It will also help you remember to take the tablet
• take one tablet every day, without interruption between one pack and the next. The days of the week are highlighted on the blisters. This will make it easier to remember when to take the tablet.

For how long

• your doctor will prescribe the lowest dose to treat your symptoms for a period that is as short as possible. If you feel that this dose is too strong or too weak, consult your doctor.
• If you are taking Femoston to prevent osteoporosis, your doctor will adjust your dose. It will depend on your bone mass.
• Take one salmon tablet every day for a 28-day cycle.

If you need surgery
If you are going to have surgery, tell your doctor that you are taking Femoston. They may
need to stop you from taking Femoston about 4 – 6 weeks before the surgery to
reduce the risk of blood clots (see section 2, “Blood clots inside the veins”). Ask your
doctor when you can start taking Femoston again.

If you take more Femoston than you should
If you have taken too many Femoston tablets (or someone else has), it is unlikely to harm you.
You may feel nauseous, or feel sick (vomiting), you may have breast pain/tension, dizziness, abdominal pain, drowsiness/fatigue, or breakthrough bleeding.
No treatment is necessary, but if you are concerned, contact your doctor for advice.

If you forget to take Femoston
Take the forgotten tablet as soon as you remember. If more than 12 hours have passed
since you were supposed to take the tablet, take the next dose at the usual time. Do not take the
forgotten dose. Do not double the dose. If you forget a dose, irregular bleeding or spotting may occur.

If you stop taking Femoston
Do not stop Femoston without your doctor's advice.

• If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The disorders listed below are more frequently observed in women using HRT (hormone replacement therapy) compared to
women who are not using it:

• breast cancer
• abnormal growth or cancer of the uterine walls (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots inside the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65.

For more information on these side effects, see Section 2.
The following side effects may occur with this medicine:

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

• headache
• abdominal pain
• back pain
• breast pain/tension

Common(may affect up to 1 in 10 treated patients):

• vaginal candidiasis (infection caused by a fungus called Candida albicans)
• feeling depressed, nervousness
• migraine. If a migraine headache occurs for the first time, stop treatment with Femoston and contact your doctor immediately
• dizziness
• feeling sick (nausea), vomiting, bloating (abdominal distension), including gas (flatulence)
• skin allergic reactions (rash, severe itching or hives)
• menstrual disorders such as irregular bleeding, spotting, painful periods (dysmenorrhea), heavy or light bleeding
• pelvic pain
• vaginal discharge
• feeling weak, tired or unwell
• swelling of the ankles, feet or toes (peripheral edema)
• weight gain

Uncommon(may affect up to 1 in 100 treated patients):

• disorders that mimic cystitis
• increase in size of uterine fibroids
• hypersensitivity reactions such as dyspnea (allergic asthma)
• changes in sexual desire
• blood clots inside the veins of the legs and lungs (venous thromboembolism or pulmonary embolism)
• increased blood pressure (hypertension)
• circulation problems (peripheral vascular disease)
• enlarged and tortuous veins (varicose veins)
• indigestion
• changes in liver function, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia) or generally unwell (malaise) and abdominal pain. If you notice yellowing of the skin or whites of the eyes, stop treatment with Femoston and contact your doctor immediately
• gallbladder disease
• breast swelling
• symptoms that mimic premenstrual syndrome
• weight loss

Rare(may affect up to 1 in 1,000 treated patients):
(*side effects reported post-marketing not observed in clinical studies to which the frequency “rare” has been attributed)

• disease characterized by the destruction of red blood cells (hemolytic anemia)*
• meningioma (brain tumor)*
• change in the surface of the eye (increased corneal curvature)*, which prevents wearing contact lenses (contact lens intolerance)*
• heart attack (myocardial infarction)
• stroke*
• swelling of the skin of the face and throat. This can cause difficulty breathing (angioedema)
• purple or pinpoint spots on the skin (vascular purpura)
• painful, reddish skin nodules (erythema nodosum)*, discoloration of the skin especially on the face or neck, known as “chloasma” or “melasma”*
• leg cramps*

The following side effects have been associated with the use of other HRT:

• estrogen-dependent tumors (both benign and malignant), such as cancer of the uterine walls, ovarian cancer (for more information see section 2)
• increase in the size of progestin-dependent tumors (such as meningioma)
• immune system disease that affects many organs of the body (systemic lupus erythematosus)
• possible dementia
• worsening of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots inside the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain fats in the blood (hypertriglyceridemia)
• skin rash with reddish or irritated target lesions (erythema multiforme)
• urinary incontinence
• nodular, painful breasts (fibrocystic breast disease)
• erosion of the cervix (cervical erosion)
• worsening of a rare disease of blood pigments (porphyria)
• elevated levels of certain fats in the blood (hypertriglyceridemia)
• increased total thyroid hormones

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can contribute to providing more information on the safety of
this medicine.

5. How to store Femoston

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use the medicine after the expiry date which is stated on the blister and the outer packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Femoston Contains

• The active ingredients are estradiol as estradiol hemihydrate and didrogesterone each tablet contains 1 mg of estradiol and 5 mg of didrogesterone
• The other components of the tablet core are lactose monohydrate, hypromellose, corn starch, anhydrous colloidal silica and magnesium stearate
• The other components of the tablet coating are: titanium dioxide (E171), yellow iron oxide (E 172), red iron oxide (E 172), hypromellose, macrogol.

Description of Femoston and Package Contents

• This medicine is constituted by a film-coated tablet. The tablet is round, biconvex, salmon-colored, and bears “379” on one side (7 mm).
• Each blister contains 28 tablets.
• The tablets are packaged in PVC/aluminum blisters.
• The packs contain 28, 84 (3 x 28) or 280 (10 x 28) film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: