Patient Information Leaflet

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Femoston mini (Femoston conti 0.5 mg/2.5 mg Film-coated Tablets)
0.5 mg + 2.5 mg, film-coated tablets
Estradiol + Dydrogesterone
Femoston mini and Femoston conti 0.5 mg/2.5 mg Film-coated Tablets are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents

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

1. What Femoston mini is and what it is used for

Femoston mini is a medicine used in hormone replacement therapy (HRT). It contains two types of female hormones: an oestrogen called estradiol and a progestagen called dydrogesterone. Femoston mini is used in postmenopausal women, i.e. women in whom at least 12 months have passed since their last menstrual period.
Femoston mini is used to
Relieve symptoms occurring after menopause
During menopause, the level of oestrogens produced by a woman's body decreases. This may cause symptoms such as flushing of the face, neck and chest (‘hot flushes’). Treatment with Femoston mini reduces these postmenopausal symptoms. Your doctor will prescribe Femoston mini only if the symptoms are significantly affecting the patient's quality of life.

2. Important information before using Femoston mini

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

Do not take Femoston mini if any of the following apply to you. If you have any doubts, consult your doctor before taking Femoston mini.

When not to use Femoston mini

if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of this medicine (listed in section 6)
if you have, have had in the past, or are suspected of having breast cancer
if you have, or are suspected of having, an estrogen-dependent tumour, such as endometrial cancer (cancer of the lining of the uterus)
if you have vaginal bleeding of unknown cause
if you have untreated excessive thickening of the endometrium (endometrial hyperplasia)
if you currently have or have had in the past blood clots in the veins (thrombosis), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
if you have a blood clotting disorder with a tendency to thrombosis (such as protein C, protein S or antithrombin deficiency)
if you currently have or have had in the past arterial thrombotic disease, such as myocardial infarction, stroke or angina pectoris
if you currently have or have had in the past liver disease and liver function tests have not returned to normal
if you have a rare inherited blood disorder called porphyria
if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the membrane between the brain and skull).

If any of the above conditions occurs for the first time while taking Femoston mini, stop taking the medicine immediately and contact your doctor as soon as possible.

Warnings and precautions
Before starting Femoston mini, inform your doctor if you currently have or have had any of the following conditions, as they may worsen or recur during treatment. More frequent check-ups may be necessary if you have:

uterine fibroids
endometriosis (endometrial tissue outside the uterus) or a history of excessive endometrial thickening (endometrial hyperplasia)
a brain tumour
an increased risk of blood clots (see section “Venous thromboembolism (thrombosis)”)
an increased risk of estrogen-dependent tumours (e.g. if a close relative such as mother, sister or grandmother had breast cancer)
high blood pressure
liver disease, e.g. benign liver tumour
diabetes
gallstones
migraine or severe headaches
autoimmune diseases affecting multiple organs (systemic lupus erythematosus)
epilepsy
asthma
otosclerosis (a disease affecting the ear drum and hearing)
very high levels of blood fats (triglycerides)
fluid retention due to heart or kidney problems
hereditary or acquired angioedema.

Meningioma
Taking Femoston mini may increase the risk of developing a usually benign tumour of the membrane between the brain and skull (meningioma). If you are diagnosed with meningioma, your doctor will stop treatment with Femoston mini (see section “When not to use Femoston mini”). If you notice any symptoms such as vision disturbances (e.g. double or blurred vision), hearing loss or tinnitus, loss of smell, worsening headaches, memory loss, seizures, or weakness in arms or legs, inform your doctor immediately.

Stop taking Femoston mini and contact your doctor immediately if any of the following symptoms occur during HRT:

any of the conditions listed under “When not to use Femoston mini”
yellowing of the skin or eyes (jaundice) – these may be signs of liver disease
swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, combined with breathing difficulties – these may be symptoms of angioedema
a significant increase in blood pressure (symptoms include headache, fatigue, dizziness)
new-onset migraine-like headaches
pregnancy
symptoms of blood clots, such as:
- painful swelling and redness in the legs
- sudden chest pain
- difficulty breathing

For more information, see section “Venous thromboembolism (thrombosis)”.

Note: Femoston mini is not a contraceptive. If less than 12 months have passed since your last menstrual period and you are under 50 years of age, you may need to use an additional method of contraception to prevent pregnancy. Please consult your doctor.

HRT and cancer

Endometrial hyperplasia (excessive thickening of the endometrium) and endometrial cancer
Taking estrogen-only HRT increases the risk of endometrial hyperplasia and endometrial cancer.
Femoston mini contains a progestagen, which helps reduce this additional risk.

Irregular bleeding
Irregular bleeding or spotting may occur during the first 3 to 6 months of taking Femoston mini. However, if irregular bleeding:

lasts longer than 6 months
occurs after a break of more than 6 months of treatment
does not stop after stopping Femoston mini

you should contact your doctor as soon as possible.

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

Comparison
Among women aged 50–54 years not using HRT, breast cancer is diagnosed in an average of 13 to 17 per 1,000 women over 5 years.
Among women aged 50 starting 5-year estrogen-only HRT, the number of cases is 16–17 per 1,000 women (i.e. 0 to 3 additional cases).
Among women aged 50 starting 5-year combined estrogen-progestagen HRT, the number of cases is 21 per 1,000 women (i.e. 4 to 8 additional cases).
Among women aged 50–59 years not using HRT, breast cancer is diagnosed in an average of 27 per 1,000 women over 10 years.
Among women aged 50 starting 10-year estrogen-only HRT, the number of cases is 34 per 1,000 women (i.e. 7 additional cases).
Among women aged 50 starting 10-year combined estrogen-progestagen HRT, the number of cases is 48 per 1,000 women (i.e. 21 additional cases).

You should examine your breasts regularly. Contact your doctor if you notice any changes such as:

skin indentation
changes around the nipple
any visible or palpable lumps

Additionally, participation in mammographic screening programmes is recommended. It is important to inform the nurse or medical staff that you are using HRT during screening mammography, as this product may increase breast density and affect mammogram results. Increased breast density may make it harder to detect all lumps on mammography.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. Using estrogen-only HRT or combined estrogen-progestagen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50–54 not using HRT, ovarian cancer is diagnosed in about 2 per 2,000 women over 5 years.
Among women using HRT for 5 years, it occurs in about 3 per 2,000 women (i.e. about 1 additional case).

Effects of HRT on the heart and circulation

Venous thromboembolism (thrombosis)
The risk of venous thrombosis is 1.3 to 3 times higher in women using HRT compared to non-users, especially during the first year of use.
Blood clots can have serious consequences and, if they travel to the lungs, may cause chest pain, shortness of breath, fainting, or even death.
The risk of venous thrombosis increases with age and if any of the following apply to you. Contact your doctor if any of these situations apply:

if you are unable to walk for a prolonged period due to major surgery, injury or illness (see also section 3 “Planned surgery”)
if you are significantly overweight (BMI >30 kg/m²)
if you have blood clotting disorders requiring long-term anticoagulant treatment
if any close relative has had blood clots in legs, lungs or other organs
if you have systemic lupus erythematosus
if you have cancer.

Symptoms of blood clots: see “Stop taking Femoston mini and contact your doctor immediately” above.

Comparison
Among women aged 50–59 not using HRT, venous thrombosis is estimated to occur in 4 to 7 per 1,000 women over 5 years.
Among women aged 50–59 using combined estrogen-progestagen HRT for over 5 years, venous thrombosis is estimated in 9 to 12 per 1,000 women (i.e. 5 additional cases).

Heart disease (myocardial infarction)
There is no evidence that HRT prevents heart attacks. In women over 60 using combined estrogen-progestagen HRT, there is a slightly increased risk of heart disease compared to non-users.

Stroke
The risk of stroke is about 1.5 times higher in women using HRT compared to non-users. The number of additional stroke cases increases with age.

Comparison
Among women aged 50–59 not using HRT, stroke is estimated to occur in 8 per 1,000 women over 5 years. Among women aged 50–59 using HRT for over 5 years, 11 strokes per 1,000 women are expected (i.e. 3 additional cases).

Other conditions
HRT does not prevent memory loss. Evidence suggests an increased risk of memory loss in women who start HRT after age 65. Consult your doctor.
Inform your doctor if any of the following conditions apply, to ensure closer monitoring:

heart disease
kidney dysfunction
elevated levels of certain blood fats (hypertriglyceridaemia)

Children and adolescents
Femoston mini is not indicated for use in children and adolescents.

Femoston mini and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the action of Femoston mini, leading to irregular bleeding or spotting. These include:

medicines for epilepsy (such as: phenobarbital, carbamazepine, phenytoin)
medicines for tuberculosis (such as: rifampicin, rifabutin)
medicines used in HIV infection (AIDS) (such as: nevirapine, efavirenz, ritonavir, nelfinavir)
herbal products containing St. John’s wort (Hypericum perforatum)

HRT may affect the action of other medicines:

the antiepileptic drug lamotrigine, potentially increasing seizure frequency
combination therapies for hepatitis C virus (HCV) infection using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir may cause increased liver function test parameters (elevated alanine aminotransferase [AlAT] enzyme activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston mini contains estradiol instead of ethinylestradiol.
It is unknown whether elevated AlAT enzyme activity may occur when Femoston mini is used concomitantly with these HCV combination therapies.

Tell your doctor or pharmacist about all other medicines you are currently or recently taking, including over-the-counter medicines, herbal remedies or other natural products. Your doctor will advise you accordingly.

Laboratory tests
Before blood tests, inform your doctor or medical staff that you are taking Femoston mini, as it may affect the results of certain tests.

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

Pregnancy and breastfeeding
Femoston mini is indicated only for postmenopausal women.
If you become pregnant:

stop taking Femoston mini and contact your doctor.

Femoston mini is not indicated for use in breastfeeding women.

Driving and operating machinery
No studies on the effects of Femoston mini on driving and operating machinery have been conducted. Such effects are not expected.

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

3. How to use Femoston mini

This medicine should always be used exactly as your doctor has told you. If you are unsure, please
consult your doctor or pharmacist.
When to start using Femoston mini
Femoston mini should not be used before 12 months have passed since the last menstrual period.
Treatment with Femoston mini may be started on any day if:

the patient is not currently using HRT
the patient is switching from another continuous combined HRT, i.e. if the patient is already taking a tablet or using a transdermal system containing both an oestrogen and a progestagen every day.

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

the patient is switching from a "cyclical" or "sequential" HRT regimen, i.e. one in which a tablet or transdermal patch containing oestrogen only is taken during the first part of the cycle, followed by 14 days of taking a tablet or applying a patch containing both oestrogen and a progestagen.

How to take Femoston mini

Swallow the tablet with water.
Tablets may be taken independently of meals.
Try to take the tablet at the same time each day. This helps maintain a constant level of medicine in the body and helps you remember to take it every day.
Take 1 tablet every day without interruption between packs. The days of the week are marked on the blister to help you remember when to take the tablet.

What dose to use

Your doctor will prescribe the lowest effective dose needed to treat your symptoms for the shortest necessary duration. If you feel the dose of medicine is too strong or too weak, consult your doctor.
Take one yellow tablet daily for 28 days.

Planned surgery
If you are scheduled for surgery, inform your surgeon that you are taking Femoston mini.
You may need to stop taking Femoston mini approximately 4 to 6 weeks before the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in the veins (venous thromboembolism)"). Consult your doctor about when you can restart taking Femoston mini.
Taking more Femoston mini than you should
If you (or someone else) take too many Femoston mini tablets, it is unlikely to cause harm. Possible symptoms may include nausea or vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness and/or fatigue, or withdrawal bleeding. Additional treatment is not usually necessary, but if in doubt, consult your doctor.
If you forget to take Femoston mini
Take the missed tablet as soon as possible. If more than 12 hours have passed, take the next tablet at the usual time without taking the missed tablet. Do not take a double dose to make up for a forgotten tablet. Breakthrough bleeding or spotting may occur if a dose is missed.
Stopping Femoston mini
Do not stop taking Femoston mini without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported more frequently in women using HRT than in women not using HRT:

breast cancer
excessive growth or cancer of the lining of the womb (endometrial hyperplasia or endometrial cancer)
ovarian cancer
blood clots in the legs or lungs (venous thromboembolic disease)
heart diseases
stroke
memory loss, if HRT is started at age over 65.

For further information about these adverse effects, see section 2.
The following adverse effects may occur during treatment with this medicine:
Very common (may affect more than 1 in 10 users):

headache
abdominal pain
back pain
breast tenderness or pain

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

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

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

symptoms resembling cystitis
enlargement of uterine fibroids
hypersensitivity reactions, such as shortness of breath (allergic asthma)
change in libido
blood clots in legs or lungs (venous thromboembolic disease, pulmonary embolism)
high blood pressure (hypertension)
circulatory disorders (peripheral circulatory failure)
enlargement and twisting of veins (varicose veins)
indigestion
liver function disorders, sometimes with yellowing of the skin (jaundice), feeling of weakness or general malaise and abdominal pain. If yellowing of the skin or whites of the eyes occurs, treatment with Femoston mini should be discontinued and you should contact your doctor immediately
gallbladder diseases
swelling (oedema) of the breasts
premenstrual tension syndrome
weight loss

Rare (may affect up to 1 in 1,000 users):
(*Adverse effects based on post-marketing reports, not observed in clinical trials, have been assigned the frequency "rare.")

disease caused by destruction of red blood cells (haemolytic anaemia)*
meningioma (brain tumour)*
changes in the cornea of the eye (keratoconus)*, intolerance to contact lenses*
heart attack
stroke*
swelling of tissues in the face and neck. May cause difficulty in breathing (angioedema)
purple spots and patches on the skin (vasculitic purpura)
painful red skin nodules (erythema nodosum)*, skin pigmentation, especially on the face and neck known as "melasma"*
cramps in the lower limbs*

The following adverse effects have been observed during treatment with other HRT medicines:

benign or malignant tumours which may be dependent on oestrogen levels, such as endometrial cancer, ovarian cancer (further information see section 2)
increased size of tumours which may be dependent on progestogen levels (such as meningioma)
autoimmune disease affecting multiple organs (systemic lupus erythematosus)
probable dementia (memory loss)
worsening of epileptic seizures (epilepsy)
involuntary muscle spasms (chorea)
arterial blood clots (arterial thrombosis)
pancreatitis, in women with previously existing elevated levels of certain blood fats (hypertriglyceridaemia)
rash in the form of red rings or blisters (erythema multiforme)
urinary incontinence
painful and (or) lumpy breasts (fibrocystic breast changes)
cervical erosion
worsening of symptoms of a rare pigment disorder (porphyria)
high levels of certain fats in the blood (hypertriglyceridaemia)
increased total concentration of thyroid hormones

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

5. How to store Femoston mini

Keep this medicine out of sight and reach of children.
No special storage precautions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Femoston mini contains

The active substances are: estradiol in the form of estradiol hemihydrate and dydrogesterone. Each coated tablet of Femoston mini contains 0.5 mg of estradiol and 2.5 mg of dydrogesterone.
Other ingredients are: monohydrate lactose, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate.

Coating Yellow 1: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171),
yellow iron oxide (E 172).

What Femoston mini looks like and contents of the pack
This medicine is available as coated tablets. The tablets are round, biconvex, with the imprint
“379” on one side. Each blister contains 28 tablets. The tablets are yellow in colour.
The tablets are packed in PVC/Aluminum blisters in a cardboard box.
Pack sizes contain either 28 or 84 coated tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Austria, country of export:
Theramex Ireland Limited, 3rd Floor Spencer Dock Kilmore House Park Lane, D01 YE64, Dublin 1,
Ireland

Manufacturer:
Abbott Biologicals B.V.
1381 CP Weesp, The Netherlands

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Austria, country of export: 1-29404
Parallel Import Licence Number: 21/26

Translation of weekday symbols printed next to each tablet on the immediate packaging:
MO – Monday
DI – Tuesday
MI – Wednesday
DO – Thursday
FR – Friday
SA – Saturday
SO – Sunday

This medicinal product is authorised for sale in the European Economic Area (EEA) under the following names:
AT Femoston conti 0.5 mg/2.5 mg Filmtabletten
BE Femoston Low 0.5 mg/2.5 mg filmomhulde tabletten
CZ Femoston mini 0.5 mg/2.5 mg
DE Femoston mini 0.5 mg/2.5 mg Filmtablette
DK Femoston Conti
EE Femoston conti 0.5 mg/2.5 mg
ES Femoston 0.5mg/2.5mg comprimidos recubiertos con película
FI Femoston conti 0.5/2.5 tabletti, kalvopäällysteinen
FR Climaston 0.5mg/2.5 mg, comprimé pelliculé
IE Femoston-conti 0.5 mg/2.5 mg film-coated tablets
IT Femoston 0.5 mg/2.5 mg compresse rivestite con film
LT Femoston conti 0.5 mg/2.5 mg plėvele dengtos tabletės
LU Femoston Low 0.5 mg/2.5 mg comprimés pelliculés
LV Femoston conti 0.5 mg/2.5 mg apvalkotās tabletes
MT Femoston-conti 0.5 mg/2.5 mg film-coated tablets
NL Femoston continu 0.5 mg/2.5 mg filmomhulde tabletten
NO Femostonconti
PL Femoston mini
PT Femoston, 2.5 mg + 0.5 mg, comprimido revestido
SE Femostonconti
SI Femphascon conti 0.5 mg/2.5 mg filmsko obložene tablete
UK
(Ireland
Northern) Femoston-conti 0.5 mg/2.5 mg, film-coated tablets