Femoston mini

Patient Information Leaflet

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What is Femoston mini and what is it used for
2. Important information before taking Femoston mini
3. How to take Femoston mini
4. Possible side effects
5. How to store Femoston mini
6. Contents of the pack and other information

1. What is Femoston mini and what is it 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 who have not had a menstrual period for at least 12 months.
Femoston mini is used to
Relieve postmenopausal symptoms
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 significantly impair 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 in treating premature menopause (due to ovarian dysfunction or surgery) is limited. The risks associated with HRT in premature menopause may differ. Consult your doctor.
Before first (or re-initiating) 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.
From the moment 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 jointly evaluate the benefits and risks of continuing treatment with Femoston mini.
Regular breast screening examinations should be performed 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 been diagnosed with, have had in the past, or are suspected of having breast cancer
• if you have been diagnosed with or are suspected of having an estrogen-dependent tumour, e.g. endometrial cancer (cancer of the lining of the uterus)
• if you have vaginal bleeding of unknown cause
• if you have untreated endometrial hyperplasia (excessive thickening of the lining of the uterus)
• if you currently have or have had in the past blood clots in the veins (thrombosis), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• if you have a blood clotting disorder with a tendency to thrombosis (such as protein C, protein S or antithrombin deficiency)
• if you currently have or have had in the past a disease caused by blood clots in the arteries, e.g. heart attack, 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 the rare inherited blood disorder – porphyria
• if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the tissue layer between the brain and skull).

If any of the above conditions occur for the first time during treatment with 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 in the past any of the following conditions, as they may worsen or recur during treatment. More frequent check-ups may be necessary in the following cases:

• presence of uterine fibroids
• presence of endometriosis or history of excessive endometrial thickening (endometrial hyperplasia)
• presence of a brain tumour
• increased risk of blood clots (see section “Blood clots in the veins (thrombosis)”)
• increased risk of estrogen-dependent cancer (e.g. family history of breast cancer in mother, sister or grandmother)
• high blood pressure
• liver diseases, 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 eardrum and hearing)
• very high levels of blood fats (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary or acquired angioedema.

Meningioma
Use of Femoston mini is associated with the development of usually benign tumours of the tissue layer between the brain and skull (meningioma). If meningioma is diagnosed in you, your doctor will discontinue treatment with Femoston mini (see section “When not to take Femoston mini”). If you notice any of the following symptoms, contact your doctor immediately:

• visual disturbances (e.g. double or blurred vision)
• hearing loss or ringing in the ears
• loss of smell
• worsening headaches
• memory loss
• seizures
• weakness in arms or legs.

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

• any of the conditions listed in the section “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, possibly with breathing difficulties, which may be symptoms of angioedema
• significant increase in blood pressure (symptoms include headache, fatigue, dizziness)
• new-onset headaches resembling migraines
• pregnancy
• symptoms of blood clots such as:
• painful swelling and redness in the legs
• sudden chest pain
• breathing difficulties.

For more information, see section “Blood clots in the veins (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. Consult your doctor.
HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and endometrial cancer
Using HRT containing only estrogens increases the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and endometrial cancer.
Femoston mini, which contains a progestagen, 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 the first 6 months of treatment
• appears after more than 6 months of taking Femoston mini
• does not stop after stopping Femoston mini, contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking hormone replacement therapy (HRT), either as estrogen-progestagen combination or estrogen-only, increases the risk of breast cancer. The additional risk depends on how long HRT is used. This additional risk becomes apparent after 3 years of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT lasted more than 5 years.
Comparison
Among women aged 50 to 54 who do not use HRT, breast cancer will be diagnosed in an average of 13 to 17 out of 1,000 women over 5 years.
Among women aged 50 who start a 5-year course of estrogen-only HRT, the number of cases will be 16–17 per 1,000 women (i.e. 0 to 3 additional cases).
Among women aged 50 who start a 5-year course of estrogen-progestagen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 who do not use HRT, breast cancer will be diagnosed in an average of 27 out of 1,000 women over 10 years.
Among women aged 50 who start a 10-year course of estrogen-only HRT, the number of cases will be 34 per 1,000 women (i.e. 7 additional cases).
Among women aged 50 who start a 10-year course of estrogen-progestagen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).
Regularly examine your breasts. 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 about your use of HRT during screening mammography, as this product may increase breast density and affect the mammogram result. Increased breast density may make it harder to detect all lumps on mammography.
Ovarian cancer
Ovarian cancer is rare – significantly less common than breast cancer. Use of HRT containing only estrogens or combined estrogen-progestagen therapy is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 women over 5 years.
Among women who have used HRT for 5 years, it will occur in about 3 out of 2,000 women (i.e. about 1 additional case).
Effect of HRT on the heart and circulatory system
Blood clots in the veins (thrombosis)
The risk of venous blood clots 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 blood clots increases with age and if any of the following apply to you. Contact your doctor if any of the following situations apply to you:

• 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 the 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”.
Comparison
Among women aged 50 to 59 who do not use HRT, venous blood clots are estimated to occur in 4 to 7 out of 1,000 women over 5 years.
Among women aged 50 to 59 who use estrogen-progestagen HRT for more than 5 years, venous blood clots are estimated to occur in 9 to 12 out of 1,000 women (i.e. 5 additional cases).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. In women over 60 years of age using estrogen-progestagen HRT, there is a slightly higher tendency to develop heart disease compared to women not using HRT.
Stroke
The risk of stroke is about 1.5 times higher in women using HRT compared to non-users. The number of additional stroke cases increases with age.
Comparison
Among women aged 50 to 59 not using HRT, stroke is estimated to occur in an average of 8 out of 1,000 women over 5 years. Among women aged 50 to 59 using HRT for more than 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 you have any of the following conditions to ensure closer monitoring:

• heart disease
• kidney dysfunction
• elevated levels of certain blood fats (hypertriglyceridemia).

Children and adolescents
Femoston mini is not indicated for use in children and adolescents.
Femoston mini and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may alter the effect of Femoston mini, leading to irregular bleeding or spotting. These include:

• medicines for epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (e.g. rifampicin, rifabutin)
• medicines used in HIV infection (AIDS) (e.g. 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, possibly increasing seizure frequency
• combination therapy 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 parameters in blood tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston mini contains estradiol instead of ethinylestradiol. It is unknown whether elevated AlAT liver enzyme activity may occur when Femoston mini is used concurrently with such combination HCV treatments.

Inform 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 provide appropriate advice.
Laboratory tests
Inform your doctor or medical staff that you are taking Femoston mini before having blood tests, as it may affect the results of certain tests.
Femoston mini with food and drink
Femoston mini can be taken independently of meals.
Pregnancy and breastfeeding
Femoston mini is indicated only for postmenopausal women.
If you become pregnant:

• stop taking Femoston mini and contact your doctor immediately.

Femoston mini is not indicated for use in breastfeeding women.
Driving and operating machinery
No studies on the effect 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 as directed by a doctor. If in doubt, consult a doctor or
pharmacist.
When to start using Femoston mini

Femoston mini should not be used until 12 months after the last menstrual period.

Femoston mini treatment 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. one in which a tablet or transdermal system containing both oestrogen and progestogen is taken daily.

Femoston mini treatment may be started after completing a 28-day cycle if:

• the patient is switching from a cyclic or sequential HRT regimen, i.e. one in which an oestrogen-only tablet or transdermal system is used during the first part of the cycle, followed by 14 days of taking a tablet or applying a patch containing both oestrogen and progestogen.

Taking Femoston mini

• Swallow the tablet with water.
• Tablets may be taken regardless 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 assists in remembering to take the tablet daily.
• Take one tablet every day without interruption between packs. Days of the week are marked on the blister to help remember when to take each tablet.

See "Translation of symbols for days of the week located next to each tablet on the immediate packaging" at the end of this leaflet.
Dosage

• The doctor will prescribe the lowest effective dose needed to treat symptoms for the shortest necessary duration. Consult a doctor if the dose seems too strong or too weak.
• Take one yellow tablet daily for 28 days.

Planned surgery
If undergoing planned surgery, inform the surgeon about taking Femoston mini. It may be necessary to stop taking Femoston mini approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2 "Venous thromboembolism (blood clots)"). Consult a doctor about when to restart Femoston mini.

Accidental overdose of Femoston mini
If a patient (or another person) takes more tablets than recommended, it is unlikely to cause harmful effects. 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 required, but if in doubt, consult a doctor.

Missed dose of 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 missed dose. Breakthrough bleeding or spotting may occur if a dose is missed.

Stopping Femoston mini
Do not stop taking Femoston mini without consulting a doctor.
If there are any further doubts about using this medicine, consult a 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 disease
• stroke
• memory loss, if HRT is started at age over 65.

For further information on 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 patients):

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

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

• vaginal fungal infection (vaginal infection with Candida albicans)
• depression, nervousness
• migraine. If migraine headaches occur for the first time, treatment with Femoston mini must be discontinued and you should contact your doctor immediately
• dizziness
• nausea, vomiting, flatulence (wind)
• 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 patients):

• symptoms resembling cystitis
• uterine fibroid enlargement
• 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 must be discontinued and you should contact your doctor immediately
• gallbladder disease
• breast swelling (breast oedema)
• premenstrual syndrome
• weight loss.

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

• disease caused by breakdown of red blood cells (haemolytic anaemia)*
• meningioma (brain tumour)*
• changes in the cornea of the eye (corneal maceration)*, contact lens intolerance*
• heart attack
• stroke*
• swelling of tissues in the face and neck area. May cause breathing difficulties (angioedema)
• purplish skin spots and patches (vasculitic purpura)
• painful red skin nodules (erythema nodosum)*, skin pigmentation, especially on the face and neck, known as "chloasma"*
• 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 oestrogen-dependent, such as endometrial cancer, ovarian cancer (further information see section 2)
• increase in size of tumours which may be progestogen-dependent (such as meningioma)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• probable dementia (memory loss)
• worsening of epileptic seizures (epilepsy)
• involuntary muscle spasms (chorea)
• blood clots in arterial vessels (arterial thrombosis)
• pancreatitis, in women with previously existing increased levels of certain fats in the blood (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 the rare blood 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, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for 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 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 instructions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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: monohydrate lactose, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate. Coating: polyethylene glycol, 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 in the form of film-coated tablets. The tablets are round, biconvex, with an imprint
"379" on one side. Each blister contains 28 tablets. The tablets are yellow in colour.
The tablets are packed in PVC/Aluminium blisters in a cardboard carton.
The pack contains 28 film-coated tablets.
A cardboard pouch is included in the package, in which the blister should be placed.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in France, the country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin, D01YE64
Ireland
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in France, the country of export: 3400949256402
Parallel Import Licence Number: 438/24
This medicine is authorised for sale in the European Economic Area countries under the following names:

Translation of the weekday symbols found on each tablet in the immediate packaging:
LU – Monday
MA – Tuesday
ME – Wednesday
JE – Thursday
VE – Friday
SA – Saturday
DI – Sunday.