Femoston mite: detailed information

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Femoston mite (Climaston 1mg/10 mg)
1 mg (white), 1 mg + 10 mg (grey), coated tablets
Estradiol, Estradiol + Dydrogesterone
Femoston mite and Climaston 1mg/10 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, ask 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 as yours.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

What Femoston mite is and what it is used for
What you need to know before taking Femoston mite
How to take Femoston mite
Possible side effects
How to store Femoston mite
Contents of the pack and other information

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

Femoston mite is a medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones: an oestrogen called estradiol and a progestogen called dydrogesterone.
Femoston mite is indicated for use in women who have symptoms of female sex hormone (oestrogen) deficiency and who have been postmenopausal for at least 6 months.

What it is used for
Femoston mite is indicated for:
Treatment of postmenopausal symptoms
During menopause, the amount of oestrogen produced by a woman's body decreases. This may lead to symptoms such as hot flushes affecting the face, neck, and chest. Femoston mite reduces these symptoms in postmenopausal women. Femoston mite is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
Some postmenopausal women may develop brittle bones (osteoporosis). Please discuss all available treatment options with your doctor.
Femoston mite may be used for the prevention of osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and who cannot take other medications.

2. Important information before using Femoston mite

Medical history and regular check-ups
HRT carries risks that should be considered when deciding whether to start or continue treatment.
Experience with treating women with premature menopause (due to ovarian dysfunction or after surgical removal of the ovaries) is limited. The risks associated with HRT in cases of premature menopause may differ. Consult your doctor.
Before starting (or re-introducing) HRT, your doctor will take a detailed medical history, including family history. Your doctor may decide to perform additional tests, including breast examination and/or gynaecological examination, if considered necessary.
Once you start taking Femoston mite, you should have regular check-ups with your doctor (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing treatment with Femoston mite.
You should undergo regular breast screening according to your doctor's recommendations.
DO NOT take Femoston mite if any of the following symptoms or medical conditions are present or have occurred in the past. If you are uncertain about any of the conditions listed below, you should consult your doctor before taking Femoston mite.
When not to take Femoston mite

if you have been diagnosed with, have had in the past, or your doctor suspects breast cancer
if you currently have or your doctor suspects a tumour whose growth is dependent on estrogens, e.g. endometrial cancer (endometrium cancer)
if you currently have or your doctor suspects a tumour whose growth is dependent on progestogens
if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the membrane between the brain and skull)
if you have vaginal bleeding of unknown cause
if you have untreated abnormal thickening of the lining of the womb (endometrial hyperplasia)
if you currently have or have had blood clots in the veins (venous thromboembolism), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
if you have a blood clotting disorder (such as protein C deficiency, protein S deficiency, or antithrombin deficiency)
if you currently have or have recently had an arterial disease caused by blood clots, e.g. heart attack, stroke, or coronary heart disease
if you have liver disease and liver function test results have not returned to normal
if you have a rare inherited blood disorder called porphyria
if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of Femoston mite (listed in section 6).

If any of the above conditions occur for the first time while taking Femoston mite, stop taking the medicine immediately and consult your doctor.
Warnings and precautions
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Femoston mite. If any of the following conditions have occurred in the past, more frequent medical check-ups are recommended:

uterine fibroids
presence of endometrial tissue outside the uterus (endometriosis) or history of abnormal thickening of the endometrium (endometrial hyperplasia)
risk factors for venous thromboembolism (see “Blood clots in the veins (thromboembolism)”)
increased risk of estrogen-dependent cancer (e.g. family history of breast cancer in mother, sister, or grandmother)
high blood pressure
liver diseases, such as benign liver tumours
diabetes
gallstones
migraine or severe headaches
an autoimmune disease affecting multiple organs (systemic lupus erythematosus)
epilepsy
asthma
a disease affecting the middle ear and causing hearing loss (otosclerosis)
very high levels of fats in the blood (triglycerides)
fluid retention due to heart or kidney disorders
hereditary or acquired angioedema.

You should stop taking Femoston mite and contact your doctor immediately if you experience any of the following symptoms while taking HRT:

any of the conditions listed under “When not to take Femoston mite”
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, combined with breathing difficulties – these may be signs of angioedema
a significant increase in blood pressure (symptoms may include: headaches, fatigue, dizziness)
new-onset migraine headaches
pregnancy
symptoms of blood clots in blood vessels, such as: painful swelling and redness in the legs, sudden chest pain, breathing difficulties. See more information under “Blood clots in the veins (thromboembolism)”.

Note: Femoston mite does not have a contraceptive effect. 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 additional contraception to prevent pregnancy. Consult your doctor.
HRT and cancer
Abnormal thickening of the lining of the womb (endometrial hyperplasia) and endometrial cancer
Taking HRT with estrogens alone increases the risk of abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer. The progestogen contained in Femoston mite protects against this additional risk.
Unexpected bleeding
While taking Femoston mite, you will experience monthly bleeding (so-called withdrawal bleeding). However, if unexpected bleeding or spotting (light bleeding) occurs in addition to the monthly bleeding, and:

persists beyond the first 6 months of treatment
begins after 6 months of taking Femoston mite
continues after stopping Femoston mite
you should contact your doctor as soon as possible.

Breast cancer
Evidence confirms that taking hormone replacement therapy (HRT), either as a combination of estrogen and progestogen or as estrogen alone, increases the risk of developing breast cancer. The additional risk depends on how long you take HRT. This additional risk becomes apparent after 3 years of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT was taken for more than 5 years.
Comparison
Among women aged 50 to 54 who do not take HRT, breast cancer will be diagnosed in an average of 13 to 17 out of 1,000 women over a 5-year period.
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-progestogen HRT, the number of cases will be 21 per 1,000 women (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 who do not take HRT, breast cancer will be diagnosed in an average of 27 out of 1,000 women over a 10-year period.
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-progestogen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).
You should regularly examine your breasts. Contact your doctor if you notice any changes such as:

dimpling of the breast skin
changes around the nipple
any visible or palpable lumps

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. Taking HRT containing only estrogens or a combination of estrogens and progestogens is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not take HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 women over a 5-year period. Among women who have taken HRT for 5 years, it will occur in about 3 out of 2,000 women (i.e. about 1 additional case).
Effects of HRT on the heart and circulation
Blood clots in the veins (thromboembolism)
The risk of venous blood clots is 1.3 to 3 times higher in women taking HRT than in those not taking it, especially during the first year of treatment.
Blood clots can have serious consequences. If they travel to the lungs, they may cause chest pain, shortness of breath, fainting, or even death.
The risk of venous thromboembolism increases with age and if any of the following conditions apply to you. Inform your doctor if you have any of the following:

inability to walk for prolonged periods due to major surgery, injury, or illness (see also section 3 “Planned surgery”)
significant overweight (BMI >30 kg/m²)
blood clotting disorders requiring long-term anticoagulant therapy
history of venous blood clots in the legs, lungs, or other organs in any close relatives
systemic lupus erythematosus
cancer.

Symptoms of blood clots are listed under “Stop taking Femoston mite and contact your doctor immediately”.
Comparative data
Among women aged 50–60 who do not take HRT, venous blood clots are expected to occur in an average of 4 to 7 out of 1,000 over 5 years.
Among women aged 50–60 who take combined estrogen-progestogen HRT for more than 5 years, there will be 9 to 12 cases per 1,000 women (i.e. 5 additional cases).
Coronary heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. In women over 60 who take combined estrogen-progestogen HRT, the risk of heart disease is significantly higher than in women not taking HRT.
Stroke
The risk of stroke is 1.5 times higher in women taking HRT than in those not taking it. The number of additional stroke cases due to HRT increases with age.
Comparative data
Among women aged 50–60 who do not take HRT, stroke is expected to occur in an average of 8 out of 1,000 women over 5 years. Among women aged 50–60 who take HRT for more than 5 years, there will be 11 cases per 1,000 women (i.e. 3 additional cases).
Meningioma
Taking Femoston mite is associated with the development of a usually benign tumour of the membrane between the brain and skull (meningioma). If meningioma is diagnosed, your doctor will stop treatment with Femoston mite (see section “When not to take Femoston mite”). If you notice any symptoms such as vision disturbances (e.g. double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in the arms or legs, inform your doctor immediately.
Other conditions
HRT does not prevent memory loss. Evidence suggests an increased risk of memory loss in women who start HRT after the age of 65. Consult your doctor.
Children
Femoston mite is indicated only for women with symptoms of estrogen deficiency who have had their last menstrual period at least 6 months ago.
Femoston mite and other medicines
Some medicines may affect the action of Femoston mite, which may lead to irregular bleeding. These include:

The following medicines may reduce the effectiveness of Femoston mite, potentially causing bleeding or spotting:

antiepileptic drugs (epilepsy) (e.g. phenobarbital, carbamazepine, phenytoin)
tuberculosis medications (e.g. rifampicin, rifabutin)
HIV (AIDS) treatments (e.g. nevirapine, efavirenz, ritonavir, nelfinavir)
herbal remedies containing St. John’s wort (Hypericum perforatum)

HRT may affect the action of other medicines:

the antiepileptic drug lamotrigine, which may increase seizure frequency
combination treatment regimens for hepatitis C virus (HCV) infection using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section 4.4) may increase liver function parameters in blood tests (elevated liver enzyme AlAT activity) in women taking combined hormonal contraceptives containing ethinylestradiol. Femoston mite contains estradiol instead of ethinylestradiol. It is not known whether elevated AlAT enzyme activity may occur when Femoston mite is taken concurrently with such HCV combination therapies.
During treatment with Femoston mite, dangerously high blood levels of the following medicines may occur:
tacrolimus, cyclosporine – used, for example, after organ transplantation
fentanyl – a painkiller
theophylline – used for asthma and other breathing problems.

Therefore, careful monitoring of drug levels may be necessary for a period of time, and dose reduction of the affected medicine may be required.
Inform your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including over-the-counter medicines, herbal remedies, or other medicinal natural products (e.g. dietary supplements). Your doctor will provide appropriate advice.
Blood tests
Before a planned blood test, inform your doctor or laboratory staff that you are taking Femoston mite, as this medicine may affect the results of certain laboratory tests.
Femoston mite with food and drink
Femoston mite can be taken with or without food.
Pregnancy and breastfeeding
Femoston mite is indicated only for women with symptoms of estrogen deficiency who have had their last menstrual period at least 6 months ago.

If pregnancy is confirmed, stop taking Femoston mite and contact your doctor. Femoston mite is not indicated during breastfeeding.

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

This medicine should always be used as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
When to start taking Femoston mite

Do not start treatment with Femoston mite before 6 months have passed since the last natural menstrual period.

Treatment with Femoston mite may be started on any day if:

the patient is not currently using any hormone replacement therapy (HRT), or
the patient is switching from another HRT product administered using the "continuous combined" method. This method involves taking a tablet or applying a patch daily, containing both an estrogen and a progestagen.

Treatment with Femoston mite may be started immediately after completing a 28-day menstrual cycle if:

the patient is switching from HRT administered using the "cyclical" or "sequential" method. This method involves taking or applying an estrogen-only tablet or patch during the first part of the cycle, followed by 14 days of taking a tablet or applying a patch containing both estrogen and progestagen.

How to take Femoston mite

Swallow the tablet with water.
Tablets may be taken with or without food.
Try to take the tablet at the same time each day. This helps maintain a constant level of medicine in the body and also helps you remember to take your tablet.
Take one tablet every day without interruption between packs. The days of the week are marked on the blister pack to help you remember when to take each tablet (the translation of the weekday symbols located next to each tablet on the immediate packaging can be found at the end of the leaflet and on the sachet included in the package).

Dosage

Your doctor will prescribe the lowest effective dose for the shortest necessary duration to treat your symptoms. Consult your doctor if the dose seems too strong or too weak.
When using Femoston mite to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on your bone mass.
Take one white tablet daily for the first 14 days, followed by one grey tablet once daily for the next 14 days. The 28-day treatment schedule is indicated on the calendar provided in the packaging.

Planned surgery

If you are scheduled for surgery, inform your surgeon that you are taking Femoston mite. You may need to stop taking Femoston mite approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2 "Blood clots in veins (venous thromboembolism)"). Ask your doctor when you can resume taking Femoston mite.

Accidental overdose of Femoston mite

If you (or someone else) take more Femoston mite tablets than prescribed, it is unlikely to cause serious harm. Possible symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. Additional treatment is not usually necessary, but if in doubt, consult your doctor.

Missed dose of Femoston mite

Take the missed tablet as soon as possible. If more than 12 hours have passed since the tablet should have been taken, take the next tablet at the usual time—do not take the missed tablet. Do not take a double dose to make up for a missed dose. Breakthrough bleeding or spotting may occur if a dose is missed.

Stopping Femoston mite

Do not stop taking Femoston mite without consulting your doctor.

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

4. Possible adverse effects

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

breast cancer
abnormal growth or cancer of the womb lining (endometrial hyperplasia or cancer of the endometrium)
ovarian cancer
blood clots in the veins of the legs or lungs (venous thromboembolic disease, pulmonary embolism)
heart disease
stroke
possible memory loss if HRT is started after the age of 65.

For more information on the above adverse effects, see section 2.
During treatment with Femoston mite, the following adverse effects may occur:
Very common (may affect more than 1 in 10 women):

headaches
abdominal pain
back pain
breast tenderness or pain.

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

vaginal thrush (a fungal infection of the vagina caused by Candida albicans)
depression, nervousness
migraine. If migraine-type headaches occur for the first time, treatment with Femoston mite should be discontinued and you should contact your doctor immediately
dizziness
nausea, vomiting, flatulence (wind)
allergic skin reactions (such as rash, severe itching, urticaria)
bleeding disorders, such as irregular bleeding or spotting, painful menstruation, excessive or scanty bleeding
pelvic pain
vaginal discharge
feeling of weakness, fatigue, and general malaise
swelling of ankles, feet or fingers (peripheral oedema)
weight gain.

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

growth of pelvic fibroids (myomas) may increase
hypersensitivity reactions, such as breathing difficulties (allergic asthma) or other systemic reactions such as nausea, vomiting, diarrhoea or low blood pressure
change in libido
blood clots causing blockages in blood vessels of the legs or lungs (venous thromboembolic disease or pulmonary embolism)
liver function disorders, sometimes with jaundice, feeling of weakness or general malaise, and abdominal pain. If yellowing of the skin or whites of the eyes occurs, treatment with Femoston mite should be stopped immediately and you should contact your doctor without delay
gallbladder disease
breast swelling (oedema)
premenstrual syndrome
weight loss.

Rare (may affect up to 1 in 1000 women):

heart attack
swelling of tissues in the face and neck causing breathing difficulties (angioedema). This may cause difficulty in breathing
purple spots and skin lesions (purpura).

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

benign or malignant estrogen-dependent tumours, such as cancer of the womb lining (cancer of the endometrium), ovarian cancer (for more information see section 2)
increased size of tumours that may be progestagen-dependent (such as meningioma)
condition involving breakdown of red blood cells (haemolytic anaemia)
autoimmune disease affecting multiple organs (systemic lupus erythematosus)
worsening of epileptic seizures (epilepsy)
involuntary muscle spasms (chorea)
arterial blood clots (arterial thrombosis)
pancreatitis, in women with previously existing high levels of certain fats in the blood (hypertriglyceridaemia)
various skin disorders: skin pigmentation, especially on the face and neck known as "melasma" (chloasma), painful red skin nodules (erythema nodosum), rash in the form of red rings or blisters (erythema multiforme)
leg cramps
urinary incontinence
painful/lumpy breasts (fibrocystic breast changes)
cervical erosion
worsening of symptoms of a rare disease affecting blood pigment (porphyria)
high levels of certain fats in the blood (hypertriglyceridaemia)
changes in the cornea of the eye (corneal oedema), inability to wear contact lenses (contact lens intolerance)
increased total concentration of thyroid hormones.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also 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 provide more information on the safety of the medicine.

5. How to store Femoston mite

Keep this medicine out of the 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 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 pack and other information

What Femoston mite contains

The active substances are: estradiol (as estradiol hemihydrate) and dydrogesterone
each white tablet contains 1 mg of estradiol
each grey tablet contains 1 mg of estradiol and 10 mg of dydrogesterone
Other ingredients: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Coating (white tablets): titanium dioxide (E 171), hypromellose, polyethylene glycol. Coating (grey tablets): titanium dioxide (E 171), iron(III) oxide (E 172), polyvinyl alcohol, polyethylene glycol, talc.

What Femoston mite looks like and contents of the pack

The coated tablets are round, biconvex, with "379" embossed on one side. Each blister contains 28 tablets.
Femoston mite contains tablets in two colours. Each pack contains 14 white tablets (for the first 14 days of the cycle) and 14 grey tablets (for the following 14 days of the cycle).
The tablets are packed in PVC/Al blisters in a cardboard box.
The pack contains 28 coated tablets.
A cardboard wallet is included with the pack, in which the blister should be placed.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in France, country of export:
Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock - D01 YE64 Dublin 1, Ireland
Manufacturer:
Abbott Biologicals B.V., Veerweg 12, 8121 AA Olst, The Netherlands
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in France, country of export: 34009 352 643 5 0
Parallel Import Authorisation Number: 394/25
Translation of weekday symbols printed next to each tablet in the immediate packaging:
LUN - Monday
MAR - Tuesday
MER - Wednesday
JEU - Thursday
VEN - Friday
SAM - Saturday
DIM - Sunday