Femoston conti

Package leaflet: Information for the patient

Femoston conti
1 mg + 5 mg, coated tablets
Estradiol + Dydrogesterone
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of contents of the leaflet

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

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

Femoston conti 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 conti is indicated for use in postmenopausal women who have been without menstruation for at least 12 months.

Femoston conti is used for the following purposes:

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 conti reduces these symptoms in postmenopausal women. Femoston conti is prescribed when these symptoms significantly interfere with daily life.

Prevention of osteoporosis
Some postmenopausal women may develop brittle bones (osteoporosis). All available treatment options should be discussed with the doctor.
Femoston conti may be used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures due to osteoporosis and for whom other medicinal treatments are not suitable.

2. Important information before using Femoston conti

Medical history and regular check-ups
Hormone replacement therapy (HRT) carries risks that should be considered when deciding whether to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or surgical removal of ovaries) is limited. In cases of premature menopause, the risks associated with HRT may differ. Consult your doctor.
Before starting (or restarting) HRT, your doctor will take a detailed medical history, including family history. The doctor may decide to perform additional tests, including breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston conti, you should attend 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 conti.
Regular breast screening should be performed according to your doctor's recommendations.

DO NOT take Femoston conti if any of the following conditions are present or have occurred in the past. If you are uncertain about any of the conditions listed below, consult your doctor before taking Femoston conti.

When not to take Femoston conti

• 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 tumor whose growth is dependent on estrogens, e.g. endometrial cancer (endometrium cancer)
• if you currently have or your doctor suspects a tumor whose growth is dependent on progestagens
• if you have meningioma or have ever been diagnosed with meningioma (usually a benign tumor of the membrane between the brain and skull)
• if you have vaginal bleeding of unknown cause
• if you have untreated abnormal thickening of the endometrium (endometrial hyperplasia)
• if you currently have or have had blood clots in the veins (thrombosis), e.g. in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• if you have a blood clotting disorder (such as protein C 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 tests have not returned to normal
• if you have a rare inherited blood disorder called porphyria
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of Femoston conti (listed in section 6)

If any of the above conditions occur for the first time while taking Femoston conti, 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 conti. If you have ever had any of the conditions listed below, you should have more frequent medical check-ups:

• uterine fibroids
• presence of endometrial tissue outside the uterus (endometriosis) or history of abnormal endometrial thickening (endometrial hyperplasia)
• risk factors for venous blood clots (see "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, such as benign liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• systemic autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• disease affecting the inner ear and hearing (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary or acquired angioedema

Stop taking Femoston conti and contact your doctor immediately if you experience any of the following symptoms while on HRT:

• any of the conditions listed under "When not to take Femoston conti"
• yellowing of the skin or whites of the eyes (jaundice) – may indicate liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, especially if combined with breathing difficulties – may indicate angioedema
• significantly increased blood pressure (symptoms may include: headache, 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
  • difficulty breathing
    See "Blood clots in the veins (thrombosis)" for more information.

Note: Femoston conti 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, additional contraception may be needed to prevent pregnancy. Consult your doctor.

HRT and cancer

Abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer
Using HRT containing estrogens alone increases the risk of abnormal thickening of the endometrium (endometrial hyperplasia) and endometrial cancer. The progestagen component in Femoston conti protects against this additional risk.

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

• continues beyond the first 6 months of treatment with Femoston conti
• starts after 6 months of treatment with Femoston conti
• continues after stopping Femoston conti
  you should contact your doctor as soon as possible.

Breast cancer
Data confirm that using hormone replacement therapy (HRT), either estrogen-progestagen combination or estrogen alone, increases the risk of developing 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 was used for 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 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-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 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-progestagen HRT, the number of cases will be 48 per 1,000 women (i.e. 21 additional cases).

• You should regularly examine your breasts and inform your doctor if you notice any changes, such as:
  • skin indentation
  • changes around the nipple
  • any visible or palpable lumps

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. Using HRT containing only estrogens or a combination of estrogens and progestagens 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).

Effects of HRT on the heart and circulatory system

Blood clots in veins (thrombosis)
The risk of venous blood clots is 1.3 to 3 times higher in women using HRT than in those not using it, especially during the first year of treatment.
Blood clots can have serious consequences – if they travel to the lungs, they may cause chest pain, shortness of breath, fainting, or even death.
The risk of venous blood clots increases with age and if any of the following apply. Inform your doctor if any of the following situations apply to you:

• 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 legs, lungs, or other organs in close relatives
• diagnosis of systemic lupus erythematosus
• diagnosis of cancer

For symptoms of blood clots, see "Stop taking Femoston conti and contact your doctor immediately".

Comparative data
Among women aged 50–60 who do not use HRT, venous blood clots are expected in 4 to 7 out of 1,000 women over 5 years.
Among women aged 50–60 who use estrogen-progestagen 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.
Women over 60 years of age using combined estrogen-progestagen HRT have a slightly increased risk of heart disease compared to women not using HRT.

Stroke
The risk of stroke is 1.5 times higher in women using HRT than in those not using it.
The number of additional stroke cases due to HRT use increases with age.

Comparative data
Among women aged 50–60 who do not use HRT, stroke is expected in an average of 8 out of 1,000 women over 5 years. Among women aged 50–60 who use HRT for more than 5 years, there will be 11 cases per 1,000 women (i.e. 3 additional cases).

Meningioma
Use of Femoston conti is associated with the development of usually benign tumors of the membrane between the brain and skull (meningioma). If meningioma is diagnosed, your doctor will discontinue treatment with Femoston conti (see section "When not to take Femoston conti"). If you notice any symptoms such as vision disturbances (e.g. double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, or weakness in arms or legs, inform your doctor immediately.

Other conditions
HRT does not prevent memory loss. Evidence suggests an increased risk of memory loss in women who start HRT after age 65. Consult your doctor.

Children
Femoston conti is indicated only for postmenopausal women in whom at least 12 months have passed since the last menstrual period.

Femoston conti and other medicines
Some medicines may affect the action of Femoston conti, which may lead to irregular bleeding. The following medicines may reduce the effectiveness of Femoston conti, causing bleeding or spotting:

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

HRT may affect the action of other medicines:

• the antiepileptic drug lamotrigine, which may increase seizure frequency
• combination treatment regimens for hepatitis C virus (HCV) using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir may increase liver function parameters in blood tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Femoston contains estradiol instead of ethinylestradiol. It is unknown whether elevated AlAT liver enzyme activity may occur when Femoston is used concurrently with such HCV combination therapies.

During treatment with Femoston conti, dangerously high blood levels of the following drugs may occur:

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

Therefore, careful monitoring of drug levels and possible dose reduction may be necessary for a period of time.

Inform your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including over-the-counter medicines, herbal remedies, or other natural health products (e.g. dietary supplements). Your doctor will provide appropriate advice.

Blood tests
Inform your doctor or laboratory staff that you are taking Femoston conti before any blood test, as this medicine may affect the results of certain laboratory tests.

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

Pregnancy and breastfeeding
Femoston conti is indicated only for postmenopausal women in whom at least 12 months have passed since the last menstrual period.

• If pregnancy occurs, stop taking Femoston conti and contact your doctor. Femoston conti is not indicated during breastfeeding.

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

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

3. How to use Femoston conti

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
When to start taking Femoston conti
Do not start treatment with Femoston conti until at least 12 months have passed since the last menstrual period.

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

• the patient is not currently using hormone replacement therapy (HRT), or
• switching from another HRT product administered using a "continuous combined" regimen. This method involves taking a tablet or applying a patch containing both estrogen and progestogen every day.

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

• the patient is switching from HRT administered using a "cyclical" or "sequential" regimen. This method involves taking a tablet or applying a patch containing estrogen during the first part of the cycle, followed by a tablet or patch containing both estrogen and progestogen for the next 14 days.

Taking Femoston conti

• 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 helps you remember to take it.
• Take one tablet every day without interruption between packs. The blister pack is marked with days of the week to help you remember when to take your tablet.

Dosage

• Your doctor will choose the lowest effective dose for the shortest duration necessary to treat your symptoms. Consult your doctor if you feel the dose of Femoston conti is too strong or too weak.
• If Femoston conti is being taken to prevent osteoporosis, your doctor will adjust the dose according to your individual needs, based on your bone mass.
• Take one salmon-coloured tablet daily for 28 days.

Planned surgery

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

Taking more Femoston conti than prescribed
If you (or someone else) take too many Femoston conti tablets, it is unlikely to cause serious harm. Symptoms may include nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/fatigue, or withdrawal bleeding. Additional treatment is not usually necessary, but consult a doctor if you have any concerns.

Missed dose of Femoston conti
Take the missed tablet as soon as possible. If more than 12 hours have passed since the dose was due, take the next tablet at the usual time. Do not take the missed tablet and do not take a double dose to make up for a missed tablet. Bleeding or spotting may occur if a dose is missed.

Stopping Femoston conti
Do not stop taking Femoston conti without first consulting your doctor.

• If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• breast cancer
• abnormal thickening or cancer of the lining of the womb (endometrial hyperplasia or cancer of the endometrium)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolic disease)
• 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.
The following adverse effects may occur during treatment with Femoston conti:
Very common (may affect more than 1 in 10 women):

• headaches
• abdominal pain
• back pain
• tenderness or pain in the breasts.

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 conti 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 the ankles, feet, or fingers (peripheral oedema)
• weight gain.

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

• fibroid tumours in the pelvis may grow
• hypersensitivity reactions, such as breathing difficulties (allergic asthma) or other systemic reactions such as nausea, vomiting, diarrhoea, or hypotension
• change in libido
• blood clots causing blockage in the 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 conti 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 1,000 women):

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

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

• benign or malignant estrogen-dependent tumours, such as cancer of the lining of the womb (cancer of the endometrium), ovarian cancer (for more information see section 2)
• increase in size of progestagen-dependent tumours (such as meningioma)
• disease involving destruction of red blood cells (haemolytic anaemia)
• autoimmune disease affecting multiple organs (systemic lupus erythematosus)
• worsening of epileptic seizures (epilepsy)
• involuntary muscle spasms (chorea)
• blood clots in arteries (arterial thrombosis)
• pancreatitis in women with previously existing high levels of certain fats in the blood (hypertriglyceridaemia)
• various skin disorders: skin discolouration, especially on the face and neck known as "pregnancy mask" (chloasma), painful red skin nodules (erythema nodosum), rash in the form of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• painful/lumpy breasts (fibrocystic changes of the breast)
• cervical erosion
• worsening of symptoms of a rare disease affecting blood pigments (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 or pharmacist. 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Femoston conti

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 after: Expiry
date. 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. This will help protect the environment.

6. Contents of the pack and other information

What Femoston conti contains

• The active substances are estradiol (in the form of estradiol hemihydrate) and dydrogesterone
  • each tablet contains 1 mg of estradiol and 5 mg of dydrogesterone
• Other ingredients are: lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Coating: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), hypromellose, Macrogol 400.

What Femoston conti looks like and contents of the pack

• The coated tablets are round, biconvex, with "379" embossed on one side. Each blister contains 28 tablets.
• The tablets are salmon-coloured.
• The tablets are packed in blisters made of PVC/Al or PVC/PVDC/Al foil.
• The pack contains 28 or 84 coated tablets.

Marketing Authorisation Holder
Theramex Ireland Limited
3rd Floor, Kilmore House
Spencer Dock, Park Lane
Dublin 1, D01 YE64
Ireland
Manufacturer
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst, Netherlands
For further information, please contact the local representative of the marketing authorisation holder at the following telephone number: +48 22 307 71 66.