Femoston conti

Leaflet accompanying the packaging: patient information

Femoston conti

1 mg + 5 mg, coated tablets
Estradiol + Dydrogesterone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Femoston conti is a medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen called estradiol and a progestogen called dydrogesterone.
Femoston conti is indicated for use in postmenopausal women, at least 12 months after their last menstrual period.

Femoston conti is used for the following purpose:

Treatment of postmenopausal symptoms

During menopause, the amount of estrogen produced in a woman's body decreases. This can cause symptoms such as hot flashes in the face, neck, and chest. Femoston conti reduces these symptoms in postmenopausal women. Femoston conti is prescribed if these symptoms significantly disrupt daily life.

Prevention of osteoporosis

In some postmenopausal women, bone fragility (osteoporosis) may occur. All available treatment options should be discussed with your doctor.
In cases of increased risk of fractures due to osteoporosis and when the patient cannot take other medications, Femoston conti may be used to prevent osteoporosis in postmenopausal women.

2. Important information before taking Femoston conti

Medical history and regular check-ups

HRT use involves risks that need to be considered when deciding to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or after ovarian surgery) is limited. In the case of premature menopause, the risk of HRT may be different. You should consult your doctor.
Before starting (or re-starting) HRT, your doctor will conduct a medical history of you and your family. Your doctor may decide to perform additional tests, including a breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston conti, you should visit your doctor for regular check-ups (at least once a year). During these check-ups, you should discuss the benefits and risks associated with continuing Femoston conti with your doctor.
You should have regular breast screening tests as recommended by your doctor.
DO NOT TAKE Femoston contiif you have or have had any of the following conditions or symptoms. If you are unsure about any of the following conditions or symptoms before taking Femoston conti, you should consult your doctor.

When not to take Femoston conti

• if breast cancer has been diagnosed, has occurred in the past, or is suspected by your doctor
• if you have or your doctor suspects you have a tumor that grows in response to estrogen, such as endometrial cancer (cancer of the lining of the uterus)
• if you have or your doctor suspects you have a tumor that grows in response to progestogens
• if you have or have ever been diagnosed with a meningioma (usually a benign brain tumor)
• if you have vaginal bleeding of unknown cause
• if you have untreated endometrial hyperplasia (thickening of the lining of the uterus)
• if you have or have had blood clots in the veins (thrombosis), such as deep vein thrombosis or pulmonary embolism
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if you have or have recently had a blood clot-related disease, such as a heart attack, stroke, or coronary artery disease
• if you have or have had liver disease, and your liver 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 conti (listed in section 6).

If any of the above conditions occur for the first time while taking Femoston conti, you should stop taking it immediately and consult your doctor.

Warnings and precautions

Before starting treatment, you should inform your doctor if you have ever had any of the following problems, as they may recur or worsen during Femoston conti treatment. If you have ever had any of the following problems, you should have more frequent medical check-ups:

• uterine fibroids
• endometriosis (growth of uterine lining tissue outside the uterus) or a history of endometrial hyperplasia
• blood clot risk factors (see "Blood clots in the veins (thrombosis)")
• increased risk of estrogen-dependent cancer (family history of breast cancer)
• high blood pressure
• liver disease, such as benign liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• systemic immune disease affecting multiple organs (systemic lupus erythematosus)
• epilepsy
• asthma
• otosclerosis (a condition affecting the eardrum and hearing)
• very high levels of triglycerides in the blood
• fluid retention due to heart or kidney problems
• hereditary or acquired angioedema.

You should stop taking Femoston conti and consult your doctor immediately

if you experience any of the following symptoms while taking HRT:

• any of the conditions listed in "When not to take Femoston conti"
• yellowing of the skin or whites of the eyes (jaundice), which may be a sign of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, along with difficulty breathing - these may be signs of angioedema
• significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine headaches that occur for the first time
• pregnancy
• symptoms of blood clots in the veins, such as painful swelling and redness of the legs, sudden chest pain, or difficulty breathing. See "Blood clots in the veins (thrombosis)" for more information.

Note:Femoston conti does not have a contraceptive effect. If it has been less than 12 months since your last menstrual period and you are under 50 years old, you may need to use additional contraception to prevent pregnancy. You should consult your doctor.

HRT and cancer

Endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer (cancer of the uterine lining) are more common in women taking HRT with estrogen alone. The progestogen in Femoston conti protects against this additional risk.

Irregular bleeding

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

• continues for more than 6 months after starting Femoston conti
• starts after 6 months of taking Femoston conti
• continues after stopping Femoston conti, you should consult your doctor as soon as possible.

Breast cancer

Data confirms that taking HRT, either estrogen alone or in combination with progestogen, increases the risk of breast cancer. The additional risk depends on how long you take HRT. This additional risk becomes apparent after 3 years of HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT lasted more than 5 years.
Comparison
In women aged 50-54 who do not take HRT, breast cancer is diagnosed in approximately 13-17 out of 1000 women over a 5-year period.
In women aged 50 who start 5-year estrogen-only HRT, the number of cases will be 16-17 per 1000 patients (i.e., 0-3 additional cases).
In women aged 50 who start 5-year combined estrogen-progestogen HRT, the number of cases will be 21 per 1000 patients (i.e., 4-8 additional cases).
In women aged 50-59 who do not take HRT, breast cancer is diagnosed in approximately 27 out of 1000 women over a 10-year period.
In women aged 50 who start 10-year estrogen-only HRT, the number of cases will be 34 per 1000 patients (i.e., 7 additional cases).
In women aged 50 who start 10-year combined estrogen-progestogen HRT, the number of cases will be 48 per 1000 patients (i.e., 21 additional cases).

• You should have regular breast exams and inform your doctor if you notice any changes, such as:
• indentation of the breast skin
• changes in the nipple area
• any visible or palpable lumps

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT with estrogen alone or in combination with progestogen is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not take HRT, ovarian cancer is diagnosed in approximately 2 out of 2000 women over a 5-year period.
In women who have taken HRT for 5 years, it occurs in approximately 3 out of 2000 women (i.e., about 1 additional case).

Effect of HRT on the heart and circulation

Blood clots in the veins (thrombosis)

The risk of blood clots in the veins is 1.3-3 times higher in women taking HRT than in those not taking it, especially during the first year of treatment.
Clot formation can have serious consequences - if they move to the lungs, they can cause chest pain, shortness of breath, fainting, or even death.
The risk of blood clots in the veins increases with age and if any of the following conditions occur. You should inform your doctor if any of the following apply to you:

• inability to walk for a long period due to major surgery, injury, or illness (see also section 3 "Planned surgery")
• severe obesity (BMI >30 kg/m)
• blood clotting disorders requiring long-term anticoagulant treatment
• any of your close relatives have had blood clots in the veins of the legs, lungs, or other organs
• you have been diagnosed with systemic lupus erythematosus
• you have been diagnosed with cancer.

Symptoms of blood clots, see "You should stop taking Femoston conti and consult your doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in the veins are expected to occur in approximately 4-7 out of 1000 women over a 5-year period.
In women aged 50-60 who take HRT for more than 5 years in combination with estrogen and progestogen, 9-12 cases occur per 1000 women (i.e., 5 additional cases).

Coronary artery disease (heart attack)

There is no evidence that HRT prevents heart attacks.
In women over 60 taking combined estrogen-progestogen HRT, there is a slightly increased risk of heart disease compared to 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
In women aged 50-60 who do not take HRT, stroke is expected to occur in approximately 8 out of 1000 women over a 5-year period.
In women aged 50-60 who take HRT for more than 5 years, 11 cases occur per 1000 women (i.e., 3 additional cases).

Meningioma

Taking Femoston conti is associated with the development of a usually benign brain tumor (meningioma). If a meningioma is diagnosed in you, your doctor will stop Femoston conti treatment (see "When not to take Femoston conti"). If you experience any symptoms such as vision disturbances (e.g., double vision 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, you should inform your doctor immediately.

Other conditions

HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start HRT at an age over 65. You should consult your doctor.

Children

Femoston conti is indicated only for postmenopausal women, at least 12 months after their last menstrual period.

Femoston conti and other medicines

Certain medicines may affect the action of Femoston conti. This may cause irregular bleeding. These include:

• medicines for epilepsy (such as phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (such as rifampicin, rifabutin)
• medicines for HIV (AIDS) (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal medicines containing St. John's Wort (Hypericum perforatum)
• HRT may affect the action of other medicines:
• the antiepileptic medicine lamotrigine, as it may increase the frequency of seizures
• the combined treatment regimen for hepatitis C virus (HCV) infection (e.g., ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and the treatment regimen with glecaprevir/pibrentasvir) may increase liver function test results in the blood (increased ALT enzyme activity) in women taking combined hormonal contraceptives containing ethinyl estradiol. Femoston conti contains estradiol instead of ethinyl estradiol. It is not known whether increased ALT enzyme activity may occur when taking Femoston conti with such a treatment regimen.

During Femoston conti treatment, high levels of the following medicines may occur in the blood:

• tacrolimus, cyclosporin - used after organ transplantation
• fentanyl - a pain reliever
• theophylline - used in asthma and other breathing problems.

Therefore, careful monitoring of the medicine's level and reduction of the dose of that medicine may be necessary for a period of time.
You should tell your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including those available without a prescription, herbal medicines, or other natural products (e.g., dietary supplements). Your doctor will provide you with appropriate guidance.

Blood tests

You should inform your doctor or laboratory staff that you are taking Femoston conti before any blood tests, as this medicine may affect the results of some 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, at least 12 months after their last menstrual period.

• If pregnancy is suspected, Femoston conti treatment should be stopped and your doctor consulted. Femoston conti is not indicated during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of Femoston conti on driving or using machines. Such an effect is unlikely.

Femoston conti contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking Femoston conti.

3. How to take Femoston conti

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

When to start taking Femoston conti

You should not start Femoston conti treatment before 12 months have passed since your last menstrual period.
Femoston conti treatment can be started on any day, if:

• you are not currently taking HRT
• you are switching from another HRT medicine to continuous combined HRT. This method involves taking a tablet or applying a patch that contains both estrogen and progestogen every day.

Femoston conti treatment can be started after completing a 28-day cycle, if:

• you are switching from a cyclic or sequential HRT regimen. This method involves taking a tablet or applying a patch that contains estrogen alone during the first part of the cycle, followed by a tablet or patch that contains both estrogen and progestogen for the next 14 days.

Taking Femoston conti

• Swallow the tablet with water.
• Tablets can be taken with or without food.
• You should try to take the tablet at the same time every day. This will help keep a constant amount of medicine in your body. It will also help you remember to take the tablet.
• You should take 1 tablet every day, without interruption between packs. The blister pack is marked with the days of the week to help you remember when to take the tablet.

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest necessary period to treat your symptoms. You should consult your doctor if you think the dose of Femoston conti is too strong or too weak.
• When taking Femoston conti to prevent osteoporosis, your doctor will adjust the dose individually according to your bone mass.
• You should take 1 salmon-colored tablet every day for 28 days.

Planned surgery

• In case of planned surgery, you should inform the surgeon that you are taking Femoston conti. It may be necessary to stop taking Femoston conti about 4-6 weeks before the planned surgery to reduce the risk of blood clots (see "Blood clots in the veins (thrombosis)"). You should ask your doctor when you can restart Femoston conti.

Taking more than the recommended dose of Femoston conti

If you (or someone else) take too many Femoston conti tablets, it is unlikely to cause harmful effects. You may experience nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or withdrawal bleeding.
No additional treatment is necessary, but if you are concerned, you should consult your doctor.

Missing a dose of Femoston conti

You should take the missed tablet as soon as possible. If more than 12 hours have passed since the time the dose was due, you should take the next tablet at the scheduled time without taking the missed tablet. You should not take a double dose to make up for the missed dose. It is likely that if you miss a dose, you may experience bleeding or spotting.

Stopping Femoston conti treatment

You should not stop taking Femoston conti without consulting your doctor.

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

4. Possible side effects

Like all medicines, Femoston conti can cause side effects, although not everybody gets them.
The following conditions have been reported more frequently in women taking HRT than in women not taking HRT:

• breast cancer
• endometrial hyperplasia or cancer (thickening or cancer of the uterine lining)
• ovarian cancer
• blood clots in the veins (venous thromboembolism)
• heart disease
• stroke
• possible memory loss, if HRT is started at an age over 65.

More information on these side effects can be found in section 2.
The following side effects may occur during Femoston conti treatment:

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

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

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

• vaginal candidiasis (yeast infection)
• depression, nervousness
• migraine. If you experience migraine headaches for the first time, you should stop taking Femoston conti and consult your doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (gas)
• skin allergic reactions (such as rash, severe itching, hives)
• bleeding disturbances, such as irregular bleeding or spotting, painful periods, heavy or light bleeding
• pelvic pain
• discharge
• feeling weak, tired, and unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain.

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

• uterine fibroids may increase in size
• allergic reactions, such as asthma or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• changes in libido
• blood clots in the veins, causing blockages in the legs or lungs (venous thromboembolism or pulmonary embolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or whites of the eyes

you should stop taking Femoston conti and consult your doctor immediately

• gallbladder disease
• breast swelling
• premenstrual syndrome
• weight loss.

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

• heart attack
• angioedema (swelling of the face, tongue, and/or throat, which can cause difficulty breathing)
• purpura (purple spots or patches on the skin).

Other side effects have been reported during HRT treatment, including Femoston conti, with unknown frequency:

• estrogen-dependent tumors, such as endometrial cancer (cancer of the uterine lining)
• growth of progestogen-dependent tumors (such as meningioma)
• a condition in which red blood cells are broken down (hemolytic anemia)
• an immune system disease affecting multiple organs (systemic lupus erythematosus)
• seizure frequency may increase (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, especially in women with high triglyceride levels in the blood
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy patches" (chloasma), painful red lumps on the skin (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• breast pain or lumps (fibrocystic breast changes)
• cervical erosion
• worsening of a rare blood disorder (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• changes in the cornea of the eye (corneal edema), intolerance to contact lenses
• increased levels of thyroid hormones.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Femoston conti

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Femoston conti contains

• The active substances of Femoston conti are estradiol (as estradiol hemihydrate) and dydrogesterone
• each tablet contains 1 mg of estradiol and 5 mg of dydrogesterone
• Other ingredients are: lactose monohydrate, hypromellose, cornstarch, 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 tablets are round, biconvex, and marked with "379" on one side. Each blister pack contains 28 tablets.
• The tablets are salmon-colored.
• The tablets are packaged in PVC/Al or PVC/PVDC/Al blisters.
• The pack contains 28 or 84 coated tablets.

Marketing authorization 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
To obtain more detailed information, you should contact the local representative of the marketing authorization holder at phone number: 22 307 71 66.

Date of last revision of the leaflet: