1 mg + 1 mg / 10 mg  film-coated tablet 
estradiol + estradiol / dydrogesterone

1. What Femoston is and what it is used for

Femoston is a preparation used for hormone replacement therapy ( hormone replacement therapy, HRT ). It contains two female sex hormones: an estrogen called estradiol and a progestogen called dydrogesterone. The gemstone is used in women who have passed menopause (menopause) when at least 6 months have passed since their last natural menstruation.

What Femoston is used for

Relieve symptoms after menopause

During menopause, the amount of estrogen in a woman’s body decreases. It can cause problems such as a hot face, neck, and chest (hot flashes). Femostone relieves these symptoms after menopause. Femostone is only prescribed if your symptoms cause significant problems in daily life.

Prevent osteoporosis

After menopause, some women suffer from osteoporosis ( osteoporosis ). Discuss all possible treatment options with your doctor. If you have an increased risk of fractures (bone fractures) due to osteoporosis and other drugs are not suitable for you, you can use Femoston to prevent osteoporosis after menopause.

Estradiol/dydrogesterone contained in Femoston may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Femoston

Medical background and regular check-ups

The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.

Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or have undergone surgery). If you belong to that group, the risks of HRT may be different. Talk to your doctor.

Before starting treatment (or resuming treatment), your doctor will ask about your own and your family’s medical background. The doctor may perform a general medical examination. If necessary, it may include an examination of the breasts and/or a gynecological examination.

Once you have started treatment with Femoston, you should have regular medical check-ups (at least once a year). During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.

Get regular check-ups of your breasts according to your doctor’s recommendations.

DO NOT USE Femoston if any of the following apply to you. Talk to your doctor before using Femoston if you are unsure at any point.

Do not use Femoston

  • if you have or have had breast cancer or there is a suspicion that you may have it
  • if you have estrogen-dependent cancer, such as cancer of the uterine lining (endometrium), or if there is a suspicion of such cancer
  • if you have unexplained vaginal bleeding
  • if you have severe thickening of the uterine lining ( endometrial hyperplasia ) and are not treated for it
  • if you have or have had a blood clot in a friend ( thrombosis ) e.g. in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism )
  • if you have coagulation disorders (eg lack of protein C, protein, S, or antithrombin)
  • if you have or have recently had a disease caused by a blood clot in an artery, e.g. heart attack, stroke, or  angina
  • if you have or have had any liver disease and still have abnormal liver values
  • if you have a rare, inherited blood disorder called porphyria
  • if you are allergic to estradiol, dydrogesterone, or any of the other ingredients of this medicine (listed in section 6)

If any of the above affects you for the first time while you are taking Femoston, stop using Femoston and contact a doctor immediately.

Warnings and cautions

If you have or have had any of the following problems, talk to your doctor or pharmacist before using Femoston. They may recur or worsen during treatment with Femoston. Should this occur, have more frequent check-ups with a doctor.

  • muscle nodules ( fibroids ) in the uterus
  • growth of the uterine lining outside the uterus ( endometriosis ) or previous severe thickening of the uterine lining ( endometrial hyperplasia )
  • brain tumor (meningioma), which can be affected by progestogen levels
  • – increased risk of getting a blood clot (see “Blood clot in a vein ( thrombosis )”)
  • increased risk of developing estrogen-dependent cancer (eg mother, sister, grandmother, or grandmother who has had breast cancer)
  • high blood pressure
  • liver disease, e.g. benign liver tumor
  • diabetes
  • gallstone disease
  • migraine or severe headache
  • an autoimmune disease that affects many organs in the body (systemic lupus erythematosus, SLE )
  • epilepsy
  • asthma
  • a disease affecting the middle ear and hearing (otosclerosis)
  • very high blood fat levels ( hypertriglyceridemia )
  • fluid retention due to heart or kidney disease

Contact a doctor immediately and stop the treatment

If any of the following occur during treatment:

  • any of the things mentioned in the section “Do not use Femoston”
  • yellowing of the skin or whites of the eyes (jaundice); it may be a symptom of liver disease
  • blood pressure rises sharply (symptoms may include headache, fatigue, or dizziness)
  • you get migraine-like headaches for the first time
  • if you become pregnant
  • if you get symptoms of blood clots, such as: 
    painful swelling and redness of the legs 
    sudden chest pain 
    difficulty breathing

For more information, see “Blood clot in a vein ( thrombosis )”.

Note: Femoston is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.

HRT and cancer

Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer) 
Use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer). The progestogen in Femoston protects you against this increased risk.

Unexpected vaginal bleeding

You will have bleeding once a month (a so-called dropout bleeding) when you take Femoston. However, if you experience unexpected bleeding or splashing in addition to your monthly bleeding, such as:

  • lasts longer than 6 months
  • starts after you have been using Femoston for over 6 months
  • continues after you stop using Femoston.

you should see a doctor as soon as possible.

Breast cancer

Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.

Comparison

Of 1,000 women aged 50 to 54 who do not take HRT, an average of 13 to 17 will be diagnosed with breast cancer over a 5-year period. In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1,000 users (ie 0-3 extra cases) will occur. In women who are 50 years old and start taking HRT with the estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (ie 4-8 extra cases). Among women aged 50–59 who do not use HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over a 10-year period. In women who are 50 years old and start taking HRT with the only estrogen in 10 years, 34 cases per 1,000 users (ie 7 extra cases) will occur. In women who are 50 years old and start taking HRT with the estrogen-progestogen for 10 years, 48 ​​cases per 1,000 users (ie 21 extra cases) will occur.

Check your breasts regularly. Contact a doctor if you notice changes such as:

  • indentations or pits in the skin
  • changes of the nipple
  • nodules you can see or feel.

Also, it is recommended that you participate in mammography screenings when they are offered to you. You must inform the nurse/healthcare professional performing the mammogram that you are using HRT, as the HRT treatment may increase the density of the breast tissue, which may affect the results of the mammogram. An increased density in the breasts can make it more difficult to detect lumps on the mammography images.

Ovarian cancer

Ovarian cancer is much rarer than breast cancer. Use of HRT with estrogen alone or combined estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 between the ages of 50 and 54 who do not take HRT for a 5-year period. For women who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (ie about 1 extra case).

How HRT affects the heart and blood circulation

A blood clot in a friend ( thrombosis )

The risk of blood clots in the veins is 1.3–3 times higher for women who take HRT than for those who do not, especially during the first year of treatment. Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, fainting, or even death. The risk of getting a blood clot in a vein increases with age and if any of the following applies to you. Tell your doctor if any of the following apply to you:

  • you cannot walk for a long time due to a major operation, injury or illness (see section 3, “If you need surgery”)
  • you are severely overweight ( BMI over 30 kg / m 2 )
  • you have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
  • if a close relative has had a blood clot in the bone, lung, or another organ
  • you have systemic lupus erythematosus ( SLE )
  • you have cancer.

The symptoms of a blood clot are described in the section “Contact a doctor immediately and stop the treatment”.

Comparison

Of women in their 50s who do not take HRT, an average of 4-7 out of 1,000 are expected to have a blood clot in a vein over a 5-year period. Of women in their 50s who take HRT with the estrogen-progestogen for more than 5 years, an average of 9-12 out of 1,000 users are expected to have a blood clot in a vein (ie 5 extra cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks. For women over the age of 60 who take HRT with the estrogen-progestogen, the risk of developing heart disease is slightly higher than for those who do not take HRT.

Stroke (apoplexy)

The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The number of cases of stroke due to the use of HRT increases with age.

Comparison

Of women in their 50s who do not take HRT  an average of 8 out of 1,000 are expected to have a stroke over a 5-year period. Of women in their 50s who take HRT for more than 5 years, an average of 11 out of 1,000 users is expected to have a stroke (ie 3 extra cases).

Other conditions

Using HRT does not prevent memory loss. The risk of memory loss is slightly higher in women who start using HRT after the age of 65. Consult your doctor.

Tell your doctor if you have or have had any of the following medical conditions as a closer follow-up is needed during treatment:

  • heart disease
  • renal impairment
  • higher than normal levels of certain blood fats ( hypertriglyceridemia ).

Children

Femoston is not intended for children.

Other drugs and Femoston

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines can affect the way Femoston works, which can lead to irregular bleeding. The following applies:

  • antiepileptic drugs (eg phenobarbital, carbamazepine and phenytoin )
  • drugs against tuberculosis (eg rifampicin, rifabutin)
  • drugs against HIV – infection [AIDS] (ritonavir, nelfinavir, nevirapine and efavirenz)
  • an herbal medicine containing St. John’s wort ( Hypericum perforatum ).

Laboratory test

If you need to take blood samples, tell your doctor or laboratory staff that you are using Femoston, as this may affect the results of some tests.

Femoston with food and drink

Femoston can be taken with or without food

Pregnancy and breastfeeding

Femoston is intended for women whose menstruation has stopped.

If you become pregnant

  • stop taking Femoston and consult a doctor.

Femostone should not be used if you are breast-feeding.

Driving and using machines

The effect of Femoston on the ability to drive and use machines has not been studied. The impact is unlikely.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Femostone contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Femoston

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

When you can start taking Femoston

Do not start taking Femoston until at the earliest 6 months after your natural menstrual bleeding has stopped.

You can start taking Femoston any day if:

  • you are not currently taking any HRT
  • you switch from a continuous combination hormone treatment. This means that you take a tablet every day or use a patch that contains both estrogen and progestogen.

You should start taking Femoston the day after the 28-day menstrual cycle if:

  • you switch from a cyclic or sequential HRT treatment. This means that you are taking a tablet or using an estrogen-containing patch during the first part of your menstrual cycle. After this, take a tablet or use a patch that contains both estrogen and progestogen for up to 14 days.

How to take Femoston

  • Swallow the tablet with water.
  • The tablets can be taken with or without food.
  • Try to take the tablet at the same time each day. In this way, the amount of drugs that work in your body is even throughout the day. This will also help you remember to take your tablets.
  • Take one tablet every day, without a break between packs. The days of the week have been marked on the blister maps. This makes it easier for you to remember when to take the tablets.

How much medicine to take

  • Your doctor prescribes the lowest effective dose that provides symptom relief and as short a treatment time as possible. Discuss with your doctor if you think your dose is too high or too low.
  • If you are taking Femoston to prevent osteoporosis, your doctor will adjust the dose individually for you. Dose one depends on your bone mass.
  • Take one white tablet every day for the first 14 days followed by a gray tablet every day for the next 14 days. This is shown on the 28-day calendar package.

If you need surgery

If you are going to have surgery, tell your staff that you are using Femoston. You may need to discontinue Femoston for 4-6 weeks before surgery to reduce the risk of blood clots (see section 2, Venous thrombosis). Ask your doctor when it is appropriate to start using Femoston again.

If you take more Femoston than you should

If you (or anyone else) take too many Femoston tablets, it is unlikely to be harmful. You may experience nausea, vomiting, tenderness or pain in the breasts, dizziness, abdominal pain, drowsiness, or loss of bleeding. No treatment is needed, but if you are worried, consult a doctor for advice.

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Femoston

Take the forgotten tablet as soon as you remember. If it has been more than 12 hours since you should have taken the tablet, skip the forgotten tablet and take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. Breakthrough bleeding or splashing bleeding may occur if you miss a dose.

If you forget to take Femoston

Do not stop taking Femoston without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following diseases are more common in women taking HRT than in those who do not:

  • breast cancer
  • – severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining
  • ovarian cancer
  • blood clots in veins in bones or blood clots in lungs ( venous thromboembolism )
  • heart disease
  • stroke (stroke)
  • possible memory loss, if HRT begins after the age of 65.

For more information on these side effects, see section 2.

The following side effects may occur with the use of this medicine:

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

– headache

– abdominal pain

– back pain

– tenderness or pain in the breasts.

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

– fungal infection of the vagina ( infection caused by the fungus Candida albicans )

– depression, nervousness

– migraine. If you experience migraine-like headaches for the first time, stop taking Femoston and see a doctor immediately.

– dizziness

– nausea, vomiting, bloating (bloating), and flatulence ( flatulence )

– allergic skin reactions (eg rash, severe itching, or hives)

– menstrual disorders such as irregular menstrual bleeding, spotting, painful menstrual bleeding ( dysmenorrhea ), more or less menstrual bleeding

– pain in the pelvis

– vaginal discharge

– weakness, fatigue, or feeling sick

– swelling of the ankles, feet, or fingers (peripheral edema )

– weight gain.

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

– symptoms reminiscent of bladder inflammation

– growth in the uterus ( fibroids ) becomes larger

– hypersensitivity reaction you like shortness of breath (allergic asthma )

altered sex drive

– blood clots in the legs or lungs ( venous thrombosis or pulmonary embolism )

– high blood pressure ( hypertension )

– disorders of blood circulation (peripheral vascular disease)

– enlarged vein and varicose veins

– indigestion

liver disease, with or without yellowing of the skin (jaundice), weakness or general malaise, and abdominal pain. If you notice that the skin or whites of the eyes turn yellow, stop taking Femoston and see a doctor immediately.

– gallbladder disease

– swollen breasts

– premenstrual syndrome (PMS)

– weight loss.

Rare (may affect up to 1 in 1,000 people):

(* Post-marketing adverse reactions that have not been observed in clinical trials have been classified as “rare”.)

– disease due to destruction of red blood cells (hemolytic anemia ) *

– meningioma (a brain tumor) *

– changes in the surface of the eye (sharper curvature of the cornea) *, problems with contact lenses (contact lens intolerance) *

– heart attack (heart attack)

– stroke (stroke) *

– swelling of the face and neck. This can lead to breathing difficulties ( angioedema )

– purple spots on the skin ( vascular purpura)

sore, red lumps on the skin (erythema nodosum) *, discoloration of the skin especially on the face or neck (so-called pregnancy spots/liver spots), (chloasma or melasma) *

– leg cramps *.

The following side effects have been reported with the use of other hormone replacement therapies:

benign or malignant estrogen-dependent tumors, such as endometrial cancer and ovarian cancer (see section 2)

– increased size of tumors that may be affected by progestogen levels (eg meningioma)

– autoimmune disease that affects many organs in the body (systemic lupus erythematosus, SLE )

– probably dementia

– aggravated epilepsy

– muscle cramps (Korea)

– blood clots in the artery (arterial thromboembolism)

– pancreatitis ( pancreatitis ) in women with high blood fat levels ( hypertriglyceridemia )

– rash with sharply defined red spots or sores (erythema multiforme)

– urinary incontinence

sore/lumpy breasts (fibrocystic breast changes)

– erosion of the cervix

– worsening of a rare, inherited pigment disorder in the blood ( porphyria )

– high blood fat levels ( hypertriglyceridemia )

– increased amount of thyroid hormone.

5. How to store Femoston

Keep this medicine out of the sight and reach of children.

No special storage instructions. Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are estradiol (estradiol hemihydrate) and dydrogesterone.

  • Each white tablet contains 1 mg of estradiol.
  • Each gray tablet contains 1 mg estradiol and 10 mg dydrogesterone.

The other ingredients in the tablet core are lactose monohydrate, hypromellose, corn starch, anhydrous colloidal silica, and magnesium stearate.

The other ingredients in the film coating of the tablet are:

  • Titanium dioxide (E171), black iron oxide (E172), polyvinyl alcohol, macrogol, talc, and hypromellose.

What the medicine looks like and the contents of the pack

– The film-coated tablets are round, biconvex with the marking 379 on one side.

– Each blister contains 28 tablets.

– Femoston consists of two different colored tablets. Each pack contains 14 white tablets (for the first 14 days of the cycle) and 14 gray tablets (for the remaining 14 days of the cycle).

– The tablets are packaged in PVC / aluminum blister packs.

– Packs containing 28, 84 (3 x 28) or 280 (10 x 28) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

BGP Products AB

Box 23033

104 35 Stockholm

Manufacturer:

Abbott Biologicals BV

Vieweg 12

8121 AA Olst

Netherlands

This medicinal product is authorized under the European Economic Area under the names:
AT Femoston mite – Filmtabletten
THE Femostone 1 mg / 10 mg, Film tablets
DK Femoston
ES Femfascon 1mg / 10 mg compresses recovered with film
FI Femoston 1/10 tablet, calvapäällysteinen
FR Climaston 1 mg / 10 mg, compressed pill
IT Femoston 1/10 compressed rivestite with film
NL Femoston 1/10, film-coated tablets
NO Femoston
PT Femoston 1/10, (10 mg + 1 mg) + (1 mg), compressed revestido
SEE Femoston
SI Femphascon 1 mg / 10 mg film-free tablet tablet

Muhammad Nadeem

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