tablets 
estradiol, norethisterone

1. What Femanor is and what it is used for

Femanor is a preparation used for hormonal substitution therapy ( HormoneReplacement Therapy, HRT ). It contains two female sex hormones; estrogen and progestogen. Femanor is used for women whose menstruation has stopped ( menopause ), at least 1 year after their last natural menstruation.

Femanor is used to:

Relieve symptoms during and after menopause

When menstruation ends ( menopause ), the woman’s estrogen drops. It can cause problems such as sweating and hot flashes. Femanor relieves these symptoms after menopause. Femanor should only be used if the problems cause problems in daily life.

Prevent osteoporosis

After menopause, some women suffer from osteoporosis. Discuss all possible options with your doctor.

If you have an increased risk of fractures (bone fractures) and other medicines that are not suitable for you, you can use Femanor to prevent osteoporosis after menopause.

2. What you need to know before taking Femanor

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 the uterus has been removed). 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. Your doctor may do a general medical and gynecological examination, which also includes an examination of your breasts.

Once you have started treatment, you should go for 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.

Perform regular breast examinations according to your doctor’s recommendations.

Do not take Femanor:

if any of the following apply to you. If you are not sure, talk to your doctor before taking Femanor.

  • If you have or have had breast cancer or there is a suspicion that you may have it
  • If you have or have had estrogen-dependent cancer, such as cancer of the uterine lining (endometrium), or if there is a suspicion of such cancer.
  • If you have unexpected genital bleeding that has not been investigated by a doctor.
  • If you have endometrial hyperplasia (severe thickening of the uterine lining) and are not being treated for it.
  • If you have or have had a blood clot in a vein (venous thromboembolism ), in your legs (deep vein thrombosis ), or your lungs ( pulmonary embolism ).
  • If you have a coagulation disorder, a condition with an increased risk of blood clots (lack of protein C, protein S, or antithrombin).
  • If you have or have had a disease caused by blood clots in the arteries are as heart attack, stroke (stroke), or angina.
  • If you have or have had any liver disease and still have abnormal liver values.
  • If you have porphyria, a rare inherited blood disorder.
  • if you are allergic to estradiol, norethisterone acetate, or any of the other ingredients of this medicine (listed in section 6).

If any of the above affects you the first time you use Femanor, stop taking Femanor and contact your doctor immediately.

Warnings and cautions

Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Femanor. Should this occur, have more frequent check-ups with a doctor.

  • if you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis, or have had endometrial hyperplasia (severe thickening of the uterine lining).
  • if you have an increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)
  • if a close relative has had breast cancer or other estrogen-dependent cancer.
  • high blood pressure
  • liver disease eg liver adenoma (benign tumor )
  • diabetes
  • gallstone disease
  • if you get a migraine or severe headache
  • if you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
  • epilepsy
  • asthma
  • otosclerosis (ossification of the middle ear leading to a hearing loss)
  • hypertriglyceridemia (elevated blood lipids).
  • fluid retention due to heart or kidney disease
  • hypothyroidism (your thyroid gland does not produce enough thyroid hormone) and you are taking thyroid hormone as a replacement therapy
  • angioedema. Estrogen can cause or worsen the symptoms of angioedema, especially if you have hereditary angioedema. Angioedema may cause symptoms such as swelling of the face, tongue, or throat, difficulty swallowing, hives, or difficulty breathing.

You should contact a doctor immediately and discontinue treatment if any of the following occur:

  • Some of what is mentioned in the section ‘Do not take Femanor’
  • If skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease
  • If your blood pressure rises sharply (symptoms may include headache, fatigue, or dizziness)
  • If you are experiencing migraine-like headaches for the first time
  • If you become pregnant
  • If you get symptoms of a blood clot, such as
    • painful swelling and redness of the legs
    • sudden chest pain
    • breathing difficulties 
      For more information, see below “Blood clots in a vein ( thrombosis )”

Note: Femanor 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)

The use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining and cancer of the uterine lining.

The progestogen in Femanor protects you against this extra risk.

Irregular bleeding

Irregular spotting or spotting may occur during the first 3 – 6 months of taking Femanor.

But about the bleeding

  • lasts longer than 6 months
  • starts after taking Femanor for 6 months
  • continues after you stop taking Femanor

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 50-54 who do not take HRT, an average of 13-17 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 1000 users (ie 0-3 extra cases) will occur.

In women who are 50 years old and start taking HRT with estrogen-progestogen for 5 years, there will be 21 cases per 1000 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 estrogen alone for 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 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
  • changes of the nipple
  • nodules you can see or feel

It is also recommended that you participate in a mammography examination when you are called to do so. At the mammogram, you must tell the nurse/healthcare professional who performs the examination that you are using HRT, as this medicine may increase the density of the breasts. An increased density in the breasts can make it more difficult to detect lumps on the mammography images.

Ovarian cancer ( ovarian cancer )

Ovarian cancer is rare – much more rare 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

Blood clots in a vein ( 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, collapse or even lead to death.

You are more likely to get a blood clot in a vein if any of the following apply to you. Tell your doctor if any of the following apply to you:

  • You have not been able to walk or stand for a long time due to a major operation, injury or illness (see also 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 SLE (systemic lupus erythematosus)
  • You have cancer

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

Comparison

For women in their 50s, who do not take HRT, during a 5-year period, an average of 4 – 7 out of 1000 are expected to get a blood clot in a vein.

For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9 – 12 out of 1000 users are expected to get 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 estrogen-progestin, the risk of developing heart disease is slightly higher than 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 risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.

Comparison

For women in their 50s who do not take HRT, an average of 8 out of 1000 people is expected to have a stroke over a 5-year period.

For women in their 50s who have taken HRT for more than 5 years, 11 out of 1000 users are expected to have a stroke (ie 3 extra cases)

Other conditions

  • Using HRT does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
  • Gallbladder disease
  • Skin changes

Other medicines and Femanor

Some medicines can affect the effect of Femanor, which can lead to irregular bleeding. The following applies:

– Medicines for epilepsy (eg phenobarbital, phenytoin, and carbamazepine)

– Medicines for tuberculosis (eg rifampicin, rifabutin)

– Drugs for HIV – infection (for example, nevirapine, efavirenz, ritonavir, and nelfinavir telaprevir)

– Herbal medicine containing St. John’s wort ( Hypericum perforatum )

– Medicines for fungal infections containing ketoconazole.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal remedies.

Results from blood test analyze

If you need to take a blood sample, tell your doctor or the person taking the blood sample that you are taking Femanor as it may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Femanor is intended for women whose menstruation has stopped. If you become pregnant, stop taking Femanor and consult a doctor.

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

Driving and using machines

Femanor does not affect your ability to drive or use tools or machines.

Femanor 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 Femanor

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Take 1 tablet daily without interruption, at about the same time each day. You can start treatment at any time, but if you switch from treatment with a sequencing drug, treatment should start immediately after your regular bleeding has stopped.

Your doctor will strive to give you the lowest dose, which will give you relief of symptoms, and that you should use Femanor for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.

Instructions for use

The package is equipped with a weekday marking that makes it possible to check the tablet intake day by day. The foil marked every week is common to several Nordic countries. For some days, the day marking has different initials in Icelandic. Therefore it says M / Má (Monday), Ti / Þ (Tuesday), O / Mi (Wednesday), To / Fi (Thursday), F / Fö (Friday).

If you need surgery

If you are going to have surgery, tell your doctor that you are taking Femanor. You may need to stop taking Femanor for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis )”). Ask your doctor when it is appropriate to start taking Femanor again.

If you take more Femanor than you should

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

If you forget to take Femanor

Do not take a double dose to make up for a forgotten tablet. Forgotten tablet should be taken within 12 hours, otherwise it should be discarded. Missing a dose can increase the likelihood of breakthrough bleeding and splashing bleeding.

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 who take HRT than those who do not:

  • Breast cancer
  • Severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
  • Ovarian cancer ( ovarian cancer )
  • Blood clots in veins in bones or lungs (venous thromboembolism )
  • Heart disease
  • Stroke (apoplexy)
  • Probable memory loss, if treatment with HRT is started after the age of 65

See section 2 for more information on these side effects .

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

Headache, pain or tenderness in the breasts, menstrual cramps, menstrual disorders.

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

Fungal infection of the abdomen or genital inflammation, accumulation of fluid in the body, depression or worsening of current depression, nervousness, emotional disorders, altered sexual drive. Dizziness, difficulty sleeping. Nausea, abdominal pain, tension or discomfort in the abdomen, diarrhea, indigestion ( dyspepsia ). Acne , skin rash, itching , dry skin. Leg cramps or back pain, pain in the legs and arms, breast edema or breast enlargement, benign uterine fibroids, or deterioration or recurrent uterine fibroids, heavy menstrual bleeding, vaginal discharge, irregular bleeding, seizures of the uterus, infections in the uterus, thickening of the uterine lining ( endometrial hyperplasia). Pain, weakness, peripheral edema (swollen arms or legs), weight gain.

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

Migraine , severe dizziness, high blood pressure , concomitant inflammation and blood clot in a superficial blood vessel (vein), varicose veins. Vomiting, gallbladder disease, gallstones . Discolored skin, muscle spasms, breast cancer (see also section 2). Elevated levels of transaminases in liver function tests.

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

Hypersensitivity ( allergic reaction ), abnormal sensations such as ant crawling, numbness. Blood clot in the lung (see also section 2), blockage of a blood vessel due to a migrating blood clot, blood clot in a deep blood vessel (vein), muscle weakness, benign uterine tumor, fallopian tube cysts, polyps in the cervix.

Very rare (may affect up to 1 in 10,000 people)

Jaundice caused by an obstruction in the liver, increased hair on the face or body.

Has been reported (occurs in an unknown number of users)

Hair loss ( alopecia ).

Bleeding pattern

Some women experience breakthrough bleeding or spotting during the first months of treatment. If such bleeding continues for longer than the first few months or starts after a period of treatment or continues even after stopping treatment, tell your doctor as soon as possible.

The following side effects have been reported with other HRTs:

  • Various skin diseases:
    • dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
    • painful reddish-purple bumps on the skin (erythema nodosum)
    • annular redness or sore rash (erythema multiforme)
  • Dry eyes
  • Changed composition of the tear fluid.

5. How to store Femanor

Do not store above 30 ° C.

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. . 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 hemihydrate corresponding to estradiol 2 mg, norethisterone acetate 1 mg.
  • The other ingredients are lactose monohydrate 60.73 mg, dyes (black iron oxide E 172, titanium dioxide E 171), corn starch, povidone, talc, magnesium stearate, hypromellose, macrogol.

What the medicine looks like and the contents of the pack

Gray tablets marked P2.

Provided in calendar packaging 3 x 28 pcs. The package is equipped with a weekday marking that makes it possible to check the tablet intake day by day.

Marketing Authorisation Holder

Meda AB, Box 906, 170 09 Solna. Tel 08 – 630 19 00

Manufacturer

Mylan Hungary Kft./Mylan Hungary Ltd.

Mylan utca 1,

Komárom, 2900,

Hungary

Muhammad Nadeem

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