Femanor 2 mg tablets Estradiol, Norethisterone
1. What Femanor Is And What Femanor Used For
Femanor is a preparation used for hormonal substitution therapy ( Hormone Replacement 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 used for:
- 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 (broken bones) 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 considered when deciding to start or continue an ongoing treatment.
Experience is limited for treating women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, HRT’s risks may differ. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask about your and your family’s medical background. Your doctor may do a general medical and gynecological examination, including 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 lining of the uterus (endometrium), or if there is a suspicion of such cancer.
- If you have unexpected genital bleeding that a doctor has not investigated.
- 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 in 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 can cause symptoms such as:
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives
- 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 the 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)
Using 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 5 years.
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 10 years.
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 in 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 examining that you are using HRT, as this medicine may increase the density of the breasts. An increased breast density can make detecting lumps on mammography images more difficult.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – 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. For example, the diagnosis of ovarian cancer will be made on about 2 women out of 2,000 between the ages of 50 and 54 who do not take HRT for 5 years. 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 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 death.
You are more likely to get a blood clot in a vein if 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 for over 5 years, 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 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 than those who do not. The risk of stroke is age-dependent. Therefore, the number of stroke cases 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 5 years.
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 age 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)
- An herbal medicine containing St. John’s wort ( Hypericum perforatum )
- Medicines for fungal infections containing ketoconazole.
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal remedies.
Results from blood tests analysis:
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 breastfeeding.
Driving And Using Machines
Femanor does not affect your ability to drive or use tools or machines.
Femanor Contains Lactose
If your doctor has told you 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 to use Femanor for the shortest time. Talk to your doctor if you do not get any relief from the symptoms or feel 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 in 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), and 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. The forgotten Femanor tablet should be taken within 12 hours. Otherwise, it should be discarded. Forgetting a dose can increase the likelihood of breakthrough bleeding and spotting.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible Femanor Side Effects
This medicine can cause side effects like all medicines, 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
- Fluid accumulation 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
- A 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
- A 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)
- An obstruction in the liver causes jaundice
- 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, 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 sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP. Date. . 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 that are 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 and 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, and 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 Femanor 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