1. What Estrofem is and what it is used for
Estrofem® is a hormone replacement therapy (HRT). It contains the female hormone estradiol. Estrofem® is used in postmenopausal women, especially in uterus (hysterectomised) and therefore non-requiring estrogen / progestogen combination therapy.
Estrofem® is used to:
Relief of post-menopausal symptoms
The amount of estrogen produced by the female body decreases during menopause. This can cause symptoms such as hot face, neck and chest ("hot flushes"), Estrofem® relieves these post-menopausal symptoms. Estrofem® should only be prescribed if your symptoms severely impede your daily life.
Prevent from osteoporosis (thinning of the bones) if you are at high risk of future fractures and if you are unable to take other medicines for this purpose.
Experience with treatment with Estrofem® in women older than 65 years is limited.
2. What you need to know before you take Estrofem
Medical history and regular examinations
Using HRT brings risks that you need to keep in mind when deciding whether to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian damage or surgery) is limited. The risk of using HRT may be different if you have premature menopause. Please talk to your doctor.
Before you start (or renew) HRT, your doctor will ask you about your family history and your family history. Your doctor may decide to do a physical examination. This may include breast examination and / or internal research if necessary.
After starting treatment with Estrofem®, you should have regular check-ups with your doctor (at least once a year). In these reviews, discuss the benefits and risks of continuing Estrofem®.
Take regular breast examination as recommended by your doctor.
Do not take an estrophy
If any of the following conditions apply to you. If you are not sure about any of the points below, talk to your doctor before taking Estrofem.
Do not take Estrofem®
If you have, have ever had or suspect that you have breast cancer.
If you have, have had or suspect that you have cancer that is sensitive to estrogens, such as the endometrial cancer of the uterus.
If you have unexplained vaginal bleeding.
If you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated.
If you have or have ever had a blood clot in a vein (thrombosis) such as in the legs (deep vein thrombosis) or lungs (pulmonary embolism).
If you have a blood coagulation disorder (such as protein C deficiency, protein S or antithrombin).
If you have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
If you have or have ever had a liver disease and the functional liver samples have not been normalized.
If you have a rare blood disorder called "porphyria" that is transmitted through the generations (inheritance).
If you are allergic (hypersensitive) to oestradiol or any of the other ingredients of Estrofem® (listed in section 6, "Package contents and further information").
If any of the above conditions appear for the first time while taking Estrofem®, immediately stop taking it and consult your doctor immediately.
Warnings and precautions
Talk to your doctor before taking Estrofem®. Before you start treatment, tell your doctor if you have any of the following conditions, as these may resume or worsen during treatment with Estrofem®.
If this happens, you should visit your doctor more often for medical checkups:
fibroma in your uterus
enlargement of the uterine lining outside the uterus (endometriosis) or anamnestic evidence of excessive uterine enlargement (endometrial hyperplasia)
increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)")
increased risk of developing estrogen-sensitive cancer (for example, you have a mother, a nurse, a grandmother who has had breast cancer)
high blood pressure
a hepatic disorder such as a benign liver tumor
migraine or severe headache
immune system disease that affects many organs in the body (systemic lupus erythematosus, SLE)
a disease that affects the eardrum and hearing (otosclerosis)
very high level of fat in the blood (triglycerides)
fluid retention due to cardiac or renal disorders.
Stop taking Estrofem and go to a doctor immediately
If you notice any of the following conditions when using HRT:
any of the conditions mentioned under "Do not take Estrofem®"
yellow skin or eye color (jaundice). These may be signs of liver disease
significant increase in blood pressure (symptoms may be headache, fatigue, dizziness)
migraine-like headache that occurs for the first time
if you become pregnant
if you notice signs of a blood collar such as:
painful swelling and reddening of the feet
sudden chest pain
For more information, see "Blood clots in a vein (thrombosis)".
Note: Estrofem® is not a contraceptive. If it has been less than 12 months since your last menstrual period or you are under the age of 50, you may still need an additional contraceptive to prevent pregnancy. Ask your doctor for advice.
HRT and cancer
Excessive growth of the lining of the uterus (endometrial hyperplasia) and uterine lining (endometrial cancer)
The use of HRT containing only an enzyme will increase the risk of excessive uterine lining (endometrial hyperplasia) and cancer of the lining of the uterus (endometrial cancer).
Taking progestagen together with estrogen for at least 12 days of each 28-day cycle prevents you from this additional risk. So, your doctor will prescribe you a separate progestagen if you still have a uterus. If you have a uterus (hysterectomy), ask your doctor if you can safely take this product without progestagen.
In women who still have a uterus and who do not receive HRT, an average of 5 per 1,000 will be diagnosed with endometrial cancer aged 50-65 years.
In women aged 50-65 years who still have uterus and receive HRT containing only estrogen, between 10 and 60 per 1,000 will be diagnosed with endometrial cancer (ie between 5 and 55 additional cases) in dose and duration of treatment.
While taking Estrofem®, you will experience bleeding once a month (so-called bleeding bleeding). But if you have unexpected bleeding or drops of blood (spotting) beyond monthly bleeding, which:
continued beyond the first 6 months
start after you have been taking Estrofem more than 6 months
continues after you have stopped taking Estrofem®
Go to the doctor as soon as possible.
According to the evidence, the intake of combined estrogen-progestagen and possibly also estrogen-containing HRT increases the risk of developing breast cancer. The additional risk depends on the duration of HRT intake. The additional risk is clarified after several years. But it returns to normal within a few years (at most 5) after cessation of treatment.
In women with uterus who have received HRT containing only estrogen for 5 years, there is little or no risk of developing breast cancer.
Women aged 50 to 79 years who do not take HRT on average 9 to 17 per 1,000 will be diagnosed with breast cancer for a period of 5 years.
In women 50 to 79 years of age who take estrogen-progestagen HRT for 5 years, the number of cases will be 13 to 23 per 1,000 patients (ie 4 to 6 additional cases).
Regularly check your chest. Visit your doctor if you notice changes such as:
wrinkling of the skin
any lumps you can see or feel.
In addition, it is recommended that you participate in mammogram screening programs when offered. In mammography, it is important to tell your nurse / medical practitioner performing X-ray that you are using HRT, as this treatment can increase the density of your chest, which may affect the outcome of mammography. When breast density is increased, mammography may not detect all lumps.
Ovarian cancer is rarely seen - much less often than breast cancer. Administration of HRT with only estrogen or combined estrogen-progestagen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50-54 who do not take HRT, about 2 per 2,000 women will be diagnosed with ovarian cancer for a period of 5 years. In women who take HRT for 5 years, there would be about 3 cases per 2000 treated (ie about 1 extra case).
Effects of HRT on heart and blood circulation
Blood clots in the vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3 times higher in patients receiving HRT than in non-adolescents, especially during the first year of treatment.
Blood clots can be serious and if one of them gets to the lungs, it can cause chest pain, shortness of breath, fainting or even death.
There is a greater likelihood of getting a blood clot in the veins as you age and if one or more of the following conditions apply to you. Tell your doctor if any of these conditions apply to you:
you can not go on for a long time due to serious surgery, injury or illness (see also section 3, "If you need an operation")
weighs well above normal (BMI> 30 kg / m2)
you have a blood coagulation problem that needs long-term treatment with a medicine used to prevent blood clots
if someone in your family has ever had a blood clot in the leg, lung or other organ
you have systemic lupus erythematosus (SLE)
you have cancer.
For signs of a blood clot, see "Stop taking Estrofem® and go to your doctor immediately".
In women aged 50-59 who do not take HRT, an average of 4 to 7 per 1,000 would have a blood clot in a vein for a 5-year period.
In women between 50 and 59 years of age receiving estrogen-progestagen HRT for more than 5 years, the number of cases will be 9 to 12 per 1,000 patients (ie 5 additional cases).
In women between 50 and 59 years of age with uterus removed and receiving estrogen therapy for 5 years, the number of cases will be 5 to 8 per 1,000 patients (ie 1 additional case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
In women over 60 years of age, estrogen-progestagen HRT is a little more likely to develop heart disease than those who do not take any HRT.
There is no increased risk of developing cardiac disease in women with uterus removed and receiving estrogen therapy alone.
The risk of stroke is about 1.5 times higher in patients taking HRT than in non-adoptive patients. The number of additional stroke cases due to HRT will increase with age.
In women aged 50-59 who do not take HRT, an average of 8 per 1,000 is expected to receive a stroke over a 5 year period.
In women between 50 and 59 years of age who receive HRT, the number of cases will be 11 per 1,000 for a 5-year period (ie 3 extra cases).
HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start to take HRT after age 65.
Consult your doctor.
Other medicines and Estrofem®
Some medicines can interfere with Estrofem®. This can lead to irregular bleeding. This applies to the following medicines:
Epilepsy drugs (such as phenobarbital, phenytoin and carbamazepine)
Medicines for tuberculosis (such as rifampicin, rifabutin)
Medicines for HIV infections (such as nevirapine, efavirenz, ritonavir and nelfinavir)
Herbal forwarding containing St John's wort (Hypericum perforatum).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, herbal or other natural products.
Estrofam with food and beverages
Tablets can be taken with or without food and beverages.
Pregnancy and breast-feeding
Estrofem® is only used in postmenopausal women. If you become pregnant, stop taking Estrofem® and contact your doctor.
Driving and using machines
Estrofem® has no known effects on the ability to drive or use machines.
Estrace contains lactose monohydrate t
Contact your doctor before taking Estrofem® if you are intolerant to some sugars.
If you need a blood test, tell your doctor or lab that you are taking Estrofem®, as this medicine may affect the results of some tests.
3. How to take Estroph
Always take this medicine exactly as your doctor prescribed. Consult your doctor or pharmacist if you are not sure.
If you have a uterus or if you do not have vaginal bleeding and do not take any other hormonal products, you can start treatment on any convenient day.
Take one tablet a day at approximately the same time of day. Once you have finished all 28 tablets in the pack, start a new pack, continuing treatment continuously.
For more information on using the calendar pack, see the "USER INSTRUCTIONS" at the end of the leaflet.
Your doctor will aim at prescribing the lowest effective dose that will relieve the symptoms for the shortest possible time. Tell your doctor if you think the dose is too strong or too strong.
If you have a uterus removed, your doctor will also not prescribe progestagen (another female hormone) unless you have a condition called endometriosis (uterine tissue deposition outside the uterus).
Check with your doctor or pharmacist when to start taking Estrofem® if you have taken other HRT products so far.
If you experience breakthrough bleeding or spotting, you usually have nothing to worry about, especially during the first few months of taking HRT (see also section 2, "HRT and Cancer", "Excessive Uterine Lymph Disease (Endometrial Hyperplasia), and Cancer of the lining of the uterus (endometrial cancer) "for more information).
If you take more Estrofem than you should
Ask your doctor or pharmacist if you have taken more Estrofem® than you should. Overdose of Estrofem® can cause a feeling of being sick or vomiting.
If you forget to take Estrofem
If you forget to take a tablet at your usual time, take it within the next 12 hours. If more than 12 hours have passed, continue treatment as usual the next day. Do not take a double dose to make up for the forgotten tablet. An unacceptable dose may increase the likelihood of breakthrough bleeding and spotting if you still have a uterus.
If you stop taking Estrofem
If you want to stop using Estrofem®, please discuss your decision with your doctor. It will explain the consequences of stopping treatment and discuss with you other treatment options.
Ask your doctor or pharmacist if you have any further questions on the use of this medicine.
If you need surgery
Tell the surgeon that you are taking Estrofem® if you are going to have surgery. You may need to stop taking Estrofem® about 4 to 6 weeks before surgery to reduce the risk of a blood clot (see section 2, "Blood clots in a vein"). Ask your doctor about when you can start taking Estrofem® again.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them
The following diseases have been reported more frequently in women taking HRT than women who do not take HRT:
abnormal growth or cervical mucosal cancer (endometrial hyperplasia or cancer)
blood clots in the veins of the legs or lungs (venous thromboembolism)
possible memory loss if HRT is started at the age of 65 years.
For more information on these side effects, see section 2.
Hypersensitivity / allergy (uncommon side effects - may affect up to 1 in 100 people).
Although there is an uncommon side effect, hypersensitivity / allergy may occur. Signs of hypersensitivity / allergy may include one or more of the following symptoms: urticaria, itching, swelling, difficulty in breathing, low blood pressure (pale and cold skin, rapid heart beat), dizziness, sweating, which may be signs of anaphylactic reaction / shock. If any of the listed symptoms occurs, stop taking Estrofem and seek immediate medical attention.
Common side effects (may affect up to 1 in 10 people)
Pain, sensitivity or enlargement of the chest
Edema (fluid retention)
Uncommon side effects (may affect up to 1 in 100 people)
Blood clots in veins (venous embolism)
Acid in the stomach (dyspepsia)
Formation of gases or swelling
Itching or rash (urticaria).
Very rare side effects (may affect up to 1 in 10,000 people)
Irregular vaginal bleeding
Change in libido
Vaginal yeast infection
Hair loss (alopecia)
Increased blood pressure.
If prescribed for women with uterus
The following side effects have been reported with other HRT:
Disease of the gall bladder
Different skin disorders:
Changing the skin color, especially on the face or neck, known as "spots in pregnancy" (chloasma)
Painful reddish skin nodules (erythema nodosum)
Rash with circular flushing or wounds (erythema multiforme).
your doctor If you get any side effects, talk to your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system:
Executive Agency for Medicines
8 Damian Gruev Str.
tel .: +359 2 8903417
As you report side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store an estroph
Keep this medicine out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store below 25 ° C.
Do not store in a refrigerator.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
contains The active substance is estradiol 2 mg (as oestradiol hemihydrate).
The other ingredients are: lactose monohydrate, corn starch, hydroxypropyl cellulose, talc and magnesium stearate.
The coat contains: hypromellose, talc, titanium dioxide (E171), macrogol 400, indigo carmine (E132).
What Estrofem looks like and contents of the pack The
film-coated tablets are blue, round and 6 mm in diameter. The tablets are engraved with NOVO 280 on one side.
Available pack sizes:
1 x 28 film-coated tablets.
Marketing Authorization Holder and Manufacturer:
Novo Nordisk A / S, Denmark