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Estrofem 2 mg film-coated tablet To be taken orally.
Each film-coated tablet contains 2 mg of estradiol (as estradiol hemihydrate).
Tablet core: Lactose monohydrate, corn starch, hydroxypropylcellulose, talc and magnesium stearate.
Film coating: Hypromellose, talc, titanium dioxide (E171), macrogol 400 and indigo carmine (E132).
Estrofem is a Hormone Replacement Therapy (HRT). Contains the female sex hormone estradiol. Estrofem is used after menopause, especially in women who have had their womb removed (had a hysterectomy) and therefore do not need combined estrogen/progestagen therapy.
Estrofem is used to reduce postmenopausal symptoms.During menopause, the amount of estrogen produced in the female body decreases. This condition can cause symptoms such as face, neck, and chest warmth (hot flashes). Estrofem reduces such post-menopausal symptoms. Estrofem should only be prescribed if your symptoms (such as postmenopausal hot flashes) seriously interfere with your daily life.Experience in the treatment of women over 65 years of age is limited.
The human body produces estradiol in small amounts during early adulthood. The levels of estradiol peak at around 200 pg/mL at the time of menstruation, and fall again at ovulation. However, estrogen levels can be increased by testosterone. Proper balance of hormones in the body is essential to avoid serious illnesses and infertility. If the body produces too little estradiol, women may experience rapid fatigability and accelerated aging.
Always use Estrofem exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
If you have had your uterus removed or you do not have vaginal bleeding and you are not using other hormone therapy products, you can start treatment on any suitable day.Take one tablet every day at the same time of day. After you have finished all 28 tablets in the calendar and cycle box, continue the treatment with a new calendar and cycle box without interruption.
Your doctor will prescribe the lowest dose that will treat your symptoms as soon as possible. If you think this dose is too strong or too weak, talk to your doctor.If you have had your uterus removed and you have not had a condition called endometriosis (the presence of tissue outside the uterus), your doctor will not prescribe a progestagen (other female hormone) additionally.
If you have ever used other HRT products, please ask your doctor or pharmacist when you should start using Estrofem.There is usually no need to worry, especially if you have breakthrough bleeding or spotting within the first few months of taking HRT (see section 2 HRT and cancer for more information, Excessive thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of the uterus (endometrial cancer).
Application route and method
Take Estrofem by mouth.Take the tablets with a sufficient amount of liquid (eg a glass of water).For the use of the calendar and recycle box, see the "Usage of Estrofem 2 mg film-coated tablet" section given at the end of this Instructions for Use.
Different age groups
Use in the elderly
Experience in the treatment of women over 65 years of age is limited.
Special use cases
Estrogens can cause fluid retention and therefore patients with cardiac or renal impairment should be carefully observed. Since the circulating levels of the active ingredients of Estrofem are expected to increase, patients with end-stage renal disease should be followed closely.
It should never be used in cases of acute liver disease or a history of liver disease that prevents liver function tests from returning to normal.
In case of liver disorders (eg liver adenoma), treatment should be closely monitored, and treatment should be stopped if jaundice or hepatic dysfunction occurs.
If you have an impression that the effect of Estrofem is too strong or weak, talk to your doctor or pharmacist.
When Using Estrofem for Feminizing Horroid Therapy, it is important to understand the risks of the treatment. This hormone is not likely to lower the sperm count, but you should still take birth control if you are in a relationship with someone who may become pregnant. However, if you are considering a higher dose of Estrofem, you should be prepared for several possible side effects, including decreased libido and a decrease in sexual desire. The effect of Estrofem on a woman's body can last from six months to several years, so it is important to plan ahead.
Some side effects of Estrofem include increased risk of diabetes, especially in women with a history of type 2 diabetes. Other risks of Estrofem are increased risks of heart disease, stroke, and breast cancer. The FDA approves most Estrofem treatments for women. These hormones are very safe and effective, but you should speak with your doctor before using Estrofem.
Some studies suggest that Estrofem may increase the risk of certain health conditions, particularly when you have a pre-existing condition or are over 50. These risks may be lessened if the estrogen has a positive effect on your life. In addition, Estrofem can reduce your stress levels, which is an added bonus. Smoking and Estrofem can also raise the risk of blood clots and stroke.
Like all medicines, there may be side effects in people who are sensitive to the substances contained in ESTROFEM.If any of the following occur, stop using ESTROFEM and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department.
Hypersensitivity (hypersensitivity) allergy (Uncommon side effects - affects 1 to 10 people in 1000)
Although uncommon, hypersensitivity/allergy may occur. Hypersensitivity/allergy may include one or more of the following symptoms: hives (hives), itching, swelling, difficulty breathing, low blood pressure (cold and dull skin, rapid heartbeat), dizziness, sweating, these are anaphylactic reaction/shock may have symptoms. If any of the above-mentioned symptoms occur, stop taking Estrofem and seek emergency medical attention.
If you have one of these, you may need emergency medical attention or hospitalization.
The frequency of possible side effects is listed below in the following order:
Very common (affects more than 1 person in 10)
Common (affects 1 to 10 people in 100)
Uncommon (affects 1 to 10 people in 1000)
As with any medicine, estrogen therapy comes with potential side effects. Many women experience temporary, minor symptoms of endocrine system imbalance while taking estrogen therapy. However, some side effects are potentially serious and require medical attention. Some of these symptoms can be life-threatening, which is why it is important to keep your hands clean and dry when applying the treatment. These side effects should also be discussed with your doctor, as severe cases may require hospitalisation.
If you have breast cancer, have had breast cancer or are suspected of having breast cancer
if you have an estrogen-sensitive cancer, such as cancer of the lining of the uterus (endometrium), if you have ever had an estrogen-sensitive cancer, such as cancer of the lining of the uterus (endometrium), or if an estrogen-sensitive cancer is suspected
If you have undiagnosed vaginal bleeding
If you have untreated excessive thickening of the lining of the uterus (endometrial hyperplasia)
if you have or have ever had a blood clot (thrombosis) in the legs (deep vein thrombosis) or lungs (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 disease that causes blood clots in the arteries, such as a heart attack, stroke or angina
If you have or have ever had liver disease for which your liver function tests have not returned to normal
If you have a rare, familial (inherited) blood disease called porphyria
If you are allergic (hypersensitive) to any of the excipients in the composition of estradiol or Estrofem (see Excipients section).
Talk to your doctor before using Estrofem. If any of the following conditions have happened before, inform your doctor before starting treatment. These conditions may recur or be exacerbated during treatment with Estrofem. If so, you should visit your doctor more often for checkups.
If you have fibroids (benign tumors in the uterus) inside your uterus
If you have a history of tissue outside of your uterus (endometriosis) or an overgrowth of intrauterine tissue (endometrial hyperplasia)
if you have an increased risk of developing a blood clot (see Chapter 2 Blood clot in a vein (thrombosis))
If you have an increased risk of developing estrogen-sensitive cancer (if you have a mother, sister, or grandmother who has had breast cancer)
if you have high blood pressure
If you have a liver disorder such as a benign liver tumor
if you have diabetes
If you have gallstones
If you have migraines or severe headaches
if you have an immune system disease (systemic lupus erythematosus, SLE) that affects most organs of the body
If you have epilepsy
if you have asthma
If you have a disease that affects the eardrum and hearing (otosclerosis)
If your blood fat levels (triglycerides) are too high
If you have fluid retention (edema) due to heart or kidney diseases.