Ethinylestradiol and Cyproterone Tablets for Treatment of Androgen Dependent Diseases in Women

• Transport Package: Box
• Specification: 2mg*21tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC083-1
• Production Capacity: 10000PCS/ Month

Product Description

Item Name:Ethinylestradiol and cyproterone tablets
Molecular formula:

Item Description

Item nanme:Ethinylestradiol and cyproterone tablets
Item character:The product is yellow

Indication:
Ethinylestradiol and cyproterone tablets can be used for oral contraception.
Ethinylestradiol and cyproterone tablets are also used in the treatment of women with androgen dependent diseases, such as acne, especially the obvious types, and acne with seborrhea or inflammation or nodules (papular pustular acne, nodular cystic acne), women with androgen alopecia, mild hirsutism, and hyperandrogenism in patients with polycystic ovary syndrome

Item specifications:2mg*21tab/box

Usage and dosage:Route of administration:
Oral administration
Administration method
Ethinylestral should be taken regularly to achieve therapeutic effect and contraceptive protection. The hormone contraception previously used should be stopped. The dose scheme of ethinylestral is similar to that of most compound oral contraceptives. This must consider the same rules of administration. The failure rate of taking compound oral contraceptive correctly is about 1% every year. Taking ethinylestral and propargyprogesterone tablets irregularly can lead to interphase bleeding and may reduce the reliability of treatment and contraception.
How to take ethinylestradiol cycloproprogesterone tablets
The clothing must be delivered with a small amount of liquid at the same time every day in the direction indicated by the packaging. Take one tablet a day for 21 days. The next box of drugs begins 7 days after the drug is stopped, and withdrawal bleeding is usually occurring during the period. Usually bleeding begins 2-3 days after the last drug in the cycle, while the bleeding is not over at the beginning of the next drug box.
How to start taking ethinylestradiol cycloproprogesterone tablets
·No hormone contraceptives have been used (last 1 month)
The drug should be taken on the first day of the woman's natural menstrual cycle (i.e. the first day of menstrual bleeding). It can also start on day 2-5, but it is recommended that barrier contraception be added within the first 7 days of the first treatment cycle.

·Change from compound hormone contraceptive (compound oral contraceptive /coc), vaginal ring or transdermal patch

Women should start taking ethinylestradiol cycloproprogesterone tablets immediately after taking the last original COC containing hormone pills, but at the latest, they should take them at the end of the period of withdrawal of the original COC or the end of the period of use of hormone free pills. If the original use is vaginal ring or transdermal patch, it is better for women to take ethinylestral cycloproprogesterone tablets on the day they are removed, and should take the product at the latest before the next use begins.

·Change from the method of simple progesterone (pellets, injection, implant) or from the release of progesterone IUS

The compound cycloproprogesterone acetate tablets may be changed from pellets (implants or IUS should be taken out on the date of withdrawal and injection should be on the next injection day) at any time, but it should be recommended that barrier contraception should be added within the first 7 days of taking the drug.
·After early pregnancy abortion
You can start taking medicine immediately. In this case, no additional contraceptive methods are required.
·After delivery or after miscarriage in the middle of pregnancy
For breast-feeding women, see the section on "medication for pregnant women and lactating women".
It should be suggested that women should take medicine after delivery or the 21st-28th day after miscarriage of the middle pregnancy. If it starts later, it should be recommended that women use barrier method within the first 7 days of taking the drug. However, if sexual behaviour has occurred, pregnancy should be excluded before taking the compound cycloproprogesterone acetate tablet, or women should wait until the first menstrual surge.
Treatment of missed medication
If the user forgets to take the medicine for less than 12 hours, the protective effect on contraception will not be reduced. Once women think about it, they must take the medicine immediately, while taking the next drug at regular times.
If you forget to take more than 12 hours, contraceptive protection may be reduced. The treatment of missed medication can follow the following two basic principles:
1. stop taking medicine for no more than 7 days
2. it is necessary to take 7 days continuously to maintain proper inhibition of hypothalamus pituitary ovarian axis
The following suggestions can be given in daily use:
·Week 1
Users should take the last missed pills as soon as they think about it, even if this means taking two pills at the same time. Then continue taking the medicine at regular times. In addition, in the next 7 days, we should add barrier contraceptive methods such as condoms. If sexual behavior has occurred within 7 days before, the possibility of pregnancy should be considered. The more missed pills and the closer to the regular stop period, the higher the risk of pregnancy.
·Week 2
Users should take the last missed pills as soon as they think about it, even if this means taking two pills at the same time. Then continue taking the medicine at regular times. If the user takes the drug correctly within 7 days before the first missed drug, no additional contraceptive method is required. However, if this is not the case, or if more than one pill is missed, women should be recommended to use other contraceptive methods for 7 days.
·Week 3
Because the drug stop period is close to 7 days, the risk of reliability reduction is very high. However, the reduction of contraceptive protection can be prevented by adjusting the medication plan. If women take the first pill correctly within 7 days before they miss the first pill, then follow either of the following two recommendations, and the user does not need to take additional contraceptive measures. If not, it is recommended that women follow the first of the two recommendations and take additional preventive measures within the next seven days.
1. the user must take the last missed pill as soon as he can remember, even if this means taking two pills at the same time. Then continue taking the medicine at regular times. The next box of drugs was taken immediately after the drug was taken, i.e. there was no stopping period between the two boxes. It is unlikely that the user will have retreating bleeding until the second box of medicine is taken, but it may have a drip or breakthrough bleeding during the medication.
2. it is also recommended that women no longer continue to take the drug cycle. Stop the drug for 7 days, including the days of missed administration, and then start taking the next cycle of medication.
If women are given a drug leak and no withdrawal bleeding occurs during the first normal interval after the drug withdrawal, the possibility of pregnancy should be considered.
Suggestions for gastrointestinal disorders
If serious gastrointestinal discomfort occurs and absorption may not be complete, other contraceptive methods are required at the same time.
If vomiting occurs within 3-4 hours after taking the drug, the absorption may not be complete. In this case, the suggestion of "treatment of missed medication" can be considered. If a woman does not want to change her normal medication plan, she must take the drug supplement from another box.
Length of time used
As a contraceptive, as long as contraception is needed without contraindications, ethinylestradiol cycloproprogesterone tablets can be used all the time.
The time of use depends on the severity of the symptoms of feminization and the response to treatment, which usually takes months. Acne, seborrheic dermatitis usually respond to treatment earlier than hirsutis and alopecia.
It is recommended that the compound CIP tablet be taken for at least 3-4 cycles after the symptoms subside. If the treatment of the ketoprostone is performed (after 4 weeks or more after the withdrawal), the increased risk of VTE should be taken into account (see [precautions].
Special people use drugs
Liver injury patients
If the liver function index is not restored to normal, the product is forbidden for women with serious liver disease. See [taboos].
Kidney injury patients
No special studies have been conducted in patients with renal injury, and the data do not show that any changes may be caused by this product in patients with renal injury. Or follow the doctor's advice.

Adverse reactions
The following serious adverse events have been reported in women using COCs and discussed in the notes.
·Venous thromboembolism
·Arterial thromboembolism
·Cerebrovascular accident
·Hypertension
·Hypertriglyceridemia
·Impaired glucose tolerance or peripheral insulin resistance
·Liver tumors (benign and malignant)
·Liver dysfunction
·Chloasma
·In women with hereditary angioedema, exogenous estrogen may induce or aggravate the symptoms of angioedema.
·The relationship between the occurrence or aggravation of the disease and COC has not been determined: cholestasis related jaundice and / or pruritus; Gallstone formation; Purinemia; Systemic lupus erythematosus; Hemolytic uremic syndrome; Chorea; Herpes zoster of pregnancy, otosclerosis related hearing loss; Crohn's disease, ulcerative colitis, cervical cancer.
The diagnostic rate of breast cancer increased slightly in patients using oral contraceptives. As breast cancer is a rare disease in women under 40 years old, the increase is small relative to the overall risk of breast cancer. The relationship with COC is unknown. For more information, see taboos and precautions.

Taboo:
Compound preparations containing estrogen and progesterone cannot be used in any of the following situations. If any of the following conditions first occurs during the use of these preparations, the drug must be stopped immediately.
·History of thrombosis (vein or artery) or thrombosis (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident)
·There are precursor symptoms of thrombosis or have a history of it (e.g. transient cerebral ischemia attack, angina)
·Diabetes involving blood vessels
·Severe or multiple risk factors for venous or arterial thrombosis are also contraindications
·There is or has been a serious liver disease as long as the liver function value is not restored to normal
·The presence or history of liver tumors (benign or malignant)
·Known or suspected of malignant tumors in the reproductive organs or breast affected by sex steroids
·Undiagnosed vaginal bleeding
·Known or suspected pregnancy
·Lactation
·Allergic to any component of compound cycloproprogesterone acetate tablets
Compound cycloproprogesterone acetate tablets can not be used in men.

Matters needing attention:
The clinical and epidemiological experience of the compound of estrogen and progesterone, similar to that of ethinylestradiol, is mainly based on the compound oral contraceptive (COCs). Therefore, the following warnings related to the use of COCs are also applicable to ethinylestradiol cycloproprogesterone tablets.
warning
If any of the following situations / risk factors exist, each woman should weigh the benefits and potential risks of the application of ethinylestral CYCLOPROPYLENE pregnancy tablets, and discuss with her before she decides to start using it. Women should contact their doctors if any of the following conditions or risk factors aggravate, deteriorate or first occur. Doctors should decide whether ethinylestral cycloproprogesterone needs to be discontinued.
Circulatory diseases
Epidemiological studies have shown that the use of compound oral contraceptives (COCs) is associated with the increased risk of arteriovenous thrombosis and thromboembolism diseases such as myocardial infarction, deep vein thrombosis, pulmonary embolism and stroke. These events are rare.
VTE was the most dangerous in the first year of use. The risk increases when COC is started or the same or different COC is used again (the interval between the discontinuation lasts for 4 weeks or longer). A large prospective cohort study showed that risk increases were mainly in the first three months.
In short, low dose estrogen (< 50 μ The risk of thromboembolism in COCs women with g-ethinylestral) was 2-3 times higher than that of women without COCs and without pregnancy, but the risk was lower than that of pregnancy and childbirth.
VTE may cause death (1% - 2%).
VTE is characterized by deep static thrombosis and / or pulmonary embolism, which may occur during all COCs.
It is extremely rare that thrombosis of other blood vessels, such as liver, mesentery, kidney or retinal vein and artery, has been reported in contraceptive users. Whether these events are related to the use of COCs has not been a number of views.
The symptoms of DVT include: unilateral leg swelling or vein swelling of extended leg; Leg pain or tenderness when standing or walking; The warmth of legs increased; The skin of the legs is red or discolored.
The symptoms of PE may include sudden unexplained shortness of breath or shortness of breath; The cough may be accompanied by bleeding; Acute chest pain may be accompanied by increased deep breathing; Anxiety; Severe dizziness or vertigo. Rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are not unique and may result from other common or non serious events (for example, respiratory infections).
Arterial hromboembolism events may include cerebrovascular accidents, vascular occlusion, or myocardial infarction (M1). The symptoms of cerebrovascular accidents may include: sudden numbness or weakness of face, arm or leg, especially one side body; The sudden consciousness is vague, language or comprehension is obstructed; One side or two sides of vision disorder; Sudden walking disorder, vertigo, loss of balance or coordination ability; Long term headache with sudden, serious or unknown reasons; Loss of consciousness or fainting with or without seizure. Other signs of occlusion may include sudden pain, swelling of extremity end and discoloration of pale blue; Acute abdominal pain.
The symptoms of MI include pain, discomfort, compression, heaviness, compression and swelling in the lungs, arms or sternum. Discomfort radiates to the back, the Hubei, throat, arm and stomach; Feeling of inflation, dyspepsia or asphyxia; Sweating, malignant, vomiting or vertigo; Extreme weakness, anxiety, or shortness of breath; Speak fast or beat irregularly.
Arterial thromboembolism may lead to death.
The risk of venous or arterial thrombosis or thromboembolism events or cerebrovascular accidents can increase with the following:
-Age:
-Obesity (BMI over 30kg / m2);
-Positive family history (such as siblings or parents having venous or arterial thromboembolism at an earlier age). If family genetic factors are suspected, consult with experts before deciding to use any COC;
-Long term braking, large surgery, any leg operation, or larger gouging. In these cases, it is suggested to stop taking COC (stop the drug at least 4 weeks at least) until the activity is fully restored for 2 weeks before taking the drug;
-Smoking (large number of smoking and increased age further increased risk, especially for women over 35 years old);
-Abnormal lipoproteinemia;
-Hypertension;
-Migraine;
-Heart valve disease;
-Atrial fibrillation.
There is no consensus on the possible role of varicose and superficial thrombophlebitis in the process of VTE.
The increased risk of thromboembolism during the puerperal period should be considered (see [medication for pregnant and lactating women].
Other clinical conditions related to circulatory adverse events include diabetes, polycystic ovarian syndrome, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (clonal disease or ulcerative colitis), and sickle cell disease.
During COC use, migraine attack frequency or severity increased (possibly a precursor symptom of cerebrovascular accident), and this may require immediate withdrawal of COC.
It suggests that there may be genetic or acquired biochemical factors of venous or arterial thrombosis, including activated protein C (APC) resistance, hypercysteinemia, antithrombin deficiency, protein C deficiency, protein S deficiency, anti phospholipid antibody (anti myocardial phospholipid antibody, lupus anticoagulant)
When weighing the benefits and disadvantages, doctors should consider that appropriate treatment of a condition may reduce the risk of associated thrombosis and that the risk of thromboembolism associated with pregnancy is higher than that associated with the use of low-dose COCs ([0.05mg ethynylene).
tumour
The most important risk factor for cervical cancer is persistent HPV infection. Some epidemiological studies have shown that long-term use of COC will further increase the risk, but there is still controversy about how much of the increased risk can be attributed to confounding effects such as cervical screening and sexual behaviour, including the use of barrier contraceptive methods.
Meta analysis of 54 epidemiological studies showed that the relative risk of breast cancer diagnosis (rr=1.24) in women who are using COCs has increased slightly. The increased risk gradually disappeared in the 10 years after the use of COC was stopped. Since breast cancer is rarely seen in women under 40 years old, there is a small increase in the number of breast cancer diagnoses in the patients who are using and recently using COC, relative to the overall risk of breast cancer. These studies do not provide causal evidence. The increased risk seen may be due to early diagnosis of breast cancer in COC users, biological effects of COC, or the combination of both. Breast cancer diagnosed is often earlier in the past than in the past.
There have been rare benign liver tumors and even more rare malignant liver tumors in COCs users. In individual cases, these tumors cause life-threatening intraperitoneal hemorrhage. When women taking COCs have severe abdominal pain, liver enlargement or signs of abdominal hemorrhage, the differential diagnosis should consider liver tumors.
Other circumstances
Women with hyperglycinemia or family history may have increased risk of pancreatitis when taking COCs.
Although mild blood pressure increases have been reported in many women taking COCs, clinically significant increases are rare. However, if a continuous clinically significant hypertension occurs during the use of a COC, the doctor should consider discontinuing COC and treating hypertension with caution. If the blood pressure is normal after the treatment of hypotension, COC can be recovered at the appropriate time.
There are reports of the following conditions or deterioration during pregnancy and when COC is used, but there is no conclusive evidence of COC use: anthrax and / or pruritus associated with cholestasis; Gallstone formation; Porphyria; Systemic lupus erythematosus; Hemolytic uremic syndrome; Sydenham choreography; Herpes gravis; Hearing loss associated with otosclerosis.
Exogenous estrogen may induce or aggravate the symptoms of vascular edema in women with hereditary vascular edema.
The COC should be stopped in the case of acute or chronic liver dysfunction until the liver function index returns to normal. COC should be stopped for the first time in the recurrence of cholestatic jaundice during pregnancy or previous use of steroid hormone.
Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence that diabetic patients taking low-dose COC (< o.o5 ethinylestral) need to change the treatment plan. However, the condition of women with diabetes should be carefully observed during coos administration.
Clonal disease and ulcerative colitis are associated with the use of COC.
Occasionally, chloasma, especially in women with a history of pregnancy, has been observed. Women with browning tendency should avoid exposure to sunlight or ultraviolet radiation during COCs.
If the symptoms of women with hirsutism are developing or aggravating, the cause of the disease (androgen producing tumor, adrenal enzyme defect) must be identified by differential diagnosis.
Each tablet contains 31 lactose. For patients with rare genetic galactose intolerance, lapprolase deficiency or glucose galactose absorption disorder who cannot take lactose, it should be considered.
Medical examination / consultation
Before starting or reusing ethinylestral cycloproperosterone tablets, complete medical history and comprehensive physical examination shall be collected according to the requirements of Taboo (see [taboo] and warning (see "warning" under [precautions], and regular review shall be conducted. Regular medical evaluation is also important because taboos (such as transient cerebral ischemia attacks, etc.) or risk factors (such as family history of venous or arterial thrombosis) may appear for the first time during the use of ethinylestradiol cycloproperosterone tablets. The frequency and nature of these medical assessments should be based on established clinical procedures and suitable for individual conditions of each woman, but special attention should be paid to blood pressure, breast, abdomen and pelvic vessels and cervical cytology.
Women should be told that oral contraceptives do not prevent HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficacy
The contraceptive effect of ethinylestral cycloproperosterone tablets may be reduced in the event of missed Administration (see "treatment of missed medication" under [usage dosage], gastrointestinal dysfunction (see "recommendations for gastrointestinal disorders" under [usage dosage], or taking other drugs (see [drug interaction]).
Influence cycle control
All patients who take the compound may have irregular bleeding (drip or breakthrough bleeding), especially in the first month of use. Therefore, it is important to evaluate any irregular bleeding after about 3 cycles of adaptation.
If irregular bleeding persists or occurs after the previous regular cycle, non hormone causes should be considered and appropriate diagnostic measures should be taken to exclude malignant tumors or pregnancy. These may include curettage.
Some women may not have retreating bleeding during the period of withdrawal. If COC is taken in accordance with the above method, it is unlikely that women will be pregnant (see Section [usage amount]. However. If no withdrawal bleeding has occurred for the first time or two times without withdrawal bleeding, pregnancy must be excluded before continuing to take COC.
No studies have been conducted on the impact of driving and mechanical operation capabilities. No effect of the use of this product on driving and mechanical operation capability was observed.
Please consult your doctor if any adverse events / adverse reactions occur during the use of this product.
Please let the doctor know if you use other drugs at the same time.

Medication for pregnant and lactating women:
pregnant woman
Ethinylestradiol and cyproterone tablets should not be used during pregnancy. If pregnancy occurs during taking ethinylestradiol and cyproterone tablets, the drug should be stopped immediately( See preclinical safety data)
lactation
Ethinylestradiol and cyproterone tablets are also forbidden during lactation. Cyproterone acetate can enter the milk of lactating women. About 0.2% of the mother's dose can reach the newborn through milk, which is equivalent to 1 mg / kg. During lactation, 0.02% of the mother's daily dose of ethinylestradiol is transported to the newborn through milk.

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