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Drospirone ethinylestradiol tablets (ursamine)

Common name:
Drospirenone and Ethinylestradiol Tablets
Product No.:
B14202011917
Approval No.:
Gyzz j20171071 (original h20130392)
Main functions:
Female contraception.
Product specification:
(0.03mg+3mg)*21s
Manufacturer:
Schering GmbH & Co. produktions kg (Germany) (sub packaged by Bayer healthcare Co., Ltd. Guangzhou Branch)
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Product name Drospirone ethinylestradiol tablets (ursamine)
Main raw materials This product is a compound preparation. Its components are: each tablet contains 3mg drospirone and 0.03mg ethinylestradiol.
Main role Female contraception.
Suitable population
Product specification (0.03mg+3mg)*21s
Usage and dosage How to take this product If taken correctly, the annual contraceptive failure rate of compound oral contraceptives is about 1%. If drugs are missed or taken incorrectly, the contraceptive failure rate will rise. It must be delivered with a small amount of liquid at about the same time every day in the order indicated on the package. Take one tablet daily for 21 days. Take the next box of medicine after 7 days of withdrawal, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last tablet of the cycle, and the bleeding may not be over when starting the next box of drugs. How to start taking this product 1. Women who did not use hormonal contraceptives before starting medication (last month) The drug should be taken on the first day of a woman's natural menstrual cycle (i.e. the first day of menstrual bleeding); It can also start from day 2-5. In this case, it is recommended to use barrier contraception in the first 7 days of the first service cycle. 2. Women who take another compound hormonal contraceptive (compound oral contraceptive / COC), vaginal ring or transdermal patch It is best to start taking this product on the second day after taking the last hormone containing drug of COC previously used. At the latest, it should start taking this product immediately at the end of the withdrawal period of COC previously used or at the end of the period of using hormone free tablets. For women who have used vaginal rings or transdermal patches, it is best to start taking this product on the day of removal, but it should be taken at the latest at the next time. 3. Women who change from simple progesterone method (pellets, injections, implants) or from the intrauterine contraceptive system (IUS) that releases progesterone This product can be changed at any time from pellets (from implants or from IUS, it should be taken on the removal date, and from injection, it should be at the next injection port). However, for all these cases, it should be recommended to use barrier contraception within the first 7 days of taking medicine. 4. Women after early pregnancy and abortion You can start taking medicine immediately. In this case, there is no need to add other contraceptive methods. 5. After delivery or second trimester pregnancy abortion Please refer to [medication for pregnant women and lactating women] for the administration method of lactating women Women should be advised to start taking it after delivery or 21-28 days after second trimester abortion. If it starts late, women should be advised to use barrier contraception within the first 7 days of taking medicine. However, if you have had sex, you should exclude the possibility of pregnancy before taking this product, or wait until the first menstrual tide. Treatment of missed medication If the user forgets to take the medicine within 12 hours, the contraceptive protection will not be reduced. Once women think of it, they must take it immediately. The next pill should be taken at a regular time. If you forget to take medicine for more than 12 hours, the protective effect of contraception may be reduced. The treatment of missing medicine can follow the following two basic principles: 1. In any case, stop taking medicine for no more than 7 days. 2. It needs to be taken continuously for 7 days to maintain full inhibition of hypothalamic pituitary ovarian axis. (see the inner package manual for details)
manufacturing enterprise Schering GmbH & Co. produktions kg (Germany) (sub packaged by Bayer healthcare Co., Ltd. Guangzhou Branch)
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[drug name]

   Common name: Drospirenone and Ethinylestradiol Tablets

   Trade name: Drospirone ethinylestradiol tablets (ursamine)

   English Name:

   Pinyin full code: QuLuoTongQueCiChunPian(YouSiMing)

[main ingredients] This product is a compound preparation. Its components are: each tablet contains 3mg drospirone and 0.03mg ethinylestradiol.

[ingredients]

   Chemical name:

   Molecular formula:

   Molecular weight:

[character] Light yellow film coated tablets, white after removing the coating.

[indications / functional indications] Female contraception.

[specification and model] (0.03mg+3mg)*21s

[usage and dosage] How to take this product If taken correctly, the annual contraceptive failure rate of compound oral contraceptives is about 1%. If drugs are missed or taken incorrectly, the contraceptive failure rate will rise. It must be delivered with a small amount of liquid at about the same time every day in the order indicated on the package. Take one tablet daily for 21 days. Take the next box of medicine after 7 days of withdrawal, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last tablet of the cycle, and the bleeding may not be over when starting the next box of drugs. How to start taking this product 1. Women who did not use hormonal contraceptives before starting medication (last month) The drug should be taken on the first day of a woman's natural menstrual cycle (i.e. the first day of menstrual bleeding); It can also start from day 2-5. In this case, it is recommended to use barrier contraception in the first 7 days of the first service cycle. 2. Women who take another compound hormonal contraceptive (compound oral contraceptive / COC), vaginal ring or transdermal patch It is best to start taking this product on the second day after taking the last hormone containing drug of COC previously used. At the latest, it should start taking this product immediately at the end of the withdrawal period of COC previously used or at the end of the period of using hormone free tablets. For women who have used vaginal rings or transdermal patches, it is best to start taking this product on the day of removal, but it should be taken at the latest at the next time. 3. Women who change from simple progesterone method (pellets, injections, implants) or from the intrauterine contraceptive system (IUS) that releases progesterone This product can be changed at any time from pellets (from implants or from IUS, it should be taken on the removal date, and from injection, it should be at the next injection port). However, for all these cases, it should be recommended to use barrier contraception within the first 7 days of taking medicine. 4. Women after early pregnancy and abortion You can start taking medicine immediately. In this case, there is no need to add other contraceptive methods. 5. After delivery or second trimester pregnancy abortion Please refer to [medication for pregnant women and lactating women] for the administration method of lactating women Women should be advised to start taking it after delivery or 21-28 days after second trimester abortion. If it starts late, women should be advised to use barrier contraception within the first 7 days of taking medicine. However, if you have had sex, you should exclude the possibility of pregnancy before taking this product, or wait until the first menstrual tide. Treatment of missed medication If the user forgets to take the medicine within 12 hours, the contraceptive protection will not be reduced. Once women think of it, they must take it immediately. The next pill should be taken at a regular time. If you forget to take medicine for more than 12 hours, the protective effect of contraception may be reduced. The treatment of missing medicine can follow the following two basic principles: 1. In any case, stop taking medicine for no more than 7 days. 2. It needs to be taken continuously for 7 days to maintain full inhibition of hypothalamic pituitary ovarian axis. (see the inner package manual for details)

[adverse reactions] The phase III clinical trial conducted in China showed that 163 (28.6%) of the 570 patients in the yousiming group had drug-related adverse events in the whole clinical trial. The three most common treatment-related adverse events (the incidence was more than or close to 5%) were irregular uterine bleeding (36 cases, i.e. 6.3%), nausea (27 cases, i.e. 4.7%) and emotional fluctuation (32 cases, i.e. 5.6%). These events were known adverse reactions of compound oral contraceptives. In the trial, two cases (0.4%) of pregnancy were the serious adverse events definitely related to the test drug in the yousiming group. Both patients had missed or delayed taking the drug before pregnancy was found. There were no other serious adverse reactions in patients taking ursamine. (see the inner package manual for details)

[taboo] Compound oral contraceptives (COCs) shall not be used in any of the following situations. If any of the following conditions occurs for the first time during the use of COC, the drug must be stopped immediately. 1. Venous or arterial thrombosis / thromboembolism (such as deep venous thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular accident, or have the above history 2. There are precursor symptoms of thrombosis or related history (e.g. transient ischemic attack, angina pectoris) 3. History of migraine with focal neurological symptoms 4. Diabetes mellitus involving blood vessels. 5. Severe or multiple risk factors for venous or arterial thrombosis are also contraindications 6. Pancreatitis or history with severe hypertriglyceridemia 7. There is or has been a history of serious liver disease, as long as the indicators of liver function do not return to normal 8. Severe renal insufficiency or acute renal failure 9. Adrenal insufficiency 10. Presence or history of liver tumor (benign or malignant) 11. Known or suspected malignant tumors affected by sex steroids (e.g. reproductive organs or breast) 12. Unexplained vaginal bleeding 13. Known or suspected pregnancy 14. Allergic to the active ingredient of this product or any of its excipients (see the inner package manual for details)

[precautions] warning If any of the following situations / risk factors exist, each woman should weigh the benefits and possible risks of applying COC and discuss with her before she decides to start taking medicine. If any of the following conditions or risk factors aggravate, worsen or appear for the first time, contact a doctor. The doctor should decide whether COC should be discontinued. ·Circulatory diseases Epidemiological studies have shown that the use of COCs is related to the increased risk of arteriovenous thrombosis and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and cerebrovascular events. These events are rare. The risk of venous thromboembolism (VTE) is the highest within the first year of use. The risk increases when COC is started or when the same or different COC is used again (the withdrawal interval lasts 4 weeks or more). Data from a large prospective 3-group cohort study showed that the increased risk mainly occurred in the first 3 months. In conclusion, low-dose estrogen (< 50 μ The risk of venous thromboembolism in women with g-ethinylestradiol) COCs is 2-3 times higher than that in women without COCs and not pregnant, but the risk is lower than that in pregnancy and delivery. VTE may be life-threatening or cause death (1% - 2%). Epidemiological studies have shown that the risk of VTE of OCS containing drospirone is higher than that of OCS containing levonorgestrel (i.e. the second generation of oral contraceptives), which may be equivalent to that of OCS containing deoxypregnene / pregnenone (i.e. the third generation of oral contraceptives). Venous thromboembolism (VTE) is characterized by deep venous thrombosis and / or pulmonary embolism, which may occur during the use of all COCs. Very rarely, thrombosis of other blood vessels, such as liver, mesentery, kidney, brain or retinal veins and arteries, has been reported in COC users. There is no consensus on whether the occurrence of these events is related to the use of COCs. Symptoms of deep venous thrombosis (DVT) include unilateral leg swelling or swelling along leg veins; Leg pain or tenderness when standing or walking; Increased warmth of legs; Redness or discoloration of leg skin. Symptoms of pulmonary embolism (PE) may include sudden unexplained shortness of breath or shortness of breath; Sudden cough may be accompanied by bleeding; Acute chest pain may be accompanied by increased deep breathing; Anxiety; Severe dizziness or dizziness; Rapid or irregular heartbeat. Some of these symptoms (e.g., shortness of breath, cough) are not unique and may be considered to result from other common or non serious events (e.g., respiratory infection). Arterial thromboembolic events may include cerebrovascular accident, vascular occlusion, or myocardial infarction (MI). Cerebrovascular accident symptoms may include: sudden anesthesia or weakness of the face, arm or leg, especially one side of the body; Sudden vague consciousness, language or comprehension disorder; Sudden unilateral or bilateral visual impairment; Sudden walking disorder, dizziness, loss of balance or coordination; Sudden, serious or unexplained long-term headache; Loss of consciousness or fainting with or without seizures. Other signs of vascular occlusion may include sudden pain, swelling and bluish discoloration at the end of the limb; Acute abdominal pain. The symptoms of myocardial infarction (MI) also include pain, discomfort, pressure, heaviness, squeezing and inflation in the lungs, arms or under the sternum, and discomfort radiates to the back, jaw, throat, arms and stomach; Feeling of fullness, indigestion or suffocation; Sweating, nausea, vomiting or dizziness; Extreme weakness, anxiety or shortness of breath; Rapid or irregular heartbeat. Arterial thromboembolic events may be life-threatening or lead to death. The risk of venous or arterial thrombosis / thromboembolic events or cerebrovascular accidents can increase with the following conditions: -Increasing age; -Obesity (body mass index over 30 kg / m2); -Positive family history (i.e. siblings or parents had venous or arterial thromboembolism at an earlier age). If genetic susceptibility is suspected, consult a specialist before deciding to use any COC; -Prolonged braking, major surgery, any leg surgery, or major trauma. For these cases, it is recommended to stop taking COC (at least 4 weeks before elective surgery) until two weeks after complete recovery of activity. -Smoking (the risk increases further with the increase of smoking volume and age, especially for women over the age of 35); -Abnormal lipoprotein; -Hypertension; -Migraine; -Heart valve disease; -Atrial fibrillation; There is no consensus on the possible role of varices and superficial thrombophlebitis in venous thromboembolism. The increased risk of puerperal thromboembolism should be considered (see [medication for pregnant and lactating women]). Other clinical conditions related to circulatory system adverse events include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease. During the use of COC, the frequency of migraine attacks or the degree of pain increase (which may be a precursor of cerebrovascular accident), which may require immediate withdrawal of COC. It is suggested that there may be biochemical factors of genetic or acquired venous or arterial thrombosis susceptibility, including active protein C (APC) resistance, homocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibody (anticardiolipin antibody, wolf sore anticoagulant). When weighing the pros and cons, doctors should consider that adequate treatment of a condition may reduce the risk of thrombosis and that the risk of thrombosis associated with pregnancy is higher than that associated with the use of low-dose COC (ethinylestradiol < 0.05 mg). ·Tumor The most important risk factor for cervical cancer is persistent HPV infection. Some epidemiological studies have shown that long-term use of COCs can further increase this risk. However, the extent to which this result should be attributed to confounding effects, such as official neck screening and sexual behavior, including the use of barrier contraceptives, has been controversial. A meta-analysis of 54 epidemiological studies showed that the relative risk of breast cancer diagnosed by COCs was slightly increased (RR=1.24). The increased risk gradually disappeared in the 10 years after the cessation of COC use. Because breast cancer rarely occurs in women under the age of 40, the number of breast cancer diagnosed in recent and COC is very small compared to the overall risk of breast cancer. These studies provide no causal evidence. The increased risk may be due to early diagnosis of breast cancer in COC users, biological effects of COCs, or both. Compared with those who never used COC, breast cancer patients who had used COC were often in an earlier stage. Rare benign liver tumors and even more rare malignant liver tumors have been reported among COCs users. In individual cases, these tumors caused life-threatening intraperitoneal bleeding. When women taking COCs have signs of severe upper abdominal pain, liver enlargement or intraperitoneal hemorrhage, liver tumors should be considered in the differential diagnosis. Malignant tumors can be life-threatening or cause death. ·Other situations In patients with renal insufficiency, potassium excretion is limited. In a clinical study, drospirone showed no effect on serum potassium concentration in patients with mild or moderate renal impairment. Only for patients with renal impairment whose serum potassium is at the upper limit of the normal range before treatment and who are using potassium preserving diuretics, there may be a risk of hyperkalemia in theory. In women with hypertriglyceridemia or family history, taking COCs may increase the risk of pancreatitis. Although mild increases in blood pressure have been reported in many women taking COCs, clinically significant increases are rare. The increase of blood pressure induced by ethinylestradiol in women with normal blood pressure may be antagonized by the anti mineralocorticoid effect of drospirone. However, if sustained clinically significant hypertension occurs during the use of a COC, doctors should carefully consider stopping COC and treating hypertension. If the blood pressure returns to normal after antihypertensive treatment, the doctor can resume taking COC at an appropriate time. It has been reported that during pregnancy and taking COC, the following conditions occur or worsen, but the evidence related to the use of COC is uncertain: jaundice and / or pruritus related to cholestasis; Gallstone formation; Porphyria; Systemic lupus erythematosus; Hemolytic uremic syndrome; Minor chorea; Herpes gravidarum; Hearing loss associated with otosclerosis. In women with hereditary angioedema, exogenous estrogen can induce or aggravate the symptoms of angioedema. Acute or chronic liver dysfunction requires discontinuation of COC until liver function indicators return to normal. COCs should be discontinued when cholestatic jaundice first occurs during pregnancy or during previous use of sex steroids. Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence that diabetic patients requiring low-dose COCs (estriol 0.05mg) need to change the treatment regimen. However, we should carefully observe the situation of diabetic women taking COCs. Crohn's disease and ulcerative colitis are associated with the use of COC. Chloasma occasionally occurs, especially in women with a history of pregnancy chloasma. Women with chloasma tendency should avoid exposure to sunlight or ultraviolet radiation during taking COCs. Each tablet contains 46mg lactose. Lactose intake should be considered in patients with rare genetic galactose intolerance, Laplace lactase deficiency or glucose galactose absorption disorder. [u] Medical examination / consultation [/ u] Before taking COC for the first time or again, complete medical history and comprehensive physical examination shall be collected and rechecked regularly according to the requirements of contraindications (see [contraindications]) and warnings (see). Regular medical evaluation is also important because contraindications (e.g. transient ischemic attack) or risk factors (e.g. family history of venous or arterial thrombosis) may appear for the first time during COC. The frequency and nature of these medical assessments should be based on established clinical norms and should be performed on individual women, but generally should focus on blood pressure, breast, abdominal and pelvic organs, including cervical cytology. Women should be told that oral contraceptives can not prevent HIV infection (AIDS) and other sexually transmitted diseases. [u] Reduced efficacy [/ u] In case of missed Administration (see [usage and dosage]), gastrointestinal disorder (see [usage and dosage]) or taking other drugs at the same time, the efficacy of COC may be reduced (see [drug interaction]). [u] Affect cycle control [/ u] Irregular bleeding (drip or breakthrough bleeding) may occur in all COCs users, especially in the first few months of use. Therefore, the evaluation of any irregular bleeding is meaningful only after about 3 cycles of adaptation. If irregular bleeding persists or occurs after regular cycles, non hormonal causes should be considered and appropriate diagnostic measures should be taken to exclude malignancies or pregnancy. These measures may include curettage. Some women may not have withdrawal bleeding during withdrawal. If COC is taken according to the method described in [usage and dosage], women are unlikely to have pregnancy. However, if you do not take medicine according to these methods before the first withdrawal bleeding, or do not take withdrawal bleeding twice, pregnancy must be excluded before continuing to take COC. ·Laboratory examination The use of steroid contraceptives may affect the results of some laboratory tests, including biochemical indexes of liver, thyroid, adrenal and renal function, plasma (carrier) protein levels, such as corticosteroid binding globulin and lipid / lipoprotein fraction, carbohydrate metabolism indexes, and coagulation and fibrinolysis indexes. Changes are usually maintained within the normal laboratory test range. Drospirone leads to the increase of plasma renin activity, and its slight anti salt cortical activity induces the increase of plasma aldosterone level. No study has been conducted on the impact on driving and mechanical operation ability. No effect of the use of COCs on driving and mechanical operation was observed. Store all medicines properly and keep out of the reach of children. (see the instructions inside the package for details) please read the instructions carefully and follow the doctor's advice.

[medication for children] This product is not suitable for children.

[medication for elderly patients] Not applicable. This product cannot be used after menopause.

[medication for pregnant and lactating women] pregnant woman This product is forbidden during pregnancy. If pregnancy occurs while taking this product, you must stop using it. However, a large number of epidemiological studies have shown that the incidence of birth defects in infants born to women taking COCs before pregnancy has not increased, and the teratogenic effect of women taking COCs during early pregnancy has not increased. One child was born with esophageal atresia. The causal relationship between this event and this product is not clear. The data on taking this product during pregnancy are very limited, and the conclusion of adverse effects on pregnancy, fetus or newborn can not be drawn. So far, there is no relevant epidemiological data.? lactation Lactation may be affected by COCs because they can reduce milk secretion and change the composition of milk. Therefore, the use of COCs is usually not recommended until lactating women are completely weaned. A small amount of contraceptive steroids and / or their metabolites may be secreted from milk. (see the inner package manual for details)

[drug interaction] drugInteractions

[drug overdose] So far, there is no clinical experience of overdose of this product. There were no reports of serious toxic effects due to drug overdose in preclinical studies. Based on the general experience of COC, the possible symptoms in this case are nausea and vomiting, and mild vaginal bleeding may occur in young girls. There is no antidote and further treatment is symptomatic treatment.

[pharmacology and toxicology] 1. Pharmacological action The contraceptive effect of compound oral contraceptives (COCs) is based on the interaction of many factors, the most important of which is to inhibit ovulation and change cervical secretion. In addition to the contraceptive effect, although COCs have the adverse characteristics mentioned in (warnings and adverse reactions), they also have many favorable characteristics: more regular menstrual cycle, less dysmenorrhea and less bleeding. The latter can reduce the occurrence of iron deficiency. In addition to contraception, drospirone also has other favorable characteristics. * spiracone has anti salt corticosteroid activity and prevents body weight gain and other symptoms caused by fluid retention. * it provides good tolerance against estrogen related sodium retention, and has a positive effect on premenstrual syndrome (PMS). When combined with ethinylestradiol, drospirone increased the level of high density lipoprotein (HDL) and showed a good lipid spectrum. The antiandrogen activity of drospirone has a good effect on the skin and reduces acne damage and sebum production. In addition, drospirone did not antagonize the increase of SHBG related to ethinylestradiol, which was conducive to the binding and inactivation of endogenous androgens. Drospirone has no activity of androgen, estrogen, glucocorticoid and anti glucocorticoid. This characteristic, combined with its anti mineralocorticoid and anti androgen characteristics, makes the biochemical and pharmacological properties of drospirone very similar to natural progesterone. In addition, there is evidence that the risk of endometrial and ovarian cancer is reduced. Moreover, higher doses of COCs (ethinylestradiol 0.05 mg) have been shown to reduce the incidence of ovarian cysts, pelvic inflammation, benign breast diseases and heterozygous pregnancies. Whether this also applies to lower doses of COCs remains to be confirmed. 2. Toxicological research Routine tests of preclinical repeated administration toxicity, genetic toxicity, potential carcinogenicity and reproductive toxicity show that it is not particularly dangerous to human body. However, it must be remembered that sex steroids may promote the growth of some hormone dependent tissues and tumors. (see the inner package manual for details)

[pharmacokinetics] Not yet clear.

[storage] Store at 30 ℃.

[packaging] 21 pieces / box

[validity period] 36 months

[executive standard] Registration standard for imported drugs jx20050089

[approval No.] Gyzz j20171071 (original h20130392)

[manufacturer] Schering GmbH & Co. produktions kg (Germany) (sub packaged by Bayer healthcare Co., Ltd. Guangzhou Branch)

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