Ethinylestradiol Cyproterone Tablets

The ingredient cyproterone acetate contained in compound cyproterone acetate tablets can inhibit the effects of androgens produced by the female body. This may treat diseases caused by excessive androgen production or special sensitivity to androgens. The increased function of sebaceous glands, which plays an important role in the occurrence of acne and seborrheic dermatitis, can be inhibited when taking compound cyproterone acetate tablets. This usually allows the existing acne rash to heal after 3-4 months of treatment. Excess oil on the hair and skin generally disappears earlier. The hair loss that usually accompanies seborrheic dermatitis will also be alleviated. Compound cyproterone acetate tablets are suitable for treatment of mild hirsutism, especially women of childbearing age with slightly more facial hair, but the treatment results often need to be clearly manifested after several months of medication. In addition to the above-mentioned anti-androgenic effects, cyproterone acetate also has obvious progestin effects. Cyproterone acetate alone can cause menstrual cycle disorders, while compound cyproterone acetate tablets with ethinyl estradiol can avoid this situation. Just take the medicine according to the instructions. The contraceptive effect of combined cyproterone acetate tablets is based on the interaction of multiple factors. The most important of these are the inhibition of ovulation and the change of cervical secretion. In addition to the unfavorable characteristics in [Precautions] and [Adverse Reactions], the combined use of estrogen and progesterone has many favorable characteristics, and its contraceptive effect is helpful in deciding the method of birth control. The menstrual cycle is more regular, dysmenorrhea is relieved, and the amount of bleeding is reduced. The latter can reduce the incidence of iron deficiency. In addition, there is evidence that the risk of endometrial cancer and ovarian cancer is reduced. Moreover, higher doses of combined oral contraceptives (0.05 mg ethinyl estradiol) have been shown to reduce the incidence of ovarian cysts, pelvic inflammation, benign breast disease and ectopic pregnancy. Whether these also apply to lower doses of combined oral contraceptives remains to be confirmed. Preclinical safety data In the systemic tolerance study of repeated oral administration in animal experiments of systemic toxicity, no signs of systemic intolerance were observed, so it does not prevent the therapeutic dose from being used in humans for the prescribed indications. Animal experimental studies on possible allergic reactions to cyproterone acetate and ethinyl estradiol have not been conducted. Embryotoxicity/Teratogenicity Studies on embryotoxic and teratogenic effects of the two active ingredients combined have shown that no common reactions suggestive of teratogenic effects were observed during the period of organogenesis before the development of the external genitalia. High doses of cyproterone acetate administered during the period of differentiation of the hormone-sensitive reproductive organs (approximately after 45 days of gestation) may result in feminization of male fetuses. No feminization signs were observed in male newborns who were exposed to cyproterone acetate in utero. However, pregnancy is a contraindication to the use of combined cyproterone acetate tablets. Reproductive toxicity and carcinogenicity Clinical experience and high-quality epidemiological studies have so far not supported an increased incidence of liver tumors in humans. Tumorigenicity studies with cyproterone acetate in rodents have also not shown a predisposition to specific tumors. However, it must be remembered that sex steroids can promote the growth of certain hormone-dependent tissues and tumors. Such DNA adducts are formed at certain exposures, which is what is expected to occur at the recommended cyproterone acetate dosage regimen. Cyproterone acetate treatment may cause focal, possibly premalignant, liver damage in vivo, manifested by changes in cellular enzymes in female rats and increased mutation rates in transgenic mice carrying a bacterial gene that was used as a mutation target.

This product is a compound preparation, and its components are: each tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinyl estradiol.

This product is a film-coated tablet. After removing the film coating, it appears white or off-white.

Cyproterone acetate can be used as an oral contraceptive. Oral contraceptives are very effective methods of birth control. When taken correctly (no missed doses), the chance of pregnancy is very small. Cyproterone acetate is also used to treat androgen-dependent diseases in women, such as acne, especially the obvious type, and acne with seborrhea or inflammation or nodule formation (papulopustular acne, nodulocystic acne), androgenic alopecia in women, mild hirsutism, and symptoms of high androgen levels in women with polycystic ovary syndrome.

1. How to take Compound Cyproterone Acetate Tablets Take with a small amount of warm or cold water at about the same time every day. Take 1 tablet daily for 21 consecutive days. Start the next box of pills 7 days after stopping the pills, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after the last pill of the cycle is taken, and the bleeding may not end when the next box of pills is started. 2. How to start taking Compound Cyproterone Acetate Tablets · Women who have not used hormonal contraceptives in the past (in the past 1 month) should start taking the pills on the first day of the woman's natural menstrual cycle (i.e. the first day of menstrual bleeding). It can also be started on the 2nd to 5th day, but it is recommended to add a barrier contraceptive method within the first 7 days of taking the pills in the first treatment cycle. · It is best to start taking Compound Cyproterone Acetate Tablets immediately after taking the last active tablet of the previous oral contraceptive, but at the latest at the end of the withdrawal period of the previous oral contraceptive. ·Switching from a progestogen-only method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) You can switch from the minipill (implant or IUS should be on the day of removal, injection should be on the day of the next injection) to combined cyproterone acetate tablets at any time, but in all these cases, a barrier method of contraception should be added during the first 7 days of taking the tablets. ·The tablets can be started immediately after an early pregnancy abortion. In this case, no other contraceptive method is needed. ·For breastfeeding women after childbirth or after a second-trimester abortion, see the section [Medication for pregnant and breastfeeding women]. Women should be advised to start taking the tablets on the 21st to 28th day after childbirth or after a second-trimester abortion. If started later, women should be advised to add a barrier method during the first 7 days of taking the tablets. However, if sexual intercourse has already occurred, pregnancy should be excluded before actually starting to take combined cyproterone acetate tablets, or the tablets should be taken until the woman's first menstrual period. 3. Treatment of missed pills If the user forgets to take a pill within 12 hours, the contraceptive protection will not be reduced. Once remembered, the pill must be taken immediately, and the next pill should still be taken at the regular time. If the time of forgetting to take a pill exceeds 12 hours, the contraceptive protection may be reduced. The following two basic principles can be followed in the treatment of missed pills: (1) Stop taking the pill for no more than 7 days. (2) It is necessary to take it continuously for 7 days to maintain appropriate suppression of the hypothalamic-pituitary-ovarian axis. Accordingly, the following advice can be given in daily use: In the first week, users should take the last missed pill as soon as they remember, even if it means taking two pills at the same time. Then continue to take the pills at the regular time. In addition, barrier contraception methods such as condoms should be used in the next 7 days. If sexual intercourse has occurred within the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer to the regular withdrawal period, the higher the risk of pregnancy. ·In week 2, the user should take the last missed pill as soon as she remembers, even if this means taking two pills at the same time. Then continue to take the pills at the regular time. If the user has taken the pills correctly in the 7 days before the first missed pill, no additional contraceptive method is required. However, if this is not the case, or if more than one pill is missed, the woman should be advised to use an additional contraceptive method for 7 days. ·In week 3, the risk of reduced reliability is high because it is close to the 7-day pill-free period. However, a reduction in contraceptive protection can still be avoided by adjusting the pill-taking schedule. If the woman has taken the pills correctly in the 7 days before the first missed pill, the user does not need to take additional contraceptive measures if one of the following two suggestions is followed. If this is not the case, the woman is advised to follow the first of these two suggestions and take additional preventive measures for the next 7 days. (1) The user must take the last missed pill as soon as she remembers, even if this means taking two pills at the same time. Then continue to take the pills at the regular time. After finishing this pack of pills, start taking the next pack of pills immediately, that is, there is no pill-free period between the two packs of pills. It is unlikely that the user will have withdrawal bleeding before the second pack of pills is finished, but spotting or breakthrough bleeding may occur during the pill-free period. (2) Women can also be advised not to continue taking the current cycle of pills. Stop taking the pills for 7 days, including the days missed, and then start taking the next cycle of pills. If a woman misses a pill and no withdrawal bleeding occurs during the first normal pill-free period, the possibility of pregnancy should be considered. 4. Advice on vomiting If severe gastrointestinal discomfort occurs, absorption may be incomplete, so other contraceptive methods should be used at the same time. If vomiting occurs within 3-4 hours after taking the pills, the advice on how to deal with missed pills can be used. If you do not want to change the normal pill-taking time, you must take the pills from another pack of pills. 5. How to change the menstrual period or delay the menstrual period To delay the menstrual period, women can continue to take the next pack of Cyproterone Acetate Tablets after finishing one pack of pills without a pill-free period. If desired, the medication may be continued until the end of the second pack. Breakthrough bleeding or spotting may occur with prolonged medication. Regular medication of Cyproterone acetate can be resumed after the usual 7-day pill-free period. If she wishes to change her current menstrual period to another day of the week, she may be advised to shorten the pill-free interval to the time she desires. The shorter the interval, the greater the risk of no withdrawal bleeding and breakthrough bleeding and spotting (as described for delaying menstruation) during the next pack of pills. Length of use As a contraceptive, Cyproterone acetate can be used as long as contraception is required and there are no contraindications. For therapeutic purposes, the duration of use depends on the severity of the clinical lesions, and treatment is usually required for several months.

●Serious adverse reactions The most serious adverse reactions associated with the use of combined oral contraceptives are listed in the [Precautions] section. ●Other possible adverse reactions The following are other possible adverse reactions that have been reported in users of combined cyproterone acetate tablets. The association between them is neither confirmed nor denied: Breast: tenderness, pain, enlargement, secretion Central nervous system: headache, migraine, changes in libido, depression/changes Gastrointestinal: nausea, vomiting, other gastrointestinal complaints Skin: skin diseases (such as rash, erythema nodosum, erythema multiforme) Urogenital system: changes in vaginal discharge Eyes: intolerance to contact lenses Other: fluid retention; weight changes; allergic reactions; abnormal liver function: increased serum triglycerides.

1. The presence or history of venous or arterial thrombotic/thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular accident. 2. The presence or history of prodromal symptoms of thrombosis (such as 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 (see the [Precautions] section). 6. Pancreatitis or history of hypertriglyceridemia. 7. The presence or history of severe liver disease, as long as liver function values have not returned to normal. 8. The presence or history of liver tumors (benign or malignant). 9. Known or suspected malignant tumors (such as reproductive organs or breast) affected by sex steroid hormones. 10. Undiagnosed vaginal bleeding. 11. Known or suspected pregnancy. 12. Breastfeeding. 13. Allergy to any component of Cyproterone Acetate Compound Tablets.

Precautions for children: Compound cyproterone acetate tablets cannot be used in children. Precautions for pregnancy and lactation: Compound cyproterone acetate tablets are contraindicated during pregnancy. If pregnancy occurs while taking compound cyproterone acetate tablets, the drug should be discontinued immediately. Compound cyproterone acetate tablets are also contraindicated during lactation. Cyproterone acetate can enter the breast milk of lactating women. About 0.2% of the maternal dose can reach the newborn through breast milk, which is equivalent to a dose of about 1mu;g/kg. During lactation, 0.02% of the mother's daily ethinyl estradiol dose is transferred to the newborn through breast milk. Precautions for the elderly: There is no special recommended dose for older women. Or follow the doctor's advice.

Drug Interactions Drugs used in combination with estrogen and progestin, such as compound cyproterone acetate tablets, can interact with other drugs and cause breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature. Liver metabolism: Drugs that induce the production of microsomal enzymes can cause drug interactions by causing increased clearance of sex hormones. (such as hydantoins, barbiturates, primidone, carbamazepine and rifampicin; suspected drugs include oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and products containing St. John. swort. Effects on enterohepatic circulation: Clinical reports suggest that the enterohepatic circulation of estrogens will be reduced after the administration of certain antibiotics, which will reduce the concentration of ethinyl estradiol. (such as penicillin, ampicillin, tetracycline) Women who are treated with any of the above drugs should temporarily add a barrier contraceptive method or choose another method of contraception while using combined cyproterone acetate tablets. When using microsomal enzyme inducing drugs simultaneously with combined cyproterone acetate tablets, a barrier contraceptive method should be added during medication and within 28 days after stopping the medication. Women receiving antibiotics (except rifampicin and griseofulvin) should add a barrier contraceptive method until 7 days after stopping the medication. If a barrier contraceptive method is used in combination If the time of administration exceeds the time of taking the last tablet of the package of Cyproterone acetate tablets, the next box of Cyproterone acetate tablets should be taken without the usual drug-free period. The dosage of this drug needs to be changed when taking any antidiabetic drugs. Drugs such as Cyproterone acetate tablets used in combination with estrogen and progestin may affect the metabolism of other drugs. Plasma and tissue drug concentrations will also be affected accordingly. (such as cyclosporine) Note: To detect possible drug interactions, the prescription information of the combined drug should be consulted. Laboratory tests The use of preparations such as Cyproterone acetate tablets may affect the results of certain laboratory tests, including biochemical indices of liver, thyroid, adrenal and kidney function, plasma levels of (carrier) proteins such as cortisol binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism indices, and coagulation and fibrinolysis indices. Changes usually remain within the normal range of laboratory parameters.

Keep in a light-proof, airtight container and out of reach of children.

Each tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinyl estradiol

36 months.

Zhejiang Xianju Pharmaceutical Co., Ltd.

• Founded in:

  2000-06-26

• Address:

  No. 1, Xianyao Road, Xianju County, Taizhou City, Zhejiang Province

• Tax NO.:

  913300007047892221

• Registered Funds:

  989.204866 million yuan

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