Diane 35 Bayer treat acne to severe to severe level (1 blister x 21 tablets)
Dosage form Tablet
Specifications Box of 1 blister x 21 tablets
Ingredient Cyproterone acetate, ethinyletradiol
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Cyproterone acetate | 2mg |
| Ethinylestradiol | 0.035mg |
Uses
Indications
Diane - 35 is indicated in the following cases:
Pharmacokic
Mucus system - Curse including sebaceous glands and hair follicles - parts of skin sensitive to Androgen. Acne, increased sebum secretion, hair hair loss are clinical diseases that are caused by the abnormalities of the target organ - these abnormalities caused by increased sensitivity to Androgen or the level of androgen in plasma.
Both active ingredients in Diane - 35 have an effective effect on androgen increasing: Cyproterone acetate is a competitive substance with androgen receptors, inhibiting androgen synthesis in target cells and reducing blood androgen levels through Gonadotropin resistance.
ethinylelestradiol increases the effect of gonadotropine resistance by adjusting the synthesis of globulin associated with sex hormones (SHBG) in plasma. Therefore, it has the effect of reducing the amount of free androgen and biological form in the circulation.
Great research on salvation 3 goals shows that the frequency of venous thrombolytic diagnosis (VTE) is between 8 and 10 every 10,000 women who use low -dose estrogen -dose coc (
The most recent data proposes the frequency of venous thromboembolism diagnosis (VTE) about 4.4 every 10,000 women of years in non -COC and non -pregnant subjects, and in about 20 to 30 every 10,000 pregnant women or after birth. Treatment with Diane - 35 healing acne, this content usually reaches after 3-4 months of treatment.
Excessive greasy hair will lose faster. However, in women who have a mild manifestation of hairy and especially have a slight increase in the right face after a few months of treatment to have clear results.
The contraceptive effect of Diane - 35 is based on the impact of many different factors, the most important factor known as Diane - 35 inhibits ovulation and changes in cervical mucus.
In addition to contraceptive effects, estrogen/progestogen combined also causes adverse effects (see "warning" and "unwanted effects") and other beneficial effects including: menstrual cycle will be more regular, less pain and menstrual blood levels also decrease. Long -term Diane - 35 has the effect of reducing the iron deficiency of the body.
pharmacokinetic
cyproterone acetate
absorption
Cyproterone Acetate is absorbed quickly and completely by oral. The maximum concentration in wall blood is 15ng/ml achieved after taking about 1.6 hours.
Birth of drugs is about 88%.
Distribution
Cyproterone acetate is connected mostly with plasma albumin. Only about 3.5 - 4.0% of the total amount of drugs in plasma are in the form of free steroids.
Ethinylestradiol increases SHBG levels but does not affect the cohesion of cyproterone acetate with plasma proteins. The distribution volume of cyproterone acetate is about 986 ± 437l.
Metabolism
Cyproterone acetate is almost completely transformed. The main metabolites in plasma are identified as 15β - OH - CPA created by the cytochrome P450 Men CYP3A4. The serum clearance coefficient is about 3.6ml/min/kg.
Elimination
Cyproterone acetate concentration decreases in 2 stages with the corresponding sale time of about 0.8 hours and from 2.3 to 3.3 days. Cyproterone Acetate is partially eliminated in the form of non -metabolic. The metabolites are eliminated through urine and biliary tract at a ratio of about 1: 2. The sale time of metabolites is about 1.8 days.
The stability of the drug
The pharmacokinetics of Cyproterone Acetate are not affected by SHGB levels. Plasma drug concentration increased by about 2.5 times in the next day and reached a stable state throughout the second half of the treatment cycle.
ethinylestradiol
absorption
EthinyleLestradiol is absorbed quickly and completely by oral. The maximum concentration in plasma is 71pg/ml achieved after drinking about 1.6 hours. In the process of initial absorption and metabolism in the liver, EthinyleLestradiol is strongly metabolized, resulting in an average oral biological use of about 45%, this ratio is different on each individual ranging from 20 - 65%.
Distribution
Ethinylellestradiol is highly cohesive but not specific to plasma albumin (approximately 98%). Ethinylestradiol increases SHBG levels in plasma. The distribution volume is about 2.8 - 8.6L/kg.
Metabolism
ethinylelestradiol is considered to be a system of system associated with the small intestinal and liver mucosa. Ethinylestradiol has initially metabolized by the process of aromatic hydroxylation but creates various types of hydrogen and methyl reducing agents in the form of free and forms combined with glucoronde and sulfate. The clearance coefficient is about 2.3 - 7ml/min/kg.
Elimination
Ethinylellestradiol in plasma is eliminated in 2 stages with the corresponding sale time of about 1 hour and from 10 to 20 hours. The non -metabolic form of EthinyleLestradiol is not eliminated, the metabolic form is eliminated through the urine and through the bile with a ratio of 4: 6 with the sale time of about 1 day.
The stability of the drug
The drug reaches a stable state throughout the second half of the treatment cycle when the drug concentration in serum reaches 60% of the dose.
Preceptic safety data
ethinyl estradiol
The toxic data of ethinylestradiol has been known. There are no clinical safety data that provides additional prescribing doctors in addition to the information in the stated sections.
cyproterone acetate
Systemic toxicity: Human studies when using toxic doses have shown that Cyproterone Acetate is not at risk of systematic toxicity.
Toxicity on the fetus/The risk of infertility in the fetus
Studies on toxicity in the fetal use combined with two components of the drug in the stage of creating organs before the development of external genitals have shown that Diane - 35 is not at risk of fetal defects.
High doses of Cyproterone Acetate during the sensitive period of differentiation of the genital organs has led to femininations in the male fetus. Observing male babies who have been exposed to Cyproterone Acetate from the fetus period does not show signs of femininity. However, contraindicated Diane - 35 for pregnant women.
Risk of gene poisoning, cancer
Research on the first generation has shown that there is no risk of gene poisoning when using cyproterone acetate. However, more deep studies show that Cyproterone Acetate can cause DNA twisting (and increase DNA repair activity) on rat and monkeys as well as healthy liver cells. On dog liver cells, the level of DNA twisting of Cyproterone Acetate is extremely low.
DNA twisted formation appears when there is a whole body contact and suspect may appear when using cyproterone acetate at the recommended dose. On Vivo, the consequence of the treatment of cyproterone acetate may increase the risk of damage, maybe the occurrence of tumors, liver damage, and where cell enzymes are also changed to female mice, and the risk of mutant phenomenon for genetically modified mice carrying genes of target bacteria for variable phenomena.
So far, clinical and epidemiological trials show that the use of cyproterone acetate does not increase the incidence of liver tumors in humans. Studies on the risk of cancer of Cyproterone Acetate on rodents also do not detect the risk of cancer that may occur.
However, it is important to keep in mind that sex steroid hormones can promote the development of tumors and tissues dependent hormones.
In short, the existing results show that there is no risk of gene poisoning and cancer in humans when using Diane - 35 in accordance with the instructions, in accordance with the recommended dose.
Before taking Diane 35 Bayer treat acne to severe to severe level (1 blister x 21 tablets)
How to use
Take medicine with a little water according to the instructions on the blister blister at a certain hour. Take 1 capsule daily for 21 consecutive days. The subsequent drug is started after 7 days of stopping taking the medicine, during the period of stopping the medication, the phenomenon of menstrual bleeding will appear. Menstrual bleeding appears for about 2-3 days after stopping taking the medication and may not end before starting the next drug.
Start using Diane - 35
For cases of not using previous contraceptive hormones
Start taking the drug on the first day of the menstrual cycle (the first day of menstruation). It is also possible to start using on the 2nd - 5th day of the cycle, but in this case, other contraceptive measures (preventive methods) need to be used in the first 7 days of taking the first medication of the first cycle.
When transferred from birth control pills containing combined hormones (oral contraceptives combined/coc), vaginal ring, or contraceptive patch
Start taking Diane - 35, preferably on the next day after taking pills containing coc's last hormones first, but at the latest on the next day after the period of stopping the pills periodically or at the time of taking cubes without Coc's hormone first. In case of using the vaginal ring or contraceptive sticker, it is best to start using Diane - 35 on the day of removing or removing the sticker or at the latest on the next ring or sticker.
When transferred from drug contraceptives containing only progesterone (pills, injection, subcutaneous implants) or uterine tools release progesterone
It is possible to start drinking Diane - 35 at any time after stopping using a minipill (after removing the uterus if you are placing the uterine tool, after the next time of injection if you are using the injection method), but for all of the above cases, additional contraceptive measures should be used within the first 7 days of medication if intercourse.
In case of miscarriage in the first 3 months of pregnancy
Patients should start taking Diane - 35 days. Once the drug is not necessary to use any other contraception.
Where after birth or after miscarriage in 3 months of pregnancy
For breastfeeding women: See the "Use of drugs in pregnant and lactating women".
Should start taking Diane - 35 on the 21st - 28th after birth or miscarriage in the middle 3 months of pregnancy. If you start taking Diane - 35 later than the above time, you should use additional contraceptive measures (preventive method) within 7 days of taking the first medication. However, if intercourse should eliminate the possibility of pregnancy before starting to take Diane - 35, or wait until the normal menstruation will return to use Diane - 35.
Dosage
Need to take Diane - 35 regularly to ensure the effectiveness of treatment and contraceptive effect if needed. The previous use of hormonal contraceptives should be stopped. The treatment regime when using Diane - 35 is similar to the usual mode of most other combined oral contraceptives. Therefore, it is necessary to consider the same principles when drinking Diane - 35.
Oral contraceptives combined, when used in accordance with the instructions on the rate of failure about 1% a year. Drinking Diane - 35 improperly can lead to bleeding between menstrual cycle, reducing the effectiveness of treatment and reducing the reliability of contraceptive effects.
In case of digestive disorders
In the case of severe digestive system disorders, the absorption of drugs will be worse, so it is advisable to use other contraception during this time.
If vomiting after taking medicine for 3-4 hours, the patient can follow the instructions in the "treatment when forgetting to take the drug". If you do not want to change the medication schedule as usual, you must take one more (or more) the necessary pills from other blisters.
Usage time
Time of use depends on the severity of the clinical scene and the patient's treatment. Usually treatment should be treated for months. The time for symptoms of remission is at least 3 months. Acne and sebum secretion often respond to the drug earlier than the hair. The treatment doctor should periodically evaluate whether it is necessary to continue using the drug.
If symptoms recur for weeks or months after stopping the drug can reuse Diane - 35. In case of re -drinking Diane - 35 (after 4 weeks or longer medical leave), it is necessary to consider increasing the risk of venous thrombosis (VTE) (see the special and cautious warnings when used).
Additional information for special population group
Children and puberty:
diane - 35 is indicated after menstruation.
Older patients:
Not applicable. Not indicated Diane - 35 after menopause.
Patients with liver failure:
Diane - 35 contraindicated women with severe liver failure as well as the parameters of liver function have not returned to normal. See the 'Contraindications' section.
Patients with renal failure:
Diane - 35 has no specialized research in patients with renal failure. The current data does not suggest changing treatment in patients with renal failure.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? There is currently no specific antidote and symptomatic treatment.
What to do when forgetting a dose? However, patients should take the tablet to forget when remembering and taking the next tablet as usual.
If you forget to take medicine for more than 12 hours compared to the daily medication time, the contraceptive effect may be reduced. Trading of the drug is forgotten based on the following two basic principles:
week 1
Patients should take the tablet to forget immediately after remembering, even when taking 2 pills at the same time. Then continue taking other tablets as usual. Other protection measures should be used such as using condoms for the next 7 days. If so, intercourse for 7 days earlier, may consider the possibility of pregnancy. The more uneven medication is taken, the shorter the break between cycles and the risk of pregnancy will increase.
week 2
Patients should take the tablet to forget immediately after remembering, even if you have to take 2 capsules at the same time. Then continue taking other tablets as usual. In the case of patients taking the medication in accordance with the instructions for 7 consecutive days before forgetting, it is not necessary to use any other contraceptive measures. However, if you do not take the drug continuously on time as above or forget to take more than 1 pill, you should use other contraception in 7 days.
Week 3
The contraceptive effect of the drug may be reduced due to nearly taken time to take medication. However, it is possible to prevent the risk of reducing contraception by adjusting the medication schedule. Following one of the two options below, it is not necessary to use any other contraception in case the patient has taken the medication in accordance with the instructions during 7 days before forgetting.
In case of not taking medicine on time 7 days before forgetting to drink, the patient should follow one of the two options below and apply other contraceptive methods in the next 7 days.
If the patient forgets to take the medicine and then there is no menstruation during the period of stopping the first medication, it must consider the risk of pregnancy.
Side Effects
When using Diane - 35, you may experience unwanted effects (ADR).
The following adverse effects have been reported from women who use, Diane - 35, but may not be due to Diane - 35. The risk of increased thrombosis in all women using Diane - 35. body parts Common (≥ 1/100) Not common (≥ 1/1000 and Rare (≥ 10000 and Nausea, abdominal pain vomiting, diarrhea Weight weight gain Headache Migrain migraine Depression, mood change Reduce libido Increase sexual needs Pain and tightening breasts Mammary glands Change in the vagina and breast Diverse instruments, redders Vascular disorders Aortic thrombolytic disorders. Stroke. High blood pressure. In women with genetic angioedema, external estrogen can appear or worsen the symptoms of angioedema. The condition appears or heavier but because drinking coc does not include: jaundice and/or itching due to bile obstruction; formation of gallstones; Porphyrinuria; Lupus system system; Bloody urea syndrome, Sydenham dance, genital herpes; Hearing loss due to fibrous fibrosis, Crohn's disease, ulcerative colitis, cervical cancer. The frequency of diagnosis of breast cancer increases slightly in women who drink COC. Due to rare breast cancer in women under 40 years old compared to common breast cancer. The relationship with drinking coc is unknown. For more information, see the ‘contraindications’ and ‘warning and caution’. Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Diane - 35 contraindications in the following cases:
Being or having a history of thrombosis or veins as well as thrombosis due to embolism (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction) or stroke. Currently or previously showed signs of congestion (transient ischemia, angina). High risk or many risk factors for arterial thrombosis or veins such as diabetes with symptoms of blood vessels, severe hypertension, severe blood lipoprotein disorders. Genetic factors or arterial thrombosis or veins include activated protein resistance, antithrombin deficiency III, C protein deficiency, Homocystein increased blood and phospholipid antibodies (anti -cardilipin antibodies, lupus anticoagulants). History of migraine migraine with symptoms related to the central nervous system. Diabetes with vascular lesions. Having severe liver disease and the parameters of liver function evaluation have not returned to normal. Currently or in a history of liver tumors (benign or malignant). There is or suspected cancer related to sex hormones (breast cancer or other genital organs). Unusual vaginal bleeding. Simultaneously used with other oral contraceptives containing hormones (see the "indication" section). Pregnant or suspected pregnancy. diane - 35 is a compound of progestogen cyproterone acetate and estrogen ethinylingiol and is taken for 21 days in a menstrual cycle. Diane - 35 has the same ingredient as a combined oral contraceptive (COC). Usage time The time to reduce symptoms is at least 3 months. Doctors need periodic assessment to decide whether to continue using the drug. Clinical and epidemiological tests with preparations combined with estrogen/progesterone are similar to Diane - 35 mainly performed with oral contraceptive oral oral contraceptive drugs (COC). Therefore, the following warnings related to the use of COC are also applicable to Diane - 35. Warnings when using If the patient has one of the following risk factors or symptoms, it is advisable to consider the effectiveness of treatment and the risks that may occur in each patient and discuss with the user before deciding to use Diane - 35. During the use of Diane - 35, if one of the risk factors below or the factors of the patient should advance, the patient should consult the doctor. The doctor will decide whether or not to stop using Diane - 35. circulatory disorders Epidemiological studies show that the relationship between the use of COC and the risk of increased thrombosis such as myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism and stroke. However, this risk rarely occurs. Using Diane - 35 increases the risk of venous thrombosis (VTE) compared to not using this drug. The highest risk (VTE) in the first year of taking medication or reusing or converting drugs after suspending the use of the drug for at least 01 month. Death may occur at 1 - 2% of cases of venous thrombosis. Data from a major study, 3 -branch salvage system suggested that an increased risk appears in the first 3 months. The frequency of VTE appears in women using Diane - 35 is 1.5 to 2 times larger than women using oral contraceptives that contain levonorgestrel and may be equivalent to the risk of oral contraceptives containing Desogestrel/Gestoden/Drospirenon. Women who use Diane - 35 may include patients who have increased cardiovascular risks such as polycystic ovary syndrome. Using hormone contraceptives is associated with an increase in the risk of arterial thrombosis (myocardial infarction, transient ischemic anemia). In general, the risk of venous thrombosis (VTE) in users of low -dose estrogen coc ( VTE, classified as deep veins and/or pulmonary embolism may appear while using coc types. The thrombosis is reported in the veins or arteries in the liver, mesenteric, kidney, intravenous and retinal artery or brain, in women using hormone contraceptives but very rare. There is no consensus of the view even though the appearance of these cases is related to the use of COCS. Symptoms of venous thrombosis or artery or stroke may include: pain and/or abnormal swelling in one leg; Sudden severe chest pain, pain radiating left or not; Sudden shortness of breath; Sudden cough; Prolonged, severe or abnormal headache; Completely visual loss or sudden part; Double vision; stuttering or losing language; dizzy; stroke, accompanied or not accompanied by local seizures; weak or paralyzed on one side or a sudden, clear body part; movement disorders; "Acute" abdominal syndrome. Symptoms of pulmonary embolism (PE) include: Suddenly breathing or breathing rapidly, suddenly coughing up blood, chest pain may increase when breathing deeply, feeling anxious, dizziness, fast or abnormal heart rate, some symptoms such as cough, shortness of breath are unclear and misunderstand as other low serious cases (such as respiratory infections). Symptoms of myocardial infarction may include: pain, discomfort, severe, pressure, pressing or heavy chest, arms and under the breastbone, uncomfortable in the back, jaw, throat, arms, stomach. Full, indigestion, suffocating, sweating, nausea, vomiting, dizziness, weakness, anxiety, shortness of breath, heart beating fast or irregular. Cases of arterial embolism can be life -threatening or fatal. It is necessary to consider the possibility of increasing the risk of thrombosis in women with many risk factors or clear manifestations of a personal risk factor. The risk of this copper can be increased even stronger than the plus of mere risk factors. Diane - 35 should only be prescribed for patients in case of assessing the risk and benefits of the drug when used (see the control item). The risk of increased venous thrombosis with: Family history of the disease (for example, in a family with siblings or parents, each one, have artery or vein thrombosis at a young age). If it is known or suspected to have a congenital genetic factor, patients should consult the specialist's advice before deciding to use the hormone contraceptives. The risk of arterial thrombosis or stroke increases with: Plasma lipoprotein disorders. Obesity (body mass index of over 30kg/m2). Atrial fibrillation. There is no consensus of the role of varicose veins and agricultural thrombosis for thrombosis in the vein. Attention should be paid to increasing the risk of thrombosis during birth (information about pregnant women and breastfeeding to see the item "using drugs in pregnant and lactating women"). The group uses Diane - 35, which is likely to include patients who have increased cardiovascular risks as combined with polycystic ovarian syndrome. Other pathological conditions can cause adverse events for the circulatory system including complicated diabetes, systemic erythema lupus, hemolytic urea syndrome, chronic bowel inflammation (Crohn's disease, colon ulcer) and sickle cell disease. Need to stop using Diane - 35 even in the case of migraine appears more or more severe during the use of Diane - 35 (because this can be a sign of a foretail of cerebrovascular events). Women use Diane - 35 should contact the doctor if the symptoms may be related to thrombosis. If doubtful or confirming thrombosis, Diane - 35 should be discontinued. It is advisable to apply appropriate contraception because the risk of teratogenicity when using anti -thrombotic therapy (Coumarin). Factors may suggest genetic or infected factors for blood vessel thrombosis in the artery or venous, including anti -activation of protein C (APC, Homocystein reduction in blood, deficiency of anticoagulant factor III, protein deficiency, S deficiency, phospholipid antibodies (anti -phospholipid anti -anti -coagulants in lupus). When considering the risk as well as the benefits of the drug, the doctor needs to consider the treatment conditions to reduce the risk of venous thrombosis and these risks are higher in pregnant women than women who use low -dose coc ( tumors The most important risk factor for cervical cancer is prolonged HPV infection. A number of epidemiological studies have shown that the use of prolonged combined contraceptives can increase this risk, but there are still controversy over the participation of other factors such as the condition of the cervix and sexual behaviors including the use of other pregnancy prevention measures. A gross analysis from 54 epidemiological studies shows that the risk of breast cancer in women is using coc slightly higher than women who do not use COC (RR = 1.24). The proportion of women diagnosed with this higher risk gradually lower after 10 years of stopping medication. Due to rare breast cancer in women under 40 years old, the number of women who have used or are using COC is diagnosed with breast cancer low in the total number of breast cancer causes. These studies do not give the cause of those risks. The reason may be because these women go to the doctor more during the use of drugs, due to the biological effects of COC or due to the combination of both causes. Breast cancer in those who use drugs tends to be diagnosed earlier before there are clinical progressive symptoms compared to women who never use. Rare cases of benign liver tumors and extremely rare cases of malignant Ugan tumor are reported when using COC. These tumors can cause internal bleeding. Notice immediately to your doctor if you appear intense pain in the lower abdomen, liver enlargement or show signs of internal bleeding during the use of COC. Malignant tumors can endanger life or death. Other conditions Women, or in families with a history of increased trilycerides in the blood, are at higher risk of pancreatitis when using COC. Although mild hypertension has been reported in women who are using COC, this condition is rarely clinically. However, if in the process of using coc patients constantly show clinical signs of hypertension, notify the doctor to stop using COC and treat hypertension. When the blood pressure parameters have returned to normal, the doctor may consider the reuse of COC. The following conditions have also been reported in pregnant women as well as coc users, but there is no conclusion about the relationship of these conditions with the use of COC, including: jaundice with itchy or not related to bile stasis, gallstones, Porphyrin metabolism disorders, lupus erythematosus, high blood urea syndrome, fetal dance hearing. In women with genetic angiema, external estrogen can appear or worse the symptoms of angioedema. It is necessary to stop using COC immediately when signs of acute or chronic liver dysfunction until the liver function returns to normal. The reappearance of jaundice occurred in the first pregnancy or by the use of previous steroid hormones is also an essential sign to stop using COC. Although COC may have an influence on peripheral insulin resistance and glucose tolerance, there is no evidence that it is necessary to change the treatment in diabetics with low doses of COC (containing Crohn's disease and ulcerative colitis are also related to the use of COC. Melasma can also appear, especially for women with a history of melasma during pregnancy. Women tend to have melasma should stay away from the sun or ultraviolet rays during the use of COC. For women with symptoms with symptoms that appear and gradually increase, it is necessary to conduct a distinct diagnosis to clearly identify the cause of the disease (with tumor to increase androgen production, lack of adrenal enzymes). Each pill contains 31 mg of lactose. Patients with rare genetic problems in galactose tolerance, lactase lactase deficiency or poor absorption of glucose - galactose are following lactose diet should consider the amount of use. Medical examination It is necessary to fully ask the patient's disease history and conduct medical examination before starting or when reusing Diane - 35, performing periodically the instructions in the contraindication and warning section, need to be reminded during the use of Diane - 35. Periodic medical examination is very important because in the first time after using Diane - 35 may appear but the contraindication to use (such as a transient local cheek ...) or risk factors (such as family history of artery thrombosis or veins). The frequency and properties of this examination need to be based on practical experiences and applies to each specific case, but it should include examination of blood pressure, breast, abdomen and cervical cytotics. It should be noted that Diane - 35 has no effect on preventing HIV infection or any other genital infection. Reduce the effectiveness of treatment The contraceptive effect of Diane - 35 may be reduced in cases such as: forgetting to take the medicine (see the item "Handling when forgetting to take the medicine", the digestive disorder when taking the drug (the part of the digestive disorders ") or the accompanying drug (part" interact with other drugs and the forms of interaction "). Reduce the effectiveness of menstrual cycle control When treated with estrogen/progestogen preparations, there may be abnormal bleeding (menorrhagia or cycle bleeding), especially during the first time using birth control pills. Therefore, evaluating abnormal bleeding is only meaningful after 3 treatment cycles. If abnormal bleeding or bleeding appears after a periodic menstrual cycle, it is advisable to consider the cause not due to the hormone and need to perform adequate diagnostic methods to determine whether there is a malignant or pregnant tumor. The cause may include abortion, in some women, the phenomenon of bleeding does not appear during the period of stopping medication. If you continue to use birth control pills in accordance with the instructions in the "Dosage and usage)" section, this does not mean that the woman is pregnant. However, if you do not take the medication as directed when you lose your period at the first cycle or the second cycle, it is necessary to eliminate the possibility of pregnancy before continuing to use coc oral medication. No research has been conducted on the effect of the drug on the ability to drive and operate machinery, not record the effect on the ability to drive and operate machinery in Diane 35 users. diane - 35 is not indicated for pregnant women. If the patient is pregnant during treatment with Diane - 35, stop using Diane - 35 (see "Clinical safety data"). diane - 35 also contraindicated for breastfeeding women. Cyproterone Acetate is excreted through breast milk. About 0.2% of the mother's Diane - 35 dose will be put into the baby's body through breast milk - this dose corresponds to about 1µg/kg. 0.02% daily dose of EthinyleLestradiol for mothers can be put into the baby's body through breastfeeding. The effect of other drugs on Diane - 35 Interactions can occur with liver enzyme induction drugs, thus increasing sex hormones and can lead to cycle bleeding and may lose the contraceptive effect of the drug. Patients who use any of the above drugs should temporarily use other contraception combined with Diane - 35 or choose other contraceptive methods. When using metabolic drugs in the liver, other contraception should be used during the time of taking the medicine and during 28 days after stopping taking the drug. If the contraceptive drug is gone during the time you are using another contraceptive method, you should start the next birth control pills and do not have time to stop taking the usual medication. Active ingredients increase Diane - 35 elimination (reducing the effect of Diane - 35 via liver touch), for example: Phenytoin, Barbiturates, Primidone, Carbamazepine, Rifampicin, maybe both Oxcarbazepine, Topiramate, Felbamate, Ritonavir, Griseofulvin and St. John). Active ingredients with different effects on Diane's clearance ability - 35, for example: When used in conjunction with Diane - 35, many HIV/HCV protease inhibitors and non -nucleoside inhibitors inhibit the reverse copy can increase or decrease the serum concentration of estrogen or progestin. These changes may be clinically related in some cases. Effect of combining estrogen/progestogen on other drugs Estrogen/Progestogen combined like Diane - 35 can affect the metabolism of other drugs so it can increase the concentration of drugs in plasma or in tissue (such as cyclosporin) or decrease (such as lamotrigine). Other types of interactions Interaction with laboratory tests: Using preparations such as Diane - 35 can affect certain tests, including liver and thyroid biochemical parameters, biochemical parameters assess adrenal and kidney function, plasma proteins (transport proteins) such as: globulin with corticosteroids and lipid/lipoprotein, carbohydrate metabolism parameters, blood coagulation and cancellation parameters. In general, these changes are still within normal limits. Note: The above information about the use of combined drugs can be referenced to identify drug interaction. Precautions when used
The ability to drive and operate machinery
Pregnancy
Breastfeeding period
Drug interaction
Storage
Store less than 30 ° C, cool dry place, avoid light.
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