Mylectin-En Tablets 180 mg (Sodium Mycophenolate)

Adult dose

(Enteric-coated tablet) This medicine should be started as soon as possible after transplantation in patients who have recently undergone a kidney transplant. ○ Adults: Administer mycophenolic acid 720 mg orally twice daily without chewing (daily dose: 1,440 mg). This medicine may be taken with or without food; however, take it either on an empty stomach (1 hour before a meal) or 2 hours after a meal, and continue to take it at the same selected times. ○ Elderly patients: No dosage adjustment is necessary in elderly patients. However, the risk of adverse reactions may generally be increased in these patients. The risk of adverse reactions may also be increased in patients receiving this medicine concomitantly with other immunosuppressants. ○ Patients with renal impairment: No dosage adjustment is necessary in patients with delayed graft function after transplantation. Patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 ㎡) should be monitored carefully. In these patients, the daily dose should not exceed 1,440 mg. ○ Patients with hepatic impairment: No dosage adjustment is necessary in kidney transplant patients with severe hepatic parenchymal disease. ○ Treatment during rejection episodes: Kidney transplant rejection does not alter the pharmacokinetics of mycophenolic acid. Discontinuation or dose reduction of this medicine is not necessary.

Child dose

○ Pediatric patients : Safety and efficacy in patients 18 years of age or younger have not been established.

Women of childbearing potential must use contraception while taking this medication. Taking this medication during pregnancy may increase the risk of miscarriage or congenital malformations. Additionally, this medication should not be taken while breastfeeding. This medication is an immunosuppressant, which may make patients more susceptible to infections and increase the risk of lymphoma or other malignant tumors. Therefore, this medication should only be used under the supervision of a physician experienced in using immunosuppressants in appropriate facilities. Patients with hypersensitivity to this medication or its components, those with specific genetic disorders, pregnant women or women of childbearing potential, and those who are breastfeeding should not use this medication. Patients with lactose intolerance should also be cautious. Patients with severe renal failure, severe gastrointestinal diseases, or delayed organ function recovery after kidney transplantation should use this medication with caution, as they may be at higher risk of adverse reactions. During the course of treatment, symptoms of infection, blood abnormalities, gastrointestinal issues, and respiratory symptoms may occur, and any unusual symptoms should be reported to a doctor immediately. This medication may interact with other drugs, so caution is needed when taken in combination with antacids, immunosuppressants, oral contraceptives, vaccines, etc. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication and must use contraception during and for a period after treatment. Men must also use contraception during and for a period after taking this medication. Safety in children and the elderly has not been adequately confirmed, so special caution is required. In case of overdose, excessive immunosuppression may significantly increase the risk of infections, and if blood disorders develop, the dosage should be adjusted or discontinued. This medication should be kept in a secure location out of the reach of children and must not be crushed or inhaled. It should not be transferred to other containers.

Viral infection, bacterial infection, fungal infection, urinary tract infection, herpes zoster, oral candidiasis, sinusitis, upper respiratory infection, gastroenteritis, herpes simplex, nasopharyngitis, pneumonia, wound infection, sepsis, osteomyelitis, leukopenia, anemia, thrombocytopenia, lymphatic cyst, lymphopenia, neutropenia, lymphadenopathy, dizziness, headache, tremor, insomnia, cough, shortness of breath, exertional dyspnea, pulmonary fibrosis, interstitial lung disease, pulmonary congestion, wheezing, diarrhea, nausea, dyspepsia, vomiting, constipation, abdominal pain, abdominal distension, flatulence, loose stools, gastritis, pneumoperitoneum, abdominal tenderness, pancreatitis, belching, bad breath, bowel obstruction, esophagitis, peptic ulcer, lower bowel obstruction, tongue depigmentation, gastrointestinal bleeding, dry mouth, cheilitis, parotid duct obstruction, gastroesophageal reflux disease, gingival hyperplasia, peritonitis, fever, fatigue, peripheral edema, influenza-like illness, lower limb edema, pain, chills, thirst, weakness, hypocalcemia, hypokalemia, hyperuricemia, hyperkalemia, hypomagnesemia, loss of appetite, hyperlipidemia, diabetes, hypercholesterolemia, hypophosphatemia, alopecia, contusion, acne, abnormal liver function tests, tachycardia, pulmonary edema, ventricular ectopy, hypertension, worsening hypertension, hypotension, conjunctivitis, blurry vision, arthralgia, asthenia, myalgia, arthritis, back pain, muscle rigidity, skin papilloma, basal cell carcinoma, Kaposi's sarcoma, lymphoproliferative disorders, squamous cell carcinoma, anxiety, abnormal dreams, hallucinations, increased blood creatinine, hematuria, renal tubular necrosis, urethral stricture, erectile dysfunction, Cushing's syndrome, hirsutism, increased blood pressure, muscle cramps, myalgia, colitis, esophagitis, duodenitis, CMV gastritis, bowel perforation, gastrointestinal bleeding, gastric ulcer, duodenal ulcer, bowel obstruction, meningitis, infectious endocarditis, tuberculosis, atypical mycobacterial infection, polyomavirus-associated kidney disease, BK virus infection-related kidney disease, progressive multifocal leukoencephalopathy, agranulocytosis, pancytopenia, pure red cell aplasia, bronchiectasis, hepatitis due to reactivation of hepatitis B virus, hypogammaglobulinemia, rash, cold, leukopenia, headache, genital herpes, thrombosis, increased heart rate, itching

This medication should be stored in a tightly closed container to protect it from air and moisture, and the temperature should be kept between 1 degree and 30 degrees Celsius at room temperature. Maintaining proper storage conditions will preserve the effectiveness and safety of the medication.

Appearance

Green round film-coated tablet

Package unit

50 tablets (10 tablets/PTP packaging x 5)