Skilarence Gastro-resistant Tablet 30 mg (Dimethyl Fumarate)

Adult dose

This medicine should be used under the supervision of a physician experienced in the diagnosis and treatment of psoriasis. To improve tolerability, it is recommended to start treatment at a low dose and gradually increase the dose. Adjust the dose according to each patient’s tolerability and treatment response, without exceeding the maximum daily dose. During the first week, take this medicine 30mg once daily. (1 tablet in the evening) During the second week, take this medicine 30mg twice daily. (1 tablet in the morning and 1 tablet in the evening) During the third week, take this medicine 30mg three times daily. (1 tablet in the morning, 1 tablet at lunchtime, and 1 tablet in the evening) During the fourth week, switch to taking 1 tablet of this medicine 120mg in the evening. Starting in the fifth week, increase the dose by 1 tablet of this medicine 120mg each week, at different times of day as shown in the table below, for 5 consecutive weeks. The maximum daily dose is 720mg (3 times daily, 2 tablets of 120mg each). However, if a treatment effect is observed before reaching the maximum dose, no further dose increase is needed. After a clinical reduction in skin lesions is observed, the dose may be gradually reduced to a maintenance dose appropriate for the patient. Take this medicine with water during or immediately after a meal. The tablets are enteric-coated to prevent gastric irritation; do not cut, dissolve, or chew the tablets. Week Number of tablets Total daily dose (mg) Morning Lunch Evening 30mg 1 - - 1 30mg 2 1 - 1 60mg 3 1 1 1 90mg 120mg 4 - - 1 120mg 5 1 - 1 240mg 6 1 1 1 360mg 7 1 1 2 480mg 8 2 1 2 600mg 9~ 2 2 2 720mg If abnormalities are observed in clinical laboratory tests (see “1. Warnings” under Precautions for Use), dose reduction or discontinuation may be necessary. Patients with renal impairment Dose adjustment is not necessary in patients with mild to moderate renal impairment. The safety and efficacy of this medicine have not been established in patients with severe renal impairment. Patients with hepatic impairment Dose adjustment is not necessary in patients with mild to moderate hepatic impairment. The safety and efficacy of this medicine have not been established in patients with severe hepatic impairment.

Before taking this medication, blood tests must be performed to check the leukocyte and lymphocyte counts. If the leukocyte count is too low or if the lymphocyte count falls below a certain standard, treatment should not be initiated or should be discontinued. Regular blood tests should be conducted during treatment to continuously monitor blood cell counts. If an infection occurs or develops, treatment should be temporarily interrupted and a doctor consulted. This medication should not be used in patients with severe gastrointestinal problems or those with severely impaired kidney and liver functions, and should be avoided by pregnant or nursing women. Common side effects include gastrointestinal disturbances, flushing, leukopenia, and other symptoms. If any unusual symptoms occur, medical staff should be notified immediately. Safety and efficacy when used in conjunction with other immunosuppressive agents have not been established, therefore caution is required when used together. This medication should be taken whole with water during or immediately after meals, and should not be crushed or chewed. Additionally, there may be dizziness or fatigue when driving or operating machinery, so caution should be exercised. This medication is not to be administered to patients with specific genetic disorders or lactose intolerance. There is no specific antidote for overdose, so symptomatic treatment should be received, and it is important to keep it out of reach of children.

Herpes zoster, lymphopenia, leukopenia, eosinophilia, leukocytosis, acute lymphoblastic leukemia, pancytopenia, loss of appetite, headache, sensory abnormalities, dizziness, progressive multifocal leukoencephalopathy, flushing, diarrhea, abdominal distension, abdominal pain, nausea, vomiting, dyspepsia, constipation, feeling of fullness, bloating, gastrointestinal perforation, ulcer, obstruction, bleeding, erythema, burning sensation, itching, allergic reaction, proteinuria, renal failure, Fanconi syndrome, fatigue, heat sensation, asthenia, increased liver enzymes, increased serum creatinine, ineffective medication, various gastrointestinal disorders, discomfort in the upper abdomen, worsening of psoriasis, skin irritation, peripheral edema, dyspnea, hypoxia, hypotension, vascular edema, rash, urticaria

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

White, biconvex, round gastro-resistant coated tablets

Package unit

42 tablets (14 tablets/blister x 3)