Fibrex 200 mg (Pirfenidone)

Adult dose

Adults: The initial dose of this medication is 1 tablet (equivalent to 200mg of pirfenidone) 3 times daily, taken orally after meals. Depending on the patient's response and tolerability, the dose may be increased by 1 tablet (200mg) per dose at 2-week intervals, up to 3 tablets per dose (600mg per dose, 1800mg per day) 3 times daily. If gastrointestinal adverse reactions occur during treatment with this medication, closely monitor the patient's response and consider reducing the dose or discontinuing treatment. Patients with hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment (e.g., Child-Pugh A or B); however, this medication should be administered with caution because its blood concentration may increase. Perform liver function tests regularly during treatment with this medication. If liver enzyme levels increase significantly, consider adjusting the dose or discontinuing treatment. (See 4. General precautions in Precautions for use.) This medication should not be administered to patients with severe hepatic impairment. Patients with renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment. This medication should not be administered to patients with severe renal impairment (creatinine clearance<30mL/min) or end-stage renal disease patients receiving dialysis. Elderly patients No dose adjustment is necessary for elderly patients aged 65 years or older.

Child dose

The safety and efficacy have not been established in pediatric and adolescent patients 18 years of age or younger.

This medicine should not be used by patients who are allergic to the active ingredient or additives. Patients with severely impaired liver function, terminal liver disease, or severely poor kidney function requiring dialysis should not take this medicine. Particularly, it should not be taken along with the drug fluvoxamine, and patients with lactose intolerance or certain genetic disorders should also avoid this medication. Patients with mildly impaired liver or kidney function, the elderly, and those with a history of photosensitivity should use this medication cautiously. This medication contains yellow dye components, so patients who have had allergic reactions to these components should be cautious. Taking this medication may cause the skin to become very sensitive to sunlight, so it is advisable to avoid direct sunlight and to wear long clothing or hats and use sunscreen when going out. If unusual reactions such as skin rashes or itching occur, notify your doctor immediately, and if necessary, the dosage may be reduced or the medication discontinued. Liver function test results may worsen, so regular liver function tests should be conducted before and during treatment; if liver enzyme levels rise significantly, the dose may need to be reduced or the medication stopped. Gastrointestinal symptoms such as loss of appetite, nausea, diarrhea, etc., may occur, and if the symptoms are severe, the dosage should be adjusted. Regular blood tests should also be conducted to check for abnormalities such as leukopenia or agranulocytosis, and if any abnormality is found, appropriate measures should be taken. This medication can cause drowsiness, dizziness, and fatigue, so caution is advised when driving or operating machinery. Weight loss may occur, so monitor weight changes while taking this medication and increase nutritional intake if necessary. If severe allergic reactions such as swelling of the face or lips or difficulty breathing occur after taking this medication, discontinue use immediately and seek treatment. Hyponatremia, which is a decrease in sodium concentration in the blood, can occur, so if related symptoms arise, testing should be performed. Very rarely, severe skin conditions can occur, so if any abnormal skin symptoms appear, discontinuation of medication should be considered immediately. This medication can change blood concentration when taken with certain drugs, so particularly avoid fluvoxamine, smoking, and grapefruit juice. Pregnant women or women who may become pregnant should not take this medication, and nursing mothers should also avoid use. Safety in patients under 18 years of age has not been established, so it is advisable not to use this medication in this population. Elderly patients may have diminished bodily functions, so they should be closely monitored and use the medication carefully. In case of overdose, the patient's condition should be monitored closely, and necessary treatment should be received. Store this medication out of the reach of children and keep it in its original container to prevent quality deterioration or misuse.

Photosensitivity, decreased appetite, elevated γ-GTP, gastric discomfort, nausea, drowsiness, dizziness, unsteadiness, headache, heaviness in the head, distorted taste, anxiety, insomnia, depression, diarrhea, heartburn, abdominal distension, vomiting, constipation, gastroesophageal reflux disease, stomatitis, abdominal discomfort, abdominal pain, papular dermatitis, chapped lips, rash, itching, erythema, eczema, lichen planus, palpitations, leukocytosis, eosinophilia, thrombocytopenia, leukopenia, agranulocytosis, neutropenia, musculoskeletal pain, fatigue, weight loss, fever, flushing, elevated liver enzymes (AST, ALT), elevated alkaline phosphatase, increased LDH, elevated bilirubin, indigestion, gastroesophageal reflux disease, upper abdominal pain, gastritis, intestinal gas retention, dyspnea, cough, productive cough, facial flushing, dry skin, erythematous rash, maculopapular rash, pruritic rash, sunburn, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction accompanied by systemic symptoms and eosinophilia, myalgia, arthralgia, weakness, chest pain, decreased appetite, upper respiratory tract infection, urinary tract infection, drug-induced liver injury, vascular edema, anaphylaxis, hyponatremia, pneumonia, worsening of illness, pneumothorax, hemoptysis, exacerbation of dyspnea, pleural effusion, aspiration pneumonia, lung cancer, myocardial infarction, colitis, gastrointestinal bleeding, influenza-like symptoms, death, limb weakness, ocular abnormalities, aortic aneurysm, pancytopenia, hemiplegia, subarachnoid hemorrhage, urticaria, facial swelling, rhinitis, sore throat, pulmonary edema, purulent sputum, post-nasal drip, pleuritic pain, back pain, chills, chest discomfort, flank pain, limb edema, elevated C-reactive protein, dry mouth, non-food-related epigastric pain, increased bowel movements, chapped lips, cheilitis, gingivitis, hyperlipidemia, hypokalemia, thirst, hypernatremia, hyperkalemia, hyperglycemia, serum lipid abnormalities, pigmentary disorders, exfoliative dermatitis, alopecia, sensory abnormalities, cerebral hypoxia, trigeminal neuralgia, neuropathy, syncope, dysuria, frequency of urination, pulmonary hypertension, peripheral cyanosis, cyanosis, clubbing, multiple fractures, joint dislocation, cataract, sleep disturbances, pain related to the use of medical instruments, pulmonary embolism, herpes zoster, COVID-19, acute otitis media, polyps, peripheral edema, angina, unstable angina, vasculitis, dry mouth, memory impairment, skin symptoms, dermatitis, skin pain, palmoplanter erythema and sensory disturbance syndrome, seborrheic dermatitis, skin discoloration, skin disorders, skin tenderness, skin lesions, skin reactions, decreased intake, pain, loss of taste, seizures, confusion, musculoskeletal discomfort, diplopia, skin abrasions

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain room temperature between 1 degree and 30 degrees Celsius. Following this will help keep the medication effective and safe for a longer period.

Appearance

Pale yellow oval film-coated tablet

Package unit

Domestic use - 90 tablets/box [6 tablets/PTPX15], Export use - 90 tablets/box