Roxopro Tablet (Roxoprofen Sodium Hydrate)

Adult dose

1. For indications 1 and 2: ○ Adults: Roxoprofen sodium (anhydrous) 60 mg orally three times a day. For a single dose therapy, take 60 to 120 mg orally. 2. For indication 3: ○ Adults: Roxoprofen sodium (anhydrous) 60 mg orally. In principle, it can be administered twice a day, with a maximum of 180 mg per day. It is advisable to avoid taking it on an empty stomach.

This medication may cause gastrointestinal bleeding in individuals who regularly consume more than three alcoholic beverages daily; consultation with a doctor or pharmacist is essential. This medication can affect the cardiovascular system, increasing the risk of serious thrombotic events such as myocardial infarction or stroke; patients with cardiovascular diseases or risk factors should be particularly cautious. Serious adverse reactions such as bleeding, ulcers, or perforations in the gastrointestinal tract may occur, especially in the elderly or with long-term use, increasing the risk. Patients with a history of peptic ulcers, severe blood disorders, liver impairments, kidney disorders, heart failure, and those allergic to this medication or similar components should not take this medication. Patients with asthma or sensitivity to aspirin, pregnant individuals in late pregnancy, nursing mothers, and those with inflammatory bowel disease should also avoid this medication. Patients with a history of peptic ulcers or issues with liver or kidney function, hypertension, or blood coagulation disorders should use this medication cautiously. If hypersensitivity reactions such as skin rash, itching, difficulty breathing, or decreased blood pressure occur during use, stop taking the medication immediately and seek medical attention. Gastrointestinal symptoms may include abdominal pain, nausea, vomiting, and diarrhea; if severe bleeding symptoms appear, discontinue administration immediately. This medication may also cause neurological symptoms like drowsiness, dizziness, and headache, so caution is needed while driving or operating machinery. Regular testing is necessary as it could cause abnormal liver and kidney function, and if abnormal signs are detected, discontinue use immediately. This medication may interact with other non-steroidal anti-inflammatory drugs, anticoagulants, diuretics, lithium, methotrexate, etc., so consult a doctor if taken together. During pregnancy, particularly in late pregnancy, it may pose risks to the fetus, so it should not be taken, and it is also advisable to avoid it while breastfeeding. Safety for use in children has not been established, so it is best not to administer it to children. Elderly patients are at a higher risk of side effects when taking this medication and should use the lowest possible dosage for the shortest duration.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, shock, anaphylaxis-like symptoms, gastrointestinal bleeding (hematemesis, melena, bloody stools), severe gastrointestinal bleeding, perforation, upper abdominal pain, abdominal pain, liver dysfunction (including jaundice), fulminant hepatitis, acute renal failure, nephrotic syndrome, interstitial nephritis, dyspnea, interstitial pneumonia, asthma attacks, Stevens-Johnson syndrome, toxic epidermal necrolysis

Mild side effects

• Occasionally
• rash
• itching
• fever
• abdominal pain
• discomfort in the upper abdomen
• loss of appetite
• nausea
• vomiting
• diarrhea

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is also advisable to keep it in a cool place, at room temperature between 1°C and 30°C.

Appearance

White round tablet

Package unit

30 tablets/bottle, 600 tablets/bottle