Roxocydiel Tablets 60mg (Roxoprofen Sodium Hydrate)

Adult dose

1. For indications 1 and 2: ○ Adults: Administer Roxoprofen Sodium (anhydrous) 60 mg orally three times a day. For a single treatment, take 60 to 120 mg orally. 2. For indication 3: ○ Adults: Administer Roxoprofen Sodium (anhydrous) 60 mg orally. Generally, it can be taken twice a day, with a maximum daily dose of 180 mg. It is preferable to avoid taking it on an empty stomach.

This medication has antipyretic, analgesic, and anti-inflammatory properties; therefore, individuals who consume alcohol frequently should consult with a physician or pharmacist before taking this medication due to the risk of gastrointestinal bleeding. This medication may also affect the heart and blood vessels, potentially increasing the risk of cardiovascular diseases such as myocardial infarction or stroke. Special caution is needed for those with existing cardiovascular diseases or risk factors, and any symptoms should be reported to medical personnel immediately. Serious issues such as gastrointestinal bleeding, ulcers, or perforations can occur; thus, those with a history of gastrointestinal diseases or older adults should use this medication with special care. If any gastrointestinal bleeding symptoms appear, use of the medication should be stopped immediately, and medical evaluation is required. Patients with peptic ulcers, severe liver and kidney impairment, severe heart failure, hypersensitivity to medications, pregnant women in late pregnancy, and nursing mothers should not take this medication. Patients with a history of gastric ulcers, blood disorders, liver impairment, kidney impairment, heart failure, asthma, hypertension, etc., should use this medication cautiously and monitor their condition closely during use. This medication can cause various side effects such as allergic reactions, rashes, breathing difficulties, gastrointestinal bleeding, liver dysfunction, kidney dysfunction, and skin diseases; consequently, if any symptoms appear, use should be stopped immediately, and consultation with medical personnel is required. It is advisable not to use this medication in combination with other non-steroidal anti-inflammatory drugs, and caution is necessary as it may interact with antihyperglycemics, antibiotics, antihypertensives, and anticoagulants. During pregnancy, especially in late stages, or while nursing, this medication should not be taken. Women who may become pregnant should consult with a doctor and use the minimum dose and duration necessary. Safety for children has not been established, and older adults are at a higher risk of side effects, so special caution is needed during use. This medication should be stored out of reach of children and kept in its original packaging for safety.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, peptic ulcer, hematemesis, melena, blood in stools, shock, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, acute generalized exanthematous pustulosis, liver dysfunction (including jaundice), fulminant hepatitis, acute renal failure, nephrotic syndrome, interstitial nephritis, respiratory distress, asthma attacks, interstitial pneumonia, and aseptic meningitis (fever, headache, nausea, vomiting, stiff neck).

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1°C to 30°C at room temperature. This helps preserve the medication's effectiveness for a longer period.

Appearance

White round tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 600 tablets/bottle