Spiroxen Soft Capsules (Naproxen)

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer 250-500 mg of naproxen orally twice daily (every 12 hours). 2. Acute gout: Administer an initial dose of 750 mg of naproxen orally and then 250 mg orally every 8 hours until the attack subsides. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendonitis, bursitis: Administer an initial dose of 500 mg of naproxen orally, followed by 250 mg every 6-8 hours, ensuring the total daily dosage does not exceed 1,250 mg. 4. Migraine: Administer an initial dose of 750 mg of naproxen orally. If necessary, an additional 250-500 mg can be administered after 30 minutes of the initial dose, ensuring the total daily dosage does not exceed 1,250 mg. Adjust according to age and symptoms.

This drug should be discussed with a doctor or pharmacist before use by individuals who regularly consume three or more alcoholic drinks a day, as taking this medication may cause gastrointestinal bleeding for frequent drinkers. This drug may increase the risk of cardiovascular disease. Serious cardiovascular issues such as myocardial infarction or stroke may occur, so patients with cardiovascular diseases or risk factors should be particularly cautious. Both the physician and the patient should carefully monitor for any cardiovascular symptoms and be prepared to act immediately if symptoms arise. This drug may increase the risk of serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforation. Elderly patients or those with a history of gastrointestinal disorders may be at greater risk, so caution is needed. The longer the duration of administration, the greater the risk of these gastrointestinal adverse reactions, so if gastrointestinal bleeding symptoms are suspected during treatment, immediate evaluation and treatment by a physician is necessary. Patients with a history of peptic ulcer, severe blood abnormalities, liver dysfunction, heart failure, kidney disorders, hypertension, or hypersensitivity to this medication or other non-steroidal anti-inflammatory drugs should not take this drug. Additionally, patients who have experienced asthma or allergic reactions due to aspirin or other non-steroidal anti-inflammatory drugs should also avoid administration. Patients with a history of peptic ulcers, blood abnormalities, bleeding tendencies, liver or kidney dysfunction, heart dysfunction, hypertension, hypersensitivity, bronchial asthma, autoimmune diseases, elderly individuals, etc. should be administered this drug with caution. This drug may rarely cause hypersensitivity reactions such as dyspnea, hypotension, and skin rashes; if such symptoms occur, administration should be stopped immediately. Rare gastrointestinal issues such as hematemesis, gastrointestinal bleeding, ulcers, and perforations may also occur, so consultation with a physician should happen immediately if these symptoms appear. Abnormalities may be found in blood tests, so regular blood testing is necessary, and administration should cease if abnormal results are noted. Abnormal liver and kidney functions have also been reported rarely, so patients should inform their physician immediately if abnormal symptoms appear. This drug may affect the central nervous system, leading to symptoms such as headaches, insomnia, drowsiness, and depression; in severe cases, administration should be discontinued immediately, and a physician should be consulted. Serious skin adverse reactions such as rashes, hair loss, and severe dermatitis may occur, so patients should carefully monitor their skin condition. This drug may interact with other non-steroidal anti-inflammatory drugs or specific medications, so patients must inform their doctor or pharmacist of any other medications they are taking. Particular caution is needed when used in conjunction with blood pressure medications, diuretics, anticoagulants, antibiotics, and anticancer drugs. Pregnant women, especially in the late stages of pregnancy, should not take this drug, and women who may become pregnant should consult a doctor before use. Breastfeeding women should avoid this drug as it may be transmitted through breast milk and affect newborns. The safety of this drug has not been established in children under 2 years old, so it is preferable not to administer it; for children, it should be given cautiously at the minimum dose. Elderly patients have a higher risk of side effects such as gastrointestinal bleeding, so administration should start with a small amount while closely monitoring the patient's condition. This drug may prolong bleeding time, so it is essential to inform relevant issues when undergoing blood-related tests. In cases of overdose, symptoms such as drowsiness, chest discomfort, indigestion, nausea, and vomiting may appear; immediate emergency care is needed in such cases. This drug should be kept out of the reach of children, and transferring it to another container is not advisable to maintain quality.

Serious side effects

• Hives
• severe swelling (edema)
• chest tightness
• difficulty breathing
• cold sweat
• pallor
• gastrointestinal bleeding
• peptic ulcers
• perforation
• agranulocytosis

Mild side effects

• Mild stomach discomfort
• stomach pain
• abdominal pain
• nausea
• vomiting
• loss of appetite
• indigestion
• heartburn
• diarrhea
• constipation

Drug interactions

Do not take this medication with other non-steroidal anti-inflammatory drugs or naproxen derivatives. Avoid using it with hydantoin anticonvulsants, sulfa drugs, sulfonylurea hypoglycemics, propranolol and other beta-blockers, ACE inhibitors (e.g., captopril), loop and thiazide diuretics, probenecid, aspirin, lithium, methotrexate, coumarin anticoagulants (such as warfarin), zidovudine, and quinolone antibiotics (such as enoxacin).

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is also best to store the medicine at room temperature between 1 to 30 degrees Celsius.

Appearance

Red transparent oblong soft capsule containing a clear liquid that is yellowish to light red.

Package unit

10 capsules (10 capsules/PTP*1)