Loxonin S

ロキソニンS

Pain Relief

Class 1 — Pharmacies only · Pharmacist required

Drug Type

NSAID analgesic and antipyretic (loxoprofen sodium)

Form

Tablets

Indication

Relief of headache, menstrual pain, toothache, post-extraction pain, sore throat, back pain, joint pain, neuralgia, muscle pain, shoulder stiffness pain, earache, bruising pain, fracture pain, sprain pain, and traumatic pain; and reduction of fever and chills

Warnings & Precautions

Some tablets may have red spots due to additives.

Active Ingredients (per 1 tablet)

• Loxoprofen sodium hydrate 68.1mg (60mg as anhydrate)

Inactive Ingredients

Hydroxypropylcellulose, magnesium stearate, lactose monohydrate, red ferric oxide

Instructions for Use

✓Take with water or lukewarm water. Avoid taking on an empty stomach. Allow at least 4 hours between doses.

Age	Dose per use	Times per day
Adults (15 years and older)	1 tablet	Up to 2 times daily (a 3rd dose may be taken if symptoms recur)
Under 15 years	Do not use	—

✕Do not take if you have had an allergic reaction to this product or any of its ingredients.
✕Do not take if you have experienced an asthma attack triggered by this product, other analgesics or antipyretics, or cold medicines.
✕Do not take if you are under 15 years of age.
✕Do not take if you are currently receiving treatment for gastric or duodenal ulcers, liver disease, kidney disease, or heart disease.
✕Do not take if you have been diagnosed with a blood disorder (anemia, low platelet count, or low white blood cell count).
✕Do not take if you are pregnant and within 12 weeks of your due date.
✕Do not use with other analgesics/antipyretics, cold medicines, or sedatives.
✕Do not drink alcohol before or after taking this medication.
✕Do not take for an extended period.
✓If any of the following occur after taking, stop immediately and consult a physician, dentist, pharmacist, or registered salesperson: skin rash, redness, or itching; stomach pain, nausea, vomiting, heartburn, or mouth ulcers; dizziness, drowsiness, or headache; increased blood pressure or palpitations; or chest pain, fever, fatigue, or blood in urine.
✓If you experience excessive temperature decrease, weakness, or cold hands and feet after taking, stop immediately and consult a physician or pharmacist.
✓If you experience stomach discomfort, heartburn, back pain, or swelling after taking, stop immediately and consult a physician or pharmacist.
✓Seek immediate medical attention if you experience itching, hives, hoarseness, difficulty breathing, palpitations, or clouded consciousness (possible anaphylactic shock); sore throat, fever, pallor, easy bleeding, or bruising that does not fade when pressed (possible blood disorder); high fever, eye redness, eye discharge, lip erosion, or widespread skin rash or redness (possible Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis); fever, rash, decreased urination, swelling, or joint pain (possible kidney disorder); general fatigue, palpitations, shortness of breath, or chest pain (possible congestive heart failure); chest tightness, difficulty breathing, or cold sweats (possible myocardial infarction); sudden difficulty moving one side of the body or speaking (possible cerebrovascular disorder); shortness of breath on exertion or persistent dry cough and fever (possible interstitial pneumonia); fever, jaundice, or dark urine (possible liver dysfunction); muscle aches, weakness, or reddish-brown urine (possible rhabdomyolysis); severe headache with neck stiffness and fever (possible aseptic meningitis); or wheezing or difficulty breathing (possible asthma).
⚠Consult a physician, dentist, pharmacist, or registered salesperson before use if you: are currently receiving medical or dental treatment; are pregnant or may be pregnant; are nursing; are elderly; have had an allergic reaction to any drug; have been diagnosed with bronchial asthma, ulcerative colitis, Crohn's disease, systemic lupus erythematosus, or mixed connective tissue disease; or have a history of gastric or duodenal ulcers, liver disease, kidney disease, or blood disease.

✓Seek immediate medical attention if any of the following serious symptoms appear:
• Shock (anaphylaxis): Itching of skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, or clouding of consciousness immediately after use.
• Blood disorder: Sore throat, fever, general fatigue, pale skin or mucous membranes, easy bleeding (bleeding gums, nosebleed), or bruising that does not fade when pressed.
• Stevens-Johnson syndrome / toxic epidermal necrolysis / erythema multiforme / acute generalized exanthematous pustulosis: High fever, redness of eyes, eye discharge, sores on lips, sore throat, widespread rash or redness on skin, blisters on reddened skin, or small blisters (pustules) on reddened skin that persists or rapidly worsens.
• Kidney disorder: Fever, rash, decreased urine output, swelling throughout the body, general fatigue, joint pain, or diarrhea.
• Congestive heart failure: General fatigue, palpitations, shortness of breath, chest discomfort, chest pain, dizziness, or fainting.
• Myocardial infarction: Squeezing chest pain, difficulty breathing, or cold sweat.
• Cerebrovascular disorder: Sudden onset of decreased or loss of consciousness, difficulty moving one side of the body, headache, vomiting, dizziness, slurred speech, or difficulty finding words.
• Interstitial pneumonia: Shortness of breath with climbing stairs or slight exertion, dry cough, or fever that appears suddenly or persists.
• Liver disorder: Fever, itching, rash, jaundice (yellowing of the skin or whites of the eyes), dark urine, general fatigue, or loss of appetite.
• Rhabdomyolysis: Pain, weakness, or stiffness in muscles of the limbs, shoulders, or lower back, general fatigue, or reddish-brown urine.
• Aseptic meningitis: Severe headache with stiff neck, fever, nausea, or vomiting. (More common in people with systemic lupus erythematosus or mixed connective tissue disease.)
• Asthma: Wheezing or whistling breath sounds, or difficulty breathing.

✓Strictly follow the prescribed dosage.
✓When removing the tablet from the PTP sheet, press the convex side firmly to break the foil on the back. Do not swallow the PTP sheet.
✓If symptoms do not improve after 1 to 2 doses, stop use and consult a physician, dentist, or pharmacist.
✓If pain or other symptoms recur after 3 to 5 days of continuous use, stop taking and seek medical attention.

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For informational purposes only. Always consult a doctor or pharmacist before taking any medication.