Loxonin S Premium

Loxonin S Premium

ロキソニンSプレミアム

Pain Relief
Class 1 — Pharmacies only · Pharmacist required
Drug Type

Combination NSAID analgesic and antipyretic (loxoprofen sodium + allylisopropylacetylurea + caffeine)

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

Active Ingredients (per 2 tablets)

• Loxoprofen sodium hydrate 68.1mg (60mg as anhydrate) • Allylisopropylacetylurea 60mg • Anhydrous caffeine 50mg • Magnesium aluminometasilicate 100mg

Inactive Ingredients

Lactose, cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium oxide, talc, red ferric oxide, carnauba wax

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) 2 tablets 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, sedatives, or motion sickness medications.
  • ✕Do not operate vehicles or machinery after taking this medication (drowsiness may occur).
  • ✕Do not drink alcohol before or after taking this medication.
  • ✕Do not take for an extended period.
  • ✓If you experience an excessive drop in body temperature, 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 vomiting blood, severe abdominal pain, black tarry stools, or bloody stools (possible gastrointestinal bleeding or perforation); or nausea, vomiting, abdominal pain, or abdominal distention that may indicate intestinal obstruction.
  • ✓If any of the following occur after taking, stop immediately and consult a physician, dentist, pharmacist, or registered salesperson: skin rash, redness, or itching; abdominal pain, stomach discomfort, loss of appetite, nausea, vomiting, abdominal distention, heartburn, mouth ulcers, or indigestion; increased blood pressure or palpitations; drowsiness, numbness, dizziness, or headache; or chest pain, fatigue, facial flushing, fever, or blood in urine.
  • ✓If dry mouth, constipation, or diarrhea persists or worsens after taking, stop use and consult a physician or pharmacist.
  • ✓Seek immediate medical attention if you experience itchy skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, or clouding of consciousness (possible anaphylactic shock); sore throat, fever, general lethargy, pallor of face or eyelids, easy bleeding from gums or nose, or bruises that do not fade when pressed (possible blood disorder); high fever, eye redness, eye discharge, lip erosion, sore throat, widespread rash or redness, or small pustules on reddened skin (possible Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis); fever, rash, decreased urine output, generalized swelling, general malaise, joint pain, or diarrhea (possible kidney disorder); general lethargy, palpitations, shortness of breath, chest discomfort, chest pain, dizziness, or fainting (possible congestive heart failure); chest tightness, difficulty breathing, or cold sweats (possible myocardial infarction); sudden loss of or decreased consciousness, difficulty moving one side of the body, headache, vomiting, dizziness, slurred speech, or difficulty forming thoughts into words (possible cerebrovascular disorder); shortness of breath on exertion or persistent dry cough and fever (possible interstitial pneumonia); fever, itching, rash, jaundice, brown urine, general malaise, or loss of appetite (possible liver dysfunction); muscle aches in the limbs, shoulders, or hips, numbness, weakness, stiffness, general lethargy, or reddish-brown urine (possible rhabdomyolysis); severe headache with neck stiffness, fever, or nausea and vomiting (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.
  • • Stevens-Johnson syndrome / toxic epidermal necrolysis: High fever, redness of eyes, eye discharge, sores on lips, sore throat, or widespread rash or redness on skin that persists or rapidly worsens.
  • • Liver disorder: Fever, itching, rash, jaundice (yellowing of the skin or whites of the eyes), dark urine, general fatigue, or loss of appetite.
  • • 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.
  • • Asthma: Wheezing or whistling breath sounds, or difficulty breathing.
  • • Aplastic anemia: Bruising, nosebleed, bleeding gums, fever, pale skin or mucous membranes, fatigue, palpitations, shortness of breath, feeling faint, or blood in 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.)
  • ✓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.