Loxoprofen Tablets Kunihiro
ロキソプロフェン錠「クニヒロ」
Class 1 — Pharmacies only · Pharmacist required
Drug Type
NSAID analgesic and antipyretic
Form
Tablets 12
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 tablet)
Loxoprofen sodium hydrate 68.1 mg (60 mg as anhydrate)
Inactive Ingredients
Lactose hydrate, cellulose, povidone, partially pregelatinized starch, crospovidone, anhydrous silicic acid, magnesium stearate, ferric oxide
Instructions for Use
- ✓Try to avoid taking on an empty stomach. Take without chewing with water or lukewarm water. Allow at least 4 hours between doses.
| Age | Dose per use | Times per day |
|---|---|---|
| Adults (15 and older) | 1 tablet | Up to 2 times daily; 3rd dose if symptoms recur |
| Under 15 years | Do not use | — |
- ✓To remove tablets from the blister pack: press firmly on the raised part of the PTP sheet to break through the aluminum foil on the back, then take out the tablet. Do not swallow the PTP sheet whole, as it may pierce the esophageal lining and cause serious injury.
- ✕Do not use this product if you:
- (1) Have ever had an allergic reaction to this product or any of its ingredients.
- (2) Have ever experienced asthma after taking this product, other analgesics, or cold medicines.
- (3) Are under 15 years of age.
- (4) Are currently being treated for gastric or duodenal ulcer, liver disease, kidney disease, or heart disease.
- (5) Have been told by a doctor that you have a blood disorder (such as anemia, low platelet count, or low white blood cell count).
- (6) Are pregnant within 12 weeks of your expected delivery date.
- ✕Do not take other analgesics, cold medicines, or sedatives while using this product.
- ✕Do not drink alcohol before or after taking.
- ✕Do not use long-term. If symptoms persist after 3–5 days, stop and consult a doctor.
- ✓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 clouded consciousness immediately after use.
- • Blood disorders: Sore throat, fever, general fatigue, pale face or inner eyelids, easy bleeding (gums or nose), or bruising that does not fade when pressed.
- • Stevens-Johnson syndrome / toxic epidermal necrolysis / erythema multiforme / AGEP: High fever, eye redness, eye discharge, lip erosion, sore throat, widespread skin rash or redness, blisters on reddened skin, small pustules, or fatigue and loss of appetite that persists or rapidly worsens.
- • Renal disorder: Fever, rash, decreased urine output, general edema, fatigue, joint pain, or diarrhea.
- • Congestive heart failure: General fatigue, palpitations, shortness of breath, chest discomfort or pain, dizziness, or fainting.
- • Interstitial pneumonia: Shortness of breath on exertion, dry cough, or fever that appears suddenly or persists.
- • Hepatic dysfunction: Fever, itching, rash, jaundice (yellowing of skin or whites of eyes), dark urine, general fatigue, or loss of appetite.
- • Rhabdomyolysis: Muscle pain in limbs, shoulders, or back; numbness or weakness in limbs; stiffness; general fatigue; or reddish-brown urine.
- • Aseptic meningitis: Severe headache with stiff neck, fever, nausea, or vomiting. (More commonly reported in patients with SLE or MCTD.)
- • Asthma: Wheezing or difficulty breathing.
- • Myocardial infarction: Squeezing chest pain, shortness of breath, or cold sweats.
- • Cerebrovascular disorder: Sudden onset of decreased or loss of consciousness, difficulty moving one side of the body, headache, vomiting, dizziness, or difficulty speaking.
- ⚠Consult a doctor, dentist, or pharmacist before use if you:
- (1) Are under medical or dental treatment.
- (2) Are pregnant or possibly pregnant.
- (3) Are breastfeeding.
- (4) Are elderly.
- (5) Have had allergic reactions to medicines or other substances.
- (6) Have been diagnosed with bronchial asthma, ulcerative colitis, Crohn's disease, systemic lupus erythematosus, or mixed connective tissue disease.
- (7) Have a history of gastric or duodenal ulcer, liver disease, kidney disease, or blood disorders.
- ✓Stop use immediately and consult a doctor, dentist, or pharmacist — bringing this package insert with you — if any of the following occur after use:
- Excessive temperature drop, weakness, or cold extremities
- Signs of peptic ulcer or edema
- In rare cases, serious conditions such as gastrointestinal bleeding (vomiting blood, nausea, vomiting, abdominal pain, black tarry stools, or bloody stools), gastrointestinal perforation (severe abdominal pain), or intestinal narrowing/obstruction (nausea, vomiting, abdominal pain, or bloating) may occur — seek immediate medical attention if these symptoms appear
- Skin: rash, redness, itching
- Digestive: abdominal pain, gastric discomfort, loss of appetite, nausea, vomiting, bloating, heartburn, mouth sores, or indigestion
- Circulatory: blood pressure increase, palpitations
- Nervous system: drowsiness, numbness, dizziness, headache
- Other: chest pain, fatigue, facial flushing, fever, anemia, blood in urine
- ✓If dry mouth, constipation, or diarrhea persists or worsens, stop use and consult a doctor or pharmacist, bringing this package insert with you.
- ✓If symptoms do not improve after 1–2 doses, stop and consult a doctor, dentist, or pharmacist, bringing this package insert with you.
- ✓Store in a cool, dry place away from direct sunlight. Keep out of reach of children. Do not transfer to another container. Do not use after the expiry date.
Additional Information
Red spots may appear on the tablet surface due to colorants used in the formulation.
Sources & Documents
- Japanese product page
- Japanese PDF
- Last verified: June 5, 2026
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For informational purposes only. Always consult a doctor or pharmacist before taking any medication.