【Daiichi Sankyo Generic of Loxonin S】Headache and menstrual pain, as well as fever, are caused by the production of a substance called prostaglandin within the body.Loxoprofen Tablets "KuniHiro" contain the active ingredient loxoprofen sodium hydrate, which suppresses the production of prostaglandins and is effective against pain and fever.
■ Precautions for Use・ Things you must not do (Failure to follow may worsen current symptoms or increase the risk of side effects)1. Do not take this medication if you are:(1) Someone who has had allergic reactions to this drug or its ingredients.(2) Someone who has experienced asthma after taking this drug or other antipyretic and analgesic medications, cold medicines.(3) Children under 15 years old.(4) Someone receiving treatment at a medical institution for: stomach or duodenal ulcers, liver disease, kidney disease, heart disease.(5) Someone diagnosed with blood abnormalities such as low red blood cell count (anemia), low platelet count (easy bleeding or bleeding tendency), low white blood cell count (blood disorders).(6) Pregnant women within 12 weeks of the expected delivery date.
2. While taking this medication, do not take any of the following medicines:- Other antipyretic and analgesic drugs, cold medicines, sedatives.
3. Do not drink alcohol before or after taking this medication.
4. Do not take continuously for a long period.(If symptoms such as pain recur after 3-5 days of use, stop taking the medication and consult a doctor.)
■ Consultations1. Before taking this medication, consult a doctor, dentist, or pharmacist if you are:(1) Under medical treatment.(2) Pregnant or suspected to be pregnant.(3) Breastfeeding.(4) Elderly.(5) Have experienced allergic reactions to medicines or other substances.(6) Diagnosed with: bronchial asthma, ulcerative colitis, Crohn’s disease, systemic lupus erythematosus, mixed connective tissue disease.(7) Have had illnesses such as stomach or duodenal ulcers, liver disease, kidney disease, blood disorders.
2. If any of the following symptoms appear after taking the medication, stop immediately and consult a doctor or pharmacist with this leaflet, as they may be side effects:(1) Symptoms such as excessive lowering of body temperature, collapse (loss of strength), cold limbs (hands and feet) after taking a fever reducer like this drug.(2) Symptoms such as peptic ulcers, swelling, or serious conditions like gastrointestinal bleeding (vomiting blood, nausea, vomiting, abdominal pain, black tarry stools, bloody stools), gastrointestinal perforation (holes in the digestive tract, with symptoms like nausea, vomiting, severe abdominal pain), or stenosis/obstruction of the small or large intestine (nausea, vomiting, abdominal pain, bloating).(3) Symptoms such as:- Skin: rash, redness, itching- Gastrointestinal: abdominal pain, stomach discomfort, loss of appetite, nausea, vomiting, bloating, heartburn, mouth ulcers, indigestion- Circulatory: high blood pressure, palpitations- Nervous system: drowsiness, numbness, dizziness, headache- Others: chest pain, fatigue, facial flushing, fever, anemia, hematuria*Rarely, severe symptoms such as the following may occur. Seek medical attention immediately:*- Shock (anaphylaxis): itching, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, altered consciousness immediately after use.- Blood disorders: sore throat, fever, general malaise, paleness of face or eyelids, easy bleeding (gum bleeding, nosebleeds), bruising that does not fade when pressed.- Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis: high fever, eye redness, eye discharge, lip sores, sore throat, widespread skin rash and redness, small blisters on red skin, persistent fatigue, loss of appetite.- Kidney impairment: fever, rash, decreased urine output, swelling, fatigue, joint pain, diarrhea.- Congestive heart failure: fatigue, palpitations, shortness of breath, chest discomfort, chest pain, dizziness, fainting.- Interstitial pneumonia: shortness of breath when climbing stairs or exerting, cough, fever, sudden or persistent symptoms.- Liver dysfunction: fever, itching, rash, jaundice (yellowing of skin and eyes), dark urine, fatigue, loss of appetite.- Rhabdomyolysis: muscle pain in limbs, shoulders, waist; numbness, weakness, stiffness, dark brown urine.- Aseptic meningitis: severe headache with neck stiffness, fever, nausea, vomiting (more common in patients with systemic lupus erythematosus or mixed connective tissue disease).- Asthma: wheezing, whistling sounds, difficulty breathing.
3. After taking the medication, symptoms such as dry mouth, constipation, or diarrhea may occur. If these persist or worsen, stop taking the medication and consult a doctor or pharmacist.
4. If symptoms do not improve after 1-2 doses (considering other possible illnesses), stop taking the medication and consult a doctor, dentist, or pharmacist.
■ Indications and Effects- Headache, menstrual pain (dysmenorrhea), toothache, post-extraction pain, sore throat, back pain, joint pain, neuralgia, muscle pain, shoulder stiffness, ear pain, bruises, fractures, sprains, trauma pain, chills, fever.
■ Usage and Dosage- Take the following amount with water or warm water, without chewing, preferably on an empty stomach when symptoms appear.- Age: 1 dose: 1 tablet, up to 2 times a day for adults (15 years and older).- If symptoms reappear, a third dose may be taken.- The interval between doses should be at least 4 hours.- Children under 15 should not take this medication.
＜Precautions related to usage and dosage＞(1) Strictly follow the prescribed usage and dosage.(2) How to take the tablet:- Push the convex part of the blister pack firmly with your finger to break the aluminum foil on the back, then take out the tablet.- Do not swallow the tablet directly without opening, as it may cause accidental injury to the esophageal mucosa.
■ Ingredients and Quantities- Active ingredient: Loxoprofen sodium hydrate: 68.1 mg per tablet (60 mg as anhydrous).- Excipients include lactose hydrate, cellulose, povidone, partially pregelatinized starch, croscarmellose sodium, anhydrous silica, magnesium stearate, and ferric oxide.
＜Note on ingredients and quantities＞- The surface of the tablet may show red spots due to coloring agents.
■ Storage and Handling Precautions(1) Store in a cool, dry place away from direct sunlight.(2) Keep out of reach of children.(3) Do not transfer to other containers to prevent misuse and maintain quality.(4) Do not use products past the expiration date.
【Country of Origin】 Japan
【Inquiries】Company: Kowa Hondo Pharmaceutical Co., Ltd.Customer Service: 0120-023520Hours: 9:00–17:00 (excluding weekends and holidays)
【Manufactured and Sold By】Company: Kowa Hondo Pharmaceutical Co., Ltd.Address: 2-8-27 Choshu Hondori, Amagasaki, Hyogo Prefecture
【Product Category】"Class 1 Pharmaceutical"