Medication info
Rosophen Tablets (Loxoprofen Sodium Hydrate)

Rosophen Tablets (Loxoprofen Sodium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Loxoprofen Sodium Hydrate›68.1mg / 1 tablet
Manufacturer / importer
태극제약(주)
Appearance
White round tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201602370 · Approved 2016.04.28 · Insurance code 644806000

Summary

Main use
Anti-inflammatory and analgesic for chronic rheumatoid arthritis, osteoarthritis, and fever/pain relief for acute upper respiratory tract infections
Who takes it
Adults
Adult dose
1. Administer 60 mg orally three times a day. For a single dose, administer 60 to 120 mg orally. 2. Administer 60 mg orally, up to twice a day, with a maximum daily dose of 180 mg. It is advisable to avoid taking on an empty stomach. Adjust according to symptoms.

Ingredients

Manufacturer
태극제약(주)

Efficacy & effects

Anti-inflammatory and analgesic for chronic rheumatoid arthritis, osteoarthritis, and fever/pain relief for acute upper respiratory tract infections

  • Chronic rheumatoid arthritis
  • osteoarthritis
  • low back pain
  • periarthritis of the shoulder
  • cervical spondylosis
  • post-operative pain
  • post-traumatic pain
  • post-extraction pain
  • acute upper respiratory tract infections
  • acute bronchitis
View approved original text

This medication is used for the anti-inflammatory and analgesic treatment of conditions associated with inflammation and pain such as chronic rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of the shoulder, and cervical spondylosis. It also helps alleviate inflammation and pain following surgery, trauma, or tooth extraction. It is effective for fever and pain caused by acute infections, including acute upper respiratory tract infections and bronchitis. Overall, this medication is used to improve various inflammatory diseases, pain, and fever symptoms.

How to take

Adult dose

1. Administer 60 mg orally three times a day. For a single dose, administer 60 to 120 mg orally. 2. Administer 60 mg orally, up to twice a day, with a maximum daily dose of 180 mg. It is advisable to avoid taking on an empty stomach. Adjust according to symptoms.

Precautions

This medication may cause gastrointestinal bleeding in individuals who regularly consume more than three cups of alcohol daily; therefore, consultation with a doctor or pharmacist is essential. This medication may increase the risk of cardiovascular diseases, and there is a possibility of serious issues such as myocardial infarction or stroke; thus, special caution is necessary for individuals with a history of cardiovascular disease or risk factors. Serious gastrointestinal issues such as gastrointestinal bleeding, ulcers, and perforation may occur with this medication, so elderly individuals or those with a history of gastrointestinal diseases need to be monitored closely when taking it. Patients with peptic ulcers, severe liver disorders, renal disorders, heart failure, or allergies to this medication's components should not take it. Individuals with a history of gastrointestinal ulcers caused by non-steroidal anti-inflammatory drugs or with blood, liver, or kidney disease history should use this medication cautiously and follow their doctor's instructions. This medication may lead to serious allergic reactions such as hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rashes with fever, blisters, skin peeling, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, or urination changes, and should be stopped immediately with medical consultation if any abnormal symptoms occur. Gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea, or constipation may arise, and severe cases require immediate treatment, so these symptoms should be monitored closely. This medication can cause neurological symptoms such as drowsiness, dizziness, or headaches, so caution is needed when driving or operating machinery. Regular testing is required as it may affect liver and kidney function, and if any abnormal signs are found, discontinuation is necessary. Taking this medication with other non-steroidal anti-inflammatory drugs may increase the risk of side effects, so it is advisable not to combine them. It should not be taken in late pregnancy due to potential risks to the fetus, and caution is warranted during early or mid-pregnancy as well. Breastfeeding women should avoid taking this medication for safety. Safety in children has not been established, so use in pediatric patients is not recommended. Elderly patients have a higher risk of side effects and should be particularly careful when taking this medication. This medication should be kept out of reach of children, and transferring it to other containers is not advisable as it may affect quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rashes with fever, blisters, skin peeling, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, or urination changes may occur.

Mild side effects

  • Occasionally
  • rashes
  • itching
  • fever
  • abdominal pain
  • discomfort in the upper abdomen
  • loss of appetite
  • nausea
  • vomiting
  • diarrhea
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  • constipation
  • chest burning
  • indigestion
  • stomatitis
  • dry mouth
  • abdominal distension
  • drowsiness
  • numbness
  • dizziness
  • headache
  • anemia
  • eosinophilia
  • swelling
  • chest pain
  • anxiety
  • fatigue
  • palpitations may occur.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be kept between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.