Medication info
Rosen Soft Capsule (Naproxen)

Rosen Soft Capsule (Naproxen)

OTC medicationSoft capsule경구
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
정우신약(주)
Appearance
Transparent green oval soft capsules containing a colorless, transparent liquid
Packaging
10 capsules / PTP
Approval status
Active

MFDS item code 201700401 · Notified 2017.01.23

Summary

Main use
Relief of inflammation and pain from rheumatoid arthritis and osteoarthritis
Who takes it
Adults
Adult dose
1. Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis Administer 250–500 mg of naproxen orally, twice daily (every 12 hours). 2. Acute Gout As an initial dose, administer 750 mg orally, then give 250 mg orally every 8 hours until the attack resolves. 3. Skeletal Muscle Disorders, Postoperative Pain, Pain After Tooth Extraction, Dysmenorrhea, Tendinitis, Bursitis Start with an initial dose of 500 mg administered orally, then follow up with 250 mg every 6–8 hours.

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

Relief of inflammation and pain from rheumatoid arthritis and osteoarthritis

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • tendinitis
  • acute gout
  • dysmenorrhea
  • bursitis
  • skeletal muscle disorders
  • sprains
  • strains
  • trauma
  • lumbago
View approved original text

This medication is used to treat rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, acute gout, and dysmenorrhea. It is also effective for relief from various musculoskeletal disorders and pain associated with bursitis, muscle sprains or strains, trauma, postoperative pain, migraines, and pain after tooth extraction. It improves pain and inflammation in various joint and soft tissue disorders.

How to take

Adult dose

1. Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis Administer 250–500 mg of naproxen orally, twice daily (every 12 hours). 2. Acute Gout As an initial dose, administer 750 mg orally, then give 250 mg orally every 8 hours until the attack resolves. 3. Skeletal Muscle Disorders, Postoperative Pain, Pain After Tooth Extraction, Dysmenorrhea, Tendinitis, Bursitis Start with an initial dose of 500 mg administered orally, then follow up with 250 mg every 6–8 hours.

Precautions

This medication may pose a risk of gastrointestinal bleeding if taken by individuals who regularly consume more than three drinks per day; it is essential to consult a physician or pharmacist. Use with caution as it may increase the risk of cardiovascular diseases; individuals with a history or risk factors for heart disease or stroke should take special care. Serious issues such as gastrointestinal bleeding, ulcers, or perforations may occur, so elderly patients or those with a history of gastrointestinal diseases should monitor symptoms closely while taking this medication. It is safer not to use this medication if there are histories of peptic ulcers, severe blood abnormalities, liver dysfunction, heart failure, kidney disorders, or hypertension. Patients with specific conditions such as a history of peptic ulcers, blood abnormalities, liver or kidney diseases, hypertension, asthma, the elderly, or drug hypersensitivity should be more cautious while taking this medication. Hypersensitivity reactions such as difficulty breathing, skin rashes, or hives may occur; if these symptoms appear, stop taking the medication immediately and consult medical personnel. Gastrointestinal symptoms such as hematemesis, gastrointestinal bleeding, abdominal pain, nausea, and diarrhea may occur; any abnormal symptoms should be discussed with a physician immediately. Various side effects such as blood disorders, liver dysfunction, kidney dysfunction, mental disturbances, and skin reactions have been reported; regular check-ups may be necessary. This medication may interact with other non-steroidal anti-inflammatory drugs or specific medications, so inform your doctor about any other drugs you are taking. It should be avoided during pregnancy, particularly in the third trimester, as it may pose risks to the fetus, and it is also advisable not to take this medication while breastfeeding as it may affect the baby through breast milk. Caution is recommended for children, particularly infants under 2 years of age, as safety has not been established, and elderly patients should start with lower doses due to a higher risk of side effects. Overdose may lead to symptoms like drowsiness, dyspepsia, and vomiting; if an overdose is suspected, contact a healthcare facility for appropriate measures immediately. Store this medication in a safe place out of reach of children, and do not transfer it to other containers as this is important for maintaining quality and safety.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweats
  • hypotension
  • respiratory distress
  • wheezing
  • asthma attacks
  • hematemesis
Show 18 more
  • gastrointestinal bleeding
  • peptic ulcers
  • perforation
  • severe skin reactions
  • Stevens-Johnson syndrome
  • epidermal necrolysis
  • severe rash with high fever
  • blisters
  • skin peeling
  • oral/ocular mucosal pain
  • jaundice
  • hepatitis
  • severe liver disorders
  • kidney disorders
  • kidney failure
  • severe edema
  • high blood pressure
  • severe allergic reactions

Mild side effects

Itching, rash, unpleasant sensation in the upper abdomen, abdominal pain, nausea, vomiting, loss of appetite, dyspepsia, heartburn, diarrhea, constipation, stomatitis, abdominal bloating, melena, thirst, agranulocytosis, eosinophilia, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia, impaired platelet function, elevated GOT, GPT, hepatitis, kidney disorders, glomerulonephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal papillary necrosis, proteinuria

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

Interactions

Drug interactions

Do not take this medication with other non-steroidal anti-inflammatory drugs (NSAIDs) and naproxen derivatives, aspirin, high doses of methotrexate, hydantoins, sulfonamides, sulfonylurea-based hypoglycemic agents, propranolol, and other beta-blockers, ACE inhibitors (such as captopril), loop diuretics, thiazide diuretics, probenecid, lithium, low-dose methotrexate, or coumarin anticoagulants.

Storage

This medication should be stored in an airtight container to prevent air from entering and is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

Transparent green oval soft capsules containing a colorless, transparent liquid

Package unit

10 capsules / PTP

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.