Medication info

NAROX Soft Capsules (Naproxen)

OTC medicationSoft capsule경구Approval withdrawn
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
(주)제뉴파마
Appearance
Orange transparent oblong soft capsule containing a slightly yellow transparent liquid.
Packaging
10 capsules/PTP
Approval status
Approval withdrawn

MFDS item code 201403475 · Notified 2014.07.29

This product's status changed to Approval withdrawn on 2024.07.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of inflammation and pain in rheumatoid arthritis and osteoarthritis.
Who takes it
Adults
Adult dose
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer 250-500 mg of naproxen orally twice a day (every 12 hours). 2. Acute gout: Administer an initial dose of 750 mg of naproxen orally, followed by 250 mg orally every 8 hours until the attack resolves. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: Administer naproxen.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Relief of inflammation and pain in rheumatoid arthritis and osteoarthritis.

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

This medication is effectively used for degenerative joint diseases such as rheumatoid arthritis and osteoarthritis, ankylosing spondylitis, tendinitis, acute gout, and dysmenorrhea. It is also helpful for bursitis and skeletal muscle disorders, such as sprains, contusions, trauma, and back pain. It is widely utilized for postoperative pain, migraine, and pain management after tooth extraction. Therefore, it is used to improve various types of joint and muscle pain and inflammation.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer 250-500 mg of naproxen orally twice a day (every 12 hours). 2. Acute gout: Administer an initial dose of 750 mg of naproxen orally, followed by 250 mg orally every 8 hours until the attack resolves. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: Administer naproxen.

Precautions

Individuals who regularly consume more than three alcoholic beverages a day should consult with their doctor or pharmacist before taking this medication. Consuming alcohol while taking this medication may increase the risk of gastrointestinal bleeding. This medication may affect the cardiovascular system, increasing the risk of severe thrombotic events such as heart attacks and strokes. Individuals with cardiovascular diseases or risk factors should use it with caution, and consult a doctor immediately if any abnormal symptoms occur. This medication can cause serious adverse reactions such as gastrointestinal bleeding, ulcers, and perforations. Therefore, elderly patients should be monitored closely for signs of gastrointestinal bleeding during treatment. Those with a history of peptic ulcers, severe blood disorders, liver damage, cardiac failure, kidney disorders, and hypertension should not take this medication. Also, individuals allergic to any component of this medication or non-steroidal anti-inflammatory drugs, as well as asthmatics sensitive to aspirin, should avoid taking this medication. Patients with a history of peptic ulcers or blood disorders, liver damage, kidney disorders, cardiac insufficiency, hypertension, and asthma should take this medication cautiously. Rarely, allergic reactions, gastrointestinal bleeding, blood disorders, liver dysfunction, kidney disorders, headaches, dizziness, skin rashes, auditory and visual impairments may occur. In the case of any abnormal symptoms, discontinue use immediately and consult a doctor. This medication should be used at the lowest possible dose and for the shortest duration necessary; regular blood tests and monitoring of liver and kidney functions are essential when used for chronic conditions. Interactions may occur when this medication is taken in combination with other non-steroidal anti-inflammatory drugs or certain medications, so be sure to inform your doctor or pharmacist of any medications you are currently taking. Do not take this medication during pregnancy, especially in the later stages of pregnancy. Women who may become pregnant should carefully consider the risks and benefits before using this medication. Breastfeeding mothers should avoid this medication as it may pass into breast milk and affect the newborn. It is not recommended for children, especially infants under 2 years of age, as safety has not been established. Elderly patients should start on a low dose and take this medication cautiously due to increased risks of side effects, such as gastrointestinal bleeding. In cases of overdose, symptoms such as drowsiness, indigestion, and vomiting may occur; contact medical personnel immediately for appropriate treatment. This medication should be kept out of reach of children, and changing containers is not advisable as it may affect the quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, gastrointestinal bleeding, peptic ulcers, perforation, hematemesis, difficulty breathing, severe headache, altered consciousness, jaundice, renal impairment, elevated blood pressure, Stevens-Johnson syndrome, epidermal necrolysis, anaphylactic reactions, severe skin adverse reactions, blood disorders (agranulocytosis, impaired platelet function), severe edema, asthma attacks, thrombotic events in the cardiovascular system, myocardial infarction.

Mild side effects

  • Nausea
  • abdominal pain
  • vomiting
  • loss of appetite
  • dyspepsia
  • heartburn
  • diarrhea
  • constipation
  • stomatitis
  • abdominal bloating
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  • black stools
  • thirst
  • hives
  • rash
  • itching
  • agranulocytosis
  • eosinophilia
  • leukopenia
  • thrombocytopenia
  • aplastic anemia
  • hemolytic anemia
  • impaired platelet function
  • elevated GOT
  • GPT levels
  • hepatitis
  • renal impairment
  • glomerulonephritis
  • hematuria
  • hyperkalemia
  • interstitial nephritis
  • nephrotic syndrome
  • renal papillary necrosis.

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

Storage

This medication can be sensitive to air and humidity, so it must be stored in a tightly sealed container. It is preferable to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy and safety for an extended period.

Appearance and packaging

Appearance

Orange transparent oblong soft capsule containing a slightly yellow 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

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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.