Medication info
Naproxen SR Soft Capsules (Naproxen)

Naproxen SR Soft Capsules (Naproxen)

OTC medicationSoft capsule경구
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
동아제약(주)
Appearance
Dark blue oblong soft capsule containing a clear colorless or blue liquid
Packaging
10 capsules/PTP
Approval status
Active

MFDS item code 202003877 · Notified 2020.05.26

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 naproxen 250-500 mg orally twice a day (every 12 hours). 2. Acute gout: Administer 750 mg naproxen orally as a loading dose, then 250 mg orally every 8 hours until the attack subsides. 3. Musculoskeletal disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: Administer naproxen as such.

Ingredients

Importer
동아제약(주)

Efficacy & effects

Relief of inflammation and pain in rheumatoid arthritis and osteoarthritis

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • tendinitis
  • acute gout
  • dysmenorrhea
  • bursitis
  • musculoskeletal 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 also helps manage pain from bursitis, musculoskeletal disorders (sprains, strains, trauma), postoperative pain, migraine, and pain after tooth extraction. It alleviates inflammation and pain in various joints and muscles, thereby improving the quality of life for patients.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer naproxen 250-500 mg orally twice a day (every 12 hours). 2. Acute gout: Administer 750 mg naproxen orally as a loading dose, then 250 mg orally every 8 hours until the attack subsides. 3. Musculoskeletal disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis: Administer naproxen as such.

Precautions

This medication may increase the risk of gastrointestinal bleeding in patients who regularly consume more than three alcoholic drinks per day; therefore, they should consult a doctor or pharmacist. This medication can affect the cardiovascular system and may cause serious heart issues such as thrombosis, myocardial infarction, and stroke, so extra caution is advised for those with heart disease or risk factors. This medication can cause serious problems such as gastrointestinal and intestinal bleeding, ulcers, and perforations; thus, caution is particularly important for the elderly or those with a history of gastrointestinal disorders. Patients with peptic ulcers, severe blood disorders, liver, heart, or kidney dysfunction, hypertension, or allergies to this medication or nonsteroidal anti-inflammatory drugs should not use this medication. Caution is necessary for those with a history of peptic ulcers, blood disorders, bleeding tendencies, liver or kidney dysfunction, heart problems, hypertension, allergies, asthma, autoimmune diseases, or the elderly. If unusual symptoms such as difficulty breathing, low blood pressure, rash, hematemesis, gastrointestinal bleeding, blood disorders, liver dysfunction, kidney issues, severe headaches, skin rashes, hearing impairments, swelling, or palpitations occur while taking this medication, it should be discontinued immediately and a doctor consulted. This medication should be taken at the lowest dosage for the shortest duration possible, and regular blood tests and liver/kidney function assessments are necessary for chronic conditions. Consult your doctor if you are taking other non-steroidal anti-inflammatory drugs, anti-epileptics, hypoglycemic agents, beta-blockers, ACE inhibitors, diuretics, or anticoagulants, as interactions may occur. This medication should not be used in late pregnancy due to the risk of ductus arteriosus closure in the fetus, and caution is advised after mid-pregnancy due to potential kidney dysfunction and oligohydramnios in the fetus. This medication can be excreted into breast milk and may affect newborns; thus, it is recommended not to take it while breastfeeding. Safety has not been established for use in infants, and it is advisable not to administer it to them. The elderly should start with a small amount due to a higher risk of gastrointestinal bleeding. Overdose may result in symptoms such as drowsiness, chest discomfort, dyspepsia, nausea, and vomiting; immediate medical attention should be sought for proper treatment. This medication should be kept out of reach of children and should not be transferred to another container for safety.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • swelling
  • chest tightness
  • difficulty breathing
  • cold sweat
  • hypotension (shock symptoms)
  • fever
  • wheezing
  • coughing
  • hematemesis
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  • gastrointestinal bleeding
  • peptic ulcers
  • perforation
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • aplastic anemia
  • hemolytic anemia
  • platelet dysfunction
  • jaundice
  • hepatitis
  • kidney issues
  • glomerulonephritis
  • hematuria
  • interstitial nephritis
  • nephrotic syndrome
  • kidney failure
  • aseptic meningitis
  • severe headache
  • altered consciousness
  • Stevens-Johnson syndrome

Mild side effects

  • Nausea
  • stomach pain
  • abdominal pain
  • vomiting
  • loss of appetite
  • dyspepsia
  • heartburn
  • diarrhea
  • constipation
  • stomatitis
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  • abdominal distension
  • black stools
  • thirst
  • rash
  • itchiness
  • urticaria
  • eczema
  • sweating
  • purpura
  • photosensitivity
  • hair loss
  • redness
  • necrotizing dermatitis
  • erythema multiforme
  • epidermal necrolysis
  • fixed drug eruption
  • tinnitus
  • hearing impairment
  • visual impairment
  • palpitations
  • muscle weakness
  • menstrual disorders
  • chills
  • fever
  • vasculitis
  • hyperglycemia
  • hypoglycemia
  • drowsiness

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

Interactions

Drug interactions

Do not take this medication in conjunction with other non-steroidal anti-inflammatory drugs (NSAIDs) and naproxen derivatives. In combination with hydantoins, sulfonamides, sulfonylurea hypoglycemic agents, propranolol and other beta-blockers, ACE inhibitors, loop diuretics and thiazide diuretics, probenecid, aspirin, lithium, methotrexate, coumarin anticoagulants, zidovudine, and quinolone antibiotics.

Storage

This medication should be stored in a tightly closed container to prevent air or moisture entry, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication longer.

Appearance and packaging

Appearance

Dark blue oblong soft capsule containing a clear colorless or blue 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.