Medication info
Naproxen Soft Gelatin Capsules (Naproxen)

Naproxen Soft Gelatin Capsules (Naproxen)

OTC medicationSoft capsule경구
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
동아제약(주)
Appearance
Orange transparent oval soft gelatin capsules containing a colorless to pale orange transparent content.
Packaging
10 capsules (10 capsules/PTP*1)
Approval status
Active

MFDS item code 201902876 · Notified 2019.05.03

Summary

Main use
Relief of inflammation and pain in rheumatoid arthritis and osteoarthritis, etc.
Who takes it
Adults
Adult dose
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis Administer naproxen as a single dose of 250–500 mg (1 capsule to 2 capsules) twice a day (every 12 hours) orally. 2. Acute gout Initially, 750 mg (3 capsules) should be taken orally, and continue to take 250 mg (1 capsule) every 8 hours until the attack subsides. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis Initial dose of 500 mg (2 capsules) is taken orally, followed by 250 mg (1 capsule) every 6-8 hours. Ensure the total daily dose does not exceed 1,250 mg (5 capsules). 4. Migraine Initially, 750 mg (3 capsules) is taken orally. If necessary, an additional 250-500 mg (1 capsule to 2 capsules) can be administered, 30 minutes after the initial dose. Ensure the total daily dose does not exceed 1,250 mg (5 capsules). Adjust according to age and symptoms.

Ingredients

Manufacturer
동아제약(주)

Efficacy & effects

Relief of inflammation and pain in rheumatoid arthritis and osteoarthritis, etc.

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

This medicine is effective for various inflammatory and degenerative diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, acute gout, and dysmenorrhea. It is also used to relieve various types of pain, including bursitis, muscle sprains and bruises, postoperative pain, migraine, and pain after tooth extraction. Overall, it helps reduce inflammation and pain in joints and muscles to improve patient discomfort.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis Administer naproxen as a single dose of 250–500 mg (1 capsule to 2 capsules) twice a day (every 12 hours) orally. 2. Acute gout Initially, 750 mg (3 capsules) should be taken orally, and continue to take 250 mg (1 capsule) every 8 hours until the attack subsides. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis Initial dose of 500 mg (2 capsules) is taken orally, followed by 250 mg (1 capsule) every 6-8 hours. Ensure the total daily dose does not exceed 1,250 mg (5 capsules). 4. Migraine Initially, 750 mg (3 capsules) is taken orally. If necessary, an additional 250-500 mg (1 capsule to 2 capsules) can be administered, 30 minutes after the initial dose. Ensure the total daily dose does not exceed 1,250 mg (5 capsules). Adjust according to age and symptoms.

Precautions

This medication may cause gastric bleeding in individuals who regularly consume more than three alcoholic beverages a day, so it must be discussed with a doctor or pharmacist. This medication may place a burden on the cardiovascular system, so patients at risk for heart disease or stroke should be especially cautious, and both the doctor and patient should closely monitor for cardiovascular symptoms. Serious gastrointestinal issues such as bleeding, ulcers, and perforations may occur, so individuals who are elderly or have a history of gastrointestinal disorders should be particularly careful. Patients with specific conditions such as peptic ulcers, severe blood disorders, liver dysfunction, heart failure, kidney impairment, and hypertension should not take this medication. Patients with hypersensitivity or allergic reactions to similar medications such as aspirin should also avoid this drug. This medicine can affect blood coagulation, so patients with a tendency to bleed or blood disorders should be administered cautiously. Patients with liver and kidney function issues should periodically check and monitor for function deterioration while taking this medication. It is advisable to avoid using this drug during late pregnancy, and after the mid-pregnancy period, it should be used with the minimum duration and dosage as it may affect fetal kidney function. Breastfeeding women should avoid taking this medication as it can be transmitted through breast milk and affect the baby. Safety has not been established for children, especially infants under two years old, so its use is not recommended. Elderly patients are at higher risk for gastric bleeding and ulcer development, so they should take the minimum dosage carefully and be wary of any adverse reactions. If this medication is taken for an extended period, regular blood tests and liver and kidney function tests should be conducted to check for any abnormalities. The risk of side effects may increase when used concurrently with other non-steroidal anti-inflammatory drugs or certain medications, so it is essential to consult healthcare professionals. In case of overdose, symptoms such as drowsiness, indigestion, and vomiting may occur, and immediate medical attention should be sought for proper treatment. This medication should be kept out of reach of children, and it is safer not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • cold sweats
  • difficulty breathing
  • chest tightness
  • vomiting blood
  • gastrointestinal bleeding
  • peptic ulcers
  • perforation
  • hypotension
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  • severe allergic reactions
  • severe skin reactions
  • jaundice
  • severe liver impairment
  • severe edema
  • severe kidney impairment
  • severe hypertension
  • severe blood disorders
  • severe heart failure
  • severe edema
  • a severe anaphylactic reaction
  • Stevens-Johnson syndrome
  • severe mucosal skin reactions
  • severe bronchospasm
  • and heart failure.

Mild side effects

  • Occasionally
  • symptoms may include rash
  • itching
  • discomfort in the stomach area
  • stomach pain
  • abdominal pain
  • nausea
  • vomiting
  • loss of appetite
  • indigestion
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  • heartburn
  • diarrhea
  • constipation
  • stomatitis
  • abdominal distension
  • black stools
  • thirst
  • agranulocytosis
  • eosinophilia
  • leukopenia
  • thrombocytopenia
  • aplastic anemia
  • hemolytic anemia
  • decreased platelet function
  • increased GOT and GPT levels
  • hepatitis
  • glomerulonephritis
  • hematuria
  • hyperkalemia
  • interstitial nephritis
  • nephrotic syndrome
  • and renal papillary necrosis.

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

Interactions

Drug interactions

Do not take this medication together with other nonsteroidal anti-inflammatory drugs and naproxen derivatives. Consult with a doctor or pharmacist before using it alongside hydantoin anticonvulsants, sulfonamides, sulfonylurea-based hypoglycemic agents, propranolol and other beta-blockers, ACE inhibitors, loop and thiazide diuretics, probenecid, aspirin, lithium, methotrexate, anticoagulants, zidovudine, and quinolone antibiotics.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance and packaging

Appearance

Orange transparent oval soft gelatin capsules containing a colorless to pale orange transparent content.

Package unit

10 capsules (10 capsules/PTP*1)

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.