Medication info
Naegen Soft Capsules (Naproxen)

Naegen Soft Capsules (Naproxen)

OTC medicationSoft capsule경구
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
(주)마더스제약
Appearance
Transparent orange rectangular soft capsules containing a milky yellow transparent substance
Packaging
10 capsules (10 capsules/PTP)
Approval status
Active

MFDS item code 201401095 · Notified 2014.03.11

Summary

Main use
Treatment of inflammatory diseases such as rheumatoid arthritis and osteoarthritis
Who takes it
Adults
Adult dose
1. Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis: Administer 250-500mg of Naproxen orally twice a day (every 12 hours). 2. Acute Gout: Administer an initial dose of 750mg of Naproxen orally, then administer 250mg orally every 8 hours until the attack subsides. 3. Skeletal Muscle Disorders, Postoperative Pain, Pain after Tooth Extraction, Dysmenorrhea, Tendinitis, Bursitis: Administer an initial dose of 500mg of Naproxen orally, then administer 250mg every 6-8 hours. The total daily dosage should not exceed 1,250mg. 4. Migraine: Administer an initial dose of 750mg of Naproxen orally. If necessary, an additional 250-500mg may be taken on the same day 30 minutes after the initial dose. The total daily dosage should not exceed 1,250mg. Titrate according to age and symptoms.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Treatment of inflammatory diseases such as rheumatoid arthritis and osteoarthritis

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

This medication is used to treat major diseases such as rheumatoid arthritis, osteoarthritis (degenerative joint disease), ankylosing spondylitis, tendinitis, acute gout, and dysmenorrhea. It is also effective for bursitis, skeletal muscle disorders (sprains, strains, trauma, low back pain), postoperative pain, migraines, and pain after tooth extraction. It is used to help improve symptoms of various inflammatory and painful diseases.

How to take

Adult dose

1. Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis: Administer 250-500mg of Naproxen orally twice a day (every 12 hours). 2. Acute Gout: Administer an initial dose of 750mg of Naproxen orally, then administer 250mg orally every 8 hours until the attack subsides. 3. Skeletal Muscle Disorders, Postoperative Pain, Pain after Tooth Extraction, Dysmenorrhea, Tendinitis, Bursitis: Administer an initial dose of 500mg of Naproxen orally, then administer 250mg every 6-8 hours. The total daily dosage should not exceed 1,250mg. 4. Migraine: Administer an initial dose of 750mg of Naproxen orally. If necessary, an additional 250-500mg may be taken on the same day 30 minutes after the initial dose. The total daily dosage should not exceed 1,250mg. Titrate according to age and symptoms.

Precautions

This medication may cause gastrointestinal bleeding in regular drinkers of more than three alcoholic beverages daily; therefore, it is essential to consult with a doctor or pharmacist. Patients with cardiovascular diseases or risk factors should closely monitor for symptoms as there may be an increased risk of cardiovascular events such as myocardial infarction and stroke while taking this medication. This medication can cause serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, or perforations, and extra caution is needed, especially for the elderly or those with a history of gastrointestinal diseases. Patients with peptic ulcers, severe blood disorders, liver dysfunction, heart failure, kidney disorders, hypertension, or hypersensitivity to this medication or non-steroidal anti-inflammatory drugs should not take this medication. Various adverse reactions such as hypersensitivity, gastrointestinal bleeding, blood disorders, liver dysfunction, kidney dysfunction, skin rashes, and respiratory distress may occur; if symptoms occur, stop taking the medication immediately and consult a doctor. This medication should be taken at the lowest possible dose for the shortest duration, and patients with chronic diseases should undergo regular blood tests and assessments of liver and kidney function. Interactions may occur when used in combination with other non-steroidal anti-inflammatory drugs, antihypertensives, diuretics, anticoagulants, etc., so it is essential to consult healthcare professionals. Pregnant women, especially in late pregnancy, should not take this medication as it may pose a risk to the fetus, and nursing mothers are also advised not to take this medication. Children, especially infants under 2 years of age, should avoid this medication as its safety has not been established, and the elderly should take it cautiously starting with a small dose due to the higher risk of gastrointestinal bleeding. During the administration of this medication, if symptoms like bleeding, allergic reactions, skin rashes, severe headaches, or respiratory distress occur, inform healthcare professionals immediately. In cases of overdose, symptoms such as drowsiness, dyspepsia, nausea, and vomiting may appear, and it is essential to receive appropriate treatment from a medical institution immediately. This medication should be stored out of the reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat → severe allergic reactions
  • Hematemesis, gastrointestinal bleeding, peptic ulcers, perforation → severe gastrointestinal adverse reactions
  • Jaundice → liver abnormalities (jaundice)
  • Severe headaches, confusion, seizures → severe neurological symptoms
  • Severe swelling accompanied by elevated blood pressure, significantly reduced urine output → severe edema or urination abnormalities
  • Stevens-Johnson syndrome, mucocutaneous syndrome, epidermal necrolysis

Mild side effects

  • Nausea
  • stomach pain
  • abdominal pain
  • vomiting
  • loss of appetite
  • dyspepsia
  • heartburn
  • diarrhea
  • constipation
  • stomatitis
Show 22 more
  • abdominal bloating
  • black stool
  • dry mouth
  • agranulocytosis
  • eosinophilia
  • leukopenia
  • thrombocytopenia
  • aplastic anemia
  • hemolytic anemia
  • platelet dysfunction
  • elevated GOT
  • GPT levels
  • hepatitis
  • glomerulonephritis
  • hematuria
  • hyperkalemia
  • interstitial nephritis
  • nephrotic syndrome
  • renal papillary necrosis
  • proteinuria
  • aseptic meningitis
  • drowsiness

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 and naproxen derivatives. Phenytoin anticonvulsants, sulfonamides, sulfonylurea antihyperglycemic agents, propranolol and other beta-blockers, ACE inhibitors (like captopril), loop and thiazide diuretics, probenecid, aspirin, lithium, methotrexate, and coumarin-type anticoagulants (like warfarin), zidovudine, quinolone antibiotics (like enoxacin)

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid very hot or very cold places, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Transparent orange rectangular soft capsules containing a milky yellow transparent substance

Package unit

10 capsules (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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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.