Medication info

Paxen Soft Capsule (Naproxen)

OTC medicationSoft capsule경구Expired
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
구주제약(주)
Appearance
A transparent green oval soft capsule filled with a colorless transparent liquid.
Packaging
10 capsules - 10 capsules/PTP [ X 1]
Approval status
Expired

MFDS item code 202003596 · Notified 2020.05.18

This product's status changed to Expired on 2025.05.18. 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 Adults: Administer Naproxen 250-500 mg orally twice daily (every 12 hours). 2. Acute Gout Adults: Initially administer 750 mg of Naproxen orally and then administer 250 mg orally at 8-hour intervals until the attack subsides. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis.

Ingredients

Manufacturer
구주제약(주)

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
  • strains
  • trauma
  • low back pain
View approved original text

This medication is used for various inflammatory and painful conditions such as rheumatoid arthritis, osteoarthritis, 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 following tooth extraction. It helps relieve multiple inflammatory conditions and pain, improving the symptoms of patients.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis Adults: Administer Naproxen 250-500 mg orally twice daily (every 12 hours). 2. Acute Gout Adults: Initially administer 750 mg of Naproxen orally and then administer 250 mg orally at 8-hour intervals until the attack subsides. 3. Skeletal muscle disorders, postoperative pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis.

Precautions

This medication should be used with caution by individuals who regularly consume more than three alcoholic drinks a day, as it may increase the risk of gastrointestinal bleeding; consultation with a doctor or pharmacist is essential. This medication can affect the cardiovascular system and may increase the risk of serious thrombotic conditions such as myocardial infarction or stroke, so individuals with cardiovascular diseases or risk factors should exercise more caution. Gastrointestinal adverse reactions may include bleeding, ulcers, and perforation in the stomach or intestines, and especially in elderly patients, the risk is greater, necessitating careful observation for gastrointestinal symptoms while taking this medication. Patients with peptic ulcers, severe blood disorders, liver dysfunction, heart failure, renal impairment, hypertension, or allergies to any component of this medication should not use it. Patients with a history of hypersensitivity, asthma, rhinitis, or urticaria may experience severe allergic reactions while using this medication, so they should be cautious. This medication may rarely cause various adverse effects such as difficulty breathing, hypotension, skin rashes, gastrointestinal bleeding, liver dysfunction, renal impairment, headaches, dizziness, dermatitis, etc.; if any unusual symptoms occur, discontinue use immediately and consult a physician. For long-term use, regular blood tests and liver and kidney function assessments should be conducted to check for abnormalities, especially in elderly patients or those with chronic conditions. This medication may interact with other non-steroidal anti-inflammatory drugs, certain antihypertensive medications, diuretics, anticoagulants, etc., so if you are taking any other medications, you must inform your healthcare provider. During pregnancy, especially in the late stages, it is advisable to avoid use as it may affect the fetus, and during breastfeeding, this medication can be passed into breast milk and cause side effects in newborns, so it is recommended not to use it. It is preferable not to use this medication in infants under 2 years of age as safety has not been established, and in elderly patients, it should be started with a small dose and administered cautiously at the minimum effective dose. In case of overdose, symptoms such as drowsiness, dyspepsia, and vomiting may occur; seek medical attention immediately for appropriate treatment. This medication should be kept out of reach of children, and it is safer not to transfer it to other containers; always check the instructions and precautions carefully before use.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reaction
  • Severe rashes, blisters, skin peeling, pain in oral/ocular mucosa → Stevens-Johnson syndrome, toxic epidermal necrolysis and other severe skin reactions
  • Difficulty breathing, asthma attacks, PIE syndrome, anaphylactic reactions, severe bronchospasm
  • Skin or eyes turning yellow (jaundice), hepatitis, severe liver adverse reactions.

Mild side effects

  • Hematemesis
  • gastrointestinal bleeding
  • peptic ulcers
  • discomfort in the stomach
  • abdominal pain
  • nausea
  • vomiting
  • loss of appetite
  • dyspepsia
  • heartburn
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  • diarrhea
  • constipation
  • stomatitis
  • abdominal distension
  • black stools
  • thirst
  • rashes
  • itching
  • drowsiness
  • cognitive dysfunction
  • dizziness
  • headaches
  • tingling in hands and feet
  • decreased libido
  • fatigue
  • depression
  • abnormal dreams
  • loss of concentration
  • disorientation
  • insomnia
  • myalgia
  • muscle weakness
  • eczema
  • sweating
  • purpura
  • photosensitivity
  • hair loss.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. This will help to preserve the effectiveness and safety of the medication over time.

Appearance and packaging

Appearance

A transparent green oval soft capsule filled with a colorless transparent liquid.

Package unit

10 capsules - 10 capsules/PTP [ X 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.