Medication info
Prisen Soft Capsules (Naproxen)

Prisen Soft Capsules (Naproxen)

OTC medicationSoft capsule경구
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
(주)씨엠지제약
Appearance
Orange, transparent, rectangular soft capsule containing a faint yellow, transparent emulsion.
Packaging
10 capsules (10 capsules/PTP*1)
Approval status
Active

MFDS item code 201403991 · Notified 2014.08.27

Summary

Main use
Relief of inflammation and pain from rheumatoid arthritis, osteoarthritis, etc.
Who takes it
Adults
Adult dose
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Take Naproxen 250-500mg orally twice a day (every 12 hours). 2. Acute gout: Take 750mg as a loading dose orally and then 250mg every 8 hours until the attack subsides. 3. Musculoskeletal disorders, postoperative pain, post-extraction pain, dysmenorrhea, tendinitis, bursitis: Take 500mg as a loading dose orally.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

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

  • Rheumatoid arthritis
  • osteoarthritis
  • ankylosing spondylitis
  • tendinitis
  • acute gout
  • dysmenorrhea
  • bursitis
  • muscular disorders
  • sprains
  • strains
  • trauma
  • lumbago
View approved original text

This medication is effective for inflammatory joint and tendon diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and tendinitis. It may also be used for acute gout and dysmenorrhea. Additionally, it helps alleviate conditions due to bursitis, sprains or strains from muscle and ligament injuries, trauma, and skeletal muscle disorders associated with low back pain. It is effective in reducing pain after surgery, migraines, and post-extraction pain. This drug has a wide application range for various musculoskeletal and painful conditions, improving symptoms.

How to take

Adult dose

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

Precautions

People who regularly consume more than three drinks a day should consult a doctor or pharmacist before taking this medication. Those who often drink alcohol are at risk for gastrointestinal bleeding when taking this medication. This drug may increase the risk of cardiovascular diseases. Serious cardiovascular issues such as myocardial infarction or stroke may occur, so individuals with cardiovascular disease or risk factors should use caution. Both the physician and patient should closely monitor for changes in cardiovascular symptoms, and immediate action should be taken if symptoms appear. This medication can cause serious gastrointestinal issues like gastrointestinal bleeding, ulcers, and perforation. Such problems may occur suddenly and without symptoms, so the elderly or those with a history of gastrointestinal diseases are at increased risk. If gastrointestinal bleeding or ulcer symptoms are suspected during use, immediate consultation with a doctor is required. Individuals with a history of peptic ulcers, severe blood disorders, liver dysfunction, heart failure, kidney impairment, severe hypertension, or allergic reactions to this drug or nonsteroidal anti-inflammatory drugs should not take this medication. Additionally, those with a history of asthma, rhinitis, or allergies may also be at risk when using this drug. Those with a history of peptic ulcers, blood disorders, bleeding tendencies, liver dysfunction, kidney impairment, heart dysfunction, hypertension, allergies, asthma, autoimmune diseases, and the elderly should take this medication with caution. This drug can rarely cause severe allergic reactions, gastrointestinal bleeding, liver or kidney dysfunction, skin rashes, hives, breathing difficulties, and palpitations. If any of these symptoms occur, discontinue use immediately and consult a doctor. This medication should be used at the lowest possible dose for the shortest duration, and regular blood tests as well as liver and kidney function tests are necessary for long-term use. Additionally, it may interact with other medications, so it is essential to inform healthcare providers of any medications being taken. During pregnancy, especially in late stages, this medication should not be used, and women who may become pregnant should only take it after consulting with a doctor. While breastfeeding, this drug can pass into breast milk and affect the baby, so it is advisable to avoid its use. Children, especially infants under 2 years, should not use this medication as its safety has not been established. The elderly are at higher risk for side effects such as gastrointestinal bleeding, so they should start with a low dose and use it with caution. In case of overdose, symptoms such as drowsiness, chest burning, indigestion, nausea, and vomiting may appear, and treatment should be sought immediately at a medical facility. This medication should be kept out of the reach of children and should not be transferred to other containers as it may alter the quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • cold sweat
  • gastrointestinal bleeding
  • ulcers
  • perforation
  • hematemesis
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
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  • aplastic anemia
  • hemolytic anemia
  • platelet dysfunction
  • jaundice
  • hepatitis
  • kidney impairment
  • glomerulonephritis
  • hematuria
  • interstitial nephritis
  • nephrotic syndrome
  • renal failure
  • aseptic meningitis
  • severe headache
  • consciousness disturbances
  • Stevens-Johnson syndrome
  • epidermal necrolysis
  • high fever
  • dyspnea
  • anaphylactic reactions
  • severe skin reactions.

Mild side effects

  • Heartburn
  • indigestion
  • nausea
  • vomiting
  • discomfort in the stomach
  • abdominal pain
  • loss of appetite
  • indigestion
  • diarrhea
  • constipation
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  • stomatitis
  • abdominal bloating
  • dark stools
  • thirst
  • rash
  • itching
  • drowsiness
  • cognitive impairment
  • dizziness
  • headache
  • numbness in hands and feet
  • decreased libido
  • fatigue
  • depression
  • abnormal dreams
  • loss of concentration
  • disorientation
  • insomnia
  • muscle pain
  • muscle weakness
  • eczema
  • sweating
  • purpura
  • photosensitivity
  • hair loss
  • erythema
  • necrosis.

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

Interactions

Drug interactions

Do not take this medication with other nonsteroidal anti-inflammatory drugs or naproxen derivatives. Consult a doctor or pharmacist if taking hydantoins, sulfa drugs, sulfonylurea hypoglycemics, propranolol or other beta-blockers, ACE inhibitors, loop and thiazide diuretics, probenecid, aspirin, lithium, methotrexate, coumarin anticoagulants, zidovudine, or quinolone antibiotics.

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air and light, and it should be kept at a room temperature between 1 to 30 degrees Celsius. This will help maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

Orange, transparent, rectangular soft capsule containing a faint yellow, transparent emulsion.

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.