Medication info
Prien EF Soft Capsule (Naproxen)

Prien EF Soft Capsule (Naproxen)

OTC medicationSoft capsule경구
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
동국제약(주)
Appearance
Yellow transparent oval soft capsules containing a colorless to pale yellow transparent content
Packaging
10 capsules/PTP
Approval status
Active

MFDS item code 201707302 · Notified 2017.09.28

Summary

Main use
Relief of inflammation and pain associated with rheumatoid arthritis and osteoarthritis
Who takes it
Adults
Adult dose
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer 250–500 mg of naproxen orally twice a day (every 12 hours). 2. Acute gout: Administer an initial dose of 750 mg orally and continue with 250 mg orally every 8 hours until the attack resolves. 3. Skeletal muscle disorders, post-surgical pain, post-extraction pain, dysmenorrhea, tendinitis, bursitis: Administer an initial dose of 500 mg orally.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Relief of inflammation and pain associated with rheumatoid arthritis and osteoarthritis

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

This medication is effective for rheumatoid arthritis and degenerative joint disease, including osteoarthritis, ankylosing spondylitis, tendinitis, and acute gout. It is also used for dysmenorrhea and helps relieve pain from bursitis, muscle and ligament sprains, contusions, trauma, lower back pain, post-surgical pain, migraines, and post-extraction pain. In summary, it is widely used for various joint and musculoskeletal diseases and pain management.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Administer 250–500 mg of naproxen orally twice a day (every 12 hours). 2. Acute gout: Administer an initial dose of 750 mg orally and continue with 250 mg orally every 8 hours until the attack resolves. 3. Skeletal muscle disorders, post-surgical pain, post-extraction pain, dysmenorrhea, tendinitis, bursitis: Administer an initial dose of 500 mg orally.

Precautions

This medication may increase the risk of gastric bleeding in individuals who regularly consume more than three alcoholic beverages a day, so consultation with a doctor or pharmacist is necessary. This medication may increase the risk of cardiovascular disease and could lead to serious issues like myocardial infarction or stroke, so individuals with cardiovascular diseases or risk factors should exercise special caution. This medication can cause serious adverse reactions such as bleeding, ulcers, or perforations in the stomach or intestines, which may be particularly dangerous for the elderly. Individuals with a history of peptic ulcers or severe liver, kidney, or heart dysfunction, and those allergic to this medication or similar medications should not take it. Individuals with hypersensitivity or a history of allergic reactions such as asthma, rhinitis, or urticaria should also avoid this medication. During the use of this medication, if symptoms of gastric bleeding, cardiovascular symptoms, skin rashes, or respiratory distress occur, the use should be immediately discontinued and a doctor consulted. This medication may increase the risk of adverse effects when taken with other non-steroidal anti-inflammatory drugs or certain medications, so it is essential to inform the healthcare provider of any other medications being taken. During pregnancy, especially in late pregnancy, it may pose a risk to the fetus, so use should be avoided. It is also advisable for breastfeeding individuals to refrain from taking this medication as it may pass into breast milk and affect the baby. It is advisable to avoid this medication in young children, particularly infants under the age of two, due to uncertain safety. Elderly patients are at higher risk of adverse effects like gastric bleeding, so they should start at the lowest dose and be monitored closely. For long-term use of this medication, regular blood tests and liver and kidney function tests should be conducted to check for abnormalities. In case of overdose, symptoms such as drowsiness, indigestion, nausea, and vomiting may occur, requiring immediate emergency treatment. This medication should be stored out of reach of children and care should be taken not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat → severe allergic reaction
  • Hematemesis, gastrointestinal bleeding, peptic ulcer, perforation → serious gastrointestinal adverse reactions
  • Fever, wheezing, coughing → pulmonary infiltrate (PIE syndrome)
  • Agranulocytosis, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia, platelet dysfunction → blood disorders
  • Jaundice, hepatitis → liver abnormalities
  • Kidney disorders, glomerulonephritis, hematuria, interstitial nephritis,

Mild side effects

  • Nausea
  • abdominal pain
  • vomiting
  • loss of appetite
  • dyspepsia
  • heartburn
  • diarrhea
  • constipation
  • stomatitis
  • abdominal bloating
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  • black stools
  • thirst
  • headache
  • drowsiness
  • cognitive impairment
  • dizziness
  • 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
  • redness
  • necrotizing fasciitis
  • erythema multiforme
  • tinnitus
  • hearing impairment

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-based antiepileptic drugs, sulfa drugs, sulfonylurea blood glucose-lowering agents, propranolol and other beta-blockers, ACE inhibitors (such as captopril), loop and thiazide diuretics, probenecid, aspirin, lithium, methotrexate, coumarin-based anticoagulants (such as warfarin), zidovudine, fluoroquinolone antibiotics (such as enoxacin)

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it should be kept in a cool room, maintaining a temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow transparent oval soft capsules containing a colorless to pale yellow transparent content

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.