Medication info

Propfen 400 Soft Capsule (Ibuprofen)

OTC medicationSoft capsuleApproval withdrawn
Ingredient · strength
Ibuprofen›400mg / 1 capsule
Manufacturer / importer
한국프라임제약(주)
Appearance
A transparent orange rectangular soft capsule containing colorless or orange contents.
Packaging
10 capsules/PTP
Approval status
Approval withdrawn

MFDS item code 201500683 · Notified 2015.02.10

This product's status changed to Approval withdrawn on 2024.02.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of fever and pain due to colds, rheumatoid arthritis, and other pain.
Who uses it
Adults · Children
Adult dosage
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injuries, non-articular rheumatic diseases, acute gout, psoriatic arthritis: 200-600 mg orally 3-4 times a day. Maximum daily dosage is 3200 mg. 3. Mild to moderate pain, colds: 200-400 mg orally 3-4 times a day. 4. Migraine: 200-400 mg orally.
Children's dosage
2. Juvenile rheumatoid arthritis: Administer 30-40 mg per kg of body weight orally in divided doses 3-4 times a day.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Relief of fever and pain due to colds, rheumatoid arthritis, and other pain.

  • Fever
  • pain
  • low back pain
  • menstrual pain
  • rheumatoid arthritis
  • juvenile rheumatoid arthritis
  • osteoarthritis
  • headache
  • migraine
  • toothache
  • muscular pain
  • neuralgia
View approved original text

This medication is primarily used to relieve fever and pain associated with colds, back pain, menstrual pain, rheumatoid arthritis and juvenile rheumatoid arthritis, osteoarthritis, and postoperative pain. It is also effective for various headaches, including tension headaches, migraines, toothaches, muscular pain, and neuralgia. Additionally, it can be used for inflammatory joint diseases such as ankylosing spondylitis, acute gout, and psoriatic arthritis. It is also used to treat soft tissue injuries such as sprains and bruises, as well as non-articular rheumatic conditions like tendinitis, tenosynovitis, and bursitis. This drug helps improve symptoms of various pain and inflammatory diseases.

Dosage and Administration

Adult dosage

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injuries, non-articular rheumatic diseases, acute gout, psoriatic arthritis: 200-600 mg orally 3-4 times a day. Maximum daily dosage is 3200 mg. 3. Mild to moderate pain, colds: 200-400 mg orally 3-4 times a day. 4. Migraine: 200-400 mg orally.

Children's dosage

2. Juvenile rheumatoid arthritis: Administer 30-40 mg per kg of body weight orally in divided doses 3-4 times a day.

Precautions

Caution is advised for individuals who consume alcohol regularly in amounts exceeding 3 drinks per day, as this may increase the risk of gastrointestinal bleeding. Individuals with heart or vascular issues or risk factors should be cautious, as long-term or high-dose use of this drug may increase the risk of cardiovascular disease. This medication can cause serious gastrointestinal issues such as bleeding, ulcers, and perforations, especially in the elderly and those on long-term therapy. It is advisable not to take this drug for individuals with a history of gastrointestinal ulcers or bleeding, or severe liver, kidney, or heart diseases. Those allergic to aspirin or other non-steroidal anti-inflammatory drugs or with a history of asthma should also avoid this medication. It should be avoided during late pregnancy, as it may harm the fetus. Patients should not exceed the recommended dosage or take this drug in combination with other non-steroidal anti-inflammatory drugs. Nursing mothers should consult their doctor as this drug may transfer to breast milk and cause adverse effects in infants. Individuals with blood disorders, liver or kidney disease, heart disease, hypertension, or hypersensitivity should consult their doctor or pharmacist before use. This medication may reduce the cardioprotective effects of aspirin and increase the risk of gastrointestinal bleeding; caution is advised if taken concurrently. There may be interaction possibilities with certain medications (e.g., ACE inhibitors, lithium, diuretics, methotrexate, anticoagulants, SSRIs), and consulting a specialist is recommended. Use cautiously if allergic to any coloring agents included in this medication. If severe allergic reactions, skin rashes, difficulty breathing, bleeding, liver dysfunction, kidney problems, or heart irregularities occur during use, immediately discontinue and consult healthcare professionals. This drug should be taken at the lowest effective dose for the shortest duration necessary, and long-term users should have regular blood tests and liver and kidney function checks. During pregnancy, particularly after week 20, it may affect fetal kidney function; therefore, it should be used at the minimum necessary dosage for a short period, with regular checks on amniotic fluid status. Keep out of reach of children and store in the original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headaches, thunderclap headaches, seizures, confusion, vision disturbances, paralysis, urinary symptoms.

Mild side effects

  • Nausea
  • vomiting
  • abdominal pain
  • indigestion
  • diarrhea
  • headache
  • dizziness
  • drowsiness
  • depression
  • visual disturbances
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  • taste disturbances
  • ear ringing
  • fatigue
  • fever
  • nosebleeds
  • stomatitis
  • skin rashes
  • itching
  • blood pressure increases and decreases
  • palpitations
  • anemia
  • thrombocytopenia
  • eosinophilia
  • hematuria
  • urine protein
  • elevated liver function tests.

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

A transparent orange rectangular soft capsule containing colorless or orange contents.

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.