Medication info
Acepen Soft Capsule (Naproxen)

Acepen Soft Capsule (Naproxen)

OTC medicationSoft capsule경구
Ingredient · strength
Naproxen›250mg / 1 capsule
Manufacturer / importer
(주)알피바이오
Appearance
An orange transparent oval soft capsule containing a colorless to light orange transparent content
Packaging
10 capsules (10 capsules/PTP*1)
Approval status
Active

MFDS item code 200403671 · Notified 2004.05.20

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 Naproxen: 250~500 mg (1 capsule~2 capsules) orally administered twice a day (every 12 hours). 2. Acute gout Initial dosage: 750 mg (3 capsules) orally administered, then 250 mg (1 capsule) orally every 8 hours until the attack subsides. 3. Skeletal muscle disorders, post-surgical pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis Initial dosage:

Ingredients

Manufacturer
(주)알피바이오

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 primarily used for rheumatoid arthritis, osteoarthritis (degenerative joint disease), ankylosing spondylitis, tendinitis (inflammation of the tendon), acute gout, and dysmenorrhea. It is also effective for bursitis, skeletal muscle disorders (sprains, strains, trauma, low back pain), post-surgical pain, migraines, and pain after tooth extraction. Overall, it is a medication that helps manage various joint and musculoskeletal disorders and pain.

How to take

Adult dose

1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis Naproxen: 250~500 mg (1 capsule~2 capsules) orally administered twice a day (every 12 hours). 2. Acute gout Initial dosage: 750 mg (3 capsules) orally administered, then 250 mg (1 capsule) orally every 8 hours until the attack subsides. 3. Skeletal muscle disorders, post-surgical pain, pain after tooth extraction, dysmenorrhea, tendinitis, bursitis Initial dosage:

Precautions

This medication should be consulted with a doctor or pharmacist if taken by individuals who regularly consume three or more alcoholic beverages per day, as it may increase the risk of gastrointestinal bleeding. It may increase the risk of cardiovascular diseases, and individuals with a history or risk factors for heart disease or stroke should monitor their condition closely, taking immediate action if cardiovascular symptoms arise. This medication can cause severe problems such as bleeding, ulcers, or perforations in the stomach or intestines, and particularly elderly individuals or those with a history of gastrointestinal diseases should use it cautiously. If gastrointestinal symptoms occur during use, consult a doctor immediately. It should not be used in patients with a history of peptic ulcers, severe blood disorders, very poor liver or kidney function, severe heart failure, severe hypertension, allergies to this medication or nonsteroidal anti-inflammatory drugs, asthma or allergy history, or for pain treatment after coronary artery bypass surgery. Particular caution should be exercised when using this medication in patients with a history of peptic ulcers, blood disorders, bleeding tendencies, liver or kidney dysfunction, heart dysfunction, hypertension, allergy history, asthma, autoimmune diseases, elderly individuals, or those with allergies to specific pigments. If any adverse reactions such as respiratory distress, blood pressure decrease, hives, rash, gastrointestinal bleeding, peptic ulcers, liver dysfunction, kidney issues, neurological symptoms, skin rash, tinnitus, hearing loss, edema, or palpitations occur, discontinue use immediately and consult with a doctor. It is important to use the minimum effective dose and keep the duration of treatment as short as possible. Regular blood tests and liver and kidney function checks are required for chronic conditions, and appropriate use should be made for acute diseases according to symptoms. This medication may mask symptoms of inflammation or pain, potentially delaying the diagnosis of infectious complications; therefore, it should be used along with antibiotics in suspected infections, with careful monitoring of the condition. When taken with other nonsteroidal anti-inflammatory drugs, specific anticonvulsants, antihypertensives, diuretics, aspirin, lithium, anti-cancer drugs, anticoagulants, etc., the risk of side effects may increase due to interactions, requiring caution and adjustment of dosage or consulting a physician if necessary. It may pose risks to the fetus, particularly in the late stages of pregnancy; therefore, individuals who are pregnant or may become pregnant should consult a physician before taking this medication. Women who are breastfeeding are advised not to take this medication due to the potential transfer to breast milk and harm to the baby. It is best not to use in children under 2 years old as safety has not been confirmed, and both children and the elderly should take it at the minimum dosage with caution for any unusual symptoms. In case of overdose, symptoms may include drowsiness, indigestion, vomiting, etc., so individuals exhibiting these symptoms should seek medical treatment immediately. This medication should be kept out of reach of children and should not be transferred to other containers for safety. Care should be taken to maintain quality during storage.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • hematemesis
  • gastrointestinal bleeding
  • peptic ulcer
  • perforation
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  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • aplastic anemia
  • hemolytic anemia
  • platelet function impairment
  • jaundice
  • hepatitis
  • kidney damage
  • glomerulonephritis
  • hematuria
  • hyperkalemia
  • interstitial nephritis
  • nephrotic syndrome
  • renal papillary necrosis
  • proteinuria
  • renal failure
  • aseptic meningitis
  • severe headache
  • disorientation
  • seizures

Mild side effects

  • Abdominal discomfort
  • stomach pain
  • abdominal pain
  • nausea
  • vomiting
  • loss of appetite
  • indigestion
  • heartburn
  • diarrhea
  • constipation
Show 29 more
  • stomatitis
  • abdominal bloating
  • black stools
  • thirst
  • rash
  • itching
  • headache
  • drowsiness
  • cognitive impairment
  • dizziness
  • 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
  • redness
  • tinnitus
  • hearing impairment
  • visual disturbances

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 and naproxen derivatives. Phenytoin anticonvulsants, sulfa drugs, sulfonylureas for blood glucose control, propranolol and other beta-blockers, ACE inhibitors (e.g. captopril), loop and thiazide diuretics, probenecid, aspirin, lithium, methotrexate, coumarin anticoagulants (e.g. warfarin), zidovudine, and quinolone antibiotics (e.g. enoxacin).

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

An orange transparent oval soft capsule containing a colorless to light orange transparent content

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.