Medication info
Apen Tablet (Aceclofenac)

Apen Tablet (Aceclofenac)

Prescription medicationTablet경구
Ingredient · strength
Aceclofenac›100mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200300497 · Notified 2003.04.03 · Insurance code 649601680

Summary

Main use
Relief of inflammation and pain in rheumatoid arthritis, ankylosing spondylitis, etc.
Who takes it
Adults
Adult dose
For adults, 100 mg of aceclofenac is taken twice a day every 12 hours. In patients with hepatic impairment, the initial dose is 100 mg per day. This medication should be swallowed whole without chewing or crushing. Adjustments may be made according to symptoms. To minimize cardiovascular adverse reactions, it should be taken at the lowest effective dose for the shortest duration necessary.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Relief of inflammation and pain in rheumatoid arthritis, ankylosing spondylitis, etc.

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • shoulder periarthritis
  • dental pain
  • inflammation from trauma
  • low back pain
  • sciatica
  • pain due to non-articular rheumatism
View approved original text

This medication is used for various types of arthritis and inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative arthritis), and shoulder periarthritis. It is also effective for relieving pain from dental pain, post-traumatic inflammation, low back pain, sciatica, and helps relieve pain caused by non-articular rheumatism. It is widely used for the improvement of various types of inflammation and pain.

How to take

Adult dose

For adults, 100 mg of aceclofenac is taken twice a day every 12 hours. In patients with hepatic impairment, the initial dose is 100 mg per day. This medication should be swallowed whole without chewing or crushing. Adjustments may be made according to symptoms. To minimize cardiovascular adverse reactions, it should be taken at the lowest effective dose for the shortest duration necessary.

Precautions

This medication may pose a risk of gastrointestinal bleeding in individuals who regularly consume more than three drinks of alcohol a day, so it is essential to consult a physician or pharmacist. This medication can increase the risk of cardiovascular and cerebrovascular diseases, hence patients with heart failure or risk factors for cardiovascular diseases should use it cautiously, taking the lowest effective dose for the shortest duration possible. Patients with a history of ulcers or gastrointestinal bleeding may experience severe gastrointestinal bleeding or perforation when taking this medication, so it should not be administered. Elderly patients are particularly at higher risk for gastrointestinal bleeding and perforation, and caution should be exercised when prescribing to them. Patients with a history of asthma or allergic reactions may exhibit hypersensitivity to this medication, so they must take precautions before use. It is safest for pregnant women in the late stages or nursing mothers not to take this medication, and women in the early to mid-pregnancy should also use it cautiously. Patients with renal or hepatic impairment, heart failure, hypertension, etc., require special attention while taking this medication, and regular monitoring may be necessary. If any unusual symptoms such as dizziness, skin rash, or difficulty breathing appear during treatment, immediate consultation with healthcare professionals is essential. Interactions may occur when taken with other medications; therefore, if other medications are being taken, it is crucial to consult a physician or pharmacist. Caution may be required while driving or operating hazardous machinery, and it is advisable to avoid such activities during treatment. It is recommended not to use this medication in children or adolescents as safety and efficacy are not established.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • anaphylactic reaction
  • shock
  • difficulty breathing
  • asthma attack
  • skin desquamation
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • severe rash with high fever
Show 18 more
  • blisters
  • abnormal skin reactions
  • gastrointestinal bleeding
  • peptic ulcers
  • perforations
  • hematemesis
  • melena
  • jaundice
  • liver abnormalities
  • liver failure
  • acute renal failure
  • heart failure
  • palpitations
  • myocardial infarction
  • stroke
  • increased blood pressure
  • severe edema
  • headache

Mild side effects

  • Dizziness
  • abnormal liver enzyme levels
  • itching
  • rash
  • anemia
  • leukopenia
  • thrombocytopenia
  • neutropenia
  • hemolytic anemia
  • aplastic anemia
Show 25 more
  • agranulocytosis
  • hyperkalemia
  • depression
  • vivid dreams
  • insomnia
  • visual impairment
  • optic neuritis
  • sensory disturbances
  • tremors
  • drowsiness
  • headache
  • taste disturbances
  • neck stiffness
  • fever
  • spatial disorientation
  • confusion
  • hallucinations
  • tinnitus
  • fatigue
  • palpitations
  • facial flushing
  • hypertension
  • heart failure
  • bronchospasm
  • stricture

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It should be kept at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

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.