Medication info
Acefen Tablets (Aceclofenac)

Acefen Tablets (Aceclofenac)

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

MFDS item code 201701471 · Approved 2017.03.28 · Insurance code 643903550

Summary

Main use
Relief of arthritis and pain such as rheumatoid arthritis and ankylosing spondylitis
Who takes it
Adults
Adult dose
The dosage is 100 mg of aceclofenac taken every 12 hours, for a total of twice a day. This medication should be taken whole and not chewed or crushed. Dosage may be adjusted according to symptoms. To minimize cardiovascular adverse reactions, the lowest effective dose should be administered for the shortest duration.

Ingredients

Manufacturer
삼일제약(주)

Efficacy & effects

Relief of arthritis and pain such as rheumatoid arthritis and ankylosing spondylitis

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • periarthritis of the shoulder
  • toothache
  • inflammation
  • low back pain
  • sciatica
  • pain due to non-articular rheumatism
View approved original text

This medication is used for rheumatoid arthritis and ankylosing spondylitis, degenerative arthritis such as osteoarthritis, and periarthritis of the shoulder. It also helps relieve pain caused by toothache, inflammation after trauma, as well as low back pain and sciatica, and pain due to non-articular rheumatism. By reducing various inflammations and pains, it aims to improve the comfort of daily life for patients. It is primarily effective in alleviating inflammation and pain in joints and surrounding tissues. Therefore, it is utilized to treat various symptoms related to rheumatic diseases.

How to take

Adult dose

The dosage is 100 mg of aceclofenac taken every 12 hours, for a total of twice a day. This medication should be taken whole and not chewed or crushed. Dosage may be adjusted according to symptoms. To minimize cardiovascular adverse reactions, the lowest effective dose should be administered for the shortest duration.

Precautions

This medication may cause gastrointestinal bleeding if taken by individuals who regularly consume more than three cups of alcohol daily; therefore, consultation with a doctor or pharmacist is essential. This medication may increase the risk of cardiovascular diseases, so patients with risk factors for heart disease or cerebrovascular disease should use it cautiously and should use the lowest effective dose for the shortest duration possible. This medication can cause serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforations, thus caution is required, especially for the elderly or patients with a history of gastrointestinal diseases. Patients with active peptic ulcers or bleeding, or those who have hypersensitivity to this medication or similar drugs, should not take this medication. Patients with severe heart failure, cardiovascular disease, or severe kidney or liver impairment are also advised against using this medication. During treatment, symptoms such as dizziness, gastrointestinal discomfort, and skin rashes may occur, and medical consultation should be sought immediately if symptoms are severe. This medication should not be used in the late stages of pregnancy as it can harm the fetus; caution is also advised during early or mid-pregnancy. Women who are breastfeeding should discuss with a doctor before taking this medication, as it may be excreted in breast milk. This medication can interact with other drugs, so patients taking anticoagulants, diuretics, blood pressure medications, etc., must inform their healthcare provider. Elderly patients are at an increased risk of gastrointestinal bleeding, so they should use this medication with more precautions, and regular health checks during use are important. In cases of overdose, symptoms such as gastrointestinal irritation, hypotension, respiratory depression, and convulsions may appear, and immediate medical attention should be sought if suspected. This medication is not recommended for children and adolescents, as its safety and efficacy have not been established.

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 fever, blisters, skin shedding, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, etc.

Mild side effects

  • Dizziness
  • itching
  • rash
  • dermatitis
  • facial flushing
  • visual impairment
  • optic neuritis
  • sensory disturbances
  • tremors
  • drowsiness
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  • headache
  • taste disturbances
  • neck stiffness
  • fever
  • spatial disorientation
  • confusion
  • hallucinations
  • tinnitus
  • fatigue
  • elevated blood urea and creatinine
  • weight gain
  • nocturia
  • aseptic meningitis
  • angioedema
  • peripheral edema
  • periorbital edema
  • abdominal pain
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal distension
  • gastritis
  • constipation
  • vomiting
  • oral ulcer
  • Crohn's disease

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

Storage

This medication is sensitive to air and moisture, so it must be kept in a sealed container. The recommended storage temperature is room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White circular film-coated tablets

Package unit

300 tablets/bottle, 30 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.