Medication info
Independent Aceclofenac Tablets

Independent Aceclofenac Tablets

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

MFDS item code 201903453 · Approved 2019.05.28 · Insurance code 057700060

Summary

Main use
Relief of inflammation and pain associated with rheumatoid arthritis, ankylosing spondylitis, etc.
Who takes it
Adults
Adult dose
Adults: Take 100 mg of aceclofenac every 12 hours, 2 times a day. Do not chew or crush the tablet; take it as is. Adjust according to symptoms as needed. To minimize cardiovascular adverse reactions, use the lowest effective dose for the shortest duration possible.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

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

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • pericapsulitis
  • toothache
  • inflammation
  • low back pain
  • sciatica
  • and pain due to non-articular rheumatism.
View approved original text

Used for rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative joint disease), pericapsulitis, toothache, inflammation following trauma, low back pain, sciatica, and pain due to non-articular rheumatism.

How to take

Adult dose

Adults: Take 100 mg of aceclofenac every 12 hours, 2 times a day. Do not chew or crush the tablet; take it as is. Adjust according to symptoms as needed. To minimize cardiovascular adverse reactions, use the lowest effective dose for the shortest duration possible.

Precautions

This medication can increase the risk of gastrointestinal bleeding in people who regularly consume more than three alcoholic beverages a day; consult a doctor or pharmacist. This medication can increase the risk of cardiovascular and cerebrovascular events; patients with a history of cardiovascular disease or cerebrovascular bleeding should use it cautiously and take the minimum effective dose for the shortest duration possible. As a non-steroidal anti-inflammatory drug, this medication may increase the risk of serious gastrointestinal adverse effects such as bleeding, ulcers, and perforation. Careful monitoring is particularly needed for elderly patients or those with a history of gastrointestinal diseases. Patients with active peptic ulcers or bleeding, those allergic to this drug or similar medications, patients with severe heart failure, pregnant women in late pregnancy, and lactating women should not take this medication. Patients with impaired renal or liver function, heart failure, hypertension or other cardiovascular diseases should be more cautious when administering this medication. Consulting a doctor is necessary if taking diuretics or ACE inhibitors. Various side effects such as dizziness, gastrointestinal disturbances, altered liver enzyme levels, skin rashes may occur. If symptoms are severe or suspected, immediate medical attention should be sought. During prolonged usage, regular blood tests and liver and kidney function tests are important to check for any abnormalities. This medication can affect the fetus, particularly in late pregnancy, so women who are pregnant or planning to become pregnant should avoid using it, as well as nursing mothers. Due to many drug interactions, consultation with a doctor is necessary when combined with anticoagulants, diuretics, lithium, methotrexate, antidiabetic medications, etc. When experiencing symptoms such as dizziness or drowsiness, it is advisable to avoid driving or operating dangerous machinery. There is no established safety and effectiveness for children, so it should generally not be used in pediatric or adolescent patients. Overdose may cause gastrointestinal irritation, hypotension, respiratory depression, convulsions, etc. If an overdose occurs, immediate medical consultation is necessary. Store the medication out of reach of children, and do not transfer it to other containers as this helps maintain the drug's quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes accompanied by high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, breathing problems, yellowing of skin or eyes (jaundice), severe lethargy, liver dysfunction (jaundice), abrupt

Mild side effects

  • Dizziness
  • altered liver enzyme levels
  • itching
  • rashes
  • skin adverse reactions
  • anemia
  • leukopenia
  • thrombocytopenia
  • neutropenia
  • hemolytic anemia
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  • aplastic anemia
  • agranulocytosis
  • hyperkalemia
  • depression
  • unusual dreams
  • insomnia
  • visual disturbances
  • optic neuritis
  • sensory disturbances
  • tremors
  • drowsiness
  • headaches
  • taste disturbances
  • neck stiffness
  • fever
  • disturbance of spatial perception
  • confusion
  • hallucinations
  • tinnitus
  • fatigue
  • palpitations
  • facial flushing
  • hypertension
  • heart failure

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The appropriate storage temperature is room temperature between 1 degree and 30 degrees Celsius, and it is advisable to avoid extremely hot or cold places.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 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.