Medication info
Sinteclofenac 100 mg (Aceclofenac)

Sinteclofenac 100 mg (Aceclofenac)

Prescription medicationTablet경구
Ingredient · strength
Aceclofenac›100mg / 1 tablet
Manufacturer / importer
(주)셀비온
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201905471 · Approved 2019.08.01 · Insurance code 055800220

Summary

Main use
Relief of inflammation and pain in conditions such as rheumatoid arthritis and ankylosing spondylitis
Who takes it
Adults
Adult dose
As aceclofenac, take 100 mg twice daily every 12 hours. Do not chew or crush the tablets, and take them as is. Adjust dose based on symptoms. To minimize cardiovascular adverse reactions, use the lowest effective dose for the shortest duration.

Ingredients

Manufacturer
(주)셀비온

Efficacy & effects

Relief of inflammation and pain in conditions such as rheumatoid arthritis and ankylosing spondylitis

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

Used for the relief of pain in various joint diseases such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative joint disease), and periarthritis of the shoulder, as well as for pain due to toothache, post-traumatic inflammation, low back pain, sciatica, and non-articular rheumatism.

How to take

Adult dose

As aceclofenac, take 100 mg twice daily every 12 hours. Do not chew or crush the tablets, and take them as is. Adjust dose based on symptoms. To minimize cardiovascular adverse reactions, use the lowest effective dose for the shortest duration.

Precautions

Patients who regularly consume more than three glasses of alcohol per day should consult a physician or pharmacist before taking this medication. There is a risk of gastrointestinal bleeding if taken with alcohol. This medication may increase the risk of cardiovascular diseases; therefore, patients with a history of cardiovascular disease or risk factors should carefully consider taking it before use. The risk increases with prolonged dosage and duration, so it should be taken for the shortest duration at the minimal effective dose. Serious gastrointestinal issues such as gastrointestinal bleeding, ulcers, and perforation may occur, making it particularly necessary for elderly patients or those with a history of gastrointestinal disease to exercise caution. If gastrointestinal symptoms appear, immediate medical consultation is advised. Patients with active peptic ulcers or bleeding, those allergic to this medication or similar drugs, and patients with severe heart failure or severely impaired liver and kidney function should not take this medication. This medication should be administered cautiously to patients with impaired kidney function, heart failure, hypertension, or asthma history, and regular monitoring as per physician's instructions is required during use. If symptoms such as dizziness, rash, or difficulty breathing occur, discontinue use immediately and consult with a healthcare professional. This medication may interact with other drugs; therefore, patients should inform their physician or pharmacist of any medications they are currently taking. Caution is particularly important for those on anticoagulants, diuretics, blood pressure medications, and antidiabetic agents. This medication should not be taken during the last three months of pregnancy, and women planning to become pregnant or in early to mid-pregnancy should consult a physician before taking. Nursing mothers should also avoid taking it. Safety and efficacy in children and adolescents have not been established, and use is not recommended. Elderly patients may experience adverse reactions such as gastrointestinal bleeding more frequently, so special care is needed during use. In case of overdose, gastrointestinal irritation, hypotension, respiratory depression, and convulsions may occur, requiring immediate medical attention for appropriate treatment. This medication should be kept out of the reach of children, and care should be taken to avoid transferring it to other containers as it may lead to accidents or degradation in quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylactic reaction (severe allergic reaction), shock, gastrointestinal bleeding, peptic ulcer, perforation, hematemesis, melena, acute myocardial infarction, stroke, heart failure, liver abnormalities (jaundice, hepatitis, liver dysfunction), skin and mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, asthma attack, respiratory distress, severe skin adverse reactions, generalized severe swelling, hypertension, acute complications

Mild side effects

  • Dizziness
  • abnormal liver enzyme levels
  • itching
  • rash
  • anemia
  • leukopenia
  • thrombocytopenia
  • neutropenia
  • hemolytic anemia
  • aplastic anemia
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  • agranulocytosis
  • hyperkalemia
  • depression
  • strange dreams
  • insomnia
  • visual disturbances
  • optic neuritis
  • sensory disturbances
  • tremors
  • drowsiness
  • headache
  • taste disturbances
  • neck stiffness
  • fever
  • disorientation
  • confusion
  • hallucinations
  • tinnitus
  • lethargy
  • 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 closed container to prevent exposure to air or moisture and should be kept at room temperature, ideally between 1 and 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 500 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.