Medication info
Enclofenac Tablet (Aceclofenac)

Enclofenac Tablet (Aceclofenac)

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

MFDS item code 201403245 · Approved 2014.07.18 · Insurance code 665001860

Summary

Main use
Relief of inflammation and pain due to rheumatoid arthritis, ankylosing spondylitis, etc.
Who takes it
Adults
Adult dose
As Aceclofenac, 100 mg should be taken twice daily at intervals of 12 hours. In patients with liver impairment, an initial dosage of 100 mg per day is recommended. This medication should not be chewed or crushed and should be taken as a whole. Dosage may be adjusted based on symptoms. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

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

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • periarthritis of the scapula and humerus
  • dental pain
  • inflammation caused by trauma
  • lower back pain
  • sciatica
  • pain due to non-articular rheumatism
View approved original text

This medication is used for chronic inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative arthritis). It is also effective for periarthritis of the shoulder joint, where inflammation occurs around the scapula and humerus. It helps to alleviate symptoms such as dental pain, inflammation caused by trauma, lower back pain, and sciatica. It is utilized for improving pain caused by non-articular rheumatism. Overall, it contributes to symptom improvement for various joint and musculoskeletal pains and inflammation.

How to take

Adult dose

As Aceclofenac, 100 mg should be taken twice daily at intervals of 12 hours. In patients with liver impairment, an initial dosage of 100 mg per day is recommended. This medication should not be chewed or crushed and should be taken as a whole. Dosage may be adjusted based on symptoms. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration.

Precautions

This medication may cause gastrointestinal bleeding in individuals who regularly consume more than three glasses of alcohol daily, so it must be discussed with a doctor or pharmacist. This medication may increase risks to the cardiovascular and cerebrovascular systems, so patients with risk factors such as heart disease, hypertension, diabetes, or smoking should use it with caution, and it should be administered at the minimum effective dosage for the shortest duration possible. This medication can cause serious gastrointestinal problems such as gastrointestinal bleeding, ulcers, or perforation, so elderly patients or those with a history of gastrointestinal diseases should exercise special caution. It should not be administered to patients with active peptic ulcers, drug hypersensitivity, severe heart failure, late pregnancy, breastfeeding, or bleeding disorders. Patients with a history of renal dysfunction, heart failure, hypertension, or asthma should be monitored closely when using this medication. Symptoms such as dizziness or drowsiness may occur while taking this medication, so it is advisable to avoid driving or operating dangerous machinery. This medication can affect the liver and kidneys; therefore, if there are symptoms suggesting liver function abnormalities or renal impairment, medical advice should be sought immediately. This medication may interact with other drugs, so it should be discussed with a doctor, especially if taking antihypertensives, diuretics, anticoagulants, lithium, or anticancer drugs. Pregnant women, particularly in late pregnancy, and breastfeeding women should not take this medication, and women planning to become pregnant should consult a specialist before taking it. The safety and efficacy of this medication have not been established in children and adolescents, so caution is advised. The elderly are at higher risk for gastrointestinal bleeding and perforation, so special care should be taken when they take this medication. In case of overdose, symptoms such as gastrointestinal irritation, hypotension, respiratory depression, and convulsions may occur, so it is important to avoid exceeding the recommended dosage, and any abnormal symptoms should be reported to a healthcare provider immediately. This medication should be kept out of the reach of children, and transferring it to another container should be avoided as it may compromise quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), severe allergic reactions, skin peeling, pain in oral/ocular mucous membranes, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, hepatic dysfunction (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, serious neurological symptoms

Mild side effects

  • Dizziness
  • abnormal liver enzyme levels
  • itching
  • rash
  • anemia
  • hyperkalemia
  • depression
  • unusual dreams
  • insomnia
  • visual disturbances
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  • optic neuritis
  • sensory disturbances
  • tremors
  • drowsiness
  • headache
  • taste disturbances
  • neck stiffness
  • fever
  • disorientation
  • hallucinations
  • tinnitus
  • fatigue
  • palpitations
  • facial flushing
  • hypertension
  • heart failure
  • respiratory distress
  • bronchospasm
  • wheezing
  • dyspepsia
  • abdominal pain
  • nausea
  • diarrhea
  • abdominal bloating
  • gastritis
  • constipation
  • vomiting
  • oral ulcers

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to keep the storage temperature between 1 degrees and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White round 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.