Medication info
Apen Tablet (Aceclofenac)

Apen Tablet (Aceclofenac)

Prescription medicationTablet경구
Ingredient · strength
Aceclofenac›100mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200802182 · Notified 2008.02.25 · Insurance code 657202270

Summary

Main use
Pain relief for rheumatoid arthritis and osteoarthritis
Who takes it
Adults
Adult dose
Adults: take 100 mg of aceclofenac once every 12 hours, for a total of 2 times a day. This medication should be taken whole, without chewing or breaking. Adjustment of the dose may be made according to symptoms. To minimize cardiovascular adverse reactions of this medication, the lowest effective dose should be given for the shortest duration.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Pain relief for rheumatoid arthritis and osteoarthritis

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • periarthritis of the scapulohumeral area
  • dental pain
  • inflammation due to trauma
  • low back pain
  • sciatica
  • pain caused by non-articular rheumatism.
View approved original text

This medication is used for inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis, degenerative osteoarthritis, and periarthritis of the scapulohumeral area. It is also effective for relieving pain caused by non-articular rheumatism such as dental pain, post-traumatic inflammation, low back pain, and sciatica. It helps improve various joint and musculoskeletal pain and inflammatory symptoms.

How to take

Adult dose

Adults: take 100 mg of aceclofenac once every 12 hours, for a total of 2 times a day. This medication should be taken whole, without chewing or breaking. Adjustment of the dose may be made according to symptoms. To minimize cardiovascular adverse reactions of this medication, the lowest effective dose should be given for the shortest duration.

Precautions

This medication should be used cautiously in individuals who regularly consume more than three glasses of alcohol daily, as it may increase the risk of gastrointestinal bleeding; consultation with a doctor or pharmacist is essential. This medication may increase the risk of cardiovascular and cerebrovascular diseases, so individuals with cardiovascular risk factors such as heart disease, hypertension, diabetes, and smoking should use it carefully. The longer the dosage and duration, the higher the cardiovascular risks, so it is best to take the lowest effective dose for the shortest duration possible. Serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforations may occur, especially in the elderly or those with a history of gastrointestinal diseases. Patients with active peptic ulcers, severe heart failure, severe renal and hepatic impairment, late-term pregnancy, breastfeeding, or bleeding disorders should not take this medication. Patients with renal or liver dysfunction, hypertension, asthma, elderly individuals, women in early or mid-pregnancy, or those taking anticoagulants should use this medication cautiously. This medication may cause side effects such as dizziness, gastrointestinal discomfort, elevated liver enzyme levels, skin rashes, and rarely, severe allergic reactions, hepatitis, or kidney damage. If abnormal symptoms occur during use, contact a doctor immediately; particularly if symptoms such as skin rashes or breathing difficulties arise, stop taking the medication immediately. This medication may interact with other drugs; if taking digoxin, anticoagulants, diabetes medications, diuretics, lithium, methotrexate, or other medications, inform the doctor. During pregnancy, especially in the last three months, this medication should be avoided as it may pose risks to the fetus, and it's advisable not to take it while breastfeeding. Safety in children and adolescents has not been established, so it is preferable not to use this medication in this population. Elderly patients are at increased risk for gastrointestinal bleeding and perforation, so special caution is needed when taking this medication. In case of overdose, symptoms such as gastrointestinal irritation, hypotension, respiratory depression, and seizures may appear, and immediate medical assistance should be sought. This medication should be stored out of reach of children and should not be transferred to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash accompanied by high fever, blisters, skin shedding, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever, skin or eye jaundice (yellowing), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Dizziness
  • abnormal liver enzyme levels
  • itching
  • rashes
  • anemia
  • leukopenia
  • thrombocytopenia
  • neutropenia
  • hemolytic anemia
  • aplastic anemia
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  • agranulocytosis
  • hyperkalemia
  • depression
  • unusual dreams
  • insomnia
  • visual disturbances
  • optic neuritis
  • sensory disturbances
  • tremor
  • drowsiness
  • headache
  • taste disturbances
  • stiff neck
  • fever
  • spatial disorientation
  • confusion
  • hallucinations
  • tinnitus
  • fatigue
  • palpitations
  • facial flushing
  • hypertension
  • heart failure
  • bronchospasm
  • stenosis.

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 important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.