Medication info

Apen CR Tablet (Aceclofenac)

Prescription medicationExpired
Ingredient · strength
Aceclofenac›Strength being verified
Manufacturer / importer
(주)이든파마
Appearance
White oblong prolonged-release film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201802769 · Approved 2018.07.03

This product's status changed to Expired on 2023.07.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of arthritis and pain such as rheumatoid arthritis and ankylosing spondylitis
Who uses it
Adults
Adult dosage
Take 200 mg of aceclofenac once daily. This medication should be taken whole without chewing or breaking. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

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

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • pericapsulitis of the scapulohumeral joint
  • low back pain
  • sciatica
  • pain due to non-articular rheumatism
View approved original text

This medication is used for the relief of pain associated with chronic joint diseases such as rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative joint disease), as well as pericapsulitis of the scapulohumeral joint, low back pain, sciatica, and pain due to non-articular rheumatism.

Dosage and Administration

Adult dosage

Take 200 mg of aceclofenac once daily. This medication should be taken whole without chewing or breaking. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration.

Precautions

This medication may pose a risk of gastrointestinal bleeding in individuals who regularly consume more than three drinks a day, so consultation with a doctor or pharmacist is essential. It may increase the risk of cardiovascular disease, so patients with risk factors for heart disease or cerebrovascular disease should be administered cautiously and should take the minimum dosage for the shortest duration possible. Given the risk of serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforations, special care should be taken in elderly patients or those with a history of gastrointestinal disease. Should not be taken by those with active peptic ulcers, severe heart failure, severe liver or kidney dysfunction, or known hypersensitivity to aspirin or drugs similar to this medication. Patients with a history of kidney dysfunction, heart failure, hypertension, liver impairment, asthma should take this medication with caution, and pregnant and breastfeeding women should also avoid it. If symptoms such as dizziness, skin rash, difficulty breathing, or gastrointestinal bleeding occur during use, immediate consultation with healthcare personnel is required. This drug may interact with other medications; patients on anticoagulants, diuretics, ACE inhibitors, or antidiabetic agents must consult a doctor. It can be harmful to the fetus, especially in late pregnancy, so women planning to become pregnant or those in early to mid-pregnancy should also exercise caution when taking it. The safety and efficacy for children and adolescents have not been established, so administration is not recommended. Elderly individuals should be especially careful as the risk of gastrointestinal bleeding and perforation is increased. Overdosage may lead to gastrointestinal irritation, hypotension, respiratory depression, seizures, etc., necessitating immediate medical attention. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, shock, anaphylactic reaction, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucous membranes, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden onset of

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
  • unusual dreams
  • insomnia
  • vision disturbances
  • optic neuritis
  • sensory disturbance
  • tremors
  • drowsiness
  • headache
  • taste disturbances
  • neck stiffness
  • fever
  • disorientation
  • confusion
  • hallucinations
  • tinnitus
  • fatigue
  • palpitations
  • facial flushing
  • hypertension
  • heart failure
  • dyspepsia
  • abdominal pain

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White oblong prolonged-release film-coated tablets

Package unit

30 tablets/bottle, 100 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.