Medication info
Apen CR Controlled-Release Tablet (Aceclofenac)

Apen CR Controlled-Release Tablet (Aceclofenac)

Prescription medicationTablet경구
Ingredient · strength
Aceclofenac›90mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
White rectangular controlled-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906060 · Approved 2019.08.26

Summary

Main use
Relief of inflammation and pain associated with rheumatoid arthritis, ankylosing spondylitis, etc.
Who takes it
Adults
Adult dose
For aceclofenac, take 200 mg once daily. This medication should be taken whole without chewing or crushing. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

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

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

This medication is used for a variety of arthritis disorders such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative arthritis), and periarthritis of the shoulder. It is also effective in relieving pain related to spinal issues such as low back pain and sciatica, as well as pain caused by non-articular rheumatism. It helps reduce inflammation and pain, improving discomfort in daily life. Therefore, this medication is used for alleviating symptoms of various joint and musculoskeletal disorders.

How to take

Adult dose

For aceclofenac, take 200 mg once daily. This medication should be taken whole without chewing or crushing. 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 alcoholic beverages a day, so it is essential to consult with a doctor or pharmacist. This medication may increase the risk of cardiovascular diseases, so patients with risk factors such as heart disease, hypertension, and diabetes should carefully consider whether to use it and should use the lowest possible dose for the shortest duration. It can cause serious gastrointestinal issues such as gastrointestinal bleeding, ulcers, and perforations, so special care is needed particularly for elderly patients or those with a history of gastrointestinal diseases. Patients with active peptic ulcers or bleeding, or who have had an allergic reaction to this medication or similar drugs, should not take it. Patients with heart failure, severe kidney or liver impairment, pregnant women in the late stages of pregnancy, nursing mothers, and patients with inflammatory bowel disease should preferably not use this medication. Patients with weak kidney function, heart failure, or hypertension should be cautious when using this medication and should regularly monitor kidney function and blood pressure during treatment. This medication can cause various side effects such as dizziness, gastrointestinal disturbances, abnormal liver enzymes, and skin rashes, so if any unusual symptoms occur, you should consult a doctor immediately. Regular blood tests and liver and kidney function tests are necessary for long-term use of this medication, and if symptoms of bleeding or skin abnormalities occur during usage, the medication should be stopped immediately. Particularly in late pregnancy, it may harm the fetus, so women who are pregnant or planning to become pregnant should consult medical staff before taking it. Due to many drug interactions, especially with anticoagulants, diuretics, antihypertensives, and anticancer drugs, it is essential to consult a doctor if you are taking any of these medications. Safety for children and adolescents has not been established, so it is advisable not to use this medication. Elderly individuals have a higher risk of side effects such as gastrointestinal bleeding, so special caution is needed during administration. In case of overdose, symptoms such as gastrointestinal irritation, hypotension, respiratory depression, and convulsions may occur, so immediate medical attention should be sought. This medication should be kept out of reach of children, and transferring it to another container may cause degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urinary changes

Mild side effects

  • Dizziness
  • abnormal liver enzyme levels
  • itching
  • rash
  • skin reactions
  • anemia
  • leukopenia
  • thrombocytopenia
  • neutropenia
  • hemolytic anemia
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  • aplastic anemia
  • agranulocytosis
  • hyperkalemia
  • depression
  • abnormal dreams
  • insomnia
  • visual impairment
  • optic neuritis
  • sensory disturbances
  • tremors
  • drowsiness
  • headache
  • taste disturbance
  • neck stiffness
  • fever
  • spatial disorientation
  • confusion
  • hallucinations
  • tinnitus
  • fatigue
  • palpitations
  • facial flushing
  • hypertension
  • heart failure
  • malaise

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Avoid extremely hot or cold places, and it is best to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White rectangular controlled-release film-coated tablet

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.