Medication info
Ostem Aceclofenac Tablet

Ostem Aceclofenac Tablet

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

MFDS item code 201908226 · Approved 2019.12.04 · Insurance code 053500180

Summary

Main use
Relief of inflammation and pain associated with rheumatoid arthritis, ankylosing spondylitis, etc.
Who takes it
Adults
Adult dose
As aceclofenac, take 100 mg every 12 hours, twice daily. Do not chew or crush the tablets and take them as a whole. Adjust according to symptoms. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration necessary.

Ingredients

Manufacturer
오스템파마주식회사

Efficacy & effects

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

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • periphricular inflammation of the scapulohumeral joint
  • toothache
  • post-traumatic inflammation
  • lower back pain
  • sciatica
  • non-joint-related rheumatism pain
View approved original text

This medicine is used for various joint-related diseases such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative arthritis), and periphricular inflammation of the scapulohumeral joint. It is also effective for relieving pain from toothache, post-traumatic inflammation, lower back pain, sciatica, and non-joint-related rheumatism. These symptoms are all associated with conditions that involve inflammation and pain, and this medication helps to reduce the discomfort associated with these, allowing for more comfortable daily life. Therefore, it is used for the treatment of pain related to joint and musculoskeletal diseases.

How to take

Adult dose

As aceclofenac, take 100 mg every 12 hours, twice daily. Do not chew or crush the tablets and take them as a whole. Adjust according to symptoms. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration necessary.

Precautions

Individuals who regularly consume more than three glasses of alcohol daily should consult their doctor or pharmacist before taking this medication or other antipyretic analgesics, as this medication may cause gastrointestinal bleeding. Non-steroidal anti-inflammatory drugs, including this medication, may increase the risk of cardiovascular and cerebrovascular events. Patients with risk factors such as heart disease, hypertension, diabetes, and smoking should be particularly cautious and consult a healthcare professional before using this drug. This medication should be administered at the lowest effective dose for the shortest duration necessary, and symptoms and responses should be evaluated periodically during treatment. If cardiovascular symptoms occur, immediate consultation with a physician is necessary, and patients with a history of cerebrovascular hemorrhage should be particularly careful. This medication may increase the risk of serious gastrointestinal adverse reactions, such as gastrointestinal bleeding, ulceration, and perforation. These reactions can occur without warning, and the risk is higher in older individuals. The longer the duration of administration, the higher the risk of gastrointestinal adverse reactions, so attention should be given to signs of gastrointestinal bleeding while taking this medication. Patients with active peptic ulcers or a history of bleeding, those allergic to this drug or similar medications, and those with a history of asthma or allergic reactions should avoid this medication. Additionally, patients with heart failure, severe renal or hepatic impairment, pregnant women in the late stages of pregnancy, nursing mothers, and patients with inflammatory bowel disease should also avoid using this drug. Patients with renal impairment, heart failure, hypertension, asthma, and elderly patients should use this medication cautiously. Pregnant women in the early or mid-stages of pregnancy or those planning to become pregnant should consult their physician before using this medication. The most common side effects of this medication include gastrointestinal adverse reactions and dizziness, and less commonly, skin rashes, abnormal liver function, and renal impairment may occur. There is a need for caution as cardiovascular adverse effects may increase the risk of myocardial infarction or stroke. This medication may interact with other drugs, so patients taking medications such as digoxin, anticoagulants, diabetes treatments, diuretics, ACE inhibitors must consult their physician. Use of this drug, especially in late pregnancy, may harm the fetus, so it should not be administered, and nursing mothers should either stop breastfeeding or consult their doctor when using this medication. Safety and efficacy in children and adolescents have not been established, so it is advisable not to use it. Elderly patients are at higher risk for gastrointestinal bleeding and perforation, so special caution is needed when using this medication. In case of overdose, symptoms such as gastrointestinal irritation, hypotension, respiratory depression, and seizures may occur, and immediate medical attention is required for appropriate treatment. This medication should be stored out of reach of children, and transferring it to other containers is discouraged as it can compromise quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, shock, chest tightness, difficulty breathing, bronchospasm, asthma attack, severe allergic reactions, severe skin adverse reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), bullous skin reactions, severe rashes with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, liver abnormalities (jaundice), yellowing of skin or eyes,

Mild side effects

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

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain the storage temperature at room temperature between 1 to 30 degrees Celsius. Proper storage will help safely maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round 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.