Medication info
Apex Tablet (Aceclofenac)

Apex Tablet (Aceclofenac)

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

MFDS item code 201404012 · Approved 2014.08.28 · Insurance code 625800250

Summary

Main use
Relief of inflammation and pain in rheumatoid arthritis, ankylosing spondylitis, etc.
Who takes it
Adults
Adult dose
As aceclofenac, take 100 mg once every 12 hours, two times a day. This medication should be taken whole and not chewed or crushed. Adjust dosage appropriately based on symptoms. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

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

  • Rheumatoid arthritis
  • ankylosing spondylitis
  • osteoarthritis
  • glenohumeral periarthritis
  • toothache
  • inflammation
  • low back pain
  • sciatica
  • pain due to non-articular rheumatism
View approved original text

This medication is used for the management of chronic arthritic conditions such as rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative arthritis), as well as for pain management associated with glenohumeral periarthritis, toothache, post-traumatic inflammation, low back pain, and sciatica. It is also effective in relieving pain due to non-articular rheumatism. Overall, it helps alleviate various inflammatory and painful conditions, improving patients' pain levels and reducing inconveniences in daily life.

How to take

Adult dose

As aceclofenac, take 100 mg once every 12 hours, two times a day. This medication should be taken whole and not chewed or crushed. Adjust dosage appropriately based on symptoms. To minimize cardiovascular adverse reactions, it should be administered at the lowest effective dose for the shortest duration.

Precautions

Individuals who regularly consume three or more alcoholic drinks per day should consult a physician or pharmacist before taking this medication or any other analgesic. Those who drink heavily are at increased risk for gastrointestinal bleeding when taking this medication. This medication may increase the risk of cardiovascular and cerebrovascular events. Patients with cardiovascular diseases or risk factors should be carefully evaluated before starting treatment as the risk of myocardial infarction or stroke may be heightened. It should be taken at the lowest effective dose for the shortest duration possible, with periodic monitoring of symptoms and responses during treatment. There is a risk of serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforations. Elderly patients or those with a history of gastrointestinal diseases should be especially cautious, and any symptoms of gastrointestinal bleeding should be reported to healthcare professionals immediately. Those with active peptic ulcers or bleeding, previous allergic reactions to this medication or similar drugs, asthma, severe heart failure, pregnant women in the late stages of pregnancy, and breastfeeding mothers should not use this medication. Patients with renal or liver function problems, hypertension, heart failure, or a history of asthma should be cautious when administering this medication, and careful monitoring of renal and liver function, as well as blood pressure is necessary during treatment. This medication may interact with various drugs, so anyone taking other medications should consult with their physician. Special caution is required when used concurrently with anticoagulants, diuretics, antidiabetic agents, lithium, and anticancer drugs. During the first and second trimesters of pregnancy, it should be administered cautiously at the lowest effective dose and duration, while it should not be administered during the latter stages of pregnancy. Breastfeeding women should consider the potential effects through breast milk and may need to stop breastfeeding or discontinue taking this medication. Safety and efficacy in children and adolescents have not been established; therefore, its use is not recommended. Elderly patients are at increased risk for gastrointestinal bleeding and perforation, requiring special attention when using this medication. In cases of overdose, symptoms like gastrointestinal irritation, hypotension, respiratory depression, and seizures may occur, necessitating appropriate treatment based on symptomatology. This medication should be kept out of reach of children, and transferring it to another container should be avoided to maintain quality and safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, tightness in the chest, difficulty breathing, cold sweats, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver issues (jaundice), sudden and severe headaches, dizziness

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
  • 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
  • wheezing
  • indigestion

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture exposure. A storage temperature between 1°C and 30°C at room temperature is recommended. Proper storage will help maintain its efficacy and safety.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 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.