PARACO-DENK 500/30mg Tablet

What is PARACO-DENK 500/30mg

PARACO-DENK 500/30mg is a combination analgesic medication that contains:

• Paracetamol (500mg) – a widely used pain reliever and fever reducer.
• Codeine phosphate hemihydrate (30mg) – an opioid analgesic used for moderate to severe pain relief.

This medication is commonly prescribed for short-term management of moderate pain that does not respond adequately to other analgesics like paracetamol or NSAIDs alone.

PARACO-DENK is typically used for conditions such as:

• Post-operative pain
• Dental pain
• Musculoskeletal pain
• Headaches (excluding migraines)
• Menstrual cramps

It comes in tablet form and is supplied in a pack of 20 tablets (10s Blister x 2).

Due to the presence of codeine, this medicine should be used cautiously, especially in children, the elderly, and patients with a history of substance abuse or respiratory conditions.

How to use PARACO-DENK 500/30mg

Always follow your healthcare provider's instructions when taking PARACO-DENK. Improper use can lead to serious health risks, including liver damage and opioid dependence.

• Administration: Oral, with or without food. Take with a full glass of water.
• Typical frequency: Every 4–6 hours as needed, but not more than 8 tablets in 24 hours.
• Maximum duration: Avoid prolonged use. Generally recommended for short-term use (no more than 3 days without medical advice).
• Missed dose: If a dose is missed, take it when you remember. If it’s almost time for the next dose, skip the missed one. Do not double dose.
• Do not:
  • Exceed the recommended dose.
  • Use alcohol while on this medication.
  • Drive or operate machinery if you feel drowsy.

If you experience persistent pain or side effects, seek medical advice immediately.

Mode of Action PARACO-DENK 500/30mg

PARACO-DENK works through a dual mechanism to relieve pain:

• Paracetamol (Acetaminophen):
  • Acts centrally in the brain by inhibiting prostaglandin synthesis.
  • Reduces the perception of pain and helps lower fever.
• Codeine phosphate hemihydrate:
  • A weak opioid analgesic that is converted to morphine in the liver via CYP2D6.
  • Binds to opioid receptors in the central nervous system (CNS) to block the transmission of pain signals.
  • Also produces mild sedation and cough suppression effects.

This synergistic combination enhances pain relief compared to using either component alone, especially for moderate to moderately severe pain.

PARACO-DENK 500/30mg Interactions PARACO-DENK 500/30mg

PARACO-DENK may interact with several other medications, leading to either enhanced effects or harmful side effects. Always inform your healthcare provider of all medications and supplements you are taking.

• CNS depressants: Such as alcohol, benzodiazepines, antihistamines, and sedatives. Increased risk of drowsiness, respiratory depression, and sedation.
• MAO inhibitors: Avoid use with or within 14 days of stopping MAOIs (e.g., phenelzine, tranylcypromine). Risk of serotonin syndrome or opioid toxicity.
• SSRIs and tricyclic antidepressants: May increase the risk of serotonin syndrome when used with codeine.
• Liver enzyme inducers: Such as rifampicin or phenytoin, which can reduce the effectiveness of paracetamol or increase liver toxicity.
• Anticholinergic drugs: Can exacerbate constipation and urinary retention caused by codeine.
• Warfarin: Long-term use of paracetamol may enhance the anticoagulant effect, increasing bleeding risk.

Avoid alcohol completely during treatment. If you're pregnant or breastfeeding, consult a doctor before using this medication.

Dosage of PARACO-DENK 500/30mg

Dosage should be individualized based on the patient’s medical condition, response to therapy, and risk of opioid addiction.

• Adults and adolescents over 12 years:
  • 1 to 2 tablets every 4–6 hours as required.
  • Do not exceed 8 tablets in 24 hours.
• Children under 12 years: Not recommended due to the risk of respiratory depression and variability in codeine metabolism.
• Older adults: Start at the lower end of the dosage range due to increased sensitivity to opioids.
• Renal or hepatic impairment: Use with extreme caution. Dosage adjustments or alternative therapies may be required.

Important Notes:

• This medicine should be used for short-term relief (3 days or less) unless advised otherwise by a doctor.
• Prolonged use may lead to dependence or tolerance.
• Consult your doctor if pain persists or worsens.

Possible side effects of PARACO-DENK 500/30mg

While generally effective and well-tolerated in prescribed doses, PARACO-DENK can cause several side effects. These may range from mild to severe.

• Common side effects:
  • Drowsiness or sedation
  • Nausea and vomiting
  • Constipation
  • Dry mouth
  • Dizziness or light-headedness
• Less common side effects:
  • Abdominal pain
  • Mood changes (e.g., euphoria, dysphoria)
  • Itching or skin rash
  • Urinary retention
• Serious side effects (seek medical help):
  • Allergic reactions – swelling of face/lips, rash, breathing difficulty
  • Signs of liver damage – yellowing of skin/eyes, dark urine, fatigue
  • Respiratory depression – shallow or slowed breathing
  • Dependence, tolerance, or withdrawal symptoms

If you experience any severe or persistent symptoms, discontinue use and consult your doctor immediately.

PARACO-DENK 500/30mg Contraindications PARACO-DENK 500/30mg

This medication should not be used in certain situations due to the risk of serious complications:

• Hypersensitivity: Allergy to paracetamol, codeine, or any excipients in the formulation.
• Children under 12 years: Increased risk of respiratory depression due to unpredictable codeine metabolism.
• Post-operative pain in children after tonsillectomy or adenoidectomy: Especially in cases of obstructive sleep apnea.
• Respiratory depression: Severe asthma, COPD, or other respiratory disorders.
• Acute liver disease or hepatic failure
• Known ultra-rapid metabolizers of codeine (CYP2D6 polymorphism): Higher risk of opioid toxicity.
• Breastfeeding mothers: Codeine may be passed to the infant through breast milk, potentially causing life-threatening effects.

Use cautiously in patients with head injury, hypothyroidism, Addison’s disease, prostate enlargement, or a history of drug abuse or alcohol dependence.

Storage of PARACO-DENK 500/30mg

Proper storage helps maintain the medicine’s potency and ensures safety:

• Temperature: Store below 25°C (77°F), away from heat and direct sunlight.
• Humidity: Keep in a dry place, away from moisture (do not store in a bathroom).
• Packaging: Keep in original blister packs until ready to use to protect from light and contamination.
• Out of reach: Store out of sight and reach of children and pets due to the risk of accidental overdose.
• Expiry: Do not use after the expiry date printed on the packaging.
• Disposal: Unused or expired tablets should be returned to a pharmacy for proper disposal. Do not flush or throw in household trash.

Always check the appearance of the tablets before use. If discolored or deteriorated, discard them safely.