Paracetamol comp. 500 mg/30 mg 100 caps
Analgesic / Pain Relief Medication
Description
Generic Name: Paracetamol + Codeine Phosphate
Brand Name: Various generics (commonly “Paracetamol comp.”)
Drug Class: Paracetamol: Non-opioid analgesic and antipyretic
This is a prescription medicine, which requires a valid prescription!
Indications
- Moderate Pain Relief:
- Used for short-term treatment of moderate to moderately severe pain when paracetamol alone is not sufficient.
- Common indications include postoperative pain, dental pain, headache, musculoskeletal pain, and dysmenorrhea.
- Used for short-term treatment of moderate to moderately severe pain when paracetamol alone is not sufficient.
- Fever (limited use):
- May be used for fever associated with painful conditions, but not first-line due to opioid content.
- Paracetamol (500 mg):
- Inhibits prostaglandin synthesis in the central nervous system, leading to analgesic and antipyretic effects.
- Inhibits prostaglandin synthesis in the central nervous system, leading to analgesic and antipyretic effects.
- Codeine Phosphate (30 mg):
- A prodrug converted into morphine in the liver via CYP2D6.
- Binds to opioid receptors in the brain and spinal cord, altering the perception of and response to pain.
- A prodrug converted into morphine in the liver via CYP2D6.
- Form: Oral capsules, each containing 500 mg Paracetamol + 30 mg Codeine
- Adults and adolescents ≥12 years:
- Dose: 1–2 capsules every 4–6 hours as needed
- Maximum: Do not exceed 8 capsules in 24 hours (equivalent to 4 g paracetamol / 240 mg codeine)
- Dose: 1–2 capsules every 4–6 hours as needed
- Duration:
- Use at lowest effective dose for the shortest duration, generally not exceeding 3 days without medical advice.
- Children <12 years:
- Contraindicated due to risk of serious breathing problems (see below).
- Contraindicated due to risk of serious breathing problems (see below).
- Common:
- Nausea, constipation
- Drowsiness, dizziness
- Dry mouth
- Mild euphoria or sedation
- Serious (rare):
- Respiratory depression (especially in ultra-rapid CYP2D6 metabolizers)
- Hepatotoxicity from paracetamol overdose
- Opioid dependence and withdrawal symptoms
- Allergic reactions (rash, swelling, anaphylaxis)
- Pancreatitis (rare)
- Known hypersensitivity to minoxidil
- Severe heart disease (e.g., ischemic heart disease, heart failure)
- Pheochromocytoma (risk of worsening hypertension)
Information
Warnings and Precautions:
- Children under 12 years: Contraindicated due to unpredictable codeine metabolism and risk of respiratory depression.
- CYP2D6 Ultra-rapid Metabolizers: Risk of morphine overdose; avoid use.
- Liver Disease / Alcohol Use: Increased risk of hepatotoxicity; use with caution.
- Breastfeeding: Contraindicated – codeine may pass into breast milk and cause life-threatening effects in the infant.
- Driving and Operating Machinery: May cause drowsiness and impair ability to drive or use machines.
- Addiction risk: Use only for short-term relief; monitor for signs of misuse or dependency.
Overdose Risk:
- Paracetamol overdose can cause fatal liver failure. Immediate medical attention is essential even if no symptoms are present.
Drug Interactions:
- Alcohol: Increases risk of liver toxicity and sedation.
- Other CNS depressants (e.g., benzodiazepines, antihistamines): Additive sedative and respiratory depressant effects.
- Enzyme inducers (e.g., rifampin, phenytoin): May reduce paracetamol efficacy and increase toxicity risk.
- MAO Inhibitors (past 14 days): Avoid use with opioids—risk of serotonin syndrome or CNS toxicity.
- Warfarin: Chronic paracetamol use may enhance anticoagulant effect; monitor INR.
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pharmacy@doctorworld.eu
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