Europe — EMA
Paracetamol/Codeína Level (Paracetamol, Codeine Phosphate Hemihydrate)
GNH USA supplies Paracetamol/Codeína Level (Paracetamol/Codeine), a combination analgesic for pain relief and fever reduction.
International sale not permitted. Listed for the domestic market and B2B only.
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What is Paracetamol, Codeine Phosphate Hemihydrate?
Paracetamol, the active ingredient in Paracetamol/Codeína Level, is a combination analgesic presented as a tablet for oral use. It treats mild to moderate pain and reduces fever in adult patients. GNH USA supplies Paracetamol/Codeína Level as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Paracetamol/Codeína Level as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Paracetamol, Codeine Phosphate Hemihydrate used for?
Paracetamol/Codeína Level is used for pain relief and fever reduction across several common clinical situations.
- Moderate pain: Provides effective relief of moderate nociceptive pain such as dental or musculoskeletal pain. - Headache: Alleviates tension‑type and migraine‑associated headache when combined with other therapies. - Fever: Reduces elevated body temperature in adults with febrile illnesses. - Post‑operative pain: Assists in managing pain after minor surgical procedures. - Dysmenorrhoea: Helps relieve menstrual‑related pain and discomfort.
What are the side effects of Paracetamol, Codeine Phosphate Hemihydrate?
Paracetamol/Codeína Level may cause a range of adverse reactions, most of which are dose‑dependent and reversible.
Common Side Effects: - Nausea: Mild to moderate nausea may occur, especially after the first doses. - Constipation: Reduced bowel motility is frequently reported with opioid‑containing products. - Drowsiness: A feeling of sleepiness or reduced alertness can develop. - Dizziness: Light‑headedness may be experienced, particularly when standing quickly. - Dry mouth: Reduced salivary flow is a typical anticholinergic effect.
Serious or Rare Side Effects: - Respiratory depression: Marked slowing of breathing, especially in opioid‑naïve individuals. - Hepatotoxicity: Elevated liver enzymes or liver injury may occur with excessive paracetamol exposure. - Allergic reactions: Rash, itching, or anaphylaxis in sensitised patients. - Seizures: Rarely, high doses can lower the seizure threshold. - Dependence or abuse potential: Prolonged use may lead to physical dependence.
What precautions apply to Paracetamol, Codeine Phosphate Hemihydrate?
When using Paracetamol/Codeína Level, consider the following safety measures:
- Liver function monitoring: Assess hepatic status before initiating therapy and during prolonged use. - Opioid tolerance assessment: Evaluate patient history for opioid use or dependence. - Concomitant CNS depressants: Use caution when combined with alcohol, benzodiazepines or other sedatives. - Pregnancy and lactation: Avoid unless clearly indicated and benefits outweigh risks. - Renal impairment: Adjust dosing in patients with reduced kidney function. - Store below 25°C: Keep in the original packaging, protect from moisture and direct sunlight.
What does Paracetamol, Codeine Phosphate Hemihydrate interact with?
Paracetamol/Codeína Level can interact with several medicines, altering efficacy or safety.
Major Interactions (Avoid): - MAO inhibitors: May precipitate hypertensive crisis or serotonin syndrome. - CNS depressants: Combined use with alcohol, benzodiazepines or other opioids can cause profound respiratory depression. - CYP2D6 inhibitors: Strong inhibitors (e.g., fluoxetine) can reduce codeine conversion to its active metabolite, diminishing analgesia.
Moderate Interactions (Monitor Closely): - Anticoagulants: May increase bleeding risk when used with high‑dose paracetamol.\n- Antihistamines: May enhance drowsiness and dizziness. - Diuretics: Potential for reduced renal clearance of paracetamol metabolites.
