Europe — EMA
Paracetamol / Codeine Phosphate Hemihydrate Accord (Paracetamol, Codeine Phosphate Hemihydrate)
GNH USA supplies Paracetamol / Codeine Phosphate Hemihydrate Accord (Paracetamol / Codeine Phosphate Hemihydrate), an Analgesic for mild to moderate pain
International sale not permitted. Listed for the domestic market and B2B only.
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What is Paracetamol, Codeine Phosphate Hemihydrate?
Paracetamol / Codeine Phosphate Hemihydrate, the active ingredient in Paracetamol / Codeine Phosphate Hemihydrate Accord, is an Analgesic presented as a strength/form not specified for oral use. It provides relief of mild to moderate pain and reduces fever in adult patients.
GNH USA supplies Paracetamol / Codeine Phosphate Hemihydrate Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and procurement teams worldwide. The product meets EU quality standards and is available for bulk distribution to meet global demand.
What is Paracetamol, Codeine Phosphate Hemihydrate used for?
Paracetamol / Codeine Phosphate Hemihydrate is used to manage pain and fever through its combined analgesic and antipyretic actions.
- Mild to moderate pain: alleviates discomfort from headaches, dental procedures, musculoskeletal injuries. - Fever: reduces elevated body temperature in febrile conditions. - Post‑operative pain: provides relief after minor surgical interventions.
What are the side effects of Paracetamol, Codeine Phosphate Hemihydrate?
Paracetamol / Codeine Phosphate Hemihydrate may cause a range of adverse reactions, varying from common to serious.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Constipation: reduced bowel movements. - Dizziness: sensation of light‑headedness. - Drowsiness: increased sleepiness. - Vomiting: occasional emesis. - Dry mouth: reduced salivation.
Serious or Rare Side Effects: - Respiratory depression: slowed breathing, especially with high doses. - Severe allergic reaction: rash, itching, swelling, or anaphylaxis. - Hepatic injury: elevated liver enzymes or jaundice. - Dependence or abuse potential: risk of opioid misuse. - Seizures: rare occurrence in susceptible individuals.
What precautions apply to Paracetamol, Codeine Phosphate Hemihydrate?
When prescribing Paracetamol / Codeine Phosphate Hemihydrate, clinicians should observe specific safety measures to minimize risk.
- Dose adjustment: use the lowest effective dose as directed by the prescriber. - Hepatic impairment: avoid or reduce use in patients with severe liver disease. - Respiratory conditions: exercise caution in individuals with asthma or chronic obstructive pulmonary disease. - Concomitant CNS depressants: limit use with alcohol, benzodiazepines, or other sedatives. - Dependence monitoring: assess for signs of opioid misuse during therapy. - Store at ambient temperature: keep in the original container, protect from moisture and heat.
What does Paracetamol, Codeine Phosphate Hemihydrate interact with?
Paracetamol / Codeine Phosphate Hemihydrate can interact with other medicines, affecting safety and efficacy.
Major Interactions (Avoid): - Other opioids: additive risk of respiratory depression and profound sedation. - Benzodiazepines or CNS depressants: increased sedation and impaired psychomotor function. - Alcohol: enhances central nervous system depression, raising overdose risk.
Moderate Interactions (Monitor Closely): - CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may reduce conversion of codeine to morphine, lowering analgesic effect. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may decrease paracetamol plasma levels, reducing efficacy. - Anticoagulants (e.g., warfarin): high‑dose paracetamol may potentiate anticoagulant effect, requiring INR monitoring.



