Paracetamol / Codeine Phosphate Hemihydrate Accord

Active Ingredient:: Paracetamol, Codeine Phosphate Hemihydrate
Origin:: EU

Paracetamol / Codeine Phosphate Hemihydrate Accord (Paracetamol, Codeine Phosphate Hemihydrate)

International sale not permitted. Listed for the domestic market and B2B only.

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 India 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.

Manufacturer / TM Owner

Accord Healthcare B.V.

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Indications & Clinical Uses

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.

How It Works

Paracetamol acts centrally by inhibiting cyclooxygenase enzymes, decreasing prostaglandin synthesis and thereby producing analgesic and antipyretic effects. Codeine Phosphate Hemihydrate is a pro‑drug converted by hepatic CYP2D6 to morphine, which binds to μ‑opioid receptors in the central nervous system, modulating pain perception and producing sedation. The combination yields synergistic pain relief while allowing lower doses of each component in clinical practice.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Paracetamol / Codeine Phosphate Hemihydrate Accord is prescribed to relieve mild to moderate pain such as headache, dental or musculoskeletal discomfort, and to lower fever in adult patients. The combination leverages both analgesic and antipyretic properties to provide effective symptom control.

Paracetamol reduces pain and fever by centrally inhibiting cyclooxygenase enzymes, which lowers prostaglandin production. Codeine phosphate hemihydrate is metabolised by the liver enzyme CYP2D6 into morphine, which activates μ‑opioid receptors in the brain, altering pain perception and adding a sedative effect. Together they produce synergistic relief.

The exact dose is determined by the prescribing clinician based on the patient’s age, weight, severity of symptoms, and overall health status. Healthcare professionals tailor the regimen to achieve optimal pain control while minimizing risk, and patients should follow the prescriber’s instructions without deviation.

Use during pregnancy or lactation should only occur when clearly indicated and after a risk‑benefit assessment by a qualified healthcare provider. Codeine can cross the placenta and be excreted in breast milk, potentially affecting the infant, so alternative therapies are often preferred.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Compared with non‑opioid NSAIDs such as ibuprofen, this combination offers stronger analgesia for moderate pain due to the opioid component, while still providing antipyretic action. Unlike pure opioid preparations, the lower dose of codeine reduces the risk of severe side effects, but it still carries dependence potential.

Store the product at ambient temperature, ideally below 25 °C, in its original packaging to protect it from moisture and direct sunlight. Keep the container tightly closed and out of reach of children. Do not refrigerate or freeze the tablets unless the label specifically advises otherwise.

The medication is taken orally, usually with a full glass of water. It may be taken with or without food, depending on the prescriber’s guidance. Swallow the tablet whole; do not crush, chew, or split it unless instructed, as this could affect absorption and increase side‑effect risk.

The most critical concerns include respiratory depression, especially in opioid‑naïve patients or when combined with other depressants, severe allergic reactions, hepatic injury from excessive paracetamol exposure, and the potential for dependence or abuse of the codeine component. Prompt medical attention is required if any of these occur.

Patients with known hypersensitivity to paracetamol, codeine, or any excipients should avoid the product. It is contraindicated in individuals with severe hepatic impairment, uncontrolled respiratory disorders, or a history of opioid dependence. Children under the age specified by local regulations should not receive this formulation without specialist advice.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 13 Oct 2026

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International sale not permitted. Listed for the domestic market and B2B only.

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