Product image of Paracetamol Comp. (Paracetamol, Codeine Phosphate Hemihydrate) supplied by GNH India

Paracetamol Comp.

Active Ingredient:
Paracetamol, Codeine Phosphate Hemihydrate
Origin:
EU

Paracetamol Comp. (Paracetamol, Codeine Phosphate Hemihydrate)

Paracetamol and Codeine Phosphate Hemihydrate, the active ingredients in Paracetamol Comp., are analgesic agents presented as an oral combination tablet for adult use. They provide relief of mild to moderate pain, reduce fever, and are commonly employed for dental discomfort and headache management in patients requiring opioid‑enhanced analgesia. The combination acts quickly to improve comfort.

GNH India supplies Paracetamol Comp. as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. Our distribution network ensures timely delivery and regulatory compliance across regions.

Manufacturer / TM Owner

Stadapharm Gmbh

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Indications & Clinical Uses

  • Paracetamol/Codeine combination analgesic is used for pain and fever management across several clinical conditions.
  • Mild to moderate pain: provides effective analgesia for musculoskeletal and postoperative discomfort.
  • Fever: reduces elevated body temperature.
  • Dental pain: alleviates postoperative dental discomfort.
  • Headache: relieves tension‑type headache.

How It Works

  • Paracetamol acts centrally by inhibiting cyclooxygenase enzymes, decreasing prostaglandin synthesis and thereby reducing pain and fever. Codeine phosphate hemihydrate is a pro‑drug that is metabolized to morphine, which binds to μ‑opioid receptors in the central nervous system, producing analgesia and cough suppression. The combined effect provides a synergistic effect that improves patient comfort.

Side Effects

Paracetamol Comp. may cause a range of adverse reactions.

Common Side Effects

  • Nausea
  • Constipation
  • Drowsiness
  • Dizziness
  • Dry mouth
  • Mild itching

Serious or Rare Side Effects

  • Respiratory depression
  • Severe allergic reactions (anaphylaxis)
  • Hepatotoxicity
  • Dependence or abuse potential
  • Severe hypotension
  • Seizures

Precautions & Warnings

Use of Paracetamol Comp. requires careful consideration of patient‑specific factors.

  • Pregnancy: use only if clearly needed after risk assessment.
  • Liver disease: avoid or adjust dose due to hepatotoxic risk.
  • Alcohol consumption: limit intake as it may increase sedation and liver strain.
  • Driving and operating machinery: may cause drowsiness; caution advised.
  • Children and adolescents: not recommended unless specifically prescribed.
  • Store at ambient temperature: keep in the original container, protect from moisture.

Avoid Interactions

Paracetamol Comp. can interact with other medicines, influencing safety and efficacy.

Major Interactions (Avoid)

  • Central nervous system depressants (e.g., benzodiazepines, barbiturates)
  • Monoamine oxidase (MAO) inhibitors
  • Alcohol
  • Other opioid analgesics
  • CYP2D6 inhibitors (e.g., fluoxetine) that may raise codeine levels

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin) may reduce analgesic effect
  • Antihistamines may increase sedation

Frequently Asked Questions

Paracetamol Comp. is a fixed‑dose combination of paracetamol and codeine phosphate hemihydrate. It is prescribed to relieve mild to moderate pain, reduce fever, and manage dental discomfort or tension‑type headaches when an opioid‑enhanced analgesic is appropriate.

Paracetamol reduces pain and fever by inhibiting central cyclooxygenase enzymes, lowering prostaglandin production. Codeine phosphate hemihydrate is a pro‑drug converted to morphine, which activates μ‑opioid receptors in the brain and spinal cord, producing analgesia and cough suppression.

The dose of Paracetamol Comp. is determined by the prescribing clinician based on the patient’s age, weight, pain severity, and clinical condition. Patients should follow the prescriber’s instructions and never adjust the dose without medical advice.

Safety in pregnancy and lactation has not been fully established. The product should be used only if the potential benefit justifies the potential risk to the fetus or infant, and only under the guidance of a qualified health professional.

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 and any required import documentation.

Compared with paracetamol alone, the addition of codeine provides stronger analgesia and can address moderate pain that may not respond to non‑opioid therapy. Compared with stronger opioids, the combination offers a lower risk of severe respiratory depression but still requires careful monitoring.

Store Paracetamol Comp. at ambient temperature, below 25 °C, in the original packaging to protect it from moisture and light. Keep out of reach of children and do not use after the expiry date printed on the label.

The product is taken orally, usually with a glass of water. It may be taken with or without food, but if gastrointestinal upset occurs, it can be taken with a light meal. Swallow tablets whole; do not crush or chew unless instructed by a healthcare professional.

Serious risks include respiratory depression, especially when combined with other CNS depressants, severe allergic reactions, hepatotoxicity from excessive paracetamol exposure, and the potential for dependence or abuse associated with codeine. Immediate medical attention is required if any of these occur.

The product should be avoided in individuals with known hypersensitivity to paracetamol or codeine, severe respiratory depression, uncontrolled liver disease, or those taking MAO inhibitors. It is also contraindicated in children under the age specified by local regulations unless prescribed by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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