Product image of Paracetamol/Codeína Level (Paracetamol, Codeine Phosphate Hemihydrate) supplied by GNH India

Paracetamol/Codeína Level

Active Ingredient:
Paracetamol, Codeine Phosphate Hemihydrate
Origin:
EU

Paracetamol/Codeína Level (Paracetamol, Codeine Phosphate Hemihydrate)

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

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 India supplies Paracetamol/Codeína Level as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

GNH India supplies Paracetamol/Codeína Level as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Laboratorios Ern, S.A.

1
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Indications & Clinical Uses

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.

How It Works

  • Paracetamol acts primarily on central cyclo‑oxygenase pathways, producing antipyretic and analgesic effects, while codeine phosphate hemihydrate is an opioid agonist that binds to µ‑opioid receptors in the central nervous system, enhancing pain relief through inhibition of nociceptive transmission.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Paracetamol/Codeína Level is a combination analgesic used to treat moderate pain and reduce fever in adult patients. It is commonly prescribed for conditions such as dental pain, musculoskeletal discomfort, postoperative pain, headache and dysmenorrhoea, providing both opioid‑mediated and non‑opioid pain relief.

Paracetamol reduces pain and fever by inhibiting central cyclo‑oxygenase enzymes, which lowers prostaglandin synthesis in the brain. This action decreases the body’s temperature set‑point and diminishes the perception of pain without significant anti‑inflammatory effects.

The appropriate dose is determined by the prescribing clinician based on the patient’s age, weight, pain severity and overall health status. Healthcare professionals set the dosing schedule and strength according to local regulatory guidelines and individual therapeutic needs.

Paracetamol/Codeína Level should only be used in pregnancy or while breastfeeding if the potential benefit justifies the potential risk to the fetus or infant. Consultation with a qualified healthcare provider is essential to evaluate safety and consider alternative therapies when appropriate.

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, confirming trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Compared with single‑ingredient paracetamol, the addition of codeine provides stronger analgesia for moderate pain but introduces opioid‑related risks such as dependence and respiratory depression. Unlike non‑steroidal anti‑inflammatory drugs, this combination lacks significant anti‑inflammatory activity but offers antipyretic effects.

Store the tablets below 25 °C in their original packaging, protecting them from moisture, heat and direct sunlight. Maintaining a stable ambient temperature helps preserve potency and prevents degradation of both paracetamol and codeine.

Paracetamol/Codeína Level is supplied as oral tablets that should be swallowed whole with water. It is typically taken at regular intervals as directed by a healthcare professional, and should not be crushed or chewed unless specifically advised.

The most serious risks include respiratory depression, especially in opioid‑naïve individuals, and liver injury from excessive paracetamol intake. Patients should be monitored for signs of overdose, allergic reactions and signs of dependence, and seek immediate medical attention if severe symptoms develop.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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

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