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

Paracetamol/Codeine Vitabalans

Active Ingredient:
Paracetamol, Codeine Phosphate Hemihydrate
Origin:
EU

Paracetamol/Codeine Vitabalans (Paracetamol, Codeine Phosphate Hemihydrate)

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

Paracetamol, the active ingredient in Paracetamol/Codeine Vitabalans, is an analgesic presented as a combination tablet for oral use. It treats mild to moderate pain and reduces fever in adult patients. Codeine, the second active ingredient, is an opioid analgesic that enhances pain relief when combined with paracetamol.

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

Manufacturer / TM Owner

Vitabalans Oy

1
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Indications & Clinical Uses

Paracetamol/Codeine Vitabalans is an analgesic combination used in the management of pain and fever pathways.

  • Dental pain: Provides effective relief of acute dental discomfort.
  • Musculoskeletal pain: Reduces inflammation‑related pain from strains, sprains and backache.
  • Post‑operative pain: Controls moderate pain following minor surgical procedures.
  • Headache and migraine: Alleviates tension‑type and mild migraine attacks.
  • Fever: Lowers elevated body temperature associated with viral or bacterial infections.

How It Works

  • Paracetamol acts centrally to inhibit cyclo‑oxygenase enzymes, reducing prostaglandin synthesis and lowering the pain‑signalling threshold. Codeine phosphate hemihydrate is a pro‑drug that is metabolised to morphine, which binds to μ‑opioid receptors in the central nervous system, producing analgesia and a modest antitussive effect. The combination provides synergistic pain relief through complementary mechanisms.

Side Effects

Paracetamol/Codeine Vitabalans may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Nausea: Mild to moderate stomach upset.
  • Constipation: Reduced bowel movements, especially with regular use.
  • Drowsiness: Feeling of sleepiness or reduced alertness.
  • Dizziness: Light‑headed sensation, particularly on standing.
  • Dry mouth: Reduced salivation leading to a parched feeling.

Serious or Rare Side Effects

  • Respiratory depression: Slowed breathing, especially in high doses or opioid‑naïve individuals.
  • Hepatotoxicity: Liver injury from excessive paracetamol exposure.
  • Allergic reactions: Rash, itching, swelling, or anaphylaxis.
  • Dependence or misuse: Potential for opioid dependence with prolonged use.
  • Severe hypotension: Marked drop in blood pressure, rarely reported.

Precautions & Warnings

Paracetamol/Codeine Vitabalans should be used with caution in specific clinical situations.

  • Liver disease: Avoid or limit use in patients with hepatic impairment.
  • Renal impairment: Adjust use in patients with reduced kidney function.
  • Respiratory conditions: Use carefully in asthma or COPD due to risk of respiratory depression.
  • Concomitant CNS depressants: Monitor when combined with alcohol, benzodiazepines or antihistamines.
  • Pregnancy and lactation: Use only if clearly needed and prescribed by a healthcare professional.
  • Store below 25°C: Keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Paracetamol/Codeine Vitabalans can interact with several medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): May reduce conversion of codeine to morphine, lowering analgesic effect.
  • MAO inhibitors: Heightened risk of serotonin syndrome when combined with codeine.
  • CNS depressants: Additive sedation and respiratory depression when taken with alcohol, benzodiazepines or antihistamines.

Moderate Interactions (Monitor Closely)

  • Warfarin: May increase INR and bleeding risk.
  • Antiepileptic drugs (e.g., carbamazepine, phenytoin): May enhance hepatic metabolism of paracetamol, reducing pain control.
  • Diuretics: Potential for reduced renal clearance of paracetamol metabolites.

Frequently Asked Questions

Paracetamol/Codeine Vitabalans is an oral analgesic combination used to treat mild to moderate pain such as dental, musculoskeletal, post‑operative and headache pain, and to reduce fever associated with infections.

Paracetamol acts centrally by inhibiting cyclo‑oxygenase enzymes, which reduces prostaglandin production and lowers the threshold for pain signals, providing antipyretic and analgesic effects.

The appropriate dose is determined by the prescribing clinician based on the patient’s age, weight, pain severity and medical history. Patients should follow the prescriber’s instructions and not exceed the recommended amount.

Use during pregnancy or lactation is only advised when clearly needed and after a risk‑benefit assessment by a healthcare professional, as both paracetamol and codeine cross the placenta and may be present in breast milk.

To place an order, submit an enquiry on the product page at gnhindia.com with 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 necessary import documentation.

Paracetamol/Codeine combines a non‑opioid analgesic with a low‑dose opioid, offering stronger pain relief than paracetamol alone while using a lower opioid dose than pure codeine products. This balance can provide effective analgesia with a reduced risk of opioid‑related side effects compared with higher‑strength opioid preparations.

Store the tablets below 25 °C in their original container, protecting them from moisture, heat and direct sunlight. Keep out of reach of children and do not use if the packaging is damaged.

The medication is taken orally, usually with a glass of water. It may be taken with or without food, but patients should follow the prescriber’s guidance regarding timing relative to meals.

Serious risks include respiratory depression, especially in opioid‑naïve individuals or when combined with other depressants, hepatotoxicity from excessive paracetamol, allergic reactions and the potential for dependence or misuse with prolonged use.

Individuals with known hypersensitivity to paracetamol, codeine or any excipients, patients with severe respiratory depression, uncontrolled asthma, significant liver disease, or those taking MAO inhibitors should avoid this medication.

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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