Europe — EMA
Paracetamol/Codeine Vitabalans (Paracetamol, Codeine Phosphate Hemihydrate)
GNH USA supplies Paracetamol/Codeine Vitabalans (Paracetamol/Codeine), a analgesic combination for pain relief and fever. Request a quote for global supply.
International sale not permitted. Listed for the domestic market and B2B only.
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What is Paracetamol, Codeine Phosphate Hemihydrate?
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 USA supplies Paracetamol/Codeine Vitabalans as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Paracetamol, Codeine Phosphate Hemihydrate used for?
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.
What are the side effects of Paracetamol, Codeine Phosphate Hemihydrate?
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.
What precautions apply to Paracetamol, Codeine Phosphate Hemihydrate?
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.
What does Paracetamol, Codeine Phosphate Hemihydrate interact with?
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.
