Europe — EMA
Paracetamol/Codeine Teva (Paracetamol, Codeine Phosphate Hemihydrate)
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What is Paracetamol, Codeine Phosphate Hemihydrate?
Paracetamol, the active ingredient in Paracetamol/Codeine Teva, is a combination analgesic presented as a tablet for oral use. It treats mild to moderate pain and reduces fever in adult patients. GNH USA supplies Paracetamol/Codeine Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
GNH USA supplies Paracetamol/Codeine Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
What is Paracetamol, Codeine Phosphate Hemihydrate used for?
Paracetamol/Codeine Teva is used for pain relief and fever reduction across several common conditions.
- Mild to moderate acute pain: provides effective analgesia when non‑opioid analgesics are insufficient. - Post‑operative pain: helps manage discomfort after minor surgical procedures. - Dental pain: alleviates pain associated with tooth extractions and dental surgery. - Musculoskeletal pain: reduces pain from strains, sprains and low‑back discomfort. - Fever: lowers elevated body temperature in adults.
What are the side effects of Paracetamol, Codeine Phosphate Hemihydrate?
Paracetamol/Codeine Teva may cause a range of adverse reactions, most of which are dose‑dependent and reversible.
Common Side Effects: - Nausea and vomiting: mild to moderate gastrointestinal upset. - Constipation: reduced bowel motility leading to hard stools. - Drowsiness: mild sedation, especially when first administered. - Dizziness: transient light‑headedness. - Dry mouth: reduced salivary flow.
Serious or Rare Side Effects: - Respiratory depression: slowed breathing, particularly at higher doses or in opioid‑naïve individuals. - Hepatotoxicity: liver injury from excessive paracetamol exposure. - Allergic reactions: rash, itching, or anaphylaxis in susceptible patients. - Seizures: rare occurrence, often linked to overdose. - Dependence or withdrawal: potential for opioid dependence with prolonged use.
What precautions apply to Paracetamol, Codeine Phosphate Hemihydrate?
Paracetamol/Codeine Teva should be used with caution in specific clinical situations.
- Liver disease: avoid exceeding recommended paracetamol limits. - Renal impairment: monitor kidney function, adjust use as needed. - Respiratory conditions: use carefully in patients with asthma or COPD. - Concomitant CNS depressants: increased sedation risk when combined with alcohol or benzodiazepines. - Pregnancy and lactation: limit use to situations where benefits outweigh risks. - 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 Teva can interact with several other medicines, affecting safety and efficacy.
Major Interactions (Avoid): - CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may reduce conversion of codeine to morphine, lowering analgesic effect. - MAO inhibitors: increased risk of serotonin‑related adverse events. - CNS depressants: additive sedation and respiratory depression.
Moderate Interactions (Monitor Closely): - Anticoagulants (e.g., warfarin): may enhance bleeding risk. - Antihistamines: may increase drowsiness. - Diuretics: potential for reduced renal clearance of paracetamol. - Alcohol: heightened risk of liver toxicity and sedation.



