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Agenzia Italiana del Farmaco
Updated on risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension® (clobazam) - Updated on risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension® (clobazam)
Updated on risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension® (clobazam)
Updated on risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension® (clobazam).
- Epaclob 1mg/ml and 2mg/ml oral suspensions are not bioequivalent to clobazam tablets (one of the clobazam reference pharmaceutical form in European Union). When taking Epaclob, clobazam reaches higher plasma levels than the same dose as a tablet. Therefore care should be taken when switching these medications from one to the other. Identically cautious is recommended when switching Epaclob and the capsule form available on the Italian market.
- This may lead to an increased risk of respiratory depression and sedation, which may be most noticeable when switching to this medicine from tablets.
The absence of data about bioequivalence between Epaclob and Clobazam hard capsules leads to the same precautions when switching from capsules to oral suspension.
Published on: 30 December 2020
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