Safety of Oral Paracetamol - Analysis of Data from a Spontaneous Reporting System in Poland

Purpose: To determine the safety of oral coated paracetamol tablets 500 mg and oral suspension 120 mg/5 mL produced by Hasco-Lek Poland. Methods: We analyzed sales volume and data obtained from the monitoring of spontaneous reports on the adverse effects of paracetamol collected in the period betwee...

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Published inTropical journal of pharmaceutical research Vol. 13; no. 4; p. 617
Main Authors Han, Stanislaw, Kuchar, Ernest, Karłowicz-Bodalska, Katarzyna, Kutycka, Elżbieta, Miśkiewicz, Katarzyna, Nitsch-Osuch, Aneta
Format Journal Article
LanguageEnglish
Published Nigeria Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria 23.09.2014
Subjects
Adverse reaction
NSAIDs
Pharmacovigillance
Pharmoepidemiology
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Abstract Purpose: To determine the safety of oral coated paracetamol tablets 500 mg and oral suspension 120 mg/5 mL produced by Hasco-Lek Poland. Methods: We analyzed sales volume and data obtained from the monitoring of spontaneous reports on the adverse effects of paracetamol collected in the period between November 2000 and June 2012. Results: A total of 45,694 units of coated paracetamol tablets (500 mg) and 6,048,289 units of paracetamol oral suspension (120 mg/5 mL) were marketed during that period. There were 4 spontaneous reports of adverse effects. Conclusion: Oral paracetamol is a safe medication rarely causing adverse effects but it is possible that the existing spontaneous monitoring system for adverse effects in Poland is not sensitive enough to detect all adverse effects, and needs improvement.
AbstractList Purpose: To determine the safety of oral coated paracetamol tablets 500 mg and oral suspension 120 mg/5 mL produced by Hasco-Lek Poland. Methods: We analyzed sales volume and data obtained from the monitoring of spontaneous reports on the adverse effects of paracetamol collected in the period between November 2000 and June 2012. Results: A total of 45,694 units of coated paracetamol tablets (500 mg) and 6,048,289 units of paracetamol oral suspension (120 mg/5 mL) were marketed during that period. There were 4 spontaneous reports of adverse effects. Conclusion: Oral paracetamol is a safe medication rarely causing adverse effects but it is possible that the existing spontaneous monitoring system for adverse effects in Poland is not sensitive enough to detect all adverse effects, and needs improvement.
Author Kuchar, Ernest
Miśkiewicz, Katarzyna
Karłowicz-Bodalska, Katarzyna
Kutycka, Elżbieta
Nitsch-Osuch, Aneta
Han, Stanislaw
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SubjectTerms Adverse reaction
NSAIDs
Pharmacovigillance
Pharmoepidemiology
Title Safety of Oral Paracetamol - Analysis of Data from a Spontaneous Reporting System in Poland
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