Other safety alerts
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| European Union: EMA to review modified-release paracetamol |
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The European Medicines Agency is to review the benefits and risks of paracetamol modified- and prolonged-release tablets, which are available in several EU Member States and are designed to release paracetamol over a prolonged period of time. They are different from the usual immediate-release tablets of paracetamol (which release their active substance more quickly and are not included in this review).
The standard procedures for assessing and managing overdose and poisoning with paracetamol are designed for the immediate-release products. In recent years there have been a number of cases of overdose with certain modified-release paracetamol tablets which indicate that the standard procedures may not be entirely suited to treat overdoses with the latter products.
The PRAC will evaluate available evidence to determine the risk of overdose with modified- and prolonged-release paracetamol, and whether any additional measures need to be taken. In the meantime, patients who have any concerns about their medication should discuss them with their healthcare professional.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000062.jsp&mid=WC0b01ac05805c516f
In Hong Kong, there are seven registered pharmaceutical products containing modified-release or prolonged-release paracetamol, namely Clariflu Sustained Release Tab (HK-47205), Panadol Long Lasting Tab 665 mg (HK-51314), Panadol Extend Tab 665mg (HK-51316), Panadol Extend Tab 665mg (Ireland) (HK-52683), Panadol Joint Extended Release Caplet 665mg (HK-59436), Xykaa Extend Prolonged Release Tablet 650mg (HK-61400) and Ensid –ER Extended Release Tablet 650mg (HK-62272). All these products are over-the-counter medicines, except HK-47205 which is a pharmacy-only-medicine. So far, DH has not received any adverse drug reaction report related to modified-release or prolonged-release paracetamol products. In view of the above EMA announcement, DH will remain vigilance on the future review results by the EMA.
Ends/ Saturday, July 9, 2016
Issued at HKT 12:00
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