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Alert on Phenytoin 100mg tablet (HK-43080)

  • 2013.05.14
The Department of Health (DH) today (May 14) alerted members of the public to a pharmaceutical product, namely Phenytoin 100mg tablet (Hong Kong registration number: HK-43080), that some bottles of the product may contain another medicine.

The DH received notification from the Hospital Authority (HA) today that they found a few tablets of another medicine, namely metamizole tablet, in some bottles of one batch (batch number: P130202) of the Phenytoin 100mg tablet. DH commenced investigation immediately.

 Information so far revealed that Phenytoin 100mg tablet (HK-43080) is manufactured by Shanghai Sine Huanghe Pharmaceutical Co Ltd in China and distributed by China Resources Chemicals International Limited in Hong Kong. According to the distributor, the affected batch was only supplied to the HA.

As no adequate alternative supply of phenytoin 100mg tablets is available in Hong Kong, patients who are on this medication are therefore advised to check their medicine in hand before consumption. Phenytoin 100mg tablet is a sugar-coated white tablet of about 8mm in diameter. The foreign metamizole tablet is a scored, plain white tablet of about 12.5mm in diameter, and marked with the words "安乃近" and "0.5".

Phenytoin is a prescription drug used for the treatment of epilepsy. Since the dose of phenytoin is specially adjusted for individual patient, patients who are taking this medicine should not stop taking it on their own, and should consult their health-care providers when in doubt. HA will contact and advise all affected patients.

Metamizole is a non-steroidal anti-inflammatory drug used for the relief of pain. Its side effects include gastrointestinal disorders, headache and dizziness, and hypersensitivity reactions.

So far, DH has not received any adverse reaction report in connection with the use of the product.

DH's investigation is continuing.
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