Product Notification

HPS Pharmacies wish to give notice that Pfizer Australia has reformulated the following Dilantin®products:

Dilantin® 30mg Capsules
Phenytoin Sodium 30mg
ARTG 295264 

Dilantin® 100mg Capsules
Phenytoin Sodium 100mg
ARTG 295265

The reformulation of these products will result in changes to the dissolution properties of the capsules. Dissolution times may be lengthened with consequent changes in absorption time and phenytoin blood levels. The need to measure serum phenytoin levels at least 7-10 days after switching to the reformulated capsules should be considered.

Distribution of reformulated batches of Dilantin® 30mg and 100mg capsules is expected to begin in the second week of August 2018. However, some patients may have received the new formulation of Dilantin® 30mg from early July 2018. Once a patient receives the new formulation of Dilantin®, it is important that they do not change back to the old formulation.

New batches of Dilantin® 30mg and 100mg capsules can be identified by the updated packaging bearing the word “Reformulation” in pink and blue respectively, as shown below.

Retain this notice in a prominent position, including in other related business units for a period of one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Pfizer Australia on 1800 675 229.

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