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Ospolot (sulthiame) tablets 200 mg

Product Defect Alert - child-resistant caps may not function correctly

3 June 2021

Consumers and health professionals are advised that Phebra Pty Ltd, in consultation with the TGA, has initiated a product defect alert for bottles of Ospolot (sulthiame) 200 mg tablets.

The affected batch numbers are:

  • 18003717 (expiry 05/21)
  • 28811 (expiry 11/22)

Ospolot (sulthiame) 200 mg tablets are used as an anticonvulsant for behavioural disorders associated with epilepsy; hyperkinetic behaviour; temporal lobe epilepsy; myoclonic seizures; grand mal attacks and Jacksonian seizures.

It has been identified that affected batches of Ospolot (sulthiame) 200 mg tablets have been supplied with child-resistant caps that may not function correctly. If this occurs, a child may be able to open a bottle and access the medicine, which could result in a potentially life-threatening risk.

If a child accidently ingests Ospolot (sulthiame) 200 mg tablets, contact the Poisons Information Centre on 13 11 26.

Information for consumers

If you or someone you care for is taking Ospolot (sulthiame) 200 mg tablets, check the batch number displayed on the bottle label.

If the bottle is from an affected batch, Phebra Pty Ltd, in consultation with the TGA, strongly recommends that extra vigilance and caution be exercised when storing this medicine. As per the product label and information, it is imperative that you keep the medicine out of reach of children.

If you have any questions or concerns about this issue, contact your health professional or Phebra Pty Ltd on 02 9420 9199 and ask to speak to the Medical Information Manager.

Information for health professionals

Phebra Pty Ltd is writing to all pharmacies and hospital pharmacies who have purchased this product, advising them about this product defect alert. Check your stock for any bottles from the affected batches.

If you are treating patients who are taking Ospolot (sulthiame) 200 mg tablets, advise them of this issue so that extra vigilance and caution is exercised when storing this medicine. As per the product label and information, it is imperative that they keep the medicine out of reach of children.

If you have any questions or concerns about this issue, contact Phebra Pty Ltd on 02 9420 9199 and ask to speak to the Medical Information Manager.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.