Flixotide and Pavtide Accuhalers

GlaxoSmithKline (GSK) Australia Pty Ltd is issuing a product correction for certain batches of their Flixotide and Pavtide Accuhalers as a small number of Accuhalers may not automatically reload the next dose.

Product image	Product	AUST R	Batch Number	Expiry Date
	FLIXOTIDE JUNIOR ACCUHALER (fluticasone propionate) 100 mcg, 60 doses	58439	PA8S	Sep-2027
	FLIXOTIDE ACCUHALER (fluticasone propionate) 250 mcg, 60 doses	58438	HM6D PA8V	Jun-2028 Sep-2028
	FLIXOTIDE ACCUHALER (fluticasone propionate) 500 mcg, 60 doses	58437	DT5H	Mar-2028
	PAVTIDE ACCUHALER 100/50 (fluticasone propionate/salmeterol (as xinafoate)) 100/50 mcg, 60 doses	208200	SJ5R	Oct-2027
	PAVTIDE ACCUHALER 250/50 (fluticasone propionate/salmeterol (as xinafoate)) 250/50 mcg, 60 doses	208201	SD3C	Oct-2027

What is the problem?

These Accuhalers each contain a dry powder respiratory product for 60 doses. Each dose is delivered via a patient-activated lever (see Figure 1). The Accuhaler has been designed to automatically reset for the next dose when the patient rotates the Accuhaler clockwise following use (see Figure 2).

• Figure 1: Accuhaler before use.
• Figure 2: Accuhaler opened with lever in correct starting position. This is an unaffected product.
• Figure 3: Accuhaler opened with lever in incorrect starting position. This is an impacted product.

GSK identified that a small number of Accuhalers may not automatically reload following the clockwise rotation (see Figure 3). The Accuhaler will function normally for several doses (anywhere between 20-59 doses) and may then stop working.

What are the risks?

If the dose is not manually reset, this may lead to a short-term flare-up of asthma symptoms.

What should I do?

In the unlikely event you have an impacted device (where the lever is in the incorrect starting position) do not stop using your Accuhaler. You can manually reset the starting position by pushing the lever down towards the mouthpiece. Following this, push the lever up, away from the mouthpiece to 'load' the dose (as per normal instructions). This will cause the dose counter to change, indicating the Accuhaler has been reset correctly.

If this problem occurs, you will need to reset the lever for each dose. After manually resetting the lever, a full dose will be delivered as normal. You should verify the dose counter advances. If this does not occur, the dose has not been delivered.

If you have an Accuhaler from any of the batches listed above and are having any difficulties administering a dose, please contact your doctor or pharmacist for support.

Further information

Please contact GSK on 1800 033 109 for further information.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our 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.