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Information for Healthcare Professionals on the Supply of Chiesi Products

Updated: 19 July 2021

We continue to work closely with all stakeholders to ensure we have an uninterrupted supply of our medicines. This includes working hard to manage supply and consistently releasing stock. We can also confirm that production of all our products, continues uninterrupted at all of our manufacturing sites.

  

Clenil® Modulite® (beclometasone): release of batch specific variation

 

To address the continued increased demand for inhalers, and in order for all strengths of Clenil Modulite (beclometasone; 50/100/200/250mcg), to be available additional batches of all strengths (with no dose indicator) have been released into the UK supply chain following authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for a batch-specific variation. 

 

The numbers of the batches authorised by the MHRA are 

Clenil 50mcg – 1600001 to 1600006
Clenil 100mcg – 1900101 to 1900121
Clenil 200mcg – 1700001 to 1700006
Clenil 250mcg – 1800001 to 1800002

 

Summary of key information related to batch variation:

  • These inhalers contain the same medication as before, beclometasone, and therefore require no change to either the way prescriptions are written, or the way patients manage their asthma.
  • Medicine is provided in the same inhaler device (pressurised metered dose inhaler; pMDI).
  • The only difference in the new additional batches is the lack of dose indicator on any strength of Clenil (50/100/200/250mcg)
    • Please note that the previous Clenil 100mcg inhalers with no dose indicator (supplied since May 2020), where the colour of the plastic actuator and protective cap were beige and yellow respectively; these may still be in the supply chain (Figure 1). From July 2021, all strengths will be replaced by new batches where the actuator and cap will revert back to the standard colours but without a dose indicator (Figure 2).
    • The numbers of the previous Clenil 100mcg batches, authorised by the MHRA, are 1112190, 1112214 to 1112219 and 1900001 to 1900100.
  • These differences have no effect on the safety profile (adverse effects) of the medicines, however, patients should have increased vigilance for when they may need a new inhaler and should confirm the dosage on the labelling of the outer packaging and canister.

 

If dispensing this product, healthcare professionals should: 

  • Advise patients/caregivers that this inhaler does not contain a dose indicator but that the medicine and the inhaler are the same.
  • Advise patients/caregivers to check the dosage on the labelling on the package and the canister.
  • As usual, recommend that patients keep track of when they start to use their inhaler – each Clenil inhaler (irrespective of batch or strength) contains 200 doses of medication so if a patient is taking two puffs of their inhaler twice a day, this means the inhaler will last for over a month.
  • Clarify to patients and caregivers that, as with all strengths of Clenil, the inhaler can be used with a Volumatic® Spacer Device.
    Remind your patients to clean their inhaler once a week as usual, referring to the package leaflet for cleaning instructions.

 

Additional information to share with your patients who have received a batch-specific variation Clenil can be downloaded here.

 

Please contact the Customer Services team via email (CustomerServices.UK@chiesi.com) should you have any further questions or require additional information. 

  

  

UK-CHI-2100358 July 2021