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UK-RES-2000248 Feb 2020
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Last updated: 17th June 2021
Prescribing Information

As Chiesi continues to experience increased demand for inhalers, in order for all strengths of Clenil (beclometasone; 50/100/200/250mcg) to be available to patients in actuators using the standard colours, new additional batches of all strengths (with no indicator) will be released into the UK supply chain following authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). These inhalers are likely to come into circulation from July 2021 for several months and will provide patients reassurance as the colour of their inhalers will be familiar.

For further information of concerned batch numbers, please visit the Chiesi UK website: https://www.chiesi.uk.com/supply-of-chiesi-products

  • 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.
  • The 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, 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).
  • 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.
  • Clenil 100mcg inhaler batch-specific variation

    Figure 1
    Clenil 100mcg inhaler subject to the batches supplied since May 2020 (to be discontinued)

  • Clenil 100mcg inhaler from a regular batch

    Figure 2
    Clenil 50/100/200/250mcg inhalers subject to the new batches available from July 2021 with no dose indicators

  • The batches will be released with previously authorised packaging i.e. the carton, label, and leaflet without the dose indicator information.
  • 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 all strengths of Clenil can be used with a volumetric spacer.
  • Remind your patients to clean their inhaler once a week as usual, referring to the package leaflet for cleaning instructions.

Please continue to report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card Scheme. Report on the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to Chiesi Limited on 0800 009 2329, or at pv.uk@chiesi.com.

Please do not hesitate to contact Medical Information (medinfo.UK@chiesi.com) should you have any further questions or require additional information.

UK-CLE-2100008 June 2021

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UK-RES-2000003 Jan 2020

INTENDED FOR UK HEALTHCARE PROFESSIONALS
Clenil® Beclometasone pMDI logo
Background
Clenil® Beclometasone pMDI logo with devices

Clenil 50mcg and 100mcg licensed for adults and children,
Clenil 200mcg and 250mcg licensed for adults only

Clenil 50mcg and 100mcg licensed for adults and children,
Clenil 200mcg and 250mcg licensed for adults only

Clenil 50mcg and 100mcg
licensed for adults and children, 
Clenil 200mcg and 250mcg
licensed for adults only

What is Clenil®?

Clenil is the most widely used brand of inhaled corticosteroid (ICS)1

Clenil is available in a pressurised metered-dose inhaler (pMDI) in four different strengths:

Clenil is the most widely used brand of inhaled corticosteroid (ICS)1

Clenil is available in a pressurised metered-dose inhaler (pMDI) in four different strengths:

  • 50 micrograms per inhalation
  • 100 micrograms per inhalation
  • 200 micrograms per inhalation
  • 250 micrograms per inhalation
  • 200 micrograms per inhalation
  • 250 micrograms per inhalation
Clenil® Modulite® pMDI devices
Each delivers 200 inhalations per device.
Indications for Clenil[[2-5]]

Clenil is indicated for the prophylactic management of mild, moderate, or severe asthma in adults2-5 or children2,3:

Mild asthma: Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular basis.

Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.

Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms.

For additional information to share with your patients who have been prescribed Clenil, please visit our Clenil patient and carer site.

References:
1. IQVIA BPI MAT January 2021.
2. Clenil Modulite 50 micrograms Summary of Product Characteristics. Chiesi Limited.
3. Clenil Modulite 100 micrograms Summary of Product Characteristics. Chiesi Limited.
4. Clenil Modulite 200 micrograms Summary of Product Characteristics. Chiesi Limited.
5. Clenil Modulite 250 micrograms Summary of Product Characteristics. Chiesi Limited.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.

UK-CLE-2100004 April 2021

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UK-CLE-2100004 April 2021