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UK-RES-2000248 Feb 2020
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Last updated: 1st May 2020

Due to an increased demand, additional batches of Clenil® Modulite® (beclometasone) 100mcg are to be released into the UK supply chain following authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). These batches are likely to come into circulation from 11th May 2020 and full details of concerned batch numbers can be found at the following website link:

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.
  • Medicine is provided in the same inhaler device (pressurised metered dose inhaler; pMDI).
  • The only differences in the batch variation are related to the appearance:
    • The colours of the plastic actuator and protective cap are beige and yellow respectively (instead of brown and beige respectively; see images below);
    • The beige actuator is not embossed, however the canister and outer packaging are both still clearly labelled Clenil;
    • There is no dose indicator, however patients who received Clenil 100mcg prior to September 2019 (when this feature was added to the inhaler) may not notice that a dose indicator is not included.
    • The differences have no effect on the safety profile (adverse effects) of the medicine, 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 package and canister.
  • Clenil 100mcg inhaler subject to the batch-specific variation

    Clenil 100mcg inhaler
    subject to the batch-specific variation

  • Clenil 100mcg inhaler from a regular batch

    Clenil 100mcg inhaler
    from a regular batch

  • Check carefully the dosage of the Clenil 100mcg inhaler written on the labelling on the packaging, prior to dispensing as the Clenil 100mcg; this medicine is a very similar colour to Clenil 50mcg. Patients/caregivers should also be advised 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 100mcg inhaler (irrespective of batch) 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.
  • 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 of Clenil 100mcg can be downloaded here.

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-2000055 May 2020

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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. IMS Xponent BPI Trawling, MAT September 2019.
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 https://yellowcard.mhra.gov.uk 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.