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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

Why prescribe Clenil®

BTS/SIGN guidelines recommend inhaled corticosteroids as the preventer drug for adults and children for achieving overall treatment goals.1

Inhaled corticosteroids (ICS) should be considered for adults, children aged 5–12 and children under the age of five with any of the following features: using inhaled β2-agonists three times a week or more; symptomatic three times a week or more; or waking one night a week. In addition, ICS should be considered in adults and children aged 5–12 who have had an asthma attack requiring oral corticosteroids in the last two years.1

Clenil Prescribing Quick Reference Guide

Clenil Prescribing Quick Reference Guide

The Volumatic™ spacer device must always be used when Clenil is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 micrograms or greater.

Clenil must always be used with the Volumatic™ spacer device when administered to children and adolescents 15 years of age and under, whatever dose has been prescribed.

Volumatic™ is a registered trademark of the GlaxoSmithKline Group of Companies.

Dosing[[2-5]]
The starting dose of inhaled beclometasone dipropionate should be adjusted to the severity of the disease. The dose may then be adjusted until control is achieved and then should be titrated to the lowest dose at which effective control of asthma is maintained.
Adults (including the elderly):

Clenil 50, 100 & 200 micrograms: The usual starting dose is 200 micrograms twice daily. In severe cases this may be increased to 600 to 800 micrograms daily.

Clenil 250 micrograms: Usually 1000 micrograms daily, which may be increased to 2000 micrograms daily.

The VolumaticTM spacer device must always be used when Clenil is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 micrograms or greater.

Volumatic™ is a registered trademark of the GlaxoSmithKline Group of Companies.

Children (only Clenil 50 & 100 micrograms licensed):

The usual starting dose is 100 micrograms twice daily. Depending on the severity of asthma, the daily dose may be increased up to 400 micrograms administered in two to four divided doses.

Clenil must always be used with the VolumaticTM spacer device when administered to children and adolescents 15 years of age and under, whatever dose has been prescribed.

Volumatic™ is a registered trademark of the GlaxoSmithKline Group of Companies.

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

References:
1. British Thoracic Society and Scottish Intercollegiate Guidelines Network. SIGN 158, British guideline on the management of asthma. July 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 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