Clenil Modulite


I havnt been on here for a couple of years as my asthma was well controlled well almost disappeared, but was too good to be true my asthma has started yet again (I have the awful chesty cough and tight chest) went to docs yesterday and have been given salbutamol which I have had before and a new one to me Clenil Modulite which I dont know much about if any one can give me some advice on this, my PF was down to 300-320 should be 450 so not good! The days are not too bad using my salbutamol its at night when I start coughing I just cant stop if anyone has any advice I would appreciate it, have to go back in a month to see how im getting on with meds.

Many thanks


5 Replies

  • Clenil Modulite 50/100/200/250 micrograms per actuation pressurised inhalation solution

    Also known as

    Beclometasone dipropionate 50/10/200/250 micrograms per metered (ex-valve) dose

    Therapeutic indications

    Clenil Modulite is indicated for the prophylactic management of mild, moderate, or severe asthma in adults or children:

    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

    method of administration -

    Clenil Modulite is for inhalation use only.

    The Volumaticâ„¢ spacer device may be used by patients who have difficulty synchronising aerosol actuation with inspiration of breath.


    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 Modulite 50 micrograms, 100 micrograms & 200 micrograms:

    The usual starting dose is 200 micrograms twice daily. In severe cases this may be increased to 600 to 800 micrograms daily. This may then be reduced when the patient's asthma has stabilised. The total daily dosage should be administered as two to four divided doses.

    Clenil Modulite 250 micrograms:

    Usually 1000 micrograms daily, which may be increased to 2000 micrograms daily. This may then be reduced when the patient's asthma has stabilised. The total daily dosage should be administered as two to four divided doses.

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


    Clenil Modulite 50 micrograms & 100 micrograms:

    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 Modulite 200 micrograms & 250 micrograms:

    Clenil Modulite 200 micrograms & 250 micrograms are not recommended for children.

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

    Patients with hepatic or renal impairment:

    No dosage adjustment is needed in patients with hepatic or renal impairment.

    Method of Administration

    The aerosol spray is inhaled through the mouth into the lungs. The correct administration is essential for successful therapy. The patient must be instructed on how to use Clenil Modulite correctly and advised to read and follow the instructions printed on the Patient Information Leaflet carefully.

    Instructions for Use

    If the inhaler is new or has not been used for three days or more, one puff should be released into the air. It is not necessary to shake the inhaler before use because this is a solution aerosol.

    Instruct the patient to remove the mouthpiece cover and check that it is clean and free from foreign objects. The patient should then be instructed to breathe out before placing the inhaler into their mouth. They should then close their lips around the mouthpiece and breathe in steadily and deeply. They must not bite the mouthpiece. After starting to breathe in through the mouth, the top of the inhaler should be pressed down. Whilst the patient is still breathing in, the patient should then remove the inhaler from their mouth and hold their breath for about 5 to 10 seconds, or as long as is comfortable, and then breathe out slowly. The patient must not breathe out into the inhaler. If another dose is required the patient should be advised to wait 30 seconds before repeating the procedure just described. Finally, patients should breathe out slowly and replace the mouthpiece cover.

    The patient should be told not to rush the procedure described. It is important that the patient breathes in as slowly as possible prior to actuation. Inform the patient that if a mist appears on inhalation, the procedure should be repeated.

    It may be helpful to advise children and patients with weak hands to hold the inhaler with two hands, by placing both forefingers on top of the inhaler and both thumbs at the bottom of the device.

    Patients who find it difficult to co-ordinate actuation with inspiration of breath should be told to use a Volumaticâ„¢ spacer device to ensure proper administration of the product.

    Young children may find it difficult to use the inhaler properly and will require help. Using the inhaler with the Volumaticâ„¢ spacer device with a face mask may help in children under 5 years.

    Advise the patient to thoroughly rinse the mouth or gargle with water or brush the teeth immediately after using the inhaler.

    The patient should be told of the importance of cleaning the inhaler at least weekly to prevent any blockage and to carefully follow the instructions on cleaning the inhaler printed on the Patient Information Leaflet. The inhaler must not be washed or put in water.

    The patient should be told also to refer to the Patient Information Leaflet accompanying the Volumatic spacer device for the correct instructions on its use and cleaning.

    Special warnings and precautions for use

    Patients should be properly instructed on the use of the inhaler to ensure that the drug reaches the target areas within the lungs. Patients should also be informed that Clenil Modulite should be used on a regular basis, even when they are asymptomatic.

    Clenil Modulite does not provide relief of acute asthma symptoms, which require a short-acting inhaled bronchodilator. Patients should have relief medication available.

    Severe asthma requires regular medical assessment, including lung-function testing, as there is a risk of severe attacks and even death. Patients should be instructed to seek medical attention if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required as this may indicate deterioration of asthma control. If this occurs, patients should be assessed and the need for increased anti-inflammatory therapy considered (eg. higher doses of inhaled corticosteroid or a course of oral corticosteroid).

    Severe exacerbations of asthma must be treated in the usual way, ie. by increasing the dose of inhaled beclometasone dipropionate, giving a systemic steroid if necessary, and/or an appropriate antibiotic if there is an infection, together with ?-agonist therapy.

    Treatment with Clenil Modulite should not be stopped abruptly.

    Systemic effects of inhaled corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

    It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroids, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should also be given to referring the patient to a paediatric respiratory specialist.

    Prolonged treatment with high doses of inhaled corticosteroids may result in clinically significant adrenal suppression.

    Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

    The transfer to Clenil Modulite of patients who have been treated with systemic steroids for long periods of time or at high doses, needs special care, since recovery from possible adrenocortical suppression may take considerable time. Reduction of the dose of systemic steroid can be commenced approximately one week after initiating treatment with Clenil Modulite. The size of the reduction should correspond to the maintenance dose of systemic steroid. For patients receiving maintenance doses of 10mg daily or less of prednisolone (or equivalent) reductions in dose of not more than 1 mg are suitable. For higher maintenance doses, larger reductions in dose may be appropriate. These oral dosage reductions should be introduced at not less than weekly intervals.

    Adrenocortical function should be monitored regularly as the dose of systemic steroid is gradually reduced.

    Some patients feel unwell during withdrawal of systemic steroids despite maintenance or even improvement of respiratory function. They should be encouraged to persevere with inhaled beclometasone dipropionate and to continue withdrawal of systemic steroid, unless there are objective signs of adrenal insufficiency.

    Patients weaned off oral steroids whose adrenocortical function is impaired should carry a steroid warning card indicating that they may need supplementary systemic steroids during periods of stress, eg. worsening asthma attacks, chest infections, major intercurrent illness, surgery, trauma, etc.

    Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be symptomatically treated with antihistamine and/or topical preparations, including topical steroids.

    As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.

    Patients should be advised that this product contains small amounts of ethanol (approximately 9mg per actuation) and glycerol. At the normal doses, the amounts of ethanol and glycerol are negligible and do not pose a risk to patients


    Undesirable effects

    Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These may include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.

    As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing, shortness of breath and cough after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. Clenil Modulite should be discontinued immediately, the patient assessed and, if necessary, alternative therapy instituted.

    Hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and oedema of the eyes, face, lips and throat, have been reported.

    Candidiasis of the mouth and throat occurs in some patients, the incidence increasing with doses greater than 400 micrograms beclometasone dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Patients may find it helpful to rinse their mouth thoroughly with water after inhalation. Symptomatic oral candidiasis can be treated with topical antifungal therapy while continuing with Clenil Modulite.

    Hoarseness or throat irritation may occur in some patients. These patients should be advised to rinse the mouth out with water immediately after inhalation. Use of the Volumaticâ„¢ spacer device may be considered.


    Acute: Inhalation of doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not require emergency action. In these patients treatment should be continued at a dose sufficient to control asthma; adrenal function recovers in a few days and can be verified by measuring plasma cortisol.

    Chronic: Use of inhaled beclometasone dipropionate in daily doses in excess of 1,500 micrograms over prolonged periods may lead to adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment should be continued at a dose sufficient to control asthma.

  • catheringanne,

    Sorry you are unwell.

    However, asthma is a variable condition so will not have gone away but just not as evident.

    DId you stop you inhalers during this time? If so it may be that it has just taken this amount of time to get to the stage where you needed to seek help. Even mild asthma will keep deteriorating for a while before symptoms are evident & asthmatics are well know to learn to live with the debilitation.

    You may not have been on your new inhaled steroid ie clenil long enough for it to have started to work ie about 2 weeks. Keep using your blue 2-4 puffs or more if needed you cannot harm yourself by taking the blue but often people dont take enoug but what you must remember is that if it is not lasting 4 hour you need more but if 10 puffs dont work really well you must seek help. You may need oral steroid to kick start the improvement or even antibiotics if you have a bacterial infection. Have you an asthma management plan? Either was you are not happy & obviously worried so go back to the GP before you get so back that you do need emergency treatment. Dont delay & dont be embarrassed about calling for help

  • Re: CM

    Hi catherineanne

    New to asthma (Feb 09), Clenil Modulite was my first preventer inhaler. Worked for me up to a point, but I still had to use the little blue inhaler as a 'reliever' quite often. Now on Seretide which is better.

    Some things about Clenil Modulite -

    1. Inhaled wrongly, it tasted yucky on my tongue (using a spacer makes this better)

    2. Gave me severe night time cramps in my legs and feet. Cramps disappeared once Clenil was changed for Seretide 125.

    3. Clenil is a long acting preventer and if it works for you, the need to use the salbutamol lessens.

    4. Salbutamol is a reliever and should be used when you need it e.g. coughing on and on at night.

    Although it takes a little while for the Clenil to kick in, I'd maybe go back to your GP or asthma nurse now and tell them about the coughing at night.

    Best wishes on finding an inhaler that works for you.


  • no one seems to have noticed by GM, you went straight to seretide from clenil, because you had problems with it.

    If you don't get on with Beclomethasone, you could try, Fluticasone, Budesonide, Triamcinolone, Flunisolide, Mometasone. All of them steroids, and you need to find the one that gives you reasonable control, if that doesn't give you total control, you then add either Salmeterol or Formoterol. If that works, and then you can combine the two into the appropriate dose of Seretide or Symbicort.

    GM, maybe thats where you've gone wrong, but hopefully I see you now have singulair, that will work, if not Accolate is an alternative.

  • Hi sorry you havent been well,

    I was taking Clenil 8 puffs a day plus Ventolin up to 8 puffs as & when needed, but since February I have been prescribed 'Symbicort' (formeterol & budoniside) once in the morning and once at night.

    It has worked well although its hard to explain but the effects seem lower key than of Clenil. However my asthma is reasonably well controlled. I found the Clenil really effective at relaeasing the awfully tight breathless feeling I had. I'm afraid I haven't got any great advice to help the nightime coughing other than if you are working and can, take a week off to lay low and rest.

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