CLENIL FORTE SPRAY Pressurised inhalation solution Ref.[28229] Active ingredients: Beclometasone

Patients should be instructed on the proper use of the inhaler. They should also be made aware of the prophylactic nature of therapy with Clenil Forte and that, for optimum benefits, they should use it regularly, every day, even when they are asymptomatic.

Clenil Forte Spray is not designed to relieve acute asthmatic symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available.

Severe asthma requires regular medical assessment, including lung function testing, as patients are at risk of severe attacks and even death.

Increasing use of bronchodilators, in particular short-acting inhaled Beta2 agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought. In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids of a course of oral corticosteroids). Severe exacerbations of asthma must be treated in the normal way.

Systemic effects of the inhaled corticosteroids may occur, particularly at high doses prescribed 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, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important therefore 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 corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Lack of response of severe exacerbations of asthma should be treated by increasing the dose of inhaled beclomethasone dipropionate and, if necessary, by giving a systemic steroid and/or an antibiotic if there is an infection, and with Beta-agonist therapy.

For the transfer of patients being treated with oral corticosteroids

The transfer of oral steroid-dependent patients to inhaled beclomethasone dipropionate and their subsequent management needs special care as recovery from impaired adrenocortical function caused by prolonged systemic steroid therapy, may take a considerable time.

Patients who have been treated with systemic steroids for long periods of time or at a high dose may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously.

After approximately a week, gradual withdrawal of the systemic steroid is commenced. Decrements in dosages should be appropriate to the level of maintenance systemic steroid, and introduce at not less than weekly intervals. For maintenance doses of prednisolone (or equivalent) of 10mg daily or less, the decrements in dose should not be greater than 1mg per day, at not less than weekly intervals. For maintenance doses of prednisolone in excess of 10mg daily, it may be appropriate to employ cautiously, larger decrements in dose at weekly intervals.

Some patients feel unwell in a non-specific way during the withdrawal phase despite maintenance or even improvement of the respiratory function. They should be encouraged to persevere with inhaled beclomethasone dipropionate and to continue withdrawal of systematic 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 steroid during periods of stress e.g. 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 treated with antihistamine and/or topical preparations, including topical steroids. Treatment with Clenil Forte Spray should not be stopped abruptly.
As with all inhaled corticosteroids, special care is necessary in patients with active quiescent pulmonary tuberculosis.

Visual Disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

CLENIL contains a small amount of ethanol. There is the theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.

Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.

There is inadequate evidence in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Clenil Forte Spray delivers the drug directly to the lungs by the inhaled route and so avoids the high level of exposure that occurs when corticosteroids are given by systemic routes.

The use of beclomethasone dipropionate in pregnancy requires that the possible benefits of the drug be weighed against the possible hazards.

No specific studies examining the transference of beclomethasone dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that beclomethasone dipropionate is secreted in milk, but at the dosages used for direct inhalation there is low potential for significant levels in breast milk.

The use of beclomethasone dipropionate in mothers breast feeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazard to the mother and baby.

None reported.

Adverse events are listed below by systemic organ class according to MedDRA and frequency. Frequencies are defined as: very common (1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and < 1/1,000), very rare (≤1/10,000), unknown (frequency cannot be estimated from the available data).

^* Systemic reactions are a possible response to inhaled corticosteroids, especially when a high dose is prescribed for a prolonged time (section 4.4 “Special Warning and precaution for use”).

As with other inhalation therapies, paradoxical bronchospasm may occur, with an immediate increase in wheezing, shortness of breath and cough after intake. This should be immediately treated with a fast-acting inhaled bronchodilator and Clenil Forte Spray should be immediately discontinued.

The incidence of candidiasis of the mouth and throat increases with doses of more than 400 micrograms Clenil Forte Spray per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Patients may benefit from thoroughly rinsing their mouths with water after inhalation. Symptomatic candidiasis in the mouth can be treated with a topical antifungal therapy while continuing treatment with Clenil Forte Spray.
Hoarseness is reversible and disappears after stopping treatment and/or resting the voice.

Systemic side effects are extremely improbable with the recommended doses; however, patients should be kept under strict control during prolonged treatments, in order to timely assess the possible occurrence of systemic diseases (osteoporosis, peptic ulcer, signs of secondary adrenocortical insufficiency, such as hypotension and weight loss) and in order to avoid, in this latter event, very serious accidents due to acute hypoadrenalism.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None reported.