Source: Υπουργείο Υγείας (CY) Revision Year: 2011 Publisher: George Petrou Ltd., 50, Areos Str, Latsia 2234, Nicosia, Cyprus
Beclazone 250 micrograms CFC-Free Inhaler is indicated for those asthmatic patients who have been shown to require high doses of beclometasone dipropionate anhydrous to control their symptoms. It may also be indicated for those patients whose asthma is no longer controlled by maximum maintenance doses of bronchodilators and lower doses of BDP. Some patients with severe asthma require oral corticosteroid therapy in addition to BDP for the adequate control of their symptoms. Many of these patients may, on transfer to Beclazone 250 micrograms CFC-Free Inhaler, be able to reduce significantly, or eliminate their requirement for additional oral corticosteroids.
The preparation is intended for oral inhalation only. For optimum results, beclometasone dipropionate anhydrous should be used regularly. The initial dose of inhaled beclometasone dipropionate anhydrous should be appropriate to the severity of the disease.
The dose should be titrated to the lowest dose at which effective control of asthma is maintained.
Adults: The dose range is from 50 mcg twice daily to 500 mcg twice daily (maximum daily dose 1000 mcg) depending on the patient’s asthma severity.
The maintenance dose is normally 200-400mcg per day in divided doses. If necessary, higher doses up to 1000mcg daily in divided doses may be used.
Beclazone 200 and 250 micrograms CFC-Free Inhalers are not recommended for use in children due to insufficient data on safety and efficacy.
When asthma symptoms remain under satisfactory control the dose may be gradually reduced to the minimum effective dose to maintain symptom control.
The therapeutic effect occurs after a few days' treatment and reaches its maximum after 2-3 weeks.
When transferring a patient to Beclazone CFC-Free inhaler from other inhaler devices switch at same dose and titrate individually if necessary.
For inhalation use.
The acute toxicity of beclometasone dipropionate anhydrous is low. The only harmful effect that follows inhalation of large amounts of the drug over a short period is suppression of hypothalamic‑pituitary‑adrenal (HPA) function. No special emergency action need be taken. Treatment with beclometasone dipropionate anhydrous should be continued at the recommended dose to control the asthma; HPA function recovers in a day or two.
In the unlikely event of grossly excessive intake of beclometasone dipropionate anhydrous for weeks or months on end, a degree of adrenocortical atrophy could occur in addition to suppression of HPA function. The patient should be treated as steroid‑dependent and transferred to a suitable maintenance dose of a systemic steroid such as prednisolone. Once the patient’s condition has stabilised he should be transferred to beclometasone dipropionate anhydrous by the method described (4.4).
3 years.
Do not store above 25°C. Do not refrigerate or freeze.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.
Pressurised container fitted with a metering valve.
The can is of 19ml nominal capacity manufactured from aluminium with either a debossed or a plain base. The can opening is configured to accept 20mm valves. Each pack contains a single inhaler which supplies a minimum of 200 actuations.
The canister is pressurised; it must not be burnt, punctured or broken even when apparently empty.
Medicines no longer required should not be disposed of via wastewater or the municipal sewage system. Return them to the pharmacy or ask your pharmacist how to dispose of them in accordance with the national regulations. These measures will help to protect the environment.
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