Prescribing Information

Prescribing Information: Beclu 100 and 200 pressurised metered dose inhaler (pMDI). Consult the full Summary of Product Characteristics (SmPC) before prescribing. Presentation: Each Beclu 100 pMDI contains 100 micrograms (mcg) beclometasone dipropionate (BDP). Each Beclu 200 pMDI contains 200 mcg BDP. Indications: Prophylactic management of mild, moderate or severe asthma in adults or children. Dosage and administration: For inhalation use only. A Volumatic™ spacer device may be used by patients who have difficulty synchronising actuation with inspiration and must always be used when Beclu is administered to adults and adolescents 16 years of age and older taking total daily doses of 1000 mcg or greater and for all doses when administered to children and adolescents 15 years of age and under. Starting dose of inhaled BDP should be adjusted to severity of disease. Dose may then be adjusted until control is achieved and then should be titrated to lowest dose at which effective control of asthma is maintained. Total daily dosage should be administered as two to four divided doses. Adults: Usual starting dose is 200 mcg twice daily. In severe cases this may be increased to 600 to 800 mcg daily. Children: Beclu 100 pMDI only: Usual starting dose 100 mcg twice daily. Depending on severity of asthma, daily dose may be increased up to 400 mcg. Beclu 200 pMDI is not recommended for children. Contraindications: Hypersensitivity to active substances or to any excipient (HFA-134a, ethanol, glycerol). Warnings and precautions: Patients should have relief medication available for acute asthma symptoms. Severe asthma requires regular medical assessment, as there is risk of severe attacks and even death. Patients must seek medical attention and have their condition assessed, should they find they are using their relief medication more often than normal or if it appears less effective. Do not stop Beclu treatment abruptly. Systemic effects may occur particularly with high doses taken for prolonged periods. These include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density and more rarely psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Prolonged treatment with high doses of inhaled corticosteroids may result in clinically significant adrenal suppression. Monitor growth of children on prolonged treatment and if necessary reduce dose. Care is needed in transferring patients to Beclu from long-term or high-dose systemic steroids. Monitor adrenocortical function regularly as dose of systemic steroid is gradually reduced. Some patients may experience symptoms during withdrawal from systemic steroids; these patients should be encouraged to continue with the gradual withdrawal and change to inhaled BDP unless there are objective signs of adrenal insufficiency. Patients withdrawn from systemic steroids whose adrenocortical function is impaired should carry a steroid warning card. Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies. Titrate dose of Beclu to the lowest dose at which effective asthma control is maintained. Patients reporting blurred vision or visual disturbances should be considered for referral to an ophthalmologist, as causes may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy. Additional systemic steroid cover may be necessary during periods of stress or elective surgery. Care is necessary in patients with active or quiescent pulmonary tuberculosis. Interactions: Beclu contains a small amount of ethanol with theoretical potential for interaction in sensitive patients taking disulfiram or metronidazole. 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. Fertility, pregnancy and lactation: Not to be used in pregnancy or lactation unless expected benefits outweigh the potential risks. Side effects: Very common: oral candidiasis. Common: hoarseness and throat irritation. Uncommon: rash, urticaria, pruritus, erythema. Very Rare: oedema of eyes, face, lips and throat, adrenal suppression, growth retardation (children and adolescents), decreased bone density, cataract, glaucoma, paradoxical bronchospasm, wheezing, dyspnoea, cough. Unknown: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disorders (predominantly in children), headache, nausea, blurred vision. Refer to SmPC for full list of side effects. Legal category: POM. Price and pack: Each presentation provides 200 actuations. Beclu 100 pMDI £5.19, Beclu 200 pMDI £11.31. Marketing authorisation (MA) no(s): PL 35507/0206, PL 35507/0207. MA Holder: Lupin Healthcare UK Ltd, The Urban Building, Second Floor, 3-9 Albert Street, Slough, Berkshire, SL1 2BE, United Kingdom. PI last revised: Jan 2023. Volumatic™ is a registered trademark of the GlaxoSmithKline Group of Companies .

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to Lupin Healthcare Limited on +44 (0)1565 751 378 or email us at EU-PV@lupin.com