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Prescribing information

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Teva UK Limited.

QVAR^® Aerosol, Autohaler^® and Easi-Breathe^®

Prescribing Information:

Presentation:.Qvar® 50 and 100 Autohaler® Inhaler, Qvar® 50 and 100 Easi-Breathe® Inhaler. Qvar® 50 and 100 Aerosol Inhaler. Each actuation of Qvar Inhalers contains beclometasone dipropionate 50 mcg or 100 mcg ex-valve. Qvar contains beclometasone dipropionate in solution in propellant HFA-134a resulting in an extrafine aerosol. Indications: Prophylactic management of mild, moderate or severe asthma. Dosage: The dose should be adjusted to individual patient needs. Adults, elderly, and children over 12 years: Starting and maintenance dose: Mild asthma: 100 to 200 mcg daily in two divided doses. Moderate asthma: 200 to 400 mcg daily in two divided doses. Severe asthma: 400 to 800 mcg daily in two divided doses. Transferring patients from CFC beclometasone inhalers and budesonide: Patients with well-controlled asthma: prescribe Qvar at about half current dose. Patients with poorly controlled asthma: switch from CFC-BDP or budesonide to Qvar at the same mcg for mcg dose up to 800 mcg daily. Transferring patients from Fluticasone: Transfer patients at the same mcg for mcg dose up to 800 mcg daily. Children under 12 years: Not recommended. Contra-indications: Hypersensitivity to beclometasone dipropionate or any other ingredients.  Special warnings and precautions: Use regularly. When symptoms are controlled, maintenance therapy should be reduced to the minimum effective dose. Not indicated for the immediate relief of asthma attacks or management of status asthmaticus. Advise patients to seek medical attention for review of their maintenance therapy if their asthma seems to be worsening. Patients receiving systemic steroids for long periods and/or at high doses should have stable asthma before transfer to inhaled steroids. Withdrawal of systemic steroids should be gradual. Patients should carry a steroid warning card and have adrenocortical function monitored regularly. Monitor height of children regularly. 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. Caution in patients with active or latent pulmonary tuberculosis. Interactions: None known. Pregnancy and lactation: Should only be used if the benefits outweigh the potential risks to foetus or neonate. Side-effects: Occasional incidence of hoarseness and/or rare occurrence of oral candidiasis (throat and mouth) may occur. Paradoxical bronchospasm with wheezing may occur. Systemic effects may occur with inhaled steroids, particularly at high doses for prolonged periods. These include: adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Hypersensitivity reactions and angioedema. Consult the Summary of Product Characteristics (SmPC) in relation to other side-effects. Overdosage: Acute overdose is unlikely to cause problems. Suppression of HPA function following inhalation of large amounts of the drug over a short period. Excessive doses taken over a prolonged period can produce a degree of atrophy of the adrenal cortex in addition to HPA suppression. In this event treat patient as steroid-dependent and transfer to a suitable maintenance dose of a systemic steroid such as prednisolone. Once the condition is stabilised, the patient should restart Qvar as described in the SmPC. Further information: AeroChamber Plus® and AeroChamber® devices are compatible with Qvar® Aerosol Inhalers. Basic NHS Price: Per 200 dose unit: Qvar® 50 Aerosol: £7.87, Qvar® 100 Aerosol: £17.21 Qvar® 50 Autohaler®: £7.87, Qvar® 100 Autohaler®: £17.21, Qvar® 50 Easi-Breathe®: £7.74, Qvar® 100 Easi-Breathe®: £16.95. Legal category: POM. Marketing Authorisation Holder: Norton Healthcare Ltd, Trading as IVAX Pharmaceuticals UK, Albert Basin, Royal Docks, London, E16 2QJ for Product licence number: Qvar® 50 Autohaler®: PL 00530/0714. Qvar® 100 Autohaler®: PL 00530/0715. Qvar® 50 Easi-Breathe®: PL 00530/0742. Qvar® 100 Easi-Breathe®: PL 00530/0743. Marketing Authorisation Holder: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG, United Kingdom for Product licence number: Qvar® 50 Aerosol: PL 00289/1371. Qvar® 100 Aerosol: PL 00289/1372.

Date of Revision: December 2009
QV/09/384

The Real website is supported by Teva UK Limited. Teva UK Limited has had the opportunity to comment on the medical content and accuracy of this website, however, final editorial control resides with the contributors and MGP Ltd. The views and opinions of the contributors to the website are not necessarily those of Teva UK Limited. Click here for Qvar® (CFC-free beclometasone dipropionate) prescribing information.
MED/09/187. Date of preparation: May 2009. © 2010 MGP Ltd