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Teva UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire WF10 5HX.


Please refer to the Summary of Product Characteristics (SmPC) for full details of Prescribing Information. Qvar® Aerosol, Autohaler®


and Easi-Breathe® Qvar® 50 and 100 Easi-Breathe® Aerosol Inhaler. Each actuation of Qvar®


Prescribing Information: Presentation: Qvar® Autohaler®


Inhaler. Qvar®


Abbreviated 50 and 100 50 and 100


Inhalers contain beclometasone


dipropionate 50 mcg or 100 mcg ex-valve. The dose delivered from the mouthpiece is an average 37.5 micrograms for the 50 mcg preparations and an average 75 mcg for the 100 mcg preparations. 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 and administration: The dose should be adjusted to individual patient needs. Patients should be instructed in the proper use of their inhaler, including rinsing out their mouth with water after use. 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 Qvar® Easi-Breathe® is a


breath-actuated inhaler that’s as easy to use as open – breathe – close.


86% of uncontrolled asthma patients cannot use their pMDI.*1


Qvar® Easi-Breathe® (CFC-free beclometasone dipropionate) ...at a comparable price too.3


with significantly better asthma control than Clenil®


Modulite®


is associated pMDI...†2


daily. Transferring patients from fluticasone: Transfer patients at the same mcg for mcg dose up to 800 mcg daily. Children under 12 years:No data in children under 12 years of age, hence no dosage recommendation can be made. Contraindications: Hypersensitivity to beclometasone dipropionate or any other ingredients. Precautions and warnings: 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. Effects on ability to drive and use machines: Not relevant. Adverse reactions: A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely. Paradoxical bronchospasm. Systemic effects may occur with inhaled steroids, particularly at high doses prescribed for prolonged periods. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Common:Hoarseness and candidiasis of the mouth and throat may occur. Taste disturbances. Pharyngitis. Consult the Summary of Product Characteristics (SmPC) in relation to other side effects. Overdose: 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® Further information: AeroChamber Plus® devices are compatible with Qvar® 200 dose unit: Qvar® Qvar® Qvar®


as described in the SmPC. and AeroChamber®


50 Autohaler® 50 Easi-Breathe®


1372. Qvar®


50 Aerosol: £7.87, Qvar® : £7.87, Qvar® : £7.74, Qvar®


50 Aerosol: PL 00289/1371. Qvar® 50 Autohaler®


50 Easi-Breathe®


Aerosol Inhalers. Price: Per 100 Aerosol: £17.21 : £17.21, : £16.95.


100 Autohaler® 100 Easi-Breathe®


Legal category: POM. Marketing Authorisation Number: Qvar®


: PL 00289/ 1373. Qvar®


PL 00289/1374. Qvar® Easi-Breathe®


100 Aerosol: PL 00289/ 100 Autohaler®


: PL 00289/ 1375. Qvar® 100 : PL 00289/1376. Marketing Authorisation


Holder: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG, United Kingdom. Date of Revision: January 2012. Job Code: MED/12/006. References: 1. Hardwell A et al. Prim Care Resp J, 2011; 20: 92–6. 2. McKnight E et al. Poster presented at ERS, September 2010. 3. MIMS February 2012. 4. Data on file. Teva UK Limited.


Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk Adverse events should also be reported to Teva UK Limited on 0207 540 7117 or medinfo@tevauk.com


Approval code: QV/12/018a


Easi-Breathe® Modulite®


Date of preparation: February 2012


* Pressurised Metered Dose Inhaler. †Percentage controlled on Qvar® Clenil®


= 64% (0.64). Percentage controlled on = 54% (0.54). p<0.04.2


Therefore ARR is 0.64–0.54 = 0.1. n=663. Numbers needed to treat =10.4 :


JEFF’S SHED


MADE IN


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