7.2 Part VI.2 Elements for a Public Summary

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1 7.2 Part VI.2 Elements for a Public Summary Part VI.2.1 Overview of disease epidemiology Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation that is usually progressive (getting worse) and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations (worsening) and comorbidities contribute to the overall severity in individual patients (Global Initiative for Chronic Obstructive Lung Disease, GOLD 2013). Unlike in asthma, airflow limitation is usually not fully reversible. Risk factors for developing COPD are smoking, air pollution and occupational exposure. Prevalence (number of affected people) estimates for COPD are approximately 600 million individuals worldwide. It is clear that prevalence is higher in smokers than in non-smokers, higher in men than in women, and increases with age. COPD is a leading cause of morbidity and mortality worldwide. Comorbidities frequently seen in COPD patients include cardiovascular disease, skeletal muscle dysfunction, metabolic syndrome, osteoporosis, depression and lung cancer.

2 Sandoz Confidential Page Part VI.2.2 Summary of treatment benefits Therapeutic approaches for COPD have converged over the past two decades. Expert panels recommend a stepwise pharmacotherapy, depending on the level of disease control and disease stage (GOLD 2013). The first step to treat COPD is smoking cessation (nicotine replacement therapy with an appropriate support programme needs to be in place). Medical treatment includes short-acting and long-acting bronchodilators, including beta 2 -agonists and/or muscarinic antagonists, oral theophylline, inhaled and oral corticosteroids therapy and mucolytic therapy. Salbutamol Sulfate is indicated for the management of bronchospasm in patients suffering from chronic obstructive pulmonary disease who require regular treatment with both ipratropium and salbutamol. Beta 2 -agonists and anticholinergic agents are the main pharmacotherapy for patients with COPD. The combination of ipratropium and salbutamol is more effective than either of the two agents alone and the safety and efficacy profiles of the combination of ipratropium bromide and salbutamol are well established Part VI.2.3 Unknowns relating to treatment benefits Salbutamol Sulfate is not recommended in children below 12 years of age due to lack of data on safety and efficacy. Moreover there are no adequate data from the use of ipratropium bromide and salbutamol together in pregnant women (in early stages of pregnancy). Furthermore it is unknown whether ipratropium bromide is excreted into human breast milk. Salbutamol is excreted in human breast milk. There is insufficient/limited information on the excretion of Salbutamol Sulfate in human or animal breast milk.

3 Sandoz Confidential Page Part VI.2.4 Summary of safety concerns Table 7-5 Important identified risks Risk What is known Preventability Hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis) Salbutamol Sulfate can cause allergic reactions. Symptoms of an allergic reaction are for example hives, difficult breathing, swelling of the face, lips, tongue or throat. Salbutamol Sulfate should not be used if a patient is allergic to salbutamol, ipratropium or atropine. Inhalation-induced bronchoconstriction/ paradoxical bronchospasm Ocular complications (acute angle glaucoma, mydriasis, blurring of vision, increased intraocular pressure, eye pain and narrow-angle glaucoma) Cardiac disorder (cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles); myocardial ischemia) Hypokalaemia As with other inhalation therapy there is a risk of inhalation-induced constriction of the airways in the lungs due to the tightening of surrounding smooth muscles. If this occurs the patient will experience an immediate increase in wheezing and shortness of breath after dosing. There are rare reports of a number of ocular complications when aerosolised ipratropium bromide, either alone or in combination with a beta 2 -adrenergic agonist, has been inadvertently sprayed into the eye. Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from postmarketing data and published literature of rare occurrences of myocardial ischaemia associated with beta-agonists. Symptoms of cardiac disorders can be for example chest pain or uneven heartbeats. Potentially serious hypokalaemia (low potassium) may result from beta 2 -agonist therapy.symptoms of low potassium can be confusion, extreme thirst, increased urination, leg discomfort or muscle The bronchoconstriction/ bronchospasm should be treated straightaway with an alternative presentation or different fastacting inhaled bronchodilator. Salbutamol Sulfate should be discontinued immediately, the patient should be assessed and, if necessary, alternative therapy instituted. Patients must therefore be instructed in the correct use of Salbutamol Sulfate with their nebuliser and must be warned not to allow the nebuliser solution or mist to enter the eyes. To avoid inadvertent entry of drug into the eye, it is preferable to administer the nebulised suspension using a mouthpiece rather than a face mask. Patients should be advised if they experience chest pain and or shortness of breath that they should contact their emergency services. Particular caution is advised in severe airway obstruction, as this effect may be potentiated by concomitant treatment with xanthine derivatives, diuretics and steroids. Potentially serious

4 Sandoz Confidential Page 19 Risk What is known Preventability weakness. arrhythmias may occur during concomitant administration of digoxin and Ipratropium Bromide + Salbutamol Sulfate. The interaction risk is aggravated by hypokalaemia and should be monitored regularly. Hypokalaemia can bring about increased sensitivity to arrhythmias in patients being treated with digoxin. Table 7-6 Risk Stroke Important potential risks What is known (Including reason why it is considered a potential risk) In 2012 the Pharmacovigilance Working Party was informed of the publication of an article by Wang et al. based on data from the Longitudinal Health Insurance Database of the Taiwan National Health Insurance programme for ipratropiumcontaining products. The UK MHRA proposed to address the signal of increased incidence of myocardial infarction and stroke in patients with COPD triggered by the publication and confirmed that initial analysis and prioritization by the Pharmacovigilance Risk Assessment Committee (PRAC) was needed. PRAC discussed the study by Wang et al. On the basis of the information provided in the publication, the PRAC considered that, given the methodological limitations of this study (e.g. confounders such as smoking status were not available) and the apparent lack of any biological plausibility, the interpretation of the results was challenging and no regulatory action is considered necessary at the moment. Table 7-7 Risk Pediatric use Pregnancy and Lactation Missing information What is known Salbutamol Sulfate should not be used in children below 12 years of age due to lack of data on safety and efficacy. It is not known whether salbutamol and ipratropium passes into breast milk or if it could harm a nursing baby. Patients should not breast-feed while using Salbutamol Sulfate.

5 Sandoz Confidential Page Part VI.2.5 Summary of additional risk minimization measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures Part VI.2.6 Planned post authorization development plan None Part VI.2.7 Summary of changes to the Risk Management Plan over time Not applicable (first submission)

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