Public Assessment Report Decentralised Procedure …

1 Public Assessment Report Decentralised Procedure Sirdupla 25 microgram/125 microgram per metered dose pressurised inhalation, suspension Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension Procedure No: UK/H/5607/001-002/DC UK Licence No: PL 04569/1449-1450 Generics [UK] Limited t/a Mylan Sirdupla 25 microgram/125 microgram and 25 microgram/250 microgram per metered dose pressurised inhalation, suspension UK/H/5067/001-002/DC 2 Lay Summary Sirdupla 25 microgram/125 microgram per metered dose pressurised inhalation, suspension Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension (salmeterol, as salmeterol xinafoate, and fluticasone proprionate ) This is a summary of the Public Assessment Report (PAR)

2 For Sirdupla 25 microgram/125 microgram per metered dose pressurised inhalation, suspension and Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension (PL 04569/1449-1450; UK/H/5607/001-002/DC). Sirdupla 25 microgram/125 microgram per metered dose pressurised inhalation, suspension and Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension will be referred to simply as Sirdupla throughout this Report , for ease of reading. This Report explains how Sirdupla was assessed and authorisation subsequently recommended.

3 The Report is not intended to provide practical advice on how to use Sirdupla. For practical information about using Sirdupla patients should read the package leaflet or contact their doctor or pharmacist. What is Sirdupla and what is it used for? Sirdupla was submitted as a hybrid application . This means that it is similar to a reference medicinal product containing the same active substances but that the Applicant has provided additional data to demonstrate equivalent safety and efficacy. The reference medicines for Sirdupla, already authorised in the European Union (EU), are Seretide Evohaler 25 microgram/125 microgram per metered dose pressurised inhalation, suspension and Seretide Evohaler 25 microgram/250 microgram per metered dose pressurised inhalation, suspension (PL 10949/0338 and PL 10949/0339, respectively).

4 Sirdupla is used to help prevent breathing problems, such as asthma, in adults 18 years of age and older. Sirdupla is NOT authorised for use in children 12 years of age and younger and is NOT authorised for use in adolescents aged 13 to 17 years of age. The safety and efficacy of Sirdupla in these young age groups have not been established; no data are available. A lower strength product, containing a lower dose of the inhaled corticosteroid would be required if this new fixed-dose combination orally inhaled product is to be used in the treatment of children with asthma. A lower strength of the reference product, Seretide Evohaler 25 microgram/50 microgram per metered dose pressurised inhalation, suspension, is available; this new fixed-dose combination orally inhaled product, Sirdupla, is NOT available in this lower strength.

5 The lack of this lower strength affects downward dose titration, a requisite of asthma management with inhaled corticosteroids and precludes use of these products in patients with mild asthma and in some patients with moderate persistent asthma (unless control of symptoms cannot be maintained with a lower strength product containing a lower dose of the corticosteroid) and also precludes use in children. If a lower strength product (containing a dose of inhaled corticosteroid of less than 125 micrograms) is required for whatever reason, a change to an alternative fixed-dose combination of Sirdupla 25 microgram/125 microgram and 25 microgram/250 microgram per metered dose pressurised inhalation, suspension UK/H/5067/001-002/DC 3 salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid will be required.

6 How does Sirdupla work? Sirdupla is a fixed-dose combination orally inhaled product containing the active substances salmeterol (as salmetrol xinafoate) and fluticasone propionate and is administered via a pressurised metered dose inhaler (pMDI). Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open, which makes it easier for air to get in and out. The effects last for at least 12 hours. Fluticasone propionate is a corticosteroid, which reduces swelling and irritation in the lungs. How is Sirdupla used? Sirdupla should be inhaled through the mouth, into the lungs.

7 It is very important to follow the prescribing doctor s instructions on how many puffs to take and how often to take the medicine. Sirdupla should be taken every day until the prescribing doctor advises the patient to stop. The patient should not take more than the recommended dose, which is 2 puffs taken twice a day, for either strength product. Use of an AeroChamber Plus spacing device with Sirdupla is recommended in patients who have, or are likely to have, difficulties in coordinating actuation of the pressurised metered dose inhaler with inspiration. Only the AeroChamber Plus spacing device should be used with Sirdupla.

8 Other spacing devices should not be used with Sirdupla and patients should not switch from one spacing device to another. Patients should be instructed in the proper use and care of their inhaler and spacing device and their technique checked regularly to ensure optimum delivery of the inhaled drug to the lungs. Please read Section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration and the duration of treatment. These medicines can only be obtained with a prescription. What benefits of Sirdupla have been shown in studies?

9 Sirdupla are hybrid applications and clinical studies have been provided to show that Sirdupla 25 microgram/125 microgram per metered dose and Sirdupla 25 microgram/250 microgram per metered dose are therapeutically equivalent to the reference medicinal products, Seretide Evohaler 25 microgram/125 microgram per metered dose and Seretide Evohaler 25 microgram/250 microgram per metered dose. Therapeutic equivalence is defined as equivalent efficacy and safety when the new orally inhaled product, for which a Marketing authorisation is sought, is compared with an appropriate reference orally inhaled product.

10 What are the possible side-effects of Sirdupla? The most common side effects seen with Sirdupla (which may affect more than 1 in 10 people) are headaches. In patients with chronic obstructive pulmonary disease (COPD), an increased number of colds have been reported. (COPD is a long-term lung disease that causes Sirdupla 25 microgram/125 microgram and 25 microgram/250 microgram per metered dose pressurised inhalation, suspension UK/H/5067/001-002/DC 4 shortness of breath, coughing and frequent chest infections. The term COPD includes conditions known as chronic bronchitis and emphysema).