Adverse Events & Side Effects

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to the Mylan on 0800 121 8267 or email ukpharmacovigilance@mylan.com

By reporting side effects you can help provide more information on the safety of medicines.

Prescribing information

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Indication: Sirdupla is indicated in the regular treatment of asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting β2 agonist.

Presentation: Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and either 125 or 250 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and either 110 or 220 micrograms respectively of fluticasone propionate.

Dosage and administration: Sirdupla is indicated in adults 18 years of age and older only. Inhalation use. Sirdupla must be used daily for optimum benefit, even when asymptomatic. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. The recommended dose is two inhalations of Sirdupla twice daily. Patients should be instructed in the proper use of their inhaler (see patient information leaflet). Sirdupla is not available in the lowest strength of this combination as currently available on the market and therefore an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid would need to be prescribed for the initial maintenance therapy in adults with moderate persistent asthma. When long-term control of symptoms is maintained with the lowest strength of such an alternative fixed-dose combination given twice daily, then the next step could include a test of inhaled corticosteroid alone. Sirdupla should not be used for patients with mild asthma. Only the Aerochamber Plus spacer device should be used with Sirdupla.

Contraindications: Known hypersensitivity to the active substances or to any of the excipients.

Warnings and precautions: Sirdupla should not be used to treat acute asthma symptoms for which a fast- and short- acting bronchodilator is required. Serious asthma-related adverse events and exacerbations may occur during treatment with Sirdupla. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Sirdupla. Treatment with Sirdupla should not be stopped abruptly due to risk of exacerbation. Therapy should be down-titrated under physician supervision. Sirdupla should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway and in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium. It is important, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained. Sirdupla is not indicated for use in the treatment of patients with COPD.

Interaction with other medicinal products: β adrenergic blockers may weaken or antagonise the effect of salmeterol, concomitant use of other β adrenergic containing drugs can have a potentially additive effect. Concomitant use with potent CYP3A4 inhibitors such as ritonavir, telithromycin, ketoconazole and itraconazole should be avoided unless the benefits outweigh the potentially increased risk of systemic side effects.

Pregnancy and lactation: There is limited clinical data for the use of Sirdupla in pregnant women. Administration of Sirdupla to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. A decision must be made whether to discontinue breast-feeding or to discontinue Sirdupla therapy taking into account the benefit for the child and for the woman.

Effects on ability to drive and use machines: Sirdupla has no or negligible influence on the ability to drive and use machines.

Undesirable effects: Very common: headache, nasopharyngitis. Common: candidiasis of the mouth and throat, pneumonia, bronchitis, hypokalaemia, throat irritation, hoarseness/dysphonia, sinusitis, contusions, muscle cramps, traumatic fractures, arthralgia, myalgia. Uncommon: cutaneous hypersensitivity reactions, respiratory symptoms, hyperglycaemia, anxiety, sleep disorders, tremor, cataract, palpitations, tachycardia, atrial fibrillation, angina pectoris.

For unknown, rare and very rare undesirable effects, please refer to SmPC.

Legal Category: POM

Marketing Authorisation Number: 25mcg/125mcg: PL 04569/1449; 25mcg/250mcg: PL 04569/1450

MAH: Generics [UK] Limited t/a Mylan

NHS Price: 25mcg/125mcg 1x120 doses: £22.45; 25mcg/250mcg 1x120 doses: £28.32

Date of Revision of Prescribing Information: December 2018
The SmPC for this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:

http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/index.htm and from Mylan Medical Information, Building 4, Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, phone no. 01707 853000, Email: info.uk@mylan.co.uk

Adverse events should be reported.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should be reported to Medical Information, Mylan, Building 4, Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, on phone no. 0800 121 8267 or on Email: ukpharmacovigilance@mylan.com