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Seretide (salmeterol/fluticasone propionate) is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate. TM
Note: Seretide 50 microgram /100 microgram strength is not appropriate in adults and children with severe asthma. TM
SeretideTM (salmeterol xinafoate and fluticasone propionate) Abridged prescribing information (see SPC for full prescribing information). Presentations: SeretideTM DiskusTM – Each dose provides 50 mcg salmeterol (as salmeterol xinafoate) and 100 mcg, 250 mcg or 500 mcg respectively of fluticasone propionate. SeretideTM EvohalerTM - Each inhalation provides 25 mcg salmeterol (as salmeterol xinafoate and 50 mcg, 125 mcg or 250 mcg respectively of fluticasone propionate. Therapeutic Indications: Seretide is indicated in the regular treatment of asthma where use of a combination (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate. Seretide 500 Diskus is indicated for the symptomatic treatment of patients with COPD with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. Dosage and administration: Adults and adolescents 12 years and over: Asthma: Seretide Diskus – one puff b.d. of: Seretide 100 or Seretide 250 or Seretide 500 (each containing 50 mcg of salmeterol and 100 mcg, 250 mcg or 500 mcg respectively of fluticasone propionate). Seretide Evohaler – two puffs b.d. of: Seretide 50 or Seretide 125 or Seretide 250 (each containing 25 mcg of salmeterol and 50 mcg, 125 mcg or 250 mcg respectively of fluticasone propionate). A short term trial of Seretide may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma for whom rapid control of asthma is essential. In these cases, the recommended initial dose is one puff of Seretide 100 Diskus or two puffs of Seretide 50 Evohaler. Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important. In general inhaled corticosteroids remain the first line treatment for most patients. Seretide is not intended for the initial management of mild asthma. Lowest strength Seretide (50 Evohaler or 100 Diskus) is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma. Children 4-11 years: Seretide 100 Diskus (50 mcg salmeterol and 100 mcg fluticasone propionate) – one puff b.d.. Seretide 50 Evohaler (25mcg salmeterol and 50mcg fluticasone propionate)- two puffs twice daily. Adults: COPD: Seretide 500 Diskus (50 mcg of salmeterol and 500 mcg fluticasone propionate) – one puff b.d.. Contraindications: Hypersensitivity. Warnings and Precautions: Seretide should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required. Patients should not be initiated on Seretide during an exacerbation. Serious asthmarelated adverse events and exacerbations may occur during treatment with Seretide. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen. Treatment with Seretide should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. For patients with COPD, cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician. As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis, severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, uncorrected hypokalaemia, thyrotoxicosis or patients predisposed to low levels of serum potassium. Paradoxical bronchospasm: substitute alternative therapy. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods, but are less likely than with oral steroids. Concomitant treatment with ketoconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided unless the benefits outweigh the potentially increased risk. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. It is important, therefore, for asthma patients that the dose of inhaled steroid is titrated to the lowest dose at which effective control is maintained. Monitor height of children on prolonged inhaled steroid therapy and the dose should be reduced to the lowest dose at which effective control is maintained. Transfer from oral steroids: special care needed, monitor adrenal function. Do not stop abruptly. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Patients with COPD: Be vigilant for possible development of pneumonia or other lower respiratory tract infections. If a patient has experienced pneumonia, treatment with Seretide should be re-evaluated. Drug Interactions: Avoid beta-blockers. Care with co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Fertility, Pregnancy and Lactation: Balance risks against benefits. Undesirable effects: Very common (≥1/10): Nasopharyngitis, headache. Common (≥1/100 and <1/10): Candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, hoarseness/dysphonia, sinusitis, contusions, traumatic fractures, arthralgia, myalagia. See SPC for other possible undesirable effects. PA Holder: GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland trading as Allen & Hanburys. PA Numbers: Seretide Diskus PA 1077/46/1-3 Seretide Evohaler PA 1077/46/4-6. Drug classification: S1B. Package quantities: Seretide Diskus is available in 60 dose Diskus. Seretide Evohaler is available in 120 inhalations Inhaler. Seretide, Evohaler and Diskus are registered trademarks of the GlaxoSmithKine group of companies. All rights reserved. Date of Preparation of API: August 2012. API Code: IE/SFC/0026/12. Further information available from: Allen & Hanburys Ltd., Stonemasons Way, Rathfarnham, Dublin 16.
SeretideTM 50 EvohalerTM 25 microgram/50 microgram/dose pressurised inhalation, suspension. SeretideTM 125 EvohalerTM 25 microgram/125 microgram/dose pressurised inhalation, suspension. SeretideTM 250 EvohalerTM 25 microgram/250 microgram/dose pressurised inhalation, suspension. (salmeterol xinafoate and fluticasone propionate) Abridged prescribing information (see SPC for full prescribing information). Presentations: Each inhalation provides 25 mcg salmeterol and 50 mcg, 125 mcg or 250 mcg respectively of fluticasone propionate. Therapeutic Indications: Seretide is indicated in the regular treatment of asthma where use of a combination (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate. Dosage and administration: Please refer to SPC for full dosage and administration details and for details on the use and cleaning of the inhaler. Seretide Evohaler is for inhalation use only. Patients should be made aware that Seretide Evohaler must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice. Adults and adolescents 12 years and over: two puffs twice daily of Seretide 50, 125 or 250. A short term trial of Seretide may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma for whom rapid control of asthma is essential. In these cases, the recommended initial dose is two puffs of Seretide 50 Evohaler. Once control of asthma is attained, consideration should be given to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients during step down is important. In general inhaled corticosteroids remain the first line treatment for most patients. Seretide is not intended for the initial management of mild asthma. Seretide 50 Evohaler is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma. Children 4-11 years: Two puffs twice daily of Seretide 50 Evohaler. The maximum licensed dose of fluticasone propionate delivered by Seretide in children is 100mcg twice daily. Contraindications: Hypersensitivity to the active ingredients or any of the excipients. Warnings and Precautions: Seretide should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required. Patients should not be initiated on Seretide during an exacerbation. Serious asthmarelated adverse events and exacerbations may occur during treatment with Seretide. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen. Treatment with Seretide should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis, severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, uncorrected hypokalaemia, thyrotoxicosis or patients predisposed to low levels of serum potassium. Paradoxical bronchospasm: substitute alternative therapy. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods, but are less likely than with oral steroids. It is important, therefore, that the dose of inhaled steroid is titrated to the lowest dose at which effective control is maintained. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Transfer from oral steroids: special care needed, monitor adrenal function. Do not stop abruptly. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Monitor height of children on prolonged inhaled steroid therapy and the dose should be reduced to the lowest dose at which effective control is maintained. Concomitant treatment with ketoconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided unless the benefits outweigh the potentially increased risk. Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD. If a patient with severe COPD has experienced pneumonia the treatment with Seretide should be re-evaluated. Drug Interactions: Avoid beta-blockers. Potential additive effect with concomitant use of other beta-adrenergic containing drugs. Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, itraconazole, telithromycin) should be avoided unless benefits outweigh potential risk. Fertility, Pregnancy and Lactation: Balance risks against benefits. Undesirable effects: Very common (≥1/10): Nasopharyngitis, headache. Common (≥1/100 and <1/10): Candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, throat irritation, hoarseness/ dysphonia, sinusitis, contusions, muscle cramps, traumatic fractures, arthralgia, myalagia. See SPC for other possible undesirable effects. Overdose: There are no data on overdose with Seretide. If Seretide therapy has to be withdrawn due to overdose of the beta agonist component, consider appropriate replacement steroid therapy. PA Holder: GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland trading as Allen & Hanburys. PA Numbers: PA 1077/46/4-6. Drug classification: POM. Package quantities: 120 inhalations Inhaler. Date of Preparation of API: August 2013. API Code: IE/SFC/0039/13. Further information available from: Allen & Hanburys Ltd., Stonemasons Way, Rathfarnham, Dublin 16.
Ref. 1. Seretide Diskus and Evohaler Summary of Product Characteristics. www.medicines.ie. Accessed 20th September 2013.
Adverse events should be reported directly to the IMB; Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie, e-mail: imbpharmacovigilance@imb.ie. Adverse events should also be reported to GlaxoSmithKline on Free phone 1800 244 255, Fax 01 4938839 or e-mail: ireland.drugsurveillance@gsk.com.
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GSK Respiratory Health – We live and breathe it. www.health.gsk.ie
IE/SFC/0040/13
Date of preparation: September 2013
09.10.2013 04/02/2014 17:10:05 11:34:55