Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler)

1. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) © The Swiss Pharmacy

2. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) is used in the regular treatment of asthma, where use of a combination (long-acting beta2- agonist and inhaled corticosteroid) has been found to be appropriate. This medicine is also used in the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). © The Swiss Pharmacy

3. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Seroflo Inhalers (Fluticasone Propionate and Salmeterol Xinafoate Inhalers) are manufactured by Cipla Limited, India. They are available as Seroflo 50 Inhaler, Seroflo 125 Inhaler and Seroflo 250 Inhaler. © The Swiss Pharmacy

4. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Chemical Structure -Fluticasone Propionate © The Swiss Pharmacy

5. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Chemical Structure - Salmeterol Xinafoate © The Swiss Pharmacy

6. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) The active ingredients contained in Seroflo inhaler are Fluticasone Propionate and Salmeterol Xinafoate. Each actuation delivers 25 mcg Salmeterol (as Salmeterol Xinafoate IP). The quantity of Fluticasone Propionate IP is 50 mcg, 125 mcg or 250 mcg. © The Swiss Pharmacy

7. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Uses of Seroflo Inhaler 50, 125 and 250: Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) is a combination of two medicines that are used to help control the symptoms of asthma and improve breathing. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started. This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

8. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Uses of Seroflo Inhaler 50, 125 and 250: Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms. Inhaled salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It relieves cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes. Seroflo Inhaler is NOT indicated for the relief of acute bronchospasm. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

9. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Recommended Adult Dosage The dose of Seroflo Inhaler Seroflo Inhaler (Fluticasone and Salmeterol Inhaler) for various indications is given below: Treatment of Asthma in Adults and Adolescents (12 years and older): Seroflo 50 Inhaler: Two inhalations twice daily Seroflo 125 Inhaler: Two inhalations twice daily Seroflo 250 Inhaler: Two inhalations twice daily Improvement in asthma control following inhaled administration of Seroflo Inhaler can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

10. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Recommended Adult Dosage Treatment of Chronic Obstructive Pulmonary Disease (COPD) in Adults and Adolescents (12 years and older): Seroflo 125 Inhaler: Two inhalations twice daily Seroflo 250 Inhaler: Two inhalations twice daily Seroflo Inhaler may be used with a Zerostat/ Zerostat VT Spacer device in patients who find it difficult to synchronize aerosol actuation with inspiration of breath. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

11. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Contraindications ➔Seroflo Inhaler is contraindicated in patients with a known hypersensitivity to Fluticasone Propionate, Salmeterol Xinafoate or any component of the tablet. ➔Administration of Seroflo Inhaler is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

12. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Storage Instructions Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

13. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Warnings Serious Asthma-Related Events – Hospitalizations, Intubations, Death: Use of long-acting beta2-adrenergic agonist (LABA) as monotherapy (without inhaled corticosteroid (ICS)) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. Deterioration of Disease and Acute Episodes: Seroflo Inhaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. Fluticasone Propionate and Salmeterol Xinafoate Inhaler (Seroflo Inhaler) has not been studied in subjects with acutely deteriorating asthma. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

14. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Warnings Excessive Use of Fluticasone and Salmeterol Inhaler and Use with Other Long-acting Beta2-agonists: Seroflo Inhaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Local Effects of Inhaled Corticosteroids: In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with Seroflo Inhaler. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with Seroflo Inhaler continues, but at times therapy with Seroflo Inhaler may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis. © The Swiss Pharmacy

15. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Warnings Pneumonia: Lower respiratory tract infections, including pneumonia, have been reported in patients with chronic obstructive pulmonary disease (COPD) following the inhaled administration of corticosteroids, including Fluticasone Propionate and Fluticasone and Salmeterol Inhaler. Immunosuppression: Persons who are using medicines that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

16. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Warnings Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

17. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Possible Side Effects Most common Fluticasone Propionate and Salmeterol Xinafoate Inhaler (Seroflo Inhaler) side effects that occurred during Clinical trials with an incidence rate of greater than or equal to 3% in the groups receiving the medicine and at a greater incidence than with placebo were: Ear, nose, and throat: Upper respiratory tract infection, pharyngitis, upper respiratory inflammation, sinusitis, hoarseness/dysphonia, candidiasis of mouth/throat, throat irritation Lower respiratory: Viral respiratory infections, bronchitis, cough Neurology: Headache, dizziness URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

18. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Possible Side Effects Gastrointestinal: Nausea and vomiting, gastrointestinal discomfort and pain, diarrhea, viral gastrointestinal infections Non-site specific: Candidiasis unspecified site, fever, malaise, and fatigue Musculoskeletal: Musculoskeletal pain, muscle cramps and spasms, traumatic fractures, arthralgia, myalgia URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

19. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Overdosage There are no data available from clinical trials on overdose with Fluticasone Propionate and Salmeterol Xinafoate Inhaler (Seroflo Inhaler). However data on overdose with both the individual medicines are given below: The signs and symptoms of salmeterol overdose are tremor, headache and tachycardia. The preferred antidotes are cardioselective beta- blocking agents, which should be used with caution in patients with a history of bronchospasm. In case Seroflo Inhaler therapy has to be withdrawn due to overdose of the beta agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. Additionally, hypokalaemia can occur and potassium replacement should be considered. © The Swiss Pharmacy

20. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Overdosage Acute: Acute inhalation of Fluticasone Propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements. Chronic Overdose of Inhaled Fluticasone Propionate: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary. When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose. In cases of both acute and chronic Fluticasone Propionate overdose SFC therapy may still be continued at a suitable dosage for symptom control. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy

21. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Seroflo Inhaler During Pregnancy Fluticasone Propionate and Salmeterol Xinafoate Inhaler (Seroflo Inhaler) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies with Fluticasone Propionate and Salmeterol Xinafoate Inhaler (Seroflo Inhaler) in pregnant women. Fluticasone and Salmeterol Inhaler was teratogenic in mice and not in rats, although it lowered fetal weight in rats. Fluticasone propionate alone was teratogenic in mice, rats, and rabbits, and Salmeterol alone was teratogenic in rabbits and not in rats. From the reproduction toxicity studies in mice and rats, no evidence of enhanced toxicity was seen using combinations of Fluticasone Propionate and Salmeterol Xinafoate when compared with toxicity data from the components administered separately. Seroflo Inhaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. © The Swiss Pharmacy

22. Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) Seroflo Inhaler Seroflo Inhaler (Fluticasone Propionate and Salmeterol Xinafoate Inhaler) is manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html https://www.theswisspharmacy.com/product_info.php?info=p9879_Seroflo-Inhaler.html © The Swiss Pharmacy