Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate

1. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) © The Swiss Pharmacy

2. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Duonase Nasal Spray (Generic Azelastine and Fluticasone Nasal Spray), containing an H1-receptor antagonist and a corticosteroid, is used for the relief of symptoms of smoderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children who require treatment with both Azelastine Hydrochloride and Fluticasone Propionate for symptomatic relief. © The Swiss Pharmacy

3. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) © The Swiss Pharmacy

4. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Duonase Nasal Spray is manufactured by Cipla Limited, India in the strength of 190 mcg (Azelastine Hydrochloride 140 mcg and Fluticasone Propionate 50 mcg). © The Swiss Pharmacy

5. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Chemical Structure -Azelastine Hydrochloride © The Swiss Pharmacy

6. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Chemical Structure - Fluticasone Propionate © The Swiss Pharmacy

7. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) The active ingredients contained in Duonase Nasal Spray are Azelastine Hydrochloride and Fluticasone Propionate. Each spray delivers 140 mcg of Azelastine Hydrochloride and 50 mcg of Fluticasone Propionate. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

8. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Uses of Duonase Nasal Spray (Azelastine 140 mcg and Fluticasone 50 mcg): Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) is used to treat an itchy or runny nose, sneezing, or other symptoms caused by seasonal hay fever (allergic rhinitis). Azelastine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Fluticasone is a steroid (cortisone-like medicine). It works by preventing the inflammation that occurs with allergic reactions. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

9. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Recommended Adult Dosage The recommended dose of Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) in in adults and adolescents 6 years of age and older is 1 spray per nostril twice daily. The recommended dosage should not be exceeded. Prime before initial use and when it has not been used for 14 or more days. Duonase Nasal Spray URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

10. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) How Does Duonase Nasal Spray Work? Azelastine/Fluticasone 140mcg/50mcg Nasal Spray relieves the symptoms of allergies, for example: symptoms relating to the nose - runny nose, post nasal drip, sneezing, itchy or blocked nose symptoms relating to the eyes - itchy, watery and red eyes. Hayfever is an inflammation or swelling of the nose lining (which may cause blockage, runny nose, itching and/ or sneezing). You may have symptoms only during spring or summer. This type of allergy is generally due to various pollens. Some people may experience symptoms all year round. This is usually caused by house dust mites, pets or moulds. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

11. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) How Does Duonase Nasal Spray Work? Duonase Nasal Spray contains two active ingredients: Azelastine Hydrochloride and Fluticasone Propionate. Azelastine Hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. This reduces symptoms of an allergic rhinitis. Fluticasone Propionate belongs to a group of medicines called corticosteroids which are used to help reduce inflammation. Due to the fast relief and the anti-inflammatory effect, Azelastine/Fluticasone 140mcg/50mcg Nasal Spray is more effective on symptoms relating to the nose and eyes than either antihistamine or corticosteroid therapy alone. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

12. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Contraindications ➔Duonase Nasal Spray is contraindicated in patients with a known hypersensitivity to Azelastine Hydrochloride, Fluticasone Propionate or any other component of the spray. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

13. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Storage Instructions Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) 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=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

14. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Warnings Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Duonase Nasal Spray. Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with Duonase Nasal Spray because further decreased alertness and impairment of CNS performance may occur. Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

15. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Warnings Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Duonase Nasal Spray slowly. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

16. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Warnings Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving Duonase Nasal Spray. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

17. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Effects On Ability To Drive And Use Machines Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) has minor influence on the ability to drive and use machines. In isolated cases fatigue, weariness, exhaustion, dizziness or weakness that may also be caused by the disease itself, may occur when using Duonase Nasal Spray. In these cases, the ability to drive and use machines may be impaired. Alcohol may enhance this effect. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

18. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Possible Side Effects Most common Azelastine Hydrochloride And Fluticasone Propionate Nasal Spray (Duonase Nasal Spray) side effects with an incidence rate of greater than or equal to 2% are dysgeusia, epistaxis, and headache. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

19. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Possible Side Effects The following side effects occurred in less than 1% of studies in adults and adolescents, and from the placebo-controlled study in children 6- 11 years of age: Ear and labyrinth disorders: Tinnitus Eye disorders: Eye irritation Gastrointestinal disorders: Dry mouth, Nausea, Abdominal discomfort, Abdominal pain upper, Vomiting General disorders and administration site conditions: Mucosal erosion, Fatigue, Product taste abnormal, Mucosal ulceration Infections and infestations: Upper respiratory tract infection, Acute sinusitis, Laryngitis, Pharyngitis, Viral upper respiratory tract infection URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

20. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Possible Side Effects The following side effects occurred in less than 1% of studies in adults and adolescents, and from the placebo-controlled study in children 6-11 years of age: Metabolism and nutrition disorders: Polydipsia Nervous systems disorders: Somnolence, Dizziness, Hypogeusia, Lethargy, Parosmia Psychiatric disorders: Disorientation Respiratory, thoracic and mediastinal disorders: Nasal discomfort, Cough, Oropharyngeal pain, Sneezing, Throat irritation, Nasal dryness, Rhinalgia, Rhinorrhoea, Upper-airway cough syndrome, Dry throat, Nasal congestion, Nasal mucosal disorder, Nasal septum ulceration Skin and subcutaneous tissue disorders: Dry skin, Pruritus, Rash papular URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

21. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Duonase Nasal Spray Overdosage Duonase Nasal Spray contains both Azelastine Hydrochloride and Fluticasone Propionate; therefore, the risks associated with overdosage for the individual components described below apply to Duonase Nasal Spray. Azelastine Hydrochloride: Azelastine Hydrochloride: There have been no reported overdosages with Azelastine Hydrochloride. Acute Azelastine Hydrochloride overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events. Clinical trials in adults with single doses of the oral formulation of Azelastine Hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse events. General supportive measures should be employed if overdosage occurs. There is no known antidote to Duonase Nasal Spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, Duonase Nasal Spray should be kept out of the reach of children. © The Swiss Pharmacy

22. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Duonase Nasal Spray Overdosage Fluticasone Propionate: Fluticasone Propionate: Chronic Fluticasone Propionate overdosage may result in signs/symptoms of hypercorticism. Intranasal administration of 2 mg (10 times the recommended dose) of Fluticasone Propionate twice daily for 7 days to healthy human volunteers was well tolerated. Single oral Fluticasone Propionate doses up to 16 mg have been studied in human volunteers with no acute toxic effects reported. Repeat oral doses up to 80 mg daily for 10 days in volunteers and repeat oral doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups. Acute overdosage with this dosage form is unlikely. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

23. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Duonase Nasal Spray During Pregnancy Azelastine Hydrochloride And Fluticasone Propionate Nasal Spray (Duonase Nasal Spray) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled clinical trials of Azelastine Hydrochloride And Fluticasone Propionate Nasal Spray, Azelastine Hydrochloride only, or Fluticasone Propionate only in pregnant women. Animal reproductive studies of Azelastine Hydrochloride and Fluticasone Propionate in mice, rats, and/or rabbits revealed evidence of teratogenicity as well as other developmental toxic effects. Because animal reproduction studies are not always predictive of human response, Duonase Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

24. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Duonase Nasal Spray During Nursing It is not known whether Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Duonase Nasal Spray is administered to a nursing woman. Since there are no data from well controlled human studies on the use of Duonase Nasal Spray by nursing mothers, based on data from the individual components, a decision should be made whether to discontinue nursing or to discontinue Dymista Nasal Spray, taking into account the importance of Dymista Nasal Spray to the mother. Azelastine Hydrochloride: It is not known if Azelastine Hydrochloride is excreted in human milk. Fluticasone Propionate: It is not known if Fluticasone Propionate is excreted in human milk. However, other corticosteroids are excreted in human milk. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy

25. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) Duonase Nasal Spray Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) is manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html https://www.theswisspharmacy.com/product_info.php?info=p9705_Duonase-Nasal-Spray.html © The Swiss Pharmacy