Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
azelastine hydrochloride, Quantity: 0.137 mg/actuation (Equivalent: azelastine, Qty 0.125 mg/actuation)
Viatris Pty Ltd
Azelastine hydrochloride
Spray, nasal
Excipient Ingredients: dibasic sodium phosphate dodecahydrate; disodium edetate; hypromellose; purified water; citric acid; sodium chloride
Nasal
10mL, 20mL, 5mL
(S2) Pharmacy Medicine
For the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis.
Visual Identification: Clear, colourless to almost colourless solution, in amber glass bottle fitted with a metered dose, pump, actuator & overcap.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2004-07-21
AZEP ® NASAL SPRAY A z e p ® N a s a l S p r a y ACTIVE INGREDIENT(S): _azelastine hydrochloride_ CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using AZEP NASAL SPRAY. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING AZEP NASAL SPRAY. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using AZEP NASAL SPRAY? 2. What should I know before I use AZEP NASAL SPRAY? 3. What if I am taking other medicines? 4. How do I use Azep Nasal Spray? 5. What should I know while using AZEP NASAL SPRAY? 6. Are there any side effects? 7. Product details 1. WHY AM I USING AZEP NASAL SPRAY? AZEP NASAL SPRAY is used to relieve runny nose, sneezing, itching or blocked nose caused by allergies, such as to pollen (hay fever) house dust mites or pet hair. AZEP NASAL SPRAY belongs to a group of medicines called antihistamines. It works by blocking the action of histamine and other substances produced by the body, which are causing your allergies. AZEP NASAL SPRAY is not addictive. 2. WHAT SHOULD I KNOW BEFORE I USE AZEP NASAL SPRAY? WARNINGS DO NOT USE AZEP NASAL SPRAY IF YOU HAVE AN ALLERGY TO AZEP NASAL SPRAY OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Always check the ingredients to make sure you can use this medicine. DO NOT GIVE AZEP NASAL SPRAY TO A CHILD UNDER 5 YEARS, UNLESS DIRECTED BY THE CHILD’S DOCTOR. The safety and effectiveness of AZEP NASAL SPRAY in children under 5 years have not been established. CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU: • have any other medical conditions, especially kidney disease • take any medicines for any other condition During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects? PREGNANCY AND BREASTFEEDING Check with your doctor or pharmacist if you are pregnant or intend to become pre Les hele dokumentet
AUSTRALIAN PRODUCT INFORMATION AZEP ® NASAL SPRAY _Azelastine hydrochloride Nasal Spray _ 1 NAME OF THE MEDICINE Azelastine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each actuation (0.137 mL) contains 137 µg azelastine hydrochloride (equivalent to 125 µg azelastine as the base). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM AZEP NASAL SPRAY is a clear, colourless, buffered, isotonic aqueous solution with a pH of 6.8. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of seasonal allergic rhinitis and perennial allergic rhinitis. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN AGED 5 YEARS AND OVER: Each spray contains 125 µg of azelastine (as hydrochloride). One spray into each nostril twice daily as necessary (equivalent to a daily dose of 0.50 mg azelastine (as hydrochloride)). LONG TERM TREATMENT: Azelastine nasal spray may be used until symptoms cease, but no longer than 6 months, uninterruptedly. INSTRUCTIONS FOR HANDLING: The spray should be used with the head held upright, after first blowing the nose. 1. The protective cap should be removed. 2. Before the first use, the pump should be primed by spraying 2-3 times, until an even spray is produced. 3. One spray should be used in each nostril with the head tilted forward (looking at toes). Do not keep the head upright or tilted backwards. 4. Sniffing should only be slow and gentle. 5. The nozzle should be wiped and the protective cap replaced. The pump should also be primed again after storage for 3 or more days. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. AZEP ® NASAL SPRAY – PRODUCT INFORMATION 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE USE IN THE ELDERLY A pharmacokinetic study in elderly patients (n=15) receiving oral azelastine hydrochloride 4.4 mg twice daily found a prolongation of the T max and an increase in C max and AUC compared to results in healthy volunteers. There have been no specific studies in the elderly with Les hele dokumentet