Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Azelastine hydrochloride
Mylan IRE Healthcare Limited
R01AC; R01AC03
Azelastine hydrochloride
1.5 milligram(s)/millilitre
Nasal spray, solution
Product subject to prescription which may be renewed (B)
Antiallergic agents, excl. corticosteroids; azelastine
Not marketed
2013-09-13
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ASTEPRO 0.15% NASAL SPRAY Azelastine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - In this leaflet Astepro 0.15% Nasal Spray is called Astepro. WHAT IS IN THIS LEAFLET : 1. What Astepro is and what it is used for 2. What you need to know before you use Astepro 3. How to use Astepro 4. Possible side effects 5. How to store Astepro 6. Contents of the pack and other information 1. WHAT ASTEPRO IS AND WHAT IT IS USED FOR Astepro contains azelastine hydrochloride which belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of histamine that the body produces as part of an allergic reaction. Astepro is used to treat allergic rhinitis in adults, adolescents and children 6 years and older. This is an allergic reaction to substances such as, for example, pollen, house dust mites or animal hair. Usually it affects you by causing a runny nose, sneezing, itching or blocked nose. Astepro should help control these symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ASTEPRO DO NOT USE ASTEPRO - if you are allergic (hypersensitive) to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Astepro. CHILDREN Astepro Nasal Spray is not recommended for use in children below 6 years of age. OTHER MEDICINES AND ASTEPRO Even if Astepro is not known to be affected by other medicines, tell your doctor or pharmacist if you are taking, Lestu allt skjalið
Health Products Regulatory Authority 30 March 2022 CRN00CJ6K Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Astepro 1.5 mg/ml nasal spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 1.5 mg azelastine hydrochloride. One actuation (0.14 ml) contains 0.21 mg azelastine hydrochloride equivalent to 0.19 mg azelastine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution Clear colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of seasonal allergic rhinitis (hayfever) in adults, adolescents and children 6 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents 12 years and older_ 2 sprays in each nostril once a day. In some cases 2 sprays in each nostril twice a day may be required. The maximum daily dose is 2 sprays in each nostril twice daily. _Children 6 to 11 years_ 1 spray in each nostril twice daily. Clinical experience of up to 4 weeks duration showed good efficacy and safety in children. Longer experiences in children have not been available; however, clinical trials of up to one year duration using a double higher daily dose showed good safety in adults and adolescents. Astepro 1.5 mg/ml Nasal Spray, Solution is not recommended for use in children below 6 years of age due to a lack of data on safety and/or efficacy. Duration of treatment Astepro 1.5 mg/ml Nasal Spray, Solution is suitable for long-term use. The duration of treatment should be a clinical decision considering the severity of allergic symptoms, safety and should correspond to the period of allergenic exposure. Use longer than 4 weeks is not recommended in children 6-11 years due to lack of clinical data. Method of administration Nasal use _Precautions to be taken before handling or administering the medicinal product:_ Spray with head held upright. Before the first use, the pump must be primed by pressing down and releasing the pump six times. When Astepro 1.5 mg/m Lestu allt skjalið