国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Azelastine hydrochloride
Meda Health Sales Ireland Limited
R01AC; R01AC03
Azelastine hydrochloride
1 milligram(s)/millilitre
Nasal spray, solution
Product subject to prescription which may be renewed (B)
Antiallergic agents, excl. corticosteroids; azelastine
Not marketed
2012-10-05
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ASTEPRO 1MG/ML NASAL SPRAY SOLUTION Azelastine hydrochloride _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. - In this leaflet Astepro 1 mg/ml Nasal Spray, Solution is called Astepro. _ _ IN THIS LEAFLET: 1. What Astepro is and what it is used for 2. Before you use Astepro 3. How to use Astepro 4. Possible side effects 5. How to store Astepro 6. Further 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. BEFORE YOU USE ASTEPRO _ _ DO NOT USE ASTEPRO IF - if you are allergic (hypersensitive) to azelastine hydrochloride or any of the other ingredients of Astepro (see section 6). If this applies to you, talk to your doctor_ _or pharmacist_._ CHECK WITH YOUR DOCTOR, OR PHARMACIST BEFORE USING ASTEPRO - if you are taking any other medicines obtained without a prescription USING OTHER MEDICINES Astepro is not known to be affected by other medicines. PREGNANCY AND BREAST-FEEDING There are only limited information on the effects of Astepro on the unborn or breast fed child. If you are pregnant, trying to be 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Astepro 1 mg/ml Nasal Spray, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Solution containing 1 mg /ml azelastine hydrochloride. The delivered dose per actuation (0.14 ml) contains 0.14 mg azelastine hydrochloride equivalent to 0.13 mg azelastine For a 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 allergic rhinitis in adults, adolescents and children 6 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and adolescents 12 years and older: 2 applications in each nostril twice daily. This dose should not be exceeded. Children 6 to 11 years: 1 application in each nostril twice daily. Astepro Nasal Spray is not recommended for use in children below 6 years of age due to a lack of data on safety and/or efficacy Astepro Nasal Spray is suitable for long-term use. There is no restriction regarding duration of use. Method of administration Nasal use (topical – nasal mucosa) _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 Nasal Spray has not been used for 3 or more days, the pump must be reprimed by pressing down and releasing the pump a sufficient number of times until a fine mist emerges. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance azelastine hydrochloride or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Nothing relevant. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ 阅读完整的文件