Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
AZELASTINE HYDROCHLORIDE
Meda Health Sales Ireland Limited
S01GX07
AZELASTINE HYDROCHLORIDE
0.5 Mg/Ml
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Other antiallergics
Authorised
2006-06-13
2155671.PA1332_010_001.4cdd2c53-921e-4963-a22e- 585e6227241e_1_.Aze ED_0255_MRP_PIL_04.2015_clean.doc.doc.1507222155671.PA13 32_010_001.4cdd2c53-921e-4963-a22e-585e6227241e_1_.Aze ED_0255_MRP_PIL_04.2015_clean.doc.doc.150722 April2015 page 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZELASTINE 0.5 MG/ML EYE DROPS, SOLUTION 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 Azelastine 0.5 mg/ml Eye Drops, Solution is called Azelastine. WHAT IS IN THIS LEAFLET 1. What Azelastine is and what it is used for 2. What you need to know before you use Azelastine 3. How to use Azelastine 4. Possible side effects 5. How to store Azelastine 6. Contents of the pack and other information. Azelastine contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines). Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce inflammation of the eye. Azelastine can be used to treat and prevent eye disorders which you get with hayfever (seasonal allergic conjunctivitis) in adults and children aged 4 years a Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azelastine Eye Drops. 0.5 mg / ml, Eye Drops, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride. Excipient with known effect: 1 ml contains 0.125 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older. Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Seasonal allergic conjunctivitis: The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary, to four times daily. If allergen exposure is anticipated Azelastine eye drops should be administered prophylactically, prior to the exposure. Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary, to four times daily. As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks. Patients should be advised to contact their doctor if symptoms worsen or do not approve after 48 hours. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Azelastine eye drops is not intended for treatment of eye infecti Прочитайте повний документ