País: Països Baixos
Idioma: neerlandès
Font: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AZELASTINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; AZELASTINE 0,46 mg/ml
Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)
S01GX07
AZELASTINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; AZELASTINE 0,46 mg/ml
Oogdruppels, oplossing
DINATRIUMEDETAAT(HYDRAAT VORM ONBEKEND) ; HYPROMELLOSE (E 464) ; NATRIUMHYDROXIDE (E 524) ; SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420) ; WATER VOOR INJECTIE,
Oculair gebruik
Azelastine
Hulpstoffen: DINATRIUMEDETAAT(HYDRAAT VORM ONBEKEND); HYPROMELLOSE (E 464); NATRIUMHYDROXIDE (E 524); SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420); WATER VOOR INJECTIE;
2015-04-29
PACKAGE LEAFLET: INFORMATION FOR THE USER AZELASTINEHYDROCHLORIDEDEVATIS 0,5 MG/ML, OOGDRUPPELS, OPLOSSING IN VERPAKKING VOOR ÉÉNMALIG GEBRUIK Azelastinehydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after 2 days. Relief of symptoms of allergic conjunctivitis should be noticed after 15-30 minutes. WHAT IS IN THIS LEAFLET 1. What Azelastine Devatis is and what it is used for 2. What you need to know before you use Azelastine Devatis 3. How to use Azelastine Devatis 4. Possible side effects 5. How to store Azelastine Devatis 6. Contents of the pack and other information 1. WHAT AZELASTINE DEVATIS IS AND WHAT IT IS USED FOR Azelastine Devatis contains azelastine which 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. Azelastine has been shown to reduce inflammation of the eye. Azelastine Devatis is used to treat and prevent the ocular symptoms of hay fever (seasonal allergic conjunctivitis), in adults and children age 4 years and above. Azelastine Devatis is used for eye disorders caused by an allergy to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children age 12 years and above. Azelastine Devatis is not suitable for treating eye infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZELASTINE DEVATIS DO NOT USE: - If you are allergic (hypersensitive) to azelastine hydrochloride or any of the o Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Azelastinehydrochloride Devatis 0,5 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.5 mg azelastine hydrochloride in a preservative free formulation. One drop contains 0.015 mg azelastine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drop solution in single dose container for administration by instillation in the conjunctival sac. Clear, colourless to nearly colourless, slightly viscous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children aged 4 years and older. - Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children aged 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ocular use POSOLOGY Seasonal allergic conjunctivitis The usual dosage in adults and children aged 4 years and older is one drop in each eye twice daily (in the morning and in the evening) that can be increased if necessary to four times daily. Non-seasonal (perennial) allergic conjunctivitis The usual dosage in adults and children aged 12 years and older is one drop in each eye twice daily (in the morning and in the evening) 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 treatment cycle should be limited to a maximum of 6 weeks. Avoid contact with soft contact lenses (See section 4.4). Advice for use without prescription: Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours. It should be pointed out, that use for more than 6 weeks must take place under medical supervision even in seasonal conjunctivitis. Paediatric population Safety and efficacy of Azelastine Devatis in children aged less than 4 years has not been established. Llegiu el document complet