Land: Malta
Språk: engelsk
Kilde: Malta Medicines Authority
AZELASTINE HYDROCHLORIDE
Bausch + Lomb Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT, Ireland
R01AC03
AZELASTINE HYDROCHLORIDE 0.14 mg
NASAL SPRAY, SOLUTION
AZELASTINE HYDROCHLORIDE 0.14 mg
POM
NASAL PREPARATIONS
Authorised
2017-11-23
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIVISPRAY 1 MG/ML NASAL SPRAY, 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. Legal status: POM WHAT IS IN THIS LEAFLET 1. What Vivispray is and what it is used for 2. What you need to know before you use Vivispray 3. How to use Vivispray 4. Possible side effects 5. How to store Vivispray 6. Contents of the pack and other information 1. WHAT VIVISPRAY IS AND WHAT IT IS USED FOR Vivispray contains azelastine, which belongs to a group of medicines that works by preventing the effect of histamine (antihistamines) and other substances that the body produces as part of an allergic reaction, usually it affects you by causing a runny nose, sneezing, itching or blocked nose. Azelastine has also an additional antiinflammatory effect. Vivispray is used for the symptomatic treatment of seasonal allergic rhinitis, and acute exacerbations (attacks) of perennial allergic rhinitis. Vivispray nasal spray is intended for use by adults and children over 6 years of age. [For member states where the medicinal product is available on prescription only:] You must talk to a doctor if you do not feel better or if you feel worse after 4 weeks. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIVISPRAY _ _ DO NOT USE VIVISPRAY: - if you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Vivispray nasal spray must not be used by children under the age of 6. The instructions for adolescents are the same as for adults (see Les hele dokumentet
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) 1. NAME OF THE MEDICINAL PRODUCT VIVISPRAY 1 mg/ml nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1mg azelastine hydrochloride. One application (0.14 mL) contains 0.14 mg azelastine hydrochloride equivalent to 0.13 mg azelastine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution. Clear colourless solution. The pH of the solution is between 6.4 -7.2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azelastine is indicated for the symptomatic treatment of seasonal allergic rhinitis (e.g hayfever) and acute exacerbations of perennial allergic rhinitis in adults, adolescents and children from 6 years of age. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of application is topical – nasal mucosa. One application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride). There have been no specific studies in the elderly. For children aged 6 years and older, one application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride). Azelastine should not be used in children below 6 years of age due to lack of data on safety and efficacy. Method of administration Nasal use _Precautions to be taken before handling or administering the medicinal product: _ Spray with head held upright. Page 2 of 5 Before the first use, press the pump several times until an even spray emerges (3-4 times). When azelastine has not been used for 6 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. After administration, wipe the pump nozzle and replace the protective cap. 4.3 CONTRAINDICATIONS Children under 6 years of age. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The spray should be used with the head held upright, see section 4.8. _ _ 4.5 INTERACTION WITH OTHER MEDICINAL PRODU Les hele dokumentet