Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
XYLOMETAZOLINE HYDROCHLORIDE
Actavis Group PTC ehf
R01AA07
XYLOMETAZOLINE HYDROCHLORIDE
1 Mg/Ml
Nasal Spray Solution
Product subject to prescription which may be renewed (B)
Sympathomimetics, plain
Authorised
2016-07-15
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT /.../ 0.5 MG/ML NASAL SPRAY, SOLUTION /.../ 1 MG/ML NASAL SPRAY, SOLUTION xylometazoline hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has 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 3 days <[To be completed nationally]> WHAT IS IN THIS LEAFLET: 1. What /…/ is and what it is used for 2. What you need to know before you use /…/ 3. How to use /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /…/ IS AND WHAT IT IS USED FOR The active ingredient in this medicine is xylometazoline. It constricts blood vessels in the nasal mucosa, thereby reducing its swelling due to various causes, and makes breathing through the nose easier. /.../ 0.5 mg/ml nasal spray is used for short-term relief of nasal congestion due to a cold or sinusitis in children between 2 and 10 years of age. /.../ 1 mg/ml nasal spray is used for short-term relief of nasal congestion due to a cold or sinusitis in adults as well as in children 10 years of age and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE /…/ DO NOT USE /.../: if you or your child is allergic to xylometazoline or any of the Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Senziola 1 mg/ml nasal spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of nasal spray contains 1 mg of xylometazoline hydrochloride. 1 spray (= 90 microlitres) contains 90 micrograms of xylometazoline hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution (nasal spray) Clear, colourless solution.(pH 3.5 – 6.5, osmolality: 0.260 – 0.320 osmol/kg) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of nasal congestion due to rhinitis or sinusitis. Senziola 1 mg/ml nasal spray is intended for adults as well as for children aged 10 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and children 10 years and over:_ 1 spray into each nostril no more than 3 times per day. The maximum treatment duration is 7 days. If after 3 days of treatment the patient does not feel better or feels worse, the clinical situation should be evaluated. Prolonged and excessive use can cause rebound congestion. The recommended dose should not be exceeded. _Children under 10 years:_ Senziola 1 mg/ml nasal spray should not be used in children less than 10 years old. Other pharmaceutical strengths may be more appropriate for administration to children between 2 and 10 years. Method of administration Before the first application, it is necessary to spray a few times (4 times) in the air, to achieve a uniformity of dose. The bottle should be in vertical position. If the product is not used for several days at least one test spray in the air should be done in order to achieve a uniform dose. The product should be used after blowing one’s nose. This medicinal product is intended for nasal use only. The nasal s Lestu allt skjalið