Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
XYLOMETAZOLINE HYDROCHLORIDE
Teva Pharma B.V.
R01AA; R01AA07
XYLOMETAZOLINE HYDROCHLORIDE
0.1 percent weight/volume
Nasal spray, solution
Product not subject to medical prescription
Sympathomimetics, plain; xylometazoline
Not marketed
2012-08-17
PACKAGE LEAFLET: INFORMATION FOR THE USER XYLONASE 0.1% W/V 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 7 days. WHAT IS IN THIS LEAFLET 1. What Xylonase 0.1% w/v Nasal Spray, Solution is and what it is used for 2. What you need to know before you use Xylonase 0.1% w/v Nasal Spray, Solution 3. How to use Xylonase 0.1% w/v Nasal Spray, Solution 4. Possible side effects 5. How to store Xylonase 0.1% w/v Nasal Spray, Solution 6. Contents of the pack and other information 1. WHAT XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION IS AND WHAT IT IS USED FOR You must talk to a doctor if you do not feel better or if you feel worse after 7 days. Xylonase 0.1% w/v Nasal Spray, Solution contains the active ingredient xylometazoline, which is a topical decongestant that relieves nasal congestion. A decongestant reduces the swelling of the nasal mucosa. Xylonase 0.1% w/v Nasal Spray, Solution is used for temporary symptomatic treatment of nasal congestion due to rhinitis or sinusitis. XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION IS INTENDED FOR ADULTS AS WELL AS FOR CHILDREN 10 YEARS OF AGE AND OLDER. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION DO NOT USE XYLONASE 0.1% W/V NASAL SPRAY, SOLUTION if you are allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6). if you have recently had neurosurgery (transsphenoidal hypophysectomy or other surgery exposing the meninx) if you Lire le document complet
Health Products Regulatory Authority 01 May 2019 CRN008XT0 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xylonase 0.1 % w/v Nasal Spray, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One actuation (equivalent to 0.09 ml nasal spray, solution) contains 0.09 mg xylometazoline hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution (nasal spray). Clear, almost colourless solution (pH 5.5-6; Osmolality 250-300 mOsm/kg). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For temporary symptomatic treatment of nasal congestion due to rhinitis or sinusitis. Xylonase 0.1% w/v Nasal Spray, Solution is intended for adults as well as for children 10 years of age and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ This medicinal product is intended for nasal use. The dose in adults and children 10 years of age and older is 1-2 sprays of Xylonase 0.1% w/v Nasal Spray, Solution into each nostril, according to need, but up to a MAXIMUM of 3 times daily. Dosages higher than those recommended must not be used. Xylonase 0.1% w/v Nasal Spray, Solution is suitable for adults as well as for children over 10 years of age. It must not be used in children below 10 years of age. Paediatric population Xylonase 0.1% w/v Nasal Spray, Solution is indicated in children aged 10 years and above to be administered as stated above. Xylonase 0.1% w/v Nasal Spray, Solution should not be used in children less than 10 years old. Other pharmaceutical strengths may be more appropriate for administration to this population Duration of use Xylonase 0.1% w/v Nasal Spray, Solution must not be used for longer than 7 days, unless prescribed by the clinician. If after 3 days of treatment the patient feels no better or worse, the clinical situation should be reevaluated. Long and excessive use can cause reactive hyperaemia or rebound congestion respectively (see section 4.4). The recommended dose should not be exceeded. An interval of several days should ela Lire le document complet