Country: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
XYLOMETAZOLINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,435 mg/ml
Jadran Galenski laboratorij d.d. Svilno 20 51000 RIJEKA (KROATIË)
R01AA07
XYLOMETAZOLINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,435 mg/ml
Neusspray, oplossing
KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340) ; WATER, GEZUIVERD ; ZEEWATER, GEZUIVERD,
Nasaal gebruik
Xylometazoline
Hulpstoffen: KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340); WATER, GEZUIVERD; ZEEWATER, GEZUIVERD;
2012-09-04
19.02.2019 Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER NASONAL 0,5 MG/ML NEUSSPRAY, OPLOSSING Xylometazoline hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD. This medicine is available without prescription. However, your child still needs to use Nasonal carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If your child gets 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 your child does not feel better or if the child feels worse after 3 days. WHAT IS IN THIS LEAFLET: 1. What Nasonal is and what it is used for 2. What you need to know before you use Nasonal 3. How to use Nasonal 4. Possible side effects 5. How to store Nasonal 6. Contents of the pack and other information 1. WHAT NASONAL 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. Nasonal is used for short-term treatment of nasal congestion in children between 2 and 10 years old. You must talk to a doctor if your child does not feel better or if the child feels worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NASONAL DO NOT USE NASONAL if your child is allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6). if your child has had recent brain surgery through the nose or mouth. if your child has a dry inflammation of the nasal mucous membrane with formation of crusts (rhinitis sicca). 19.02.2019 Page 2 of 7 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Nasonal if your child has: a tendency to hypersensitivity to sympathomimetics (drugs, such as adrenaline Aqra d-dokument sħiħ
19.02.2019 Page 1 of 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nasonal 0,5 mg/ml neusspray, oplossing 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of nasal spray contains 0.5 mg of xylometazoline hydrochloride. 1 dose (= 90 microlitres) contains 45 micrograms of xylometazoline hydrochloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution. Clear, colourless solution. pH 5.5 – 6.5, osmolality: 0.260 – 0.320 osmol/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of nasal congestion. Nasonal 0.5 mg/ml nasal spray may be used in children 2-10 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose in children between 2 and 10 years of age is 1 expression into each nostril but no more than once every 10-12 hours. If it should be necessary the medicinal product may be used up to 3 times daily. _PAEDIATRIC POPULATION_ Nasonal 0.5 mg/ml nasal spray is indicated in children between 2 and 10 years to be administered as stated below. Nasonal 0.5 mg/ml is not recommended to be taken by children under 2 years of age. The safety and efficacy of Nasonal 0.5 mg/ml in children younger than 2 years have not yet been established. The maximum treatment duration is 5 days, if after 3 days of treatment the patient does not feel better or feels worse, the clinical situation should be evaluated. Long and excessive use can cause rebound congestion. The recommended dose should not be exceeded. Method of administration 19.02.2019 Page 2 of 2 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 products should be used after blowing one’s nose. Nasonal nasal spray is intended for intranasal use only. Nasal spray should be delivered while seated. In addition, small children should b Aqra d-dokument sħiħ