País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
XYLOMETAZOLINEHYDROCHLORIDE 1 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,869 mg/ml
Jadran Galenski laboratorij d.d. Svilno 20 51000 RIJEKA (KROATIË)
R01AA07
XYLOMETAZOLINEHYDROCHLORIDE 1 mg/ml SAMENSTELLING overeenkomend met ; XYLOMETAZOLINE 0,869 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 MERALYS 1 MG/ML NEUSSPRAY, OPLOSSING Xylometazoline hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to usecarefully 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 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. WHAT IS IN THIS LEAFLET: 1. What Meralys is and what it is used for 2. What you need to know before you use Meralys 3. How to use Meralys 4. Possible side effects 5. How to store Meralys 6. Contents of the pack and other information 1. WHAT MERALYS 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. Meralys is used for short-term treatment of nasal congestion. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MERALYS DO NOT USE MERALYS if you are allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6). if you have had recent brain surgery through the nose or mouth. if you have 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 Meralys if you have: a tendency to hypersensitivity to sympathomimetics (drugs, such as adrenaline); Meralys may cause insomnia, dizziness, trembling, arrhythmia or increased blood pressure. cardiovascular Leer el documento completo
19.02.2019 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Meralys 1 mg/ml neusspray, oplossing 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of nasal spray contains 1 mg of xylometazoline hydrochloride. 1 dose (= 90 microlitres) contains 90 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. Meralys 1 mg/ml nasal spray may be used in adults and in children aged 10 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose in adults and children 10 years of age and older is 1 - 2 expressions 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_ Meralys 1 mg/ml nasal spray is indicated in children aged 10 years and above to be administered as stated below. Meralys 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 this population. 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. Long and excessive use can cause rebound congestion. The recommended dose should not be exceeded. Method of administration 19.02.2019 Page 2 of 6 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. Meralys nasal spray is intended for intranasal use only. Nasal spray should be delivered while seated. In addition, small c Leer el documento completo