Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Xylometazoline hydrochloride
Haleon Ireland Limited
R01AA; R01AA07
Xylometazoline hydrochloride
0.1 percent weight/volume
Nasal spray, solution
Product not subject to medical prescription
Sympathomimetics, plain; xylometazoline
Marketed
1991-02-27
Page 1 of 4 Package leaflet: Information for the patient Otrivine Sinusitis Relief 0.1% w/v Nasal Spray Xylometazoline Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without a prescription. However, you still need to use Otrivine Sinusitis Relief Spray 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. - You must contact a doctor if the symptoms worsen or do not improve after 7 days. - If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Otrivine Sinusitis Relief Spray is and what it is used for 2. What you need to know before you use Otrivine Sinusitis Relief Spray 3. How to use Otrivine Sinusitis Relief Spray 4. Possible side effects 5. How to store Otrivine Sinusitis Relief Spray 6. Contents of the pack and other information 1. WHAT OTRIVINE SINUSITIS RELIEF SPRAY IS AND WHAT IT IS USED FOR Otrivine Sinusitis Relief Spray is for application in the nose to give relief from: • nasal congestion (blocked nose, including colds); • perennial and allergic rhinitis (recurring inflammation of the nasal mucous membranes, including hay fever); • sinusitis. Otrivine Sinusitis Relief Spray contains the active ingredient xylometazoline hydrochloride which helps to open up and clear the nasal passages by reducing the excessive nasal secretions and returning the swollen blood vessels to their normal size. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE SINUSITIS RELIEF SPRAY DO NOT use the spray if you: - are allergic to xylometazoline hydrochloride or any of the other ingredients of the spray (see section 6). Symptoms include: rash, swelling of the face and throat, difficulty breathing. - If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs) - have an overac Preberite celoten dokument
Health Products Regulatory Authority 28 November 2023 CRN00DQ8Y Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Otrivine Sinusitis Relief 0.1% w/v Nasal Spray, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1mg xylometazoline hydrochloride equivalent to 0.1 % w/v. Excipients: Benzalkonium chloride 0.1mg/ml. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution (nasal spray). A clear, colourless, virtually odourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a nasal decongestant for relief of the symptoms of acute rhinitis in allergic or upper respiratory tract infections, including the common cold or influenza. Relief of sinusitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Otrivine should not be used for more than seven consecutive days (see section 4.4). The recommended dose should not be exceeded, especially in children and elderly. ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS OVER 12 YEARS OF AGE: 1 spray into each nostril, up to 3 times daily as needed. Do not exceed 3 applications daily into each nostril. It is recommended to make the last application shortly before retiring to bed. PAEDIATRIC POPULATION: Otrivine Nasal Spray should not be used in aged less than 12 years old. Route of administration: Nasal use. 1. Blow the nose gently. 2. Remove protective cap. 3. Do not cut the nozzle. The metered dose spray is ready to prime before use. 4. Before the first application, prime the pump by actuating (depressing the pump) 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Should the spray not be ejected during the full actuation, the pump will need to be re-primed by actuating 4 times. Be very careful not to spray in the eyes or mouth. 5. Hold the bottle upright with thumb under base and nozzle between two fingers. 6. Lean forward slightly and insert the nozzle into the nostril. 7. Spray and breathe in gently through the nose at the same Preberite celoten dokument