Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Xylometazoline hydrochloride
Haleon Ireland Limited
R01AA; R01AA07
Xylometazoline hydrochloride
0.1 percent weight/volume
Nasal drops, solution
Product not subject to medical prescription
Sympathomimetics, plain; xylometazoline
Marketed
1984-05-24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OTRIVINE ADULT 0.1% W/V NASAL DROPS 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 Adult Nasal Drops 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 Adult Nasal Drops are and what they are used for 2. What you need to know before you use Otrivine Adult Nasal Drops 3. How to use Otrivine Adult Nasal Drops 4. Possible side effects 5. How to store Otrivine Adult Nasal Drops 6. Contents of the pack and other information 1. WHAT OTRIVINE ADULT NASAL DROPS ARE AND WHAT THEY ARE USED FOR HAT OTRIVINE ADULT NASAL DROPS ARE AND WHAT THEY ARE USED Otrivine Adult Nasal Drops are 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 Adult Nasal Drops contain 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 ADULT NASAL DROPS HAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE ADULT NASAL DROPS DO NOT USE THE DROPS IF YOU: – Are allergic to xylometazoline hydrochloride or any of the other ingredients in the drops (see Section 6). Symptoms include: rash, swelling of the face and throat, difficulty breathing. – are taking, or have taken in the last two weeks, drugs for depress Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 28 November 2023 CRN00DQ8Y Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Otrivine Adult 0.1% w/v Nasal Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Xylometazoline Hydrochloride 0.1% w/v Excipients: Benzalkonium chloride 0.01% w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal drops, solution (nasal drops) A clear, colourless 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 ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS OVER 12 YEARS OF AGE: 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 the elderly. Adults (including the elderly) and adolescents over 12 years of age: 2 to 4 drops 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 Adult Nasal Drops should not be used in children aged less than 12 years old. ROUTE OF ADMINISTRATION: Nasal use. 1. Blow your nose gently. 2. Before using, practice using the dropper to develop good dosage control. 3. Tilt your head back as far as is comfortable or, if lying on a bed, hang the head over the side. 4. Without touching your nose with the dropper, apply the drops into each nostril and keep the head tilted back for a short time to allow the drops to spread throughout the nose. 5. If the drop completely misses your nose, administer the drop again. 6. If any part of the drop gets into your nose, do not administer the drop again. 7. Repeat with the other nostril. 8. Clean and dry the dropper before replacing it back into the bottle right after use. 4.3 CONTRAINDICATIO Olvassa el a teljes dokumentumot