Šalis: Airija
kalba: anglų
Šaltinis: 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
Not marketed
1998-07-13
OTRIVINE ADULT MENTHOL 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 Adult Menthol Nasal 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 gets 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 Menthol Nasal Spray is and what it is used for 2. Before you use Otrivine Adult Menthol Nasal Spray 3. How to use Otrivine Adult Menthol Nasal Spray 4. Possible side effects 5. How to store Otrivine Adult Menthol Nasal Spray 6. Further information 1. WHAT OTRIVINE ADULT MENTHOL NASAL SPRAY IS AND WHAT IT IS USED FOR Otrivine Adult Menthol Nasal 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 Adult Menthol Nasal 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. BEFORE YOU USE OTRIVINE ADULT MENTHOL NASAL SPRAY DO NOT USE THE SPRAY IF YOU: • are allergic to xylometazoline hydrochloride or any of the other ingredients in the spray (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 depression known as monoamine Oxidase Inhibitors (MAOIs) • have an overactive thyroid gland (hyperthyroidism) • have acute heart disease • have undergone r Perskaitykite visą dokumentą
Health Products Regulatory Authority 28 November 2023 CRN00DQ8Y Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Otrivine Adult Menthol 0.1% w/v Nasal Spray, 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 spray, solution (nasal spray) Colourless to whitish, clear to opalescent nasal spray solution with an odour of menthol and eucalyptus. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), 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 the elderly. ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS OVER 12 YEARS OF AGE: 1 to 2 sprays 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 Menthol Nasal Spray should not be used in children aged less than 12 years old. ROUTE OF ADMINISTRATION: Nasal use. 1. To produce a fine spray, the nebuliser should be held upright with the nozzle pointing upwards. Be careful not to spray in the eyes. 2. Blow your nose gently. 3. Remove protective cap. 4. Lean forward slightly and insert the nozzle into a nostril. 5. Squeeze the bottle once and breathe in gently at the same time. 6. Remove the nozzle before releasing the pressure on the bottle. 7. Repeat with the other nostril. 8. Clean and dry the nozzle before replacing back the cap right after use. 4.3 CONTRAINDICATIONS Hypersensitivity to xylometazoline or to any of the excipients (see list in section 6.1). Otrivine should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater. Perskaitykite visą dokumentą