País: Malta
Idioma: inglés
Fuente: Medicines Authority
XYLOMETAZOLINE HYDROCHLORIDE
Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece
R01AA07
XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml
NASAL SPRAY, SOLUTION
XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml
OTC
NASAL PREPARATIONS
Authorised
2007-02-09
PACKAGE LEAFLET: INFORMATION FOR THE USER OTRIVIN 0.05% METERED-DOSE NASAL SPRAY xylometazoline hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD. This medicine is available without prescription. However, you still need to use Otrivin 0.05% 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 your symptoms worsen or do not improve. • 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 OTRIVIN 0.05% IS AND WHAT IT IS USED FOR ................................................. 1 2 BEFORE YOU USE OTRIVIN 0.05%..................................................................................... 1 3 HOW TO USE OTRIVIN 0.05% .............................................................................................. 2 4 POSSIBLE SIDE EFFECTS ..................................................................................................... 3 5 HOW TO STORE OTRIVIN 0.05% ......................................................................................... 4 6 FURTHER INFORMATION .................................................................................................... 4 1 WHAT OTRIVIN 0.05% IS AND WHAT IT IS USED FOR Otrivin 0.05% is indicated in children aged 1 to 11 years old. Otrivin 0.05% is a nasal decongestant that quickly clears blocked noses. Otrivin 0.05% clears your child’s stuffy nose quickly so your child can breathe easier. It is used for the relief of blocked nose caused by colds, hay fever or other allergic rhinitis, sinusitis. The effect of Otrivin 0.05% starts within minutes and lasts for up to 12 hours. It is well tolerated, even by patients with a sensitive nasal mucosa. Otrivin 0.05% may also be used in ear infections to help to decongest the nasopharyngeal mucosa (lining of n Leer el documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OTRIVIN 0.1% AND 0.05% (MOISTURISING FORMULA) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Otrivin 0.1% contains 1 mg/ml of xylometazoline hydrochloride. Otrivin 0.05% contains 0.5 mg/ml of xylometazoline hydrochloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORMS Nasal Drops, Solution 0.1% F.5 clear, colourless and practically odourless solution Nasal Spray, Solution (metered-dose spray) 0.05% F.5 clear, colourless and practically odourless solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the relief of nasal congestion due to colds, hay fever or other allergic rhinitis, sinusitis. To aid drainage of secretions in affections of the paranasal sinuses. As an adjuvant in otitis media, to decongest the nasopharyngeal mucosa. To facilitate rhinoscopy. Otrivin 0.05% is indicated in children aged 1 to 11 years old with adult supervision. Otrivin 0.1% is indicated in adults and adolescents over 12 years of age. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Paediatric population: OTRIVIN 0.05% should not be used in children aged less than 1 year old. It is recommended for use in children aged 1 to 11 years old only under adult supervision. OTRIVIN 0.1% should not be used in children aged less than 12 years old. Posology and method of administration: OTRIVIN NASAL DROPS Otrivin should not be used for more than ten consecutive days. (see section 4.4) 2 The recommended dose should not be exceeded, especially in children and older people. STRENGTH AGE POSOLOGY 0.1% Adults 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. Each drop of Otrivin 0.1% delivers 0.025 mg of xylometazoline hydrochloride. 1. Clear the nose. 2. Tilt the head back as far as is comfortable or, if lying on a bed, hang the head over the side. 3. Apply the drops into ea Leer el documento completo