Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
XYLOMETAZOLINE HYDROCHLORIDE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
R01AA07
NASAL SOLUTION
XYLOMETAZOLINE HYDROCHLORIDE 0.1 %W/V
NASAL
Not required
NOVARTIS CONSUMER HEALTH SA, SWITZERLAND
XYLOMETAZOLINE
XYLOMETAZOLINE
Rapid relief of nasal congestion for up to ten hours in adults and adolescents aged 12 years and older.
2014-07-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS ’ REGULATIONS ) PREPARATIONS ( – This edi i e is dispesed ithout a do to ’s p es iptio OT I I NASAL SOLUTIO D OPS . % / OT I I NASAL SOLUTIO METE ED DOSE SP A . % / OT I I NASAL SOLUTIO SP A . % / A TI E I G EDIE T A D ITS O E T ATIO X LO ETAZOLI E H D O HLO IDE . % / I a ti e i g ediets a d alleges i the p epa atio – please see setio a d setio ) I po ta t i fo atio a out so e of the i g ediets of the edi i e ( . READ THE ETI E LEAFLET A EFULL EFO E USI G THE EDI I E. This leaflet o tai s o ise i fo atio a out the edi i e. If ou ha e a othe uestio s, efe to the do to o the pha a ist. Use the p epa atio a o di g to the i st u tio s i the dosage setio of this leaflet. Co sult the pha a ist if ou eed o e i fo atio . Refe to the do to if sig s of the ail et ) s pto s ( o se o do ot i p o e afte da s. . WHAT IS THE EDI I E I TE DED FO ? The edi i e is i teded fo apid elief of asal o gestio fo up to hou s i adults a d adoles ets o e ea s old. THE APEUTI LASS: Ot i i o tai s lo etazoli e h d o hlo ide, hi h elo gs to the lass of s patho i eti agets. Ot i i helps ope a d lea the asal passages edu i g the fo atio of e ess asal se etio s a d etu i g the s olle lood essels to thei o igi al size. . BEFO E USI G THE EDI I E DO OT USE THE P EPA ATIO IF: • You a e se siti e ) allegi ( to the a ti e i g ediet ) lo etazoli e h d o hlo ide ( o to a o e of the othe i g ediets the edi i e o tai s – please see setio . • You a e afte a t a s-sphe oidal esetio ) th ough the asal a it ( of the pituita gla d o a opeatio du i g hi h the oute ei ges of the et al e ous s ste ee eposed. • You ha e a o a gle glau o a. • You ha e h o i asal i fla atio ith e d asal passages ) hi itis si a o at ophi hi itis ( . • You ha e a e la ged p ostate gla d. • You ha e a a e tu o i the ad eal gla d that p odu es e ess ad eali e a d o ad eali e ) pheo h o o to a ( . • You a e taki g edi i es that i hi it the e z e o oa i e o idase ) MAO i hi ito s ( o if ou ha e stopped taki g the i Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OTRIVIN OTRIVIN OTRIVIN NASAL SOLUTION NASAL SOLUTION NASAL SOLUTION DROPS 0.1% w/v SPRAY 0.1% w/v METERED DOSE SPRAY 0.1% w/v 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: 0.1% w/v Xylometazoline Hydrochloride For excipients see 6.1 3. PHARMACEUTICAL FORM OTRIVIN NASAL SOLUTION DROPS Nasal drops, solution; A clear, colourless solution OTRIVIN NASAL SOLUTION SPRAY Nasal spray Solution; A clear, colourless solution OTRIVIN NASAL SOLUTION METERED DOSE SPRAY Nasal spray, solution A clear, colourless solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rapid relief of nasal congestion for up to ten hours adults and adolescents aged 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _OTRIVIN NASAL SOLUTION DROPS: _ Adults and adolescents over 12 years of age: 2-3 drops in each nostril, every 8-10 hours, as necessary. Do not exceed a dosage of 3 daily applications in each nostril. Route of administration: Nasal use _OTRIVIN NASAL SOLUTION SPRAY: _ Adults and adolescents over 12 years of age: 1 inhalation in each nostril, every 8-10 hours, as necessary. Do not exceed 3 daily applications in each nostril. Route of administration: Nasal use _OTRIVIN NASAL SOLUTION METERED DOSE SPRAY: _ Adults and adolescents over 12 years of age: 1 inhalation in each nostril, every 8-10 hours, as necessary. Do not exceed 3 daily applications in each nostril. Route of administration: Application to the nasal passages. Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be reprimed with 4 actuations. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mat Aqra d-dokument sħiħ