País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Camphor; Siberian fir oil; Menthol
Procter & Gamble (Health & Beauty Care) Ltd
R01AX; R01AX10
Camphor; Siberian fir oil; Menthol
125/50/10 milligram(s)
Nasal stick
Product not subject to medical prescription
Other nasal preparations; various
Marketed
1988-11-18
INHALER Nasal Stick _Menthol 125mg Camphor 50mg _ _Siberian Pine Needle Oil 10mg_ FAST RELIEF FROM STUFFY NOSES INHALER Nasal Stick _Menthol 125mg Camphor 50mg _ _Siberian Pine Needle Oil 10mg_ FAST RELIEF FROM STUFFY NOSES Vicks Inhaler is a 0.5 ml nasal stick for nasal use. Insert well into nostril. Inhale deeply to make breathing feel cool and clear. NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS. Do not store above 25°C. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. For EXP & Lot No. see base. PL 00129/5009R PA 441/27/1 WHAT IS VICKS INHALER AND HOW DOES IT WORK?_ _ Vicks Inhaler is a 0.5 ml decongestant nasal stick containing the active ingredients: • menthol (125mg) • camphor (50mg) • Siberian pine needle oil (10mg) It also contains methyl salicylate. When you inhale these actives through your nose, they work on the lining of your nasal passages to ease breathing and help relieve a stuffy nose caused by colds or allergic reactions. Relief of nasal congestion associated with upper respiratory tract disorders and allergies. DIRECTIONS FOR USE:_ _(adults & children 6 years & over): Use as often as needed. Remove the screw cap. Insert well into nostril, holding the other nostril closed. Inhale deeply to make breathing feel clear and cool. NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS. Do not store above 25°C. DO NOT USE VICKS INHALER: • if you are allergic to any of its ingredients • after the expiry date If your symptoms persist or worsen consult your doctor or pharmacist. Nasal discomfort may occur very rarely. If you get any side effects, including any not listed, talk to your doctor or pharmacist. You can also report side effects directly (see details below). UNITED KINGDOM: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard IRELAND: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie MALTA: ADR Reporting, www.medicinesauthority.gov.mt/adrportal KEEP OUT OF THE SIGHT AND REACH OF CHILDREN FURTHER INFO Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vicks Inhaler Nasal Stick Menthol 125mg Camphor 50mg Siberian Pine Needle Oil 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Nasal Stick The nasal stick contains a cellulose wick soaked in 0.5ml of product. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the relief of symptoms of nasal congestion such as are associated with allergic and infectious upper respiratory tract disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.3 CONTRAINDICATIONS Use in patients hypersensitive to any of the ingredients 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If there is no improvement or aggravation of the disorder consult the doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. ACTIVE INGREDIENTS mg/inhaler Menthol 125.00 Camphor 50.00 Siberian Pine Needle Oil 10.00 For a full list of excipents, see section 6.1 _Adults and children over 6 years_: Vicks Inhaler is used by inserting the inhaler into each nostril, holding the other nostril closed and inhaling deeply. It can be used as frequently as needed. _Children under 6 years_: Not recommended. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _3_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _5_ _7_ _6_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.6 FERTILITY, PREGNANCY AND LACTATION There is no evidence to indicate that this product should not be used during pregnancy and Leia o documento completo