Страна: Малта
Език: английски
Източник: Medicines Authority
CAMPHOR, PINE OIL, MENTHOL
WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH Sulzbacher Str. 40, 65823, Schwalbach am Taunus,, Germany
R01AX30
CAMPHOR 50 mg PINE OIL 10 mg MENTHOL 125 mg
NASAL STICK
CAMPHOR 50 mg PINE OIL 10 mg MENTHOL 125 mg
OTC
NASAL PREPARATIONS
Authorised
2007-03-02
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. PA2294/005/001 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 via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN FURTHER INFORMATION All enquiries to licence holder: WICK Pharma, Zweigniederlassung der Procter & Gamble GmbH, 65823 Schwalbach, Germany. Manufacturer: Procter & Gamble Manufacturing GmbH, Прочетете целия документ
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 ACTIVE INGREDIENTS mg/inhaler Menthol 125.00 Camphor 50.00 Siberian Pine Needle Oil 10.00 For a full list of excipients, see section 6.1 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 _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 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 4.6 FERTILITY, PREGNANCY AND LACTATION There is no evidence to indicate that this product should not be used during pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None 4.8 UNDESIRABLE EFFECTS In general no serious or severe side effects are expected with this product. Very rarely cases of nasal discomfort have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. 4.9 OVERDOSE No clinically significant cases o Прочетете целия документ