Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Camphor; Levomenthol; Eucalyptus oil; Turpentine oil
Procter & Gamble (Health & Beauty Care) Ltd
R05X
Camphor; Levomenthol; Eucalyptus oil; Turpentine oil
N/A
Inhalation vapour, ointment
Product not subject to medical prescription
OTHER COLD PREPARATIONS
Marketed
2000-06-23
PGT2483 0000000 VICKS VAPORUB INHALATION VAPOUR, OINTMENT Levomenthol 2.75 % w/w Camphor 5.00 % w/w Eucalyptus oil 1.50 % w/w Turpentine oil 5.00 % w/w PATIENT INFORMATION LEAFL ET IN THIS LEAFL ET: 1. WHAT VICKS VAPORUB IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE VICKS VAPORUB 3. HOW TO USE VICKS VAPORUB 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE VICKS VAPORUB 6. FURTHER INFORMATION READ ALL OF THIS LEAFL ET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Vicks VapoRub carefully to get the best results from it. - KEEP THIS LEAFL ET. 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leafl et. See section 4. 1. WHAT VICKS VAPORUB IS AND WHAT IT IS USED FOR Vicks VapoRub is an ointment which is used to relieve nasal catarrh (infl ammation of mucous membranes in the nose and throat), congestion (a blocked nose), sore throat and coughs due to colds. Vicks VapoRub contains four active ingredients: Camphor, Turpentine oil, Levomenthol and Eucalyptus oil. • Levomenthol and camphor calm a cough • Eucalyptus oil and Levomenthol relieve nasal congestion (blocked nose) • Eucalyptus oil relieves catarrh 2. BEFORE YOU USE VICKS VAPORUB DO NOT USE VICKS VAPORUB: • if you are allergic to any of the actives or other ingredients (see section 6) • on children under 2 years • as an inhalation for children under 6 years • on broken skin, wounds or mucous membranes • swallow or apply directly onto the nostrils, eyes, mouth or face Do not bandage tightly. Do not use with heat wrap. Do not use boiling water to prepare inhalations. Do not heat or re-heat the mixture in a microwave. TAKE SPECIAL CARE WITH VICKS VAPORUB Talk to your doctor or pharmacist before taking this medicine if you: • have Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vicks Vaporub Inhalation Vapour, Ointment Levomenthol 2.75% w/w Camphor 5.00% w/w Eucalyptus Oil 1.50% w/w Turpentine Oil 5.00% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation vapour, ointment A soft, white or yellow unctuous ointment with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of nasal catarrh and congestion, sore throat, also cough due to colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TOPICAL Adults and children over 2 years Rub the indicated amount onto the areas indicated (e.g. chest, back) and repeat up to 2-4 times a day as needed. Wear loose clothing to facilitate the inhalation of the vapours. INHALATION Adults and children over 6 years: Place 1 – 2 x 5ml Spoonfuls as indicated into a bowl of hot (not boiling) water. Inhale the vapours for up to 10 – 15 minutes per time. Do not heat in the microwave or reheat this mixture. Children should always be supervised. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Do not administer to children < 2 years. Do not use as an inhalation for children < 6 years. Name of the active substances: Quantity Unit Levomenthol 2.75 % w/w Camphor 5.00 % w/w Eucalyptus oil 1.50 % w/w Turpentine oil 5.00 % w/w 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_ _ _ _2_ _4_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ Read the complete document