Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Malta Medicines Authority
CAMPHOR, EUCALYPTUS OIL, TURPENTINE OIL, LEVOMENTHOL
NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta
R05X
CAMPHOR 5 % (W/W) EUCALYPTUS OIL 1.5 % (W/W) TURPENTINE OIL 5 % (W/W) LEVOMENTHOL 2.75 % (W/W)
INHALATION VAPOUR, OINTMENT
CAMPHOR 5 % (W/W) EUCALYPTUS OIL 1.5 % (W/W) TURPENTINE OIL 5 % (W/W) LEVOMENTHOL 2.75 % (W/W)
OTC
COUGH AND COLD PREPARATIONS
Licence number in the source country: Greece - 12544/19-09-2013
Authorised
2014-04-30
VICKS VAPORUB OINTMENT CAMPHOR 5% W/W, TURPENTINE OIL 5% W/W, LEVOMENTHOL 2.75% W/W, EUCALYPTUS OIL 1.5% W/W PATIENT INFORMATION LEAFLET IN THIS LEAFLET: 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 LEAFLET 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 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. WHAT VICKS VAPORUB IS AND WHAT IT IS USED FOR Vicks VapoRub is an ointment which is used to relieve nasal catarrh (inflammation 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 12 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 TAKE SPECIAL CARE WITH VICKS VAPORUB Talk to your doctor or pharmacist before taking this medicine if you: • have a history of airway disease or asthma PREGNANCY AND BREAST-FEEDING If you are pregnant, ask your doctor or pharmacist for advice before using Vick Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vicks Vaporub 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 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 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 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The following patient groups should use with caution or consult a doctor before use; History of airway disease or pronounced hypersensitivity of the airways / asthma Keep out of reach and sight of children. If symptoms persist, consult your doctor TOPICAL: Do not apply to broken skin, wounds or mucous membranes. Do not swallow or apply directly onto the nostrils, eyes, mouth or face. For external use only Do not bandage tightly. Do not use with heat wrap. INHALATION: Do not use boiling water to prepare inhalations. Do not heat or re-heat the mixture in a microwave. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS Izlasiet visu dokumentu