País: Malta
Idioma: inglés
Fuente: Medicines Authority
PEPPERMINT OIL, CAJUPUT OIL, EUCALYPTUS OIL, CLOVE OIL, METHYL SALICYLATE, JUNIPER BERRY, LEVOMENTHOL
LanesHealth (Ireland) Limited Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, D18 NW62, Ireland
R05X
CAJUPUT OIL 18.5 % (W/W) EUCALYPTUS OIL 35.45 % (W/W) CLOVE OIL 0.1 % (W/W) METHYL SALICYLATE 3.7 % (W/W) JUNIPER BERRY OIL 2.7 % (W/W) LEVOMENTHOL 4.1 % (W/W) PEPPERMINT OIL 35.45 % (W/W)
INHALATION VAPOUR, LIQUID
CAJUPUT OIL 18.5 % (W/W) EUCALYPTUS OIL 35.45 % (W/W) CLOVE OIL 0.1 % (W/W) METHYL SALICYLATE 3.7 % (W/W) JUNIPER BERRY OIL 2.7 % (W/W) LEVOMENTHOL 4.1 % (W/W) PEPPERMINT OIL 35.45 % (W/W)
OTC
COUGH AND COLD PREPARATIONS
Authorised
2005-12-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER OLBAS OIL INHALANT DECONGESTANT READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. IN THIS LEAFLET 1. What Olbas Oil is and what it is used for 2. What you need to know before you use Olbas Oil 3. How to use Olbas Oil 4. Possible side effects 5. How to store Olbas Oil 6. Contents of the pack and other information 1. WHAT OLBAS OIL IS AND WHAT IT IS USED FOR Olbas Oil contains the active substances (w/w) Cajuput Oil 18.5%, Clove Oil 0.1%, Eucalyptus Oil 35.45%, Juniper Oil 2.7%, Levomenthol 4.1%, Methyl Salicylate 3.7% and Mint Oil, Partly Dementholised 35.45% Olbas Oil is a blend of pure plant oils for the relief of nasal congestion by inhalation in adults and children aged 5 years and above. When applied to the skin, Olbas Oil also relieves the symptoms of muscular pain and stiffness including: • backache • lumbago • fibrositis (pain, stiffness and tenderness of muscles, tendons and joints) 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OLBAS OIL DO NOT USE OLBAS OIL: • if you are allergic to any of the ingredients (listed in section 6) • on broken skin WARNINGS AND PRECAUTIONS Talk to your doctor if you do not feel better or if you feel worse. CHILDREN Do not give this medicine to children under the age of 5 years. OTHER MEDICINES AND OLBAS OIL T ell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. PREGNANCY AND BREAST-FEEDING If you are p Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Olbas Oil 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients %w/w Cajuput Oil 18.50 Eucalyptus Oil 35.45 Methyl Salicylate 3.70 Clove Oil 0.10 Juniperberry Oil 2.70 Levomenthol 4.10 Mint Oil, Partly Dementholised 35.45 3. PHARMACEUTICAL FORM Inhalation vapour, liquid. Cutaneous liquid. Pale green transparent liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inhalation Use: For the relief of bronchial and nasal congestion caused by colds, catarrh, influenza and hayfever, rhinitis and minor infections of the respiratory tract. Cutaneous Use Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For inhalation use: Adults and children aged 2 and over: Sprinkle 2 or 3 drops on a handkerchief, or add to hot water and inhale the vapours. Children aged 3 months to 2 years: Sprinkle 1 drop on a tissue placed out of the child’s reach. Not recommended for babies under 3 months old. For cutaneous use: Adults and children aged 12 and over: Apply lightly to the painful area three times daily. Not recommended for children under 12 years old. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms worsen or do not improve after 7 days, a doctor should be contacted. Incorrect use or accidental exposure to Olbas Oil may be harmful. If the product is accidentally put into the nose or swallowed, or gets into the eye(s) the patient should seek immediate medical advice. If the product comes into direct contact with the surface of the eye(s) the patient should wash the eye(s) thoroughly. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. In the literature, Methyl Salicylate has been reported to potentiate the anticoagulant effects of warfarin when applied topically. 4.6 PREGNANCY AND LACTATION There are no or l Leer el documento completo