Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Cajuput oil; Clove oil; Eucalyptus oil; Juniper oil; Levomenthol; Mint oil, partly dementholised ; Methyl salicylate
LanesHealth (Ireland) Limited
R05X
Cajuput oil; Clove oil; Eucalyptus oil; Juniper oil; Levomenthol; Mint oil, partly dementholised ; Methyl salicylate
Inhalation vapour, liquid
OTHER COLD PREPARATIONS
Marketed
1988-09-01
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 5. HOW TO STORE OLBAS OIL Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the bottle label, as “EXP” and refers to the last day of the stated month. Do not store above 25ºC. Store in the original container with the cap tightly closed. Do not use if cap seal is broken or missing. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Olbas Oil contains The active substances (w/w) are: Cajuput Oil ..................................................................18.5% Clove Oil .........................................................................0.1% Eucalyptus Oil .........................................................35.45% Juniper Oil .......................................................................2.7% Levomenthol .................................................................4.1% Mint Oil, Partly Dementholised ....................35.45% Methyl Salicylate ..........................................................3.7% Perskaitykite visą dokumentą
Health Products Regulatory Authority 22 December 2023 CRN00DQXY Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olbas Oil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances % w/w Cajuput Oil 18.50 Clove Oil 0.10 Eucalyptus Oil 35.45 Juniper Oil 2.70 Menthol 4.10 Mint Oil, Partly Dementholised 35.45 Methyl Salicylate 3.70 3 PHARMACEUTICAL FORM Inhalation vapour, liquid Cutaneous liquid A pale green transparent liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic, decongestant and analgesic for topical use in relief of nasal congestion and oropharyngeal inflammation and of pain due to muscular trauma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Inhalation: Adults and children over 5 years: Sprinkle 2/3 drops on a handkerchief, or add to hot water and inhale the vapour. Topical: Apply lightly to the painful area 3 times daily. 4.3 CONTRAINDICATIONS (i) Hypersensitivity to the active substances. (ii) Use on broken skin. (iii) Use in infants or young children under 5 years. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If there is no improvement or there is an aggravation of the condition consult the doctor. 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 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. 4.6 FERTILITY, PREGNANCY AND LACTATION Health Products Regulatory Authority 22 December 2023 CRN00DQXY Page 2 of 3 There are no reports of adverse effects when used during pregnancy and lactation. Hence the product may be used. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Olbas Oil has no influence on the ability to drive and use machines. 4.8 UNDESIRABLE EFFECTS Burns at application site, frequency: not known. Repo Perskaitykite visą dokumentą