Страна: Мальта
Язык: английский
Источник: Medicines Authority
PEPPERMINT OIL, EUCALYPTUS OIL, CLOVE OIL, METHYL SALICYLATE, JUNIPER BERRY, LEVOMENTHOL
G. R. Lane Health Products Limited Sisson Road, Gloucester, GL2 0GR, United Kingdom
R05X
PEPPERMINT OIL 19 mg EUCALYPTUS OIL 19.7 mg CLOVE OIL 0.034 mg METHYL SALICYLATE 0.8 mg JUNIPER BERRY OIL 1.14 mg LEVOMENTHOL 1.7 mg
PASTILLE
PEPPERMINT OIL 19 mg EUCALYPTUS OIL 19.7 mg CLOVE OIL 0.034 mg METHYL SALICYLATE 0.8 mg JUNIPER BERRY OIL 1.14 mg LEVOMENTHOL 1.7 mg
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2005-12-23
DO NOT USE IF SEALED INNER POUCH IS CUT OR TORN. THE PURE NATURAL REMEDY FOR SYMPTOMATIC RELIEF OF COLDS, COUGHS, CATARRH, SORE THROATS AND FLU, CATARRHAL HEADACHE AND NASAL CONGESTION. OLBAS PASTILLES CONTAIN ESSENTIAL OILS WHICH HAVE DECONGESTANT PROPERTIES. ACTIVE INGREDIENTS PER PASTILLE: Eucalyptus Oil ........ 19.7mg Peppermint Oil....... 19.0mg Levomenthol ............ 1.7mg Juniper Oil ............. 1.14mg Methyl Salicylate ..... 0.8mg Clove Oil................. 0.03mg OTHER INGREDIENTS: Modified Starch, Sucrose, Glucose, Sodium Copper Chlorophyllin (E141). Manufactured by Ernest Jackson & Co. Ltd., Crediton, Devon, EX17 3AP, UK, for the Marketing Authorisation holder G. R. Lane Health Products Ltd., Sisson Road, Gloucester, GL2 0GR, UK, to whom any letters should be addressed. Approved May 2008 PL 01074/0001 BEFORE YOU TAKE OLBAS PASTILLES Do not take if you are allergic to any of the ingredients. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding It is best not to take any non-essential medication when pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients of Olbas Pastilles If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This product contains 677mg of sucrose per pastille. This should be taken into account in people with diabetes mellitus. HOW TO TAKE OLBAS PASTILLES Adults and children aged 7 and over: Dissolve 1 pastille slowly in the mouth when required. Do not take more than 8 pastilles in any 24 hour period. Not recommended for children under 7 years old. You must contact a doctor if symptoms worsen or do not improve after 7 days. If you take more Olbas Pastilles than you shou Прочитать полный документ
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Olbas Pastilles 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients %w/w mg per pastille Eucalyptus Oil 1.160 19.70 Peppermint Oil 1.120 19.00 Levomenthol 0.100 1.70 Juniper Oil 0.067 1.14 Methyl Salicylate 0.047 0.80 Clove Oil 0.002 0.03 Excipients: Glucose, Sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pastille. Dull green, oval ribbed, sugar-coated pastille. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications For the symptomatic relief of colds, coughs, catarrh, sore throats, influenza, catarrhal headache and nasal congestion. 4.2 Posology and method of administration For oropharyngeal use. Adults and children aged 7 and over: Dissolve 1 pastille slowly in the mouth when required. Do not take more than 8 pastilles in any 24-hour period. Not recommended for children under 7 years old. Page 2 of 5 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients. 4.4 Special warnings and precautions for use Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. If symptoms worsen or do not improve after 7 days, a doctor should be contacted. 4.5 Interactions with other medicinal products and other forms of interaction No interaction studies have been performed. 4.6 Pregnancy and lactation There are no or limited amount of data from the use of Olbas Pastilles in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Olbas Pastilles should not be used during pregnancy unless potential benefits outweigh any risks. It is unknown whether Olbas Pastilles/ Прочитать полный документ