Država: Malta
Jezik: angleščina
Source: Medicines Authority
DEQUALINIUM CHLORIDE
Marco Antonetto Farmaceutici S.p.A Via Arsenale 29, 10121 Torino I, Italy
R02AA02
DEQUALINIUM CHLORIDE 0.25 mg
TABLET
DEQUALINIUM CHLORIDE 0.25 mg
OTC
THROAT PREPARATIONS
Withdrawn
2006-08-30
OSANGIN DEQUALINIUM CHLORIDE PLEASE READ ALL THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. Nevertheless you still need to use OSANGIN carefully to get the best results from it. ¾ Keep this leaflet. You may need to read it again. ¾ Ask your pharmacist if you need more information or advice. ¾ You must see a doctor if your symptoms worsen or do not improve after a short treatment period. IN THIS LEAFLET 1 What OSANGIN is and what it is used for 1 Before you take OSANGIN 2 How to take OSANGIN 3 Possible side effects 4 Storing OSANGIN 5 Further information OSANGIN, 0.250 MG. 20 TABLETS FOR ORAL USE. DEQUALINIUM CHLORIDE The active substance is : Dequalinium chloride The other ingredients are : Sorbitol, talc, magnesium stearate, mint extract Marketing Authorisation Holder : Marco Antonetto Farmaceutici S.p.A. Via Arsenale 29 TO Manufacturer or Contract manufacturers: A) Marco Antonetto Farmaceutici S.p.A. Via Arsenale 29 TO B) Farmaceutici Procemsa S.p.A. Via Mentana 10 Nichelino C) Segix Italia S.p.A. Via dl Mare 36 Pomezia, RM The letters A), B), C), printed on the carton next to the lot number, indicate the site where manufacture and control are performed. 1. WHAT OSANGIN IS AND WHAT IT IS USED FOR OSANGIN is a throat preparation. It is an antiseptic of the oropharyngeal cavity. It is available in packs of 20 tablets divided into two blister strips of 10 tablets each. It is indicated in the treatment of the most common infection of the mouth and of the throat. Tablets should be allowed to slowly dissolve in the mouth. 2. BEFORE YOU TAKE OSANGIN DO NOT TAKE OSANGIN — Preberite celoten dokument
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Osangin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet for oral use contains 0.250 mg of dequalinium chloride. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiseptic of the oropharyngeal cavity 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Unless otherwise prescribed, one tablet every 3-4 hours. Tablets should be allowed to dissolve slowly in the mouth to ensure the best antiseptic action in the oral cavity. 4.3 CONTRAINDICATIONS Individual hypersensitivity to any of the ingredients 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Prolonged or repeated use of products intended for topical use, may induce irritation or sensitisation phenomena. In such an occurrence treatment should be discontinued and a suitable therapy established. Medical advice should be sought if, after a brief period of treatment, satisfactory results are not achieved. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Do not exceed the stated dose. Keep out of the reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No clinically significant drug interaction known. 4.6 PREGNANCY AND LACTATION Contraindications to the product’s use during pregnancy and lactation have not been established; however, usual precautions as regards the use of drugs during pregnancy or lactation should be observed. Page 2 of 3 4.7 EFFECTS ON ABILITY TO DRIVE AND USE M Preberite celoten dokument