Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
CHLORHEXIDINE GLUCONATE, TYROTHRICIN, LIDOCAINE HYDROCHLORIDE
Engelhard Arzneimittel GmbH & Co. KG Herzbergstrasse 3 61138 Niederdorfelden, Germany
R02A
TYROTHRICIN 0.5 mg LIDOCAINE HYDROCHLORIDE 1 mg CHLORHEXIDINE GLUCONATE 1 mg
LOZENGE
TYROTHRICIN 0.5 mg LIDOCAINE HYDROCHLORIDE 1 mg CHLORHEXIDINE GLUCONATE 1 mg
OTC
THROAT PREPARATIONS
Authorised
2007-03-02
Trachisan Tab Exp Pb1643202 20.12.2006 8:15 Uhr Seite 1 BSBSS - - Package leaflet: Information for the user Trachisan® LOZENGES Lidocaine hydrochloride 1 H 2 0, chlorhexidine digluconate, tyrothricin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • lf you get any side effects, talk to your doctor or pharmacist. This in- cludes any possible side effects not listed in this leaflet. See section 4. - What is in this leaflet 1. What Trachisan® Lozenges are and what they are used for 2. What you need to know before you take Trachisan® Lozenges 3. How to take Trachisan® Lozenges 4. Possible side effects 5. How to store Trachisan® Lozenges 6. Contents of the pack and other information 1. What Trachisan® Lozenges are and what they are used for Trachisan® Lozenges are used for: lnflammations and infections in the oral cavity and throat, such as stomatitis, gingivitis, parodontitis, glossitis, tonsillitis and pharyngitis; dysphagia. For prophylaxis against infections before and after surgery in the oral cavity and throat (tooth extraction, surgical treatment of the gingiva, tonsillectomy). 2. What you need to know before you take Trachisan® Lozenges Do not use Trachisan® Lozenges The preparation should not be used in the case of known hypersen- sivity to any of the ingredients, non-bleeding desquamation of the oral mucosa (erosive and desquamative changes), larger, fresh wounds in the oral and pharyngeal cavities. Precautions for use lngredients Each lozenge contains 0.69 g sorbitol, corresp. to 0.057 BU. Therefore this drug should not be administered to patients with the rare congenital fructose intolerance. Trachisan® Lozenges contain lidocaine. Cross-allergy to lidocaine hy- drochloride is expected in patients Læs hele dokumentet
Page 1 of 7 1. NAME OF THE MEDICINAL PRODUCT Trachisan Lozenges, lozenges 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (ACTIVE INGREDIENTS) Each lozenge contains: Tyrothricin 0.5 mg Lidocaine hydrochloride 1 H 2 O 1.0 mg Chlorhexidine gluconate 1.0 mg Excipients see under point 6.1. 3. PHARMACEUTICAL FORM Lozenges. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inflammations in the oral cavity and throat, such as stomatitis, gingivitis, parodontitis, glossitis, tonsillitis and pharyngitis; disphagia. For prophylaxis against infections before and after surgery in the oral cavity and throat (tooth extraction, surgical treatment of the gingiva, tonsillectomy). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults suck one lozenge at two hour intervals, up to 8 times daily, children up to 6 times daily. With regular use of preparation, the indications generally subside after a few days. In order to ensure lasting succsess of treatment, Trachisan ® Lozenges should be taken for a further 2- 3 days even when symptoms have subsided. However, if there is no significant improvement after 5 days, a physician should be consulted at all events. Trachisan ® Lozenges should not be used for more than 2 weeks without interruption, unless otherwise prescribed by a doctor or dentist. 4.3 CONTRAINDICATIONS The preparation should not be used in the case of known hypersensivity to the active constituents contained in Trachisan ® Lozenges, non-bleeding desquamation of the oral mucosa (erosive and desquamative changes), larger, fresh wounds in the oral and pharyngeal cavities Page 2 of 7 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE None. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Adverse effects associated with the concomitant use of other drugs in conjunction with Trachisan ® Lozenges have so far not become known. 4.6 PREGNANCY AND LACTATION Although the active constituent combination contained in Trachisan ® Lozenges is safe in therapeutic doses due to its pharmacological properties, the p Læs hele dokumentet