Ország: Örményország
Nyelv: angol
Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
biclotymol, lysozyme (lysozyme hydrochloride), enoxolone
Laboratoires Bouchara-Recordati
R02AX
biclotymol, lysozyme (lysozyme hydrochloride), enoxolone
5mg+5mg+5mg
tablets orodispersible
(30/3x10/) blisters
OTC
Registered
2016-06-07
APPENDIX 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT HEXALYSE, TABLET TO BE SUCKED 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BICLOTYMOL 5.0 mg LYSOZYME HYDROCHLORIDE 5.0 mg ENOXOLONE 5.0 mg for one tablet to be sucked of 1200.0 mg EXCIPIENTS: Icing sugar, orange yellow S (E110) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet to be sucked. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Infectious inflammatory diseases of the oral mucosa (stomatitis, gingivitis including caused by dental prosthesis) pharynx, larynx caused hypersensitivity agents to biclotymol,, lysozyme and enoxolole Local treatment is over all indications of inflammatory and infectious diseases of the nasopharynx, acute and chronic pharyngitis, pharyngolaryngitis, tonsillitis, post tonsillectomy, glossitis 4.2 Posology and method of administration Suck the tablets slowly, without chewing them. Adults 1 tablets to be sucked every 2 hours Eight tablets to be sucked during 24 hours, spreading out the doses. Children under 6 years of age 1 tablets to be sucked every 4 hours Four tablets to be sucked during 24 hours, This medicine should not be used for an extended period exceeding10 days. 4.3 Contra-indications This medicinal product is contra-indicated in the following circumstances : - Children under 6 years of age, - Hypersensitivity to biclotymol or any other ingredients of the tablet. The use should be avoided in patients with fructose intolerance, glucose-galactose malabsorption syndrome or a sucrase/isomaltase deficiency. 4.4 Special precautions for use SPECIAL PRECAUTIONS FOR USE: If other symptoms should occur (significant sore throat, headaches, nausea, vomiting, etc.) or if there is a concomitant fever, the course of action should be re-assessed. This medicine contains sucrose. The use should be avoided in patients with fructose intolerance, glucose-galactose malabsorption syndrome or a sucrase/isomaltase deficiency. If the patient is diabetic or is on low sugar diet, take Olvassa el a teljes dokumentumot