Hexalyse 5mg+5mg+5mg tablets orodispersible

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

biclotymol, lysozyme (lysozyme hydrochloride), enoxolone

Disponibil de la:

Laboratoires Bouchara-Recordati

Codul ATC:

R02AX

INN (nume internaţional):

biclotymol, lysozyme (lysozyme hydrochloride), enoxolone

Dozare:

5mg+5mg+5mg

Forma farmaceutică:

tablets orodispersible

Unități în pachet:

(30/3x10/) blisters

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2016-06-07

Caracteristicilor produsului

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