Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
phenazone, lidocaine (lidocaine hydrochloride)
S.C. Rompharm Company S.R.L.
S02DA30
phenazone, lidocaine (lidocaine hydrochloride)
40mg/g+ 10mg/g
drops ear
15ml plastic bottle-dropper
OTC
Registered
2017-03-06
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OTIRELAX (40 mg/10 mg)/1 g, ear drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of solution contains 40 mg of phenazone and 10 mg of lidocaine hydrochloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops, solution. Clear, colourless to slightly brownish-yellow solution, practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local symptomatic treatment of certain painful conditions of the middle ear with intact tympanic membrane: - congestive acute otitis media, - so-called phlyctenular viral otitis, - barotrauma otitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In order to avoid unpleasant contact of the cold solution with the ear, warm the container between the hands before use. - Dropper bottle: instill 4 drops in the auditory meatus of the painful ear, 2 or 3 times a day. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Tympanic perforation of infectious or traumatic origin (see section 4.4 Special warnings and special precautions for use). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE WARNINGS As a precautionary measure, ensure that the tympanic membrane is intact before any administration. If there is tympanic destruction, intra-auricular administration may bring the product into contact with the structures of the middle ear, with adverse effects upon them. 2 This medicine contains an active ingredient which may give a positive result in the anti- doping tests. PRECAUTIONS FOR USE Limit treatment duration to 10 days. Management must be reviewed after that time. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 FERTILITY, PREGNANCY AND LACTATION In the absence of any tympanic breach, systemic penetration is unlikely. As a result, under normal conditions of use, this medicine can, if necessary, be used during pregnancy and lactation. 4.7 EFFECTS ON THE ABILITY Read the complete document