Country: Հայաստան
language: անգլերեն
source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluconazole
Egyptian International Pharmaceutical Industries Company (EIPICO)
J02AC01
fluconazole
150mg
capsules hard
(2/2x1/) in strip
Prescription
Registered
2019-09-09
- 1 - TONOFUNGYN 150 MG CAPSULE SPC SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tonofungyn® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatin capsule contains: Fluconazole 150 mg Excipient(s) with known effects: each hard capsule also contains 125 mg lactose monohydrate. For full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Hard gelatin capsule 150 mg hard gelatin capsule of size No1 with opaque sky-blue cap and white body containing hygroscopic white powder. 4. CLINICAL PARTICULARS _4.1 THERAPEUTIC INDICATIONS _ Tonofungyn is indicated for the treatment of the following infections when caused by fungi that are known or likely to be fluconazole-susceptible: Acute or recurrent vaginal candidiasis. For treatment of partners with associated candidal balanitis. _4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _Posology _ _Adults (16 to 60 years) _ Vaginal candidiasis or candidal balanitis - 150mg as a single oral dose. _Pediatric population (children under 16 years) _ Not recommended in children aged under 16 years unless antifungal treatment is imperative, and no suitable alternative agent exists, due to insufficient safety and efficacy (see section 5.2). - 2 - TONOFUNGYN 150 MG CAPSULE SPC _Special population _ _Elderly _ Not recommended in patients aged over 60 years. _Use in renal impairment _ Fluconazole is excreted predominantly in the urine as unchanged drug. No adjustments in single dose therapy are required. _Use in patients with hepatic insufficiency _ Tonofungyn should only be administered with special care and under careful monitoring in patients with liver insufficiency (see section 4.4). _Method of administration _ For oral administration. The capsules should be swallowed whole and independent of food intake. _4.3 CONTRAINDICATIONS _ Fluconazole should not be used in patients with hypersensitivity to the active substance, to related azole substances, or to any of the excipients listed in section 6.1. Co-administration of terfenadine is contraindicated in pat read_full_document