Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluconazole
Waymade Healthcare Plc
J02AC01
Fluconazole
150mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100
PRODUCT NAME DIMMENSION NO OF COLOR FONT USED VERSION LANGUAGE SOFTWARE ARTWORK LEGEND BELL’S HEALTHCARE- THRUSH RELIEF ORAL RELIEF 150MG CAPSULE PIL-S/L-ENG 140 X 330 MM HUMANST521 BT -12 PTS & 9PTS V0 / 3-7-19 ENGLISH ADOBE ILLUSTRATOR( CREATIVE CLOUD) 01- BLACK (FONTS USED IN LEGEND : ARIAL TYPE SIZE :10POINTS) Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole 150 mg Capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg fluconazole. Excipients with known effect: Also contains Lactose Monohydrate and Sunset Yellow E110. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. Fluconazole 150 mg Capsules are yellow capsules_._ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole 150mg capsule is indicated for the treatment of candidal vaginitis, acute or recurrent. It should also be used for treatment of partners with associated candidal balanitis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Fluconazole is administered orally. ADULTS (16 TO 60 YEARS): One capsule should be swallowed whole. CHILDREN (UNDER 16 YEARS): Paediatric use is not recommended. ELDERLY: Not recommended in patients over 60 years. RENAL IMPAIRMENT: There is no separate dosage schedule in patients with renal impairment for single dose therapy. 4.3 CONTRAINDICATIONS Fluconazole should not be used in patients with known hypersensitivity to the drug, any of the inert ingredients listed in section 6.1 or to related azole compounds. Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400mg per day or higher based upon results of a multiple dose interaction study. Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin are contraindicated in patients receiving fluconazole (see section 4.4 and 4.5). Fluconazole should not be used in patients with porphyria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Renal system Fluconazole should be administered with caution to patients with renal dysfunction (see section 4.2). Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency, and this could also, although rarely seen, be applicable to fluconazole. Adrenal Izlasiet visu dokumentu