1 ml of the syrup contains 5 mg of fluconazole (Fluconazolum).
Fluconazole is indicated in the treatment of fungal infections (see section 5.1).
Fluconazole is indicated in adult patients in the treatment of the following infections:
cryptococcal meningoencephalitis (see section 4.4);
coccidioidomycosis (see section 4.4);
invasive candidiasis;
yeast-like fungal infections involving mucous membranes, including infections of the throat, oesophagus, presence of yeasts in urine and chronic mucocutaneous candidiasis;
chronic atrophic oral candidiasis (denture related) if oral hygiene or topical treatment prove insufficient;
acute or recurring vaginal yeast infection if topical treatment proves insufficient;
penile yeast infection if topical treatment proves insufficient,
skin candidiasis, including feet, body, lower legs, pityriasis versicolor, candida skin infection, if systemic therapy is indicated;
fungal nail infection (onychomycosis) if other drugs are found inadequate.
Fluconazole is indicated in adult patients in the prevention of the following infections:
recurrence of cryptococcal meningoencephalitis in patients with an increased risk of recurrence;
recurrence of yeast-like fungal infections involving mucous membranes, including infections of the throat, oesophagus in HIV patients with an increased risk of recurrence; recurrence of vaginal yeast infection (4 or more infections in a year);
fungal infections in patients with prolonged neutropenia (e.g. in patients with blood cancer receiving chemotherapy or in haematopoietic stem cell transplant recipients (see section 5.1.))
Fluconazole is indicated in the following infections in neonates, infants, children and youth of 0 to 17 years of age:
yeast-like fungal infection (of the mouth, throat and oesophagus).
invasive candidiasis;
cryptococcal meningoencephalitis,
prevention of yeast infections in immunosuppressed patients.
Fluconazole can be used as supportive therapy to prevent relapse of cryptococcal meningoencephalitis in children with a high risk of recurrence (see section 4.4).
Treatment may be initiated before receipt of plating or other lab test results, and should be adjusted afterwards.
Official guidelines on proper use of antifungals should be taken into account.
Hypersensitivity to the active substance (fluconazole) or other azole derivatives, or any of the excipients.
Interactions studies in multiple administration of fluconazole indicate that terfenadine is contraindicated in patients receiving fluconazole in multiple doses of 400 mg daily or more.
Administration of other drugs that prolong QT in ECG and are metabolised with cytochrome P450 (CYP3A4 isoenzyme), such as: cisapride, astemizole , pimozide, quinidine and erythromycin, is contraindicated in patients receiving fluconazole.
This is a drug. For safety, use it according to the package insert and only when necessary. If in doubt, consult your doctor or pharmacist.
phone: (+48 22) 742 00 22
informacjaoleku@hasco-lek.pl
1 ml of the syrup contains 5 mg of fluconazole (Fluconazolum).
Fluconazole is indicated in the treatment of fungal infections (see section 5.1).
Fluconazole is indicated in adult patients in the treatment of the following infections:
cryptococcal meningoencephalitis (see section 4.4);
coccidioidomycosis (see section 4.4);
invasive candidiasis;
yeast-like fungal infections involving mucous membranes, including infections of the throat, oesophagus, presence of yeasts in urine and chronic mucocutaneous candidiasis;
chronic atrophic oral candidiasis (denture related) if oral hygiene or topical treatment prove insufficient;
acute or recurring vaginal yeast infection if topical treatment proves insufficient;
penile yeast infection if topical treatment proves insufficient,
skin candidiasis, including feet, body, lower legs, pityriasis versicolor, candida skin infection, if systemic therapy is indicated;
fungal nail infection (onychomycosis) if other drugs are found inadequate.
Fluconazole is indicated in adult patients in the prevention of the following infections:
recurrence of cryptococcal meningoencephalitis in patients with an increased risk of recurrence;
recurrence of yeast-like fungal infections involving mucous membranes, including infections of the throat, oesophagus in HIV patients with an increased risk of recurrence; recurrence of vaginal yeast infection (4 or more infections in a year);
fungal infections in patients with prolonged neutropenia (e.g. in patients with blood cancer receiving chemotherapy or in haematopoietic stem cell transplant recipients (see section 5.1.))
Fluconazole is indicated in the following infections in neonates, infants, children and youth of 0 to 17 years of age:
yeast-like fungal infection (of the mouth, throat and oesophagus).
invasive candidiasis;
cryptococcal meningoencephalitis,
prevention of yeast infections in immunosuppressed patients.
Fluconazole can be used as supportive therapy to prevent relapse of cryptococcal meningoencephalitis in children with a high risk of recurrence (see section 4.4).
Treatment may be initiated before receipt of plating or other lab test results, and should be adjusted afterwards.
Official guidelines on proper use of antifungals should be taken into account.
Hypersensitivity to the active substance (fluconazole) or other azole derivatives, or any of the excipients.
Interactions studies in multiple administration of fluconazole indicate that terfenadine is contraindicated in patients receiving fluconazole in multiple doses of 400 mg daily or more.
Administration of other drugs that prolong QT in ECG and are metabolised with cytochrome P450 (CYP3A4 isoenzyme), such as: cisapride, astemizole , pimozide, quinidine and erythromycin, is contraindicated in patients receiving fluconazole.
Przedsiębiorstwo Produkcji
Farmaceutycznej
Hasco-Lek S.A.
st. Żmigrodzka 242e
51-131 Wroclaw
phone: (+48) 71 352 95 22
fax: (+48) 71 352 76 36
hasco@hasco-lek.pl
