FLUCONAZOLE TEVA 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUCONAZOLE

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

J02AC01

Pharmaceutical form:

CAPSULES

Composition:

FLUCONAZOLE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY

Therapeutic group:

FLUCONAZOLE

Therapeutic area:

FLUCONAZOLE

Therapeutic indications:

Fluconazole is indicated in adults for the treatment of:• Cryptococcal meningitis.• Coccidioidomycosis.• Invasive candidiasis.• Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.• Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.• Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.• Candidal balanitis when local therapy is not appropriate.• Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.• Tinea unguinium (onychomycosis) when other agents are not considered appropriate.Fluconazole is indicated in adults for the prophylaxis of:• Relapse of cryptococcal meningitis in patients with high risk of recurrence.• Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.• To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).• Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation).Fluconazole is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:Fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.Consideration should be given to official guidance on the appropriate use of antifungals.

Authorization date:

2023-05-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
FLUCONAZOLE TEVA 150 MG
CAPSULES
COMPOSITION:
Each capsule contains:
Fluconazole 150 mg
For a list of inactive and allergenic ingredients in this medicine,
see section 2
under ‘Important information about some of this medicine’s
ingredients’, and
section 6 ‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if it seems to you that their medical condition is
similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
ADULTS:
Fluconazole Teva 150 mg is intended for treating the following types
of fungal
infections:
Cryptococcal meningitis – a fungal infection in the brain.
Coccidioidomycosis – a disease of the bronchopulmonary system.
Infections caused by _Candida_ and originating in the blood stream,
body
organs (for example heart, lungs) or urinary tract.
Oral thrush – infection affecting the mucosa of the oral cavity,
throat and
dentures.
Genital thrush – infection of the vagina or penis.
Skin fungus, including athlete’s foot, fungus in the groin area,
tinea versicolor,
nail fungus and skin inflammations caused by _Candida_.
THE MEDICINE IS ALSO INTENDED FOR:
Preventing cryptococcal meningitis from coming back.
Preventing oral thrush from coming back.
Reducing the recurrence of vaginal thrush.
Preventing you from getting an infection caused by _ Candida_ (if your
immune system is weak and not working properly).
CHILDREN AND ADOLESCENTS (0 TO 17 YEARS OLD):
Fluconazole Teva 150 mg is intended for treating the following types
of fungal
infections:
Oral thrush – infection affecting the mucosa of the oral cavity and
throat.
Infections caused by _Candida_ and originating in the blo