Fluconazole 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluconazole

Available from:

Viatris UK Healthcare Ltd

ATC code:

J02AC01

INN (International Name):

Fluconazole

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100

Patient Information leaflet

PRODUCT NAME
DIMMENSION
NO OF COLOR
FONT USED
VERSION
LANGUAGE
SOFTWARE
ARTWORK LEGEND
FLUCONAZOLE 50MG,150MG & 200MG CAPSULES-S/L-ENG PIL
148 X 410 MM
V1- 29-7-19
ENGLISH
ADOBE ILLUSTRATOR( CREATIVE CLOUD)
01- BLACK
01- ARIAL -9PT
(FONTS USED IN LEGEND : ARIAL TYPE SIZE :10POINTS)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 50mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg fluconazole.
Excipients with known effect:
Each capsules also contains 16.6 mg lactose monohydrate.
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard.
Fluconazole 50mg Capsules are green-white capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole capsules is indicated in the following fungal infections
(see section 5.1).
Fluconazole is indicated in adults for the treatment of:
•
Cryptococcal meningitis (see section 4.4).
•
Coccidioidomycosis (see section 4.4).
•
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 (see section 5.1)).
Fluconazole is indicated in term newborn infants, infants, toddlers,
children, and
adolescents aged from 0 to 17 years old:
Fluc