Fluconazole 50mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Fluconazole

Beschikbaar vanaf:

A A H Pharmaceuticals Ltd

ATC-code:

J02AC01

INN (Algemene Internationale Benaming):

Fluconazole

Dosering:

50mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 05020100; GTIN: 5037563004638

Bijsluiter

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)

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 50 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg fluconazole.
Excipient(s) with known effect
Also contains 16.6mg lactose per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard.
Fluconazole 50 mg Capsules are green-white capsules_._
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole 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 unguium_ (_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