Fluconazole 50mg capsules

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Fluconazole

थमां उपलब्ध:

Almus Pharmaceuticals Ltd

ए.टी.सी कोड:

J02AC01

INN (इंटरनेशनल नाम):

Fluconazole

डोज़:

50mg

फार्मास्यूटिकल फॉर्म:

Oral capsule

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 05020100; GTIN: 05060057400203

सूचना पत्रक

“
”
–
–
–
–
“
”
“
”
‘
’
“
”
‘
’
‘
’
’
−
−
PATIENT INFORMATION LEAFLET
1
WHAT FLUCONAZOLE IS AND
WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FLUCONAZOLE
·
·
·
·
FLUCONAZ
(FLUCONAZOLE)
3
HOW TO TAKE FLUCONAZOLE
OLE 50, 100, 200MG CAPSULES
FLUCONAZOLE 150MG CAPSULES CONTAIN LACTOSE
HARD TO READ?
0800 970 6115
Phone
for help
μ
˘
“
”
“
”
°
−
−
−
−
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE FLUCONAZOLE
6
CONTENTS OF THE PACK AND
OTHER INFORMATION
Fluconazole 50mg Capsules: PL 36722/0120
Fluconazole 100mg Capsules: PL 36722/0121
Fluconazole 200mg Capsules: PL 36722/0123
Date of approval: July 2019
RxFarma
Colonial Way,
Watford, Hertfordshire,
WD24 4YR
HARD TO READ?
0800 970 6115
Phone
for help

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 50mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluconazole 50mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard gelatin capsule
Size 4, white/green capsules containing white crystalline powder
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole capsule is indicated in the following fungal infections
(see section 5.1).
Fluconazole capsule 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 capsule 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 capsule is indicated in term newborn infants, infants,
toddlers, children,
and adolescents aged from 0 to 17 years old:
Fluconazole capsule is