Fluconazole 50mg capsules

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Fluconazole

متاح من:

Mawdsley-Brooks & Company Ltd

ATC رمز:

J02AC01

INN (الاسم الدولي):

Fluconazole

جرعة:

50mg

الشكل الصيدلاني:

Oral capsule

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 05020100

نشرة المعلومات

To treat mucosal infections affecting
200 mg to 400 mg on the first
the lining of the mouth, throat and
day then 100 mg to 200 mg until
denture sore mouth
you are told to stop
To treat mucosal thrush – dose
50 mg to 400 mg once daily for 7
depends on where the infection is
to 30 days until you are told to
located
stop
To stop mucosal infections affecting
100 mg to 200 mg once daily, or
the lining of the mouth, throat
200 mg 3 times a week, while
you are at risk of getting an
infection
To treat genital thrush
150 mg as a single dose
To reduce recurrence of vaginal thrush
150 mg every third day for a total
of 3 doses (day 1, 4 and 7) and
then once a week for 6 months
while you are at risk of getting an
infection
To treat fungal skin and nail infections
Depending on the site of the
infection 50 mg once daily,
150 mg once weekly, 300 to
400 mg once weekly for 1 to 4
weeks (Athlete’s foot may be up
to 6 weeks, for nail infection
treatment until infected nail is
replaced)
To stop you from getting an infection
200 mg to 400 mg once daily
caused by Candida (if your immune
while you are at risk of getting
system is weak and not working
an infection
properly)
USE IN CHILDREN AND ADOLESCENTS
The capsules formulation may be unsuitable for children under 5-6
years
of age.
ADOLESCENTS FROM 12 TO 17 YEARS OLD
Follow the dose prescribed by your doctor (either adults or children
posology).
CHILDREN TO 11 YEARS OLD
The maximum dose for children is 400 mg daily.
The dose will be based on the child’s weight in kilograms. CONDITION
DAILY DOSE
Mucosal thrush and throat infections
3 mg per kg of body weight (6
caused by Candida – dose and
mg per kg of body weight might
duration depends on the severity of
be given on the first day)
the infection and on where the
infection is located
Cryptococcal meningitis or internal
6 mg to 12 mg per kg of body
fungal infections caused by Candida
weight
To stop children from getting an
3 mg to 12 mg per kg of body
infection caused by Candida (if their
weight
immune system is not working
proper

خصائص المنتج

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