Fluconazole 50mg capsules

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Fluconazole

Доступна з:

Sun Pharma UK Ltd

Код атс:

J02AC01

ІПН (Міжнародна Ім'я):

Fluconazole

Дозування:

50mg

Фармацевтична форма:

Oral capsule

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 05020100; GTIN: 5015525060816

інформаційний буклет

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs
of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not
listed in this leaflet. See section 4.
5217578 - LIT. FLUCONAZOLE CAP 50/200MG, MARKET : UK-R, SIZE :
150X580MM, SINGLE FOLD, OLD CODE : 5177633
, ITF CODE : 05217578, COLOUR : BLACK, REF. BLUE,
SPIL-DWS : 22/02/21NM, 20/02/21NM, 19/02/21NM, 17/02/21NM, 16/02/21VS,
13/02/21NM, 10/02/21NM
5217578
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50 MG, 200 MG CAPSULES
(fluconazole)
FONT SIZE : 9 PT
CONDITION
DOSE
To treat
cryptococcal
meningitis
400 mg on the first day then
200 mg to 400 mg once daily
for 6 to 8 weeks or longer if
needed. Sometimes doses
are increased up to 800 mg
To stop
cryptococcal
meningitis from
coming back
200 mg once daily until you
are told to stop
To treat
coccidioidomycosis
200 mg to 400 mg once daily
from 11 months for up to 24
months or longer if needed.
Sometimes doses are
increased up to 800 mg
To treat internal
fungal infections
caused by _Candida _
800 mg on the first day then
400 mg once daily until you
are told to stop
To treat mucosal
infections affecting
the lining of mouth,
throat and denture
sore mouth
200 mg to 400 mg on the first
day then 100 mg to 200 mg
once daily until you are told
to stop
To treat mucosal
thrush – dose
depends on where
the infection is
located
50 mg to 400 mg once daily
for 7 to 30 days until you are
told to stop
To stop mucosal
infections affecting
the lining of mouth,
throat from coming
back
100 mg to 200 mg once daily,
or 200 mg 3 times a week,
while you are at risk of
getting an infection
To treat genital
thrush
150 mg as a si

Характеристики продукта

1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 50 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluconazole 50 mg
Excipients with known effect:
Each capsule also contains 38.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard capsules
Blue/white hard gelatin, self locked capsules of size '4' imprinted
with 'RANBAXY'
in black edible ink on both cap and body containing white to off-white
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole capsules are indicated in the following fungal infections
(see section 5.1).
Fluconazole capsules are 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 capsules are 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)).
Fl