Fluconazole 50mg capsules

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Fluconazole

Доступна з:

Teva 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: 5017007052401

інформаційний буклет

Package leaflet: Information for the user
FLUCONAZOLE 50 MG AND 200 MG CAPSULES
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 or pharmacist.

This medicine has been prescribed for you. 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.
WHAT IS IN THIS LEAFLET
1.
What Fluconazole is and what it is used for
2.
What you need to know before you take Fluconazole
3.
How to take Fluconazole
4.
Possible side effects
5.
How to store Fluconazole
6.
Contents of the pack and other information
1.
WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole is one of a group of medicines called “antifungals”.
The active substance is
fluconazole.
Fluconazole is used to treat infections caused by fungi and may also
be used to stop you from
getting a candidal infection. The most common cause of fungal
infections is a yeast called
_Candida_
.
ADULTS
You might be given this medicine by your doctor to treat the following
types of fungal
infections:

Cryptococcal meningitis – a fungal infection in the brain

Coccidioidomycosis – a disease of the bronchopulmonary system

Infections caused by
_Candida _
and found in the blood stream, body organs (e.g. heart,
lungs) or urinary tract

Mucosal thrush - infection affecting the lining of the mouth, throat
and denture sore
mouth

Genital thrush – infection of the vagina or penis

Skin infections - e.g. athlete's foot, ringworm, jock itch, nail
infection.
You might also be given Fluconazole to:

stop cryptococcal meningitis from coming back

stop mucosal thrush from coming back

reduce recurrence of vaginal thrush

stop you from getting an infection caused by
_Candida

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 50 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluconazole 50 mg.
Excipients: each capsule also contains 47 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsules
Gelatine capsules filled with white to yellowish white homogeneous
powder,
with a light blue opaque cap and white opaque body.
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 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