FLUCONAZOLE

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

FLUCONAZOLE

Доступна с:

Accord Healthcare Limited

код АТС:

J02AC01

ИНН (Международная Имя):

FLUCONAZOLE

дозировка:

50 Milligram

Фармацевтическая форма:

Capsules Hard

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

fluconazole

Статус Авторизация:

Marketed

Дата Авторизация:

2012-03-30

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50 MG
HARD CAPSULE
FLUCONAZOLE 150 MG
HARD CAPSULE
FLUCONAZOLE 200 MG
HARD CAPSULE
(Fluconazole)
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 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 or
pharmacist.This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Fluconazole capsule is and what it is
used for
2. What you need to know before you take
Fluconazole capsule
3. How to take Fluconazole capsule
4. Possible side effects
5. How to store Fluconazole capsule
6. Contents of the pack and other information 1. WHAT FLUCONAZOLE CAPSULE IS
AND WHAT IT IS USED FOR
Fluconazole capsule is one of a group of
medicines called “antifungals”. The active
substance is fluconazole. Fluconazole capsule 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
infection is a yeast called _Candida_.
ADULTS
You might be given this medicine by your doctor
to treat the following type 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 capsule to:
•
stop cryptococcal meningitis from coming back
•
stop mucosal thrush

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 50 mg hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg fluconazole
Excipients: Contains 52 mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Capsule shell: Size 4, white body and green cap.
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 is indicated in term newborn infants, infants, toddlers,
children, and adolescents aged from 0 to 17 years
old:
Fluconazole is used for the treatment of mucosal ca