Fluconazole 50mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Fluconazole

Mevcut itibaren:

PLIVA Pharma Ltd

ATC kodu:

J02AC01

INN (International Adı):

Fluconazole

Doz:

50mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 05020100

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50MG AND 200MG 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 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 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 Capsules are used to treat infections caused by fungi and
may also be used to stop you
from getting 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 Capsules to:

stop cryptococcal meningitis from coming back

stop mucosal trush from coming back

reduce recurrence of vaginal trush

stop you from getting an infection cau

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 50 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg fluconazole.
Excipient(s) with known effect
Also contains 16.6mg lactose per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard.
Fluconazole 50 mg Capsules are green-white capsules_._
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 unguium_ (_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, infants, toddlers,
children, and
adolescents aged from 0 to 17 years