Fluconazole 50mg capsules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Fluconazole

Tilgængelig fra:

Wockhardt UK Ltd

ATC-kode:

J02AC01

INN (International Name):

Fluconazole

Dosering:

50mg

Lægemiddelform:

Oral capsule

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05020100; GTIN: 5012727905969

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50MG, 200MG HARD 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 Capsules are and what they are used for
2. What you need to know before you take Fluconazole Capsules
3. How to take Fluconazole Capsules
4. Possible side effects
5. How to store Fluconazole Capsules
6. Contents of the pack and other information
1. WHAT FLUCONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR
The active substance is fluconazole. Fluconazole is one of a group of
medicines called
“antifungals”.
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 fr

Produktets egenskaber

OBJECT 1
FLUCONAZOLE 50MG HARD CAPSULES
Summary of Product Characteristics Updated 04-Apr-2018 | Wockhardt UK
Ltd
1. Name of the medicinal product
Fluconazole 50mg Hard Capsules
2. Qualitative and quantitative composition
Each capsule contains 50mg of fluconazole.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules, hard.
Fluconazole 50mg 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 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, infants, toddlers,
children, and adolescents aged fr