Diflucan 50mg capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Fluconazole

Tillgänglig från:

Pfizer Ltd

ATC-kod:

J02AC01

INN (International namn):

Fluconazole

Dos:

50mg

Läkemedelsform:

Oral capsule

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 05020100; GTIN: 5013457012118

Bipacksedel

DIFLUCAN
® 50 MG CAPSULES
(fluconazole)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available using the above name but will be referred
to as
Diflucan throughout this leaflet. Also available in 200 mg strength.
WHAT IS IN THIS LEAFLET:
1. What Diflucan is and what it is used for
2. What you need to know before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. Contents of the pack and other information
1. WHAT DIFLUCAN IS AND WHAT IT IS USED FOR
Diflucan is one of a group of medicines called “antifungals”. The
active
substance is fluconazole.
Diflucan 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 Diflucan to:
- stop cryptococcal meningitis from coming back
- stop mucosal thrush from coming back

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diflucan 50 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fluconazole 50 mg
Excipient(s) with known effects: each hard capsule also contains 49.70
mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule.
The 50 mg hard gelatin capsule has a white body and a turquoise blue
cap
overprinted with “Pfizer” and the code “FLU-50” with black
ink. The capsule
size is no. 4.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diflucan is indicated in the following fungal infections (see section
5.1).
Diflucan 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.
Diflucan 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
Transplanta