Diflucan 10 mg/ml powder for oral suspension

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Fluconazole

Inapatikana kutoka:

Pfizer Healthcare Ireland

ATC kanuni:

J02AC; J02AC01

INN (Jina la Kimataifa):

Fluconazole

Kipimo:

10 milligram(s)/millilitre

Dawa fomu:

Powder for oral suspension

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Triazole derivatives; fluconazole

Idhini hali ya:

Marketed

Idhini ya tarehe:

1991-11-12

Taarifa za kipeperushi

Page 1 of 12
2023-0089584
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFLUCAN® 10 MG/ML POWDER FOR ORAL SUSPENSION
DIFLUCAN® 40 MG/ML POWDER FOR ORAL SUSPENSION
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, 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.
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
-
reduce recurrence of vaginal thrush
-
sto

Tabia za bidhaa

Health Products Regulatory Authority
26 March 2024
CRN00F50Z
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflucan 10 mg/ml powder for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of reconstituted suspension contains 10 mg fluconazole.
Excipients with known effects: 0.58 g sucrose, 1.13 mg sodium and 2.38
mg sodium benzoate per ml of reconstituted
suspension.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
White to off-white powder for oral suspension providing a white to
off-white orange-flavoured suspension after reconstitution.
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 m