Flucol 150 mg Hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluconazole

Available from:

Rowex Ltd

ATC code:

J02AC; J02AC01

INN (International Name):

Fluconazole

Dosage:

150 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Triazole derivatives; fluconazole

Authorization status:

Marketed

Authorization date:

2004-07-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCOL 50 MG HARD CAPSULES
FLUCOL 150 MG HARD CAPSULES
FLUCOL 200 MG HARD CAPSULES
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 Flucol is and what it is used for
2.
What you need to know before you take Flucol
3.
How to take Flucol
4.
Possible side effects
5.
How to store Flucol
6.
Contents of the pack and other information
1.
WHAT FLUCOL IS AND WHAT IT IS USED FOR
Flucol is one of a group of medicines called “antifungals”. The
active substance is fluconazole.
Flucol 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 Flucol to:
-
stop cryptococcal meningitis from coming back
-
stop mucosal thrush from coming back
-
reduce recurrence of vaginal thrush
-
stop you from getting an infection caused by
_Candida _
(if your immu

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2024
CRN00F4SK
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucol 150 mg Hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg of fluconazole.
Excipient(s) with known effects:
Each hard capsule also contains 139 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Flucol 150 mg Hard capsule has a white body and a white cap. It has
"FC 150" printed on it.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flucol is indicated in the following fungal infections (see section
5.1).
Flucol 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.
Flucol 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
Haematopoietic Stem Cell Transplantation (see section
5.1)).
Flucol is ind