Flucol 2 mg/ml Solution for Infusion

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:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Triazole derivatives; fluconazole

Authorization status:

Not marketed

Authorization date:

2003-02-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCOL 2 MG/ML SOLUTION FOR INFUSION, 100 ML
fluconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
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 Flucol 2 mg/ml is and what it is used for
2. What you need to know before you use Flucol 2 mg/ml
3. How to use Flucol 2 mg/ml
4. Possible side effects
5. How to store Flucol 2 mg/ml
6. Contents of the pack and other information
1.
WHAT FLUCOL 2 MG/ML IS AND WHAT IT IS USED FOR
Flucol 2 mg/ml is one of a group of
medicines called “antifungals”. The active substance is
fluconazole.
Flucol 2 mg/ml 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.
You might also be given Flucol 2 mg/ml to:
-
stop cryptococcal meningitis from coming back
-
stop mucosal thrush from coming back
-
stop you from getting an infection caused by _Candida _(if your immune
system is weak and not
working properly).
CHILDREN AND ADOLESCENTS (0 TO 17 YEARS OLD)
You might be given this medicine by your doctor to treat the following
types of fungal infections:
-
Mucosal thrush - infection affecting the lining of the mouth, throat
-
Infections caused by _Can

Summary of Product characteristics

Health Products Regulatory Authority
24 September 2019
CRN008MDK
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucol 2 mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution for infusion contains 2 mg of fluconazole.
Each vial of 100 ml solution for infusion contains 200 mg of
fluconazole.
Excipient(s) with known effect:
Each ml contains 9 mg sodium chloride (equivalent to 0.154 mmol
sodium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution with no visible particles.
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.
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.

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)).
Flucol is indicated in term newborn infants, infants, toddlers,
children, and adolescents aged from 0 to 17 years old:
Flucol is used for the treatment of mucosal candidiasis
(oropharyngeal, oesophageal), invasive candidiasis, cryptococcal
meningitis and the prophylaxis of candidal infections in
immunocompromised patients. Flucol can be used as maintenance
therapy to prevent relapse of cryptococcal