Fluconazole 150 mg hard capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluconazole

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

J02AC; J02AC01

INN (International Name):

Fluconazole

Dosage:

150 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Triazole derivatives; fluconazole

Authorization status:

Marketed

Authorization date:

2012-08-17

Patient Information leaflet

SE/H/1063/001-004/IA/031, ver 01, JAN 2024
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50 MG HARD CAPSULE
FLUCONAZOLE 150 MG HARD CAPSULE
FLUCONAZOLE 200 MG HARD CAPSULE
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 Fluconazole capsule is and what it is used for
2.
What you need to know before you take Fluconazole capsule
3.
How to take Fluconazole capsule
4.
Possible side effects
5.
How to store Fluconazole capsule
6.
Contents of the pack and other information
1.
WHAT FLUCONAZOLE CAPSULE IS AND WHAT IT IS USED FOR
Fluconazole capsule is one of a group of medicines called
“antifungals”. The active substance is
fluconazole. Fluconazole capsule 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
type 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 capsule to:
•
stop crypt

Summary of Product characteristics

Health Products Regulatory Authority
26 February 2024
CRN00F3Q3
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 150 mg hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg fluconazole
Excipients: Contains 157 mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Capsule shell: Size 1, blue body and blue cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole capsule is indicated in the following fungal infections
(see section 5.1).
Fluconazole capsule 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 capsule is indicated in adults for the prophylaxis of:

Relapse of cryptococcal meningitis in patients with high risk of
recurrence.
o
Relapse of oropharyngeal or oesophageal candidiasis in patients
infected with HIV who are at high risk of
experiencing relapse.
o
To reduce the incidence of recurrent vaginal candidiasis (4 or more
episodes a year).
o
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 capsule is indicated in term newborn infants,