Fluconazole 200 mg capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluconazole

Available from:

Actavis Group PTC ehf

ATC code:

J02AC; J02AC01

INN (International Name):

Fluconazole

Dosage:

200 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:

2011-04-15

Patient Information leaflet

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Details
FLUCONAZOLE 50, 150, 200MG CAPSULES, HARD PIL - IRELAND
Black
Text Free Area
BBBA2887
T. Hull
07.09.2018
13.09.2018
T. Hull
170x320
7pt
Specifar S.A.
n/a
2
Version 2
01.11.2017
FLUCONAZOLE 50 MG CAPSULES, HARD
FLUCONAZOLE 150 MG CAPSULES, HARD
FLUCONAZOLE 200 MG CAPSULES, HARD
fluconazole
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
WHAT IS IN THIS LEAFLET
1
WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE
3
HOW TO TAKE FLUCONAZOLE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE FLUCONAZOLE
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole is one of a group of medicines called “antifungals”.
The active
substance is fluconazole.
Fluconazole 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 doc

Summary of Product characteristics

Health Products Regulatory Authority
29 March 2019
CRN008N41
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 200 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg fluconazole.
Excipient with known effect:
Each hard capsule contains 164 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Fluconazole 200 mg consists of blue cap and white body, size “0”
hard gelatine capsules, filled with white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole 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 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
Transplantation