DIFLAZOLE 50 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
12-07-2016
Summary of Product characteristics
(SPC)
27-06-2017
Active ingredient:
FLUCONAZOLE
Available from:
Teva Pharma B.V.
ATC code:
J02AC01
INN (International Name):
FLUCONAZOLE
Dosage:
50 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Triazole derivatives
Authorization status:
Authorised
Authorization date:
2010-09-10
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
Diflazole 50 mg Capsules, hard
Diflazole 200 mg Capsules, hard
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 or nurse. This includes any
possible side effects not listed in this leaflet, See section 4.
WHAT IS IN THIS LEAFLET
1.
What Diflazole is and what it is used for?
2.
What you need to know before you take Diflazole
3.
How to take Diflazole
4.
Possible side-effects
5.
How to store Diflazole
6.
Contents of the pack and other information
1. WHAT DIFLAZOLE IS AND WHAT IT IS USED FOR
Diflazole is one of a
group of medicines called “antifungals”. The active
substance is fluconazole.
_ _
Diflazole Capsules, hard are used to treat infections caused by fungi and may also be used to stop
you from getting 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 affectin
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflazole 50mg Capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg fluconazole.
Excipient(s) with known effect
Also contains 16.6 mg lactose per capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Diflazole 50 mg capsules, hard are green-white capsules.
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 unguium_ (_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).
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