DIFLAZOLE 150 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCONAZOLE

Available from:

Teva Pharma B.V.

ATC code:

J02AC01

INN (International Name):

FLUCONAZOLE

Dosage:

150 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 150 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 question,
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 150 mg Capsules, hard is used in adults to treat infections caused by fungi. The most common 
cause of fungal infections is a yeast called_ Candida_.  
You might be given this medicine
by your doctor to treat genital thrush, infection of the
vagina or penis.  

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFLAZOLE  
_ _
DO NOT TAKE DIFLAZOLE_  _

  If you

are allergic to fluconazole, to other medicines you have taken to treat fungal infections or 
to any of the other ingredients of this medicine (listed in section 6). The symptoms may include 
itching, reddening of the skin or difficulty in breathing 

  If you

are taking astemizole, terfenadine (antihistamine medicines

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflazole 150 mg Capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg fluconazole.
Excipient(s) with known effect:
Also contains 50 mg lactose and 0.02mg Sunset yellow (E110) per
capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Diflazole 150 mg Capsules, hard are yellow capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole is indicated for the treatment of the following fungal
infections in adults (see section 5.1):
Acute vaginal candidiasis when local therapy is not appropriate.
_Candidal balanitis_ when local therapy is not appropriate.
Therapy may be instituted before the results of the cultures and other
laboratory studies are known; however, once
results become available, anti-infective therapy should be adjusted
accordingly.
Consideration should be given to official guidance on the appropriate
use of antifungals.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Single dose 150 mg.
Special populations
_Elderly_
Where there is no evidence of renal impairment, normal dose
recommendations should be adopted.
_Renal impairment_
Fluconazole is predominantly excreted in the urine as unchanged active
substance. No adjustments in single dose
therapy are necessary.
_Hepatic impairment_
Limited data are available in patients with hepatic impairment,
therefore fluconazole should be administered with
caution to patients with liver dysfunction (see sections 4.4 and 4.8).
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