FLUCONAZOLE PFIZER 150 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCONAZOLE

Available from:

Pfizer Healthcare Ireland

INN (International Name):

FLUCONAZOLE

Dosage:

150 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

2014-0005949 

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          dDF 2_2 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

FLUCONAZOLE PFIZER 150MG HARD CAPSULE 
fluconazole  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE. 

- 
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. Do not pass it on to
others. It may harm 
them, even if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you
notice any side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET:  

1. 
What Fluconazole Pfizer is and what it is used for 
2. 
Before you take Fluconazole Pfizer  
3. 
How to take Fluconazole Pfizer 
4. 
Possible side effects 
5. 
How to store Fluconazole Pfizer  
6.    
Further information 

1. 
WHAT FLUCONAZOLE PFIZER IS AND WHAT IT IS USED FOR

Fluconazole Pfizer is one of a group of medicines called
“antifungals”. The active substance is 
fluconazole.  

Fluconazole Pfizer 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. 
BEFORE YOU TAKE FLUCONAZOLE PFIZER 

DO NOT TAKE FLUCONAZOLE PFIZER IF YOU 

- 
are allergic (hypersensitive) to
fluconazole, to other medicines you have taken to treat 
fungal infections or to any of the other ingredients
of Fluconazole Pfizer. The 
symptoms may include itching, reddening of the skin or difficulty in breathing 
- 
are taking astemizole, terfenadine (antihistamine m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole Pfizer 150 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fluconazole 150 mg.
Excipients: each hard capsule also contains 149.12 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
The 150 mg hard gelatin capsule has a turquoise blue body and turquoise blue cap overprinted with “Pfizer” and the
code “FLU
-150” with black ink. The capsule size is no. 1.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole Pfizer is indicated in 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
these 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 15/09/2014_
_CRN 2146509_
_page number: 1_
_Hepatic impairment_
Limited data are available in patients with hepatic impairment, therefore fluconazole should be administered with
caution to patients with liver dysfu