REFAZ 250 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOFLOXACIN HEMIHYDRATE

Available from:

Pharmathen S.A.

ATC code:

J01MA12

INN (International Name):

LEVOFLOXACIN HEMIHYDRATE

Dosage:

250 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Fluoroquinolones

Authorization status:

Authorised

Authorization date:

2011-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

REFAZ 250 MG FILM-COATED TABLETS 
REFAZ 500 MG FILM-COATED TABLETS 

Levofloxacin 

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. See section 4. 

WHAT IS IN THIS LEAFLET:  
1.  What Refaz is and what it is used for 
2.  What you need to know before you take Refaz 
3.  How  to take  Refaz 
4.  Possible side effects 
5.  How to store Refaz 
6.  Contents of the pack and other information 

1.  WHAT REFAZ TABLETS ARE AND WHAT THEY ARE USED FOR 

WHAT THIS MEDICINE IS 
The name of your medicine is Refaz. Refaz contain a medicine
called levofloxacin. This belongs to a 
group of medicines called antibiotics. Levofloxacin is a
‘quinolone’ antibiotic. It works by killing the 
bacteria that cause infections in your body..  

REFAZ CAN BE USED TO TREAT INFECTIONS OF THE: 
-
  Sinuses 
-
  Lungs, in people with long-term breathing problems or
pneumonia 
-
  Urinary tract, including your kidneys or bladder 
-
  Prostate gland, where you have a long lasting infection 
-
  Skin and underneath the skin, including muscles. This is
sometimes called ‘soft tissue’. 
In some special situations, Refaz may be used to lessen the
chances of getting a pulmonary disease 
named anthrax or worsening of the disease after you are exposed
to the bacteria causing anthrax. 

2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE REFAZ TABLETS 

DO NOT TAKE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Refaz 250mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 256.23 mg of levofloxacin hemihydrate equivalent to 250 mg of levofloxacin.
Excipients:
Each tablet contains sunset yellow (E110).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oblong, biconvex film-coated tablet with a scoreline.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Refaz tablets are indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
• Acute bacterial sinusitis
• Acute exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Complicated skin and soft tissue infections.
For the above-mentioned infections Refaz should be used only when it is considered inappropriate to use antibacterial
agents that are commonly recommended for the initial treatment of these infections.
• Pyelonephritis and complicated urinary tract infections (see section 4.4)
• Chronic bacterial prostatitis.
• Uncomplicated cystitis (see section 4.4)
• Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4)
Refaz may also be used to complete a course of therapy in patients who have shown improvement during initial
treatment with intravenous levofloxacin.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Refaz tablets are administered once or twice daily.
The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen.
Refaz tablets may also be used to complete a course of therapy in patients who have�