LEVOFLOXACIN 500 Milligram Film Coated Tablet

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

LEVOFLOXACIN

Disponibil de la:

Rowex Ltd

INN (nume internaţional):

LEVOFLOXACIN

Dozare:

500 Milligram

Forma farmaceutică:

Film Coated Tablet

Tip de prescriptie medicala:

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

Statutul autorizaţiei:

Authorised

Data de autorizare:

0000-00-00

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER 

LEVOFLOXACIN 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. 

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

1. WHAT LEVOFLOXACIN IS AND WHAT IT IS USED FOR

The name of your medicine is Levofloxacin 500 mg Film-Coated
Tablets. Levofloxacin 500 mg Film-
Coated Tablets 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. 

Levofloxacin tablets 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, Levofloxacin tablets 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 LEVOFLOXACI

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains levofloxacin hemihydrate equivalent to 500 mg levofloxacin.
Excipient(s): Contains 26.54 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light orange-pink, octagonal, biconvex film-coated tablet, with a score line on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levofloxacin 500 mg Film-Coated 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 Levofloxacin 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: post exposure prophylaxis and curative treatment (see section 4.4)
Levofloxacin film-coated tablets 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
Levofloxacin film-coated 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.
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