Orelox Tablets 100mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

CEFPODOXIME

Tilgjengelig fra:

Sanofi Malta Limited

ATC-kode:

J01DD13

INN (International Name):

CEFPODOXIME

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

CEFPODOXIME 100 mg

Resept typen:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisasjon status:

Authorised

Autorisasjon dato:

2005-10-12

Informasjon til brukeren

20/11/2008 16:33 - VISTAlink folder 216373 - Page 1/3
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING
THIS MEDICINE.
•
Keep this leaflet. You may need to read
it again.
•
If you have any further questions, ask
your doctor or your 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 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 your
pharmacist.
IN THIS LEAFLET:
1.
What Orelox Tablets are and what they
are used for
2.
Before you take Orelox Tablets
3.
How to take Orelox Tablets
4.
Possible side effects
5.
How to store Orelox Tablets
6.
Further information
Orelox Tablets contains a medicine c

Preparatomtale

Page 1 of 9 

SUMMARY OF PRODUCT CHARACTERISTICS 
__________________________________________________________________ 

1. 
NAME OF THE MEDICINAL PRODUCT 

Orelox tablets 100 mg 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each Orelox tablet contains 130.45 mg of cefpodoxime proxetil
(equivalent to 100 mg 
cefpodoxime). 

3. 
PHARMACEUTICAL FORM  

Film-coated tablet for oral use 

4. 
CLINICAL PARTICULARS  

4.1 
THERAPEUTIC INDICATIONS  

Orelox is a bactericidal cephalosporin antibiotic
active against a wide range of Gram-
negative and Gram-positive organisms. It is indicated for the
treatment of the following 
infections either before the infecting organism has been
identified or when caused by 
bacteria of established sensitivity. 

Upper respiratory tract infections caused
by organisms sensitive to cefpodoxime, 
including sinusitis. 

In tonsillitis and pharyngitis, Orelox should be reserved for
recurrent or chronic 
infections, or for infections where the causative organism is
known or suspected to be 
resistant to commonly used antibiotics. 

Lower respiratory tract infections caused by organisms sensitive to
cefpodoxime, 
including acute bronchitis, relapses or exacerbations of chronic
bronchitis and bacterial 
pneumonia. 

Upper and lower urinary tract infections
caused by organisms sensitive to cefpodoxime 
including cystitis and acute pyelonephritis. 

Skin and soft tissue infections caused by organisms sensitive to
cefpodoxime such as 
abscesses, cellulitis, infected wounds, furuncles, folliculitis,
paronychia, carbuncles and 
ulcers. 

Page 2 of 9 

Gonorrhoea – uncomplicated gonococcal urethritis.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

_Route of administration_: Oral. 

_ADULTS_: 

_ADULTS WITH NORMAL RENAL FUNCTION_: 

_Upper respiratory tract infections_: For upper respiratory tract
infec