Cefuroxime Axetil Actavis 500mg film coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFUROXIME

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

J01DC02

INN (International Name):

CEFUROXIME 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CEFUROXIME 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2011-02-21

Patient Information leaflet

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26.01.2012
26.01.2012
08.02.2012
K. Mutafchieva
K. Mutafchieva
22.02.2012
Orchid, India
AAAD2370
Cefuroxime Axetil, All Strengths, PIL, Malta & Cyprus
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 symp-
toms 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 Cefuroxime axetil Actavis is and what it is used for
2.  Before you take Cefuroxime axetil Actavis
3.  How to take Cefuroxime axetil Actavis
4.  Possible side effects
5.  How to store Cefuroxime axetil Actavis
6.  Further information
1.  WHAT  CEFUROXIME AXETIL ACTAVIS IS AND WHAT IT IS USED FOR
Cefuroxime axetil Actavis is an antibiotic. It belongs to a group of
antibiotics that are called cephalosporins.
These types of antibiotics are similar to penicillin. Cefuroxime
axetil Actavis kills bacteria and it can be used
against various sorts of infections.
Like all antibiotics Cefuroxime axetil Actavis is only effective
against some types of bacteria. So, it is only suitable
for treating some types of infection.
Cefuroxime axetil Actavis can be used to treat:
•  ear, sinus and throat infections
•  chest infections such as bronchitis
•  infectio

Summary of Product characteristics

Page 1 of 9 
SUMMARY OF PRODCUT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Cefuroxime Axetil Actavis 250 mg film-coated tablets 
Cefuroxime Axetil Actavis 500 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 250 mg cefuroxime as cefuroxime axetil 
Each tablet contains 500 mg cefuroxime as cefuroxime axetil 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet. 

_250 mg:_ Light blue-coloured film-coated, capsule shaped tablets
marked “250” on one side and 
“P125” on the other side. 
_500 mg:_ Light blue coloured film-coated capsule shaped tablets
marked “500” on one side and 
“P126” on the other side. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Cefuroxime Axetil Actavis is indicated for the treatment of mild to
moderately severe infections 
caused by micro-organisms susceptible to cefuroxime, such as: 
- upper 
respiratory 
tract 
infections: acute otitis media, sinusitis, tonsillitis and
pharyngitis 
- 
acute bronchitis, acute exacerbations of chronic bronchitis 
- 
lower uncomplicated urinary tract infections: cystitis 
- 
skin and soft tissue infections: furunculosis, pyoderma and
impetigo 
- 
treatment of early stage Lyme disease (stadium I) and subsequent
prevention of late 
complications in adults and children above 12 years of age. 

Consideration should be given to official guidance on the appropriate
use of antibacterial agents. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

For an individual dosage, Cefuroxime Axetil Actavis 250 mg and 500
mg film-coated tablets are 
available. General dosage recommendations for cefuroxime depend on
the sensitivity of the 
respective pathogen and on the site of infection.  

Cefuroxime Axetil Actavis tablets are coated to mask their
taste: they should not be broken, crushed 
or chewed. 

The usual duration of therapy is 7 days (ran