Eurocefix 250mg/5ml granules for oral suspension

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

CEFACLOR

Dostępny od:

Alta Care Laboratoires Piazza di Spagna 6, 00187 Roma, Italy

Kod ATC:

J01DC04

INN (International Nazwa):

CEFACLOR 250 mg/5ml

Forma farmaceutyczna:

GRANULES FOR ORAL SUSPENSION

Skład:

CEFACLOR 250 mg/5ml

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIBACTERIALS FOR SYSTEMIC USE

Status autoryzacji:

Authorised

Data autoryzacji:

2007-10-10

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER 

EUROCEFIX 500 MG HARD CAPSULES 
EUROCEFIX 250 MG / 5ML GRANULES FOR ORAL SUSPENSION 
Cefaclor 

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. 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. 

IN THIS LEAFLET:  
1. 
What EUROCEFIX is and what it is used for 
2. 
Before you take EUROCEFIX 
3. 
How to take EUROCEFIX 
4. 
Possible side effects 
5. 
How to store EUROCEFIX 
6. Further 
information 

1. 
WHAT EUROCEFIX IS AND WHAT IT IS USED FOR 
Cefaclor is a semisynthetic 2nd generation cephalosporin
antibiotic, orally administered. 
EUROCEFIX is indicated in the treatment of the following infections
when caused by 
susceptible strains of the designated microorganisms: 
•  Respiratory infections: such as pneumonia, bronchitis,
re-acutisation of chronic bronchitis, 
pharyngitis and tonsillitis. 
•  Otitis media (inflammatory processes of bacterial origin on
the otitis media). 
•  Skin infections and soft tissues. 
•  Urinary tract infections, including phelonephritis and
cystitis.  
•  Sinusitis. 
Your doctor will be able to explain and tell you more. It is used to
treat many different sorts of 
infection. Your doctor can tell you about your infection. 

2. 
BEFORE YOU TAKE EUROCEFIX 

DO NOT TAKE EUROCEFIX 
- if you are allergic to it’s active substance (cefaclor and
other cephalosporins), any of the other 
ingredients, or with history of allergic reaction to penicillin. 

TAKE SPECIAL CARE AND LET YOUR DOCTOR KNOW 
- Before starting treatment with cefaclor, inform your doctor of
any know hypersensi

Charakterystyka produktu

 
             Page 1 of 6 
   SUMMARY 
OF 
PRODUCT 
CHARACTERISTICS 

1. TRADE NAME 

EUROCEFIX – hard capsules 
EUROCEFIX - granules for oral suspension  

ATC CODE 
J01DA08 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION   

EUROCEFIX 500 MG HARD CAPSULES 

Each capsule contains: 
Active Ingredient: cefaclor monohydrate equivalent to
500mg cefaclor.  
Excipients: starch 62.1mg, dimethicone 350
6.9mg, magnesium stearate 8mg.  
Capsule Constituents: gelatine 9.6mg, titanium dioxide 2mg. 

EUROCEFIX 250 MG/5 ML GRANULES FOR ORAL SUSPENSION 

5 ml of suspension contain: 
Active Ingredient: cefaclor monohydrate equivalent to
250mg cefaclor.  
Excipients: modified starch 10mg, dimethicone 350
1mg, methylcellulose 15 3mg, saccharose 
2.87g, sodium laurylsulfate 0.75mg, strawberry flavour 15mg,
polysaccharide gum 7.5mg, 
erythrosine E127 2.4mg.  

3. PHARMACEUTICAL FORM 

Hard capsules. 
Granules for oral suspension. 

4. CLINICAL INFORMATION 

4.1. THERAPEUTIC INDICATIONS 

Treatment of the following infections when caused by susceptible
strains: 
•  Respiratory infections: such as pneumonia, bronchitis,
re-acutisation of chronic bronchitis, 
pharyngitis and tonsillitis. 
•  Otitis media (inflammatory processes of bacterial origin
on the otitis media). 
•  Skin infections and soft tissues. 
•  Urinary tract infections, including phelonephritis and
cystitis.  
•  Sinusitis. 

4.2. DOSES, DIRECTIONS AND ADMINISTRATION  

EUROCEFIX is administered orally and can
be administered independently without meals.  

ADULTS: 250mg every 8 hours.  
For more severe infections doses may be increased.
The maximum recommended dose is of 2g a 
day. 

             Page 2 of 6 
CHILDREN: 20 mg/kg/day in divided doses every 8 hours:  
In more serious infections, otitis media, 40 mg/kg/day are
recommended, with