Aristin-C

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CIPROFLOXACIN

Available from:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

ATC code:

J01MA02

INN (International Name):

CIPROFLOXACIN 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CIPROFLOXACIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2007-02-09

Patient Information leaflet

 
1
INSTRUCTION LEAFLET 

1.1 
TRADENAME 

ARISTIN-C Film Coated Tablets 250mg/tablet and 500mg/tablet 

1.2 
COMPOSITION 

Active Ingredient: 
Ciprofloxacin 
Excipients:  
ARISTIN-C F.C.TAB. 250MG & 500MG: Starch maize, Cellulose 
Microcrystalline,   Crospovidone, Silicon Dioxide, Colloidal, 
Magnesium Stearate, Hypromellose, Macrogol 4000, Titanium 
Dioxide E171, Cl 77891 

1.3 
PHARMACEUTICAL FORM 

Tablets 

1.4 
STRENGTH 

ƒ  Tablets 250mg/tab 
Each tablet contains 250mg of the active ingredient
Ciprofloxacin 

ƒ  Tablets 500mg/tab 
Each tablet contains 500mg of the active ingredient
Ciprofloxacin 

1.5 
DESCRIPTION OF PACKAGING 

ƒ  Tablets 250mg/tab 
Carton Box, which contains an aluminium PVC/PVDC foil blister
(blister 1 x 10), of 10 
tablets. 

ƒ  Tablets 500mg/tab 
Carton Box, which contains an aluminium PVC/PVDC foil blister (blister
1 x 10), of 10 
tablets. 

1.6 
PHARMACOTHERAPEUTICAL CATEGORY 

Antibacterial 

1.7 
MARKETING AUTHORIZATION HOLDER 

ANFARM HELLAS S.A. 
K. Paleologou & 27, Perikleous str. 
Halandri 152 32 
Athens - GREECE 

1.8 
MANUFACTURER 

ANFARM HELLAS S.A. 
Schimatari Viotias 

2. 
INFORMATION ABOUT THE DRUG YOUR PHYSICIAN HAS PRESCRIBED YOU 
2.1 
INDICATIONS 

2
Ciprofloxacin is indicated for the treatment of the
following infections caused by sensitive 
bacteria:  
_ADULTS:_ 
Respiratory tract infections: e.g. lobar and bronchopneumonia,
acute and chronic bronchitis, 
acute exacerbation of cystic fibrosis, bronchiectasis,
empyema. Ciprofloxacin is not 
recommended as first-line therapy for the
treatment of pneumococcal pneumonia. 
Ciprofloxacin may be used for treating
Gram-negative pneumonia.  
Ear, nose and throat infections: e.g. mastoiditis, otitis
media and sinusitis, especially if due to 
Gram-negative
bacteria (including Pseudomonas spp.). Ciprofloxacin is not
reco

Summary of Product characteristics

Page 1 of 13 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
ARISTIN-C 

2. QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION 
Each tablet
contains 582.0mg ciprofloxacin hydrochloride equivalent
to 500mg 
Ciprofloxacin (INN). 
For excipients see Section 6.1 

3.  
PHARMACEUTICAL FORM 
Immediate release film-coated tablet for oral administration. 

4.  
CLINICAL 
PARTICULARS 

4.1  
THERAPEUTIC INDICATIONS 
Ciprofloxacin is indicated for the treatment of the
following infections caused by sensitive 
bacteria:  
_ADULTS:_ 
Respiratory tract infections: e.g. lobar and bronchopneumonia, acute
and chronic bronchitis, 
acute exacerbation of cystic fibrosis, bronchiectasis,
empyema. Ciprofloxacin is not 
recommended as first-line therapy for the
treatment of pneumococcal pneumonia. 
Ciprofloxacin may be used for treating Gram-negative pneumonia.  
Ear, nose and throat infections: e.g.
mastoiditis, otitis media and sinusitis, especially if due 
to Gram-negative bacteria (including Pseudomonas spp.).
Ciprofloxacin is not 
recommended for the treatment of acute tonsillitis.  
Eye infections: e.g. bacterial conjunctivitis.  
Urinary tract infections: e.g. uncomplicated
and complicated urethritis, cystitis, 
pyelonephritis, prostatitis, epididymitis.  
Skin and soft tissue infections: e.g.
infected ulcers, wound infections, abscesses, cellulitis, 
otitis externa, erysipelas, infected burns.  
Bone and joint infections: e.g. osteomyelitis, septic arthritis.  
Intra-abdominal infections: e.g. peritonitis,
intra-abdominal abscesses.  
Infections of the
biliary tract: e.g. cholangitis, cholecystitis, empyema of the
gall bladder.  
Gastro-intestinal infections: e.g. enteric fever,
infective diarrhoea.  
Pelvic infections: e.g.
salpingitis, endometritis, pelvic inflammatory disease.  
Severe systemic infections: e.g. septicaemia, bacteraemia,
peritonitis, infections