CIPROXIN 500 Base Milligrams Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
CIPROFLOXACIN HYDROCHLORIDE
Available from:
PCO Manufacturing
INN (International Name):
CIPROFLOXACIN HYDROCHLORIDE
Dosage:
500 Base Milligrams
Pharmaceutical form:
Film Coated Tablet
Authorization status:
Withdrawn
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciproxin 500 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg ciprofloxacin (as hydrochloride).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the Netherlands, Greece and Hungary:_
White, oblong tablets with ‘Bayer’ impressed on one side and ‘CIP’, a breakline and ‘500’ on the other.
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, empysema. Ciprofloxacin is not recommended as first-line therapy for the treatment of
pneumococcal pneumonia. In circumstances where a physician considers it appropriate to use ciprofloxacin in patients
with pneumococcal pneumonia, a dose of 750mg twice daily should provide adequate cover in the majority of cases
_(see Dosage and Administration section). _Ciprofloxacin may be used for treating Gram-negative pneumonia.
_Urinary tract infections:_e.g. uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.
_Gastro-intestinal infections: _e.g. enteric fever, infective diarrhoea.
_Gonorrhoea: _including urethral, rectal and pharyngeal gonorrhoea caused by ß-lactamase producing organisms or
organisms moderately sensitive to penicillin.
_Children: _For the treatment of acute pulmonary exacerbation of cystic fibrosis associated with P. aeruginosa infection
in paediatric patients aged 5-17 years.
Inhalation Anthrax in Adults and Children: To reduce the incidence or progression of disease following confir
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