Cifloxager 500 mg Film-coated Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Ciprofloxacin

Commercializzato da:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codice ATC:

J01MA; J01MA02

INN (Nome Internazionale):

Ciprofloxacin

Dosaggio:

500 milligram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Fluoroquinolones; ciprofloxacin

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2005-02-04

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIFLOXAGER 250 MG FILM-COATED TABLETS
CIFLOXAGER 500 MG FILM-COATED TABLETS
ciprofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cifloxager is and what it is used for
2.
What you need to know before you take Cifloxager
3.
How to take Cifloxager
4.
Possible side effects
5.
How to store Cifloxager
6.
Contents of the pack and other information
1.
WHAT CIFLOXAGER IS AND WHAT IT IS USED FOR
Cifloxager is an antibiotic belonging to the fluoroquinolone family.
The active substance is
ciprofloxacin. Ciprofloxacin works by killing bacteria that cause
infections. It only works
with specific strains of bacteria.
Adults
Cifloxager is used in adults to treat the following bacterial
infections:

respiratory tract infections

long lasting or recurring ear or sinus infections

urinary tract infections

genital tract infections in men and women

gastro-intestinal tract infections and intra-abdominal infections

skin and soft tissue infections

bone and joint infections

to prevent infections due to the bacterium _Neisseria meningitidis_

anthrax inhalation exposure
Ciprofloxacin may be used in the management of patients with low white
blood cell counts
(neutropenia) who have a fever that is suspected to be due to a
bacterial infection.
If you have a severe infection or one that is caused by more than one
type of bacterium, you
may be given additional antibiotic treatment in addition to
ciprofloxacin.
Children and adolescents
Cifloxager

Scheda tecnica

Health Products Regulatory Authority
12 September 2022
CRN00CZ2Q
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cifloxager 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg ciprofloxacin (as
hydrochloride).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, biconvex, capsule-shaped tablets marked 'CF 500' on either side
of a score line on one side and 'G' on the other.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cifloxager Film-coated Tablets are indicated for the treatment of the
following infections (see sections 4.4 and 5.1). Special
attention should be paid to available information on resistance to
ciprofloxacin before commencing therapy.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Adults:

_Lower_ r_espiratory tract infections _due to Gram-negative bacteria:
o
exacerbation of chronic obstructive pulmonary disease
o
broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
o
pneumonia
In exacerbation of chronic obstructive pulmonary disease Cifloxager
should be used only when it is considered inappropriate to
use other antibacterial agents that are commonly recommended for the
treatment of these infections.

Chronic suppurative otitis media

Acute exacerbation of chronic sinusitis especially if these are caused
by Gram-negative bacteria

Uncomplicated acute cystitis
In uncomplicated acute cystitis Cifloxager should be used only when it
is considered inappropriate to use other antibacterial
agents that are commonly recommended for the treatment of these
infections.

Acute pyelonephritis

Complicated urinary tract infections

Bacterial prostatitis

Genital tract infections
o
gonococcal urethritis and cervicitis due to susceptible _Neisseria
gonorrhoeae_
o
epididymo-orchitis in