Ciplox 250 mg Film-coated Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

CIPROFLOXACIN HYDROCHLORIDE

Disponibil de la:

Accord Healthcare Limited

Codul ATC:

J01MA; J01MA02

INN (nume internaţional):

CIPROFLOXACIN HYDROCHLORIDE

Dozare:

250 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Fluoroquinolones; ciprofloxacin

Statutul autorizaţiei:

Marketed

Data de autorizare:

2004-07-02

Caracteristicilor produsului

Health Products Regulatory Authority
12 December 2018
CRN008RG5
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciplox 250 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of ciprofloxacin (as
hydrochloride).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet
White or yellowish, 11 mm circular, biconvex, film-coated tablets.
Scored on both
sides and side-wall scored, marked ‘C250’ on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciplox 250 mg 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 respiratory tract infections due to Gram-negative bacteria
- exacerbations of chronic obstructive pulmonary disease
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
- pneumonia

Chronic suppurative otitis media

Acute exacerbation of chronic sinusitis especially if these are caused
by
Gram-negative bacteria

Urinary tract infections

Gonococcal uretritis and cervicitis

Epididymo-orchitis including cases due to _Neisseria gonorrhoeae_

Pelvic inflammatory disease including cases due to _Neisseria
gonorrhoeae _
Health Products Regulatory Authority
12 December 2018
CRN008RG5
Page 2 of 28
_In the above genital tract infections when thought or known to be due
to _
_Neisseria gonorrhoeae it is particularly important to obtain local
information _
_on the prevalence of resistance to ciprofloxacin and to confirm
susceptibility _
_based on laboratory testing._

Infections of the gastro-intestinal tract (e.g. travellers’
diarrhoea)

Intra-abdominal infections

Infections of the skin and soft tissue caused by Gr