Ciplox 750 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE

Available from:

Accord Healthcare Limited

ATC code:

J01MA; J01MA02

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Dosage:

750 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Fluoroquinolones; ciprofloxacin

Authorization status:

Marketed

Authorization date:

2004-07-02

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2018
CRN008RG5
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciplox 750 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 750 mg of ciprofloxacin (as
hydrochloride).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet
White or yellowish, 10 x 19 mm oval, biconvex, film-coated tablets.
Scored on one
side and side-wall scored, marked ‘C750’ on one side.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciplox 750 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
18 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