TRUOXIN 100 MG FILM-COATED TABLETS 100 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE

Available from:

Sinclair IS Pharma Limited

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Dosage:

100 Milligram

Pharmaceutical form:

Tablets

Prescription type:

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

Authorization status:

Withdrawn

Authorization date:

2012-12-13

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Truoxin 100 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ciprofloxacin 100 mg as the hydrochloride.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White or yellowish, 8mm round, biconvex, film-coated tablets marked ‘C100’. 
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin is indicated for the treatment of infections caused by sensitive bacteria:
_Upper and lower respiratory tract infections: _For example broncho- and lobar-pneumonia, bronchitis (acute and
chronic), acute exacerbation of cystic fibrosis, bronchiectasis, empyema, Gram-negative pneumonia (but _not _first-line
therapy for pneumococcal pneumonia).
_Urinary tract infections: _For example urethritis (complicated and uncomplicated), cystitis, pyelonephritis, prostatitis,
epididymitis.
_Gastro-intestinal infections: _For example enteric fever, infective diarrhoea.
_Gonorrhoea: _For example urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or
bacteria moderately sensitive to penicillin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage is determined by the type and severity of infection, sensitivity of the causal organism(s) and the age, weight
and renal function status of the patient.
Truoxin Tablets should be swallowed whole with an adequate amount of liquid. If Truoxin Tablets are taken on an
empty stomach, the active substance is absorbed more rapidly. In this case, the tablets should not be taken concurrently
with dairy products or with mineral fortified drinks alone (e.g. milk, yoghurt, calcium and fortified orange juice).
However, a normal diet that will contain small amounts of calcium, does not significantly affect ciprofloxacin
a