Truoxin 500 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciprofloxacin

Available from:

Fannin Limited

ATC code:

J01MA; J01MA02

INN (International Name):

Ciprofloxacin

Dosage:

500 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:

2001-12-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRUOXIN 250MG FILM-COATED TABLETS
TRUOXIN 500MG 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, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you personally and you should
not pass it on to
others. It may harm them, even if their symptoms 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 Truoxin film-coated tablets are and what they are used for.
2. What you need to know before you take Truoxin film-coated tablets.
3. How to take Truoxin film-coated tablets.
4. Possible side effects.
5. How to store Truoxin film-coated tablets.
6. Contents of the pack and other information
1. WHAT TRUOXIN FILM-COATED TABLETS ARE AND WHAT THEY ARE
USED FOR
The active ingredient, CIPROFLOXACIN, belongs to a group of medicines
called quinolone
antibiotics. Truoxin film-coated tablets are used to treat infections
caused by susceptible
bacteria.
Adults
Truoxin is used in adults to treat the following bacterial infections:

respiratory tract infections, e.g. pneumonia, bronchitis, worsening of
symptoms of
cystic fibrosis

long lasting or recurring ear or sinus infections

urinary tract infections

gastro-intestinal infections, e.g. infective diarrhoea, travellers’
diarrhoea

intra-abdominal infections

genital tract infections in men and women e.g. gonorrhoea, a commonly
occurring
sexually transmitted disease

skin and soft tissue infections

bone and joint infections

to prevent infections due to the bacterium _Neisseria meningitidis_

anthrax inhalation exposure
Children and adolescents
Truoxin film-coated tablets can also be used in children and
adolescents, under medical
su

Summary of Product characteristics

Health Products Regulatory Authority
24 April 2020
CRN009NCV
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Truoxin 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ciprofloxacin 500 mg as the hydrochloride.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White or yellowish, scored, 8.2 x 17mm oval, biconvex, film-coated
tablets. Scored on one side and side wall scored, marked
C500 on one side.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin is indicated for the treatment of the following
infections caused by sensitive bacteria (see section 4.4 and 5.1).
Particular attention should be paid to available information on
resistance to ciprofloxacin before starting treatment.
Adults
_Upper and lower respiratory tract infections:_
- Exacerbation of chronic obstructive pulmonary disease. In acute
exacerbations of chronic obstructive pulmonary disease
including chronic bronchitis, Truoxin should be used only when it is
considered inappropriate to use other antibacterial agents
that are commonly recommended for treatment of these infections.
- Gram-negative pneumonia (but _not_first-line therapy for
pneumococcal pneumonia).
- Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
- Chronic suppurative otitis media
- Acute exacerbation of chronic sinusitis especially if these are
caused by Gram-negative bacteria
_Urinary tract infections_
- Uncomplicated acute cystitis_: _In uncomplicated acute cystitis,
Truoxin should be used only when it is considered
inappropriate to use other antibacterial agents that are commonly
recommended for the treatment of these infection.
- Acute pyelonephritis
- Complicated urinary tract infections
- Bacterial prostatitis
_Genital tract infections:_
_ - _gonococcal uretritis and cervicitis due to susceptible
_Neisseriagonorrhoeae_
- epididymo-orchitis including cases due to susceptible
_Neisseriagonorrhoe