CIPLOX 750 Base Milligrams Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE

Available from:

Actavis Group PTC ehf

ATC code:

J01MA02

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Dosage:

750 Base Milligrams

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Fluoroquinolones

Authorization status:

Authorised

Authorization date:

2008-05-16

Patient Information leaflet

Package Leaflet: Information for the user

CIPLOX 250 MG FILM-COATED TABLETS 
CIPLOX 500 MG FILM-COATED TABLETS 
CIPLOX 750 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

any

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

CIPLOX

IS

AND

WHAT

IT IS

USED

FOR

2. WHAT YOU NEED TO KNOW BEFORE

YOU

TAKE

CIPLOX

3. HOW

TO

TAKE

CIPLOX

4. POSSIBLE

SIDE

EFFECTS

5. HOW

TO

STORE

CIPLOX

6. CONTENTS OF THE PACK AND OTHER

INFORMATION

1. 
WHAT CIPLOX IS AND WHAT IT IS USED FOR 

Ciplox

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_ 
Ciplox

is

used

in

adults

to

treat

the

following

bacterial

infections:

• 
respiratory

tract

infections

• 
long

lasting

or

recurring

ear

or

sinus

infections

• 
urinary

tract

infections

• 
infections

of

the

testicles

• 
genital

organ

infections

in

women

• 
gastro-intestinal

tract

i

Summary of Product characteristics

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_
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�