Zindolin 250mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CIPROFLOXACIN

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

J01MA02

INN (International Name):

CIPROFLOXACIN 250 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CIPROFLOXACIN 250 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2007-04-05

Patient Information leaflet

mt-zindolin-250mg-fc-tabs-a14
Page
1
of
10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZINDOLIN 250 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 symptoms 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 Zindolin is and what it is used for
2.
What you need to know before you take Zindolin
3.
How to take Zindolin
4.
Possible side effects
5.
How to store Zindolin
6.
Contents of the pack and other information
1.
WHAT ZINDOLIN IS AND WHAT IT IS USED FOR
Zindolin contains the active substance ciprofloxacin. Ciprofloxacin is
an antibiotic belonging to
the fluoroquinolone family. Ciprofloxacin works by killing bacteria
that cause infections. It only
works with specific strains of bacteria.
Adults
Zindolin is used in adults to treat the following bacterial
infections:
-
respiratory tract infections
-
long lasting or recurring ear or sinus infections
-
urinary tract infections
-
genital tract infections in men and women
-
gastro-intestinal tract infections and intra-abdominal infections
-
skin and soft tissue infections
-
bone and joint infections
-
to prevent infections due to the bacterium
_Neisseria meningitidis _
-
anthrax inhalation exposure
Ciprofloxacin may be used in the management of patients with low white
blood cell counts
(neutropenia) who have a fever that is suspected to be due to a
bacterial infection.
If you have a severe infection or one that is caused by more than one
type of bacterium, you
may be given additional antibiotic treatment in addition to Zindolin.
Children and adolescents
Zindolin is used

Summary of Product characteristics

mt-spc-zindolin-250mg-fc-tabs-v15-r00-a0
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zindolin 250 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
ciprofloxacin
hydrochloride
equivalent
to
250 mg
ciprofloxacin.
For the full list of excipients, see section 6.1.
_ _
_ _
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, scored, film-coated tablet.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zindolin 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. In
exacerbations of chronic
obstructive pulmonary disease Zindolin should be used only when it is
considered
inappropriate to use other antibacterial agents that are commonly
recommended for
the treatment of these infections.
-
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:
mt-spc-zindolin-250mg-fc-tabs-v15-r00-a0
Page 2 of 24
–
uncomplicated acute cystitis. In uncomplicated acute cystitis Zindolin
should be used
only when it is considered inappropriate to use other antibacterial
agents that are
commonly recommended for the treatment of these infections.
-
acute pyelonephritis.
- complicated urinary tract infections.
- bacterial prostatitis
•
Genital tract infections
-
gonococcal urethritis and cervicitis due to susceptible
_Neisseria gonorrhoeae_
.
-
epididymo-orchitis including cases due to susceptible
_Neisser