Siprox 250mg film-coated tablets

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CIPROFLOXACIN

Fáanlegur frá:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC númer:

J01MA02

INN (Alþjóðlegt nafn):

CIPROFLOXACIN 250 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

CIPROFLOXACIN 250 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTIBACTERIALS FOR SYSTEMIC USE

Leyfisstaða:

Withdrawn

Leyfisdagur:

2006-11-23

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIPROX 250 MG, 500 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 or
nurse.
•
This medicine has been prescribed for you. Do 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 or
nurse.This includes any side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Siprox is and what it is used for
2.
What you need to know before you take Siprox
3.
How to take Siprox
4.
Possible side effects
5.
How to store Siprox
6.
Contents of the pack and other information
1.
WHAT SIPROX IS AND WHAT IT IS USED FOR
Siprox 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
Siprox 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 infections and intra-abdominal infections
•
skin and soft tissue infections
•
bone and joint infections
•
to treat infections in patients with a very low white blood cell count
(neutropenia)
•
to prevent infections in patients with a very low white blood cell
count (neutropenia)
•
to prevent infections due to the bacterium
_Neisseria meningitidis _
•
anthrax inhalation exposure
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 Siprox.
Children and adolescents
Siprox is used in children and adolescents,

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Siprox 250 mg film-coated tablets
Siprox 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg or 500 mg ciprofloxacin (as
ciprofloxacin hydrochloride
monohydrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
250 mg: White, round, biconvex, film-coated tablets scored on both
sides and side wall scored,
marked C250 on one side.
500 mg: White, oval, biconvex, film-coated tablets scored on one side
and side wall scored, marked
C500 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Siprox 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
•
Uncomplicated acute cystitis
_In uncomplicated acute cystitis, Siprox 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
2
•
Gonococcal urethritis and cervicitis due to susceptible
_Neisseria gonorrhoeae _
•
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 loca