Medociprin

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

CIPROFLOXACIN

Beschikbaar vanaf:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC-code:

J01MA02

INN (Algemene Internationale Benaming):

CIPROFLOXACIN 250 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

CIPROFLOXACIN 250 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisatie-status:

Authorised

Autorisatie datum:

2007-04-11

Bijsluiter

PIL-CIPR-TABS-4.1-MT
© MEDOCHEMIE LTD
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEDOCIPRIN 250MG FILM-COATED TABLETS
MEDOCIPRIN 500MG FILM-COATED TABLETS
Ciprofloxacin (as ciprofloxacin hydrochloride)
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 Medociprin is and what it is used for
2.
What you need to know before you take Medociprin
3.
How to take Medociprin
4.
Possible side effects
5.
How to store Medociprin
6.
Contents of the pack and other information
1.
WHAT MEDOCIPRIN IS AND WHAT IT IS USED FOR
Medociprin 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
Medociprin 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
PIL-CIPR-TABS-4.1-MT
© MEDOCHEMIE LTD
2
•
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

Productkenmerken

SPC-CIPR-TABS-4.0-CY
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medociprin 250 mg film-coated tablets
Medociprin 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
the
equivalent
of
either
250mg
or
500mg
ciprofloxacin
as
ciprofloxacin
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Medociprin 250mg film-coated tablets: White, round, convex film-coated
tablet.
Medociprin 500mg film-coated tablets: White, capsule shaped
film-coated tablet embossed MC.
For oral administration
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Medociprin is 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.
Adults
•
Lower respiratory tract infections due to Gram-negative bacteria
-
Exacerbations of chronic obstructive pulmonary disease. In
exacerbations of chronic
obstructive pulmonary disease Medociprin 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
SPC-CIPR-TABS-4.0-CY
2
•
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
Medociprin 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
-
Gonoccocal urethritis and cervicitis due to susceptible
_Neisseria gonorrhoeae_
-
Epididymo-orchitis including cases due to susceptible
_Neisseria gonorrhoeae_
-
Pelvic inflammatory disease including cases due