Ciprofloxacin Krka 250 mg film-coated tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Ciprofloxacin hydrochloride

Доступно од:

KRKA, d.d., Novo mesto

АТЦ код:

J01MA; J01MA02

INN (Међународно име):

Ciprofloxacin hydrochloride

Дозирање:

250 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

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

Терапеутска област:

Fluoroquinolones; ciprofloxacin

Статус ауторизације:

Marketed

Датум одобрења:

2005-10-07

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN KRKA 250 MG FILM-COATED TABLETS
CIPROFLOXACIN KRKA 500 MG FILM-COATED TABLETS
CIPROFLOXACIN KRKA 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 Ciprofloxacin Krka is and what it is used for
2.
What you need to know before you take Ciprofloxacin Krka
3.
How to take Ciprofloxacin Krka
4.
Possible side effects
5.
How to store Ciprofloxacin Krka
6.
Contents of the pack and other information
1.
WHAT CIPROFLOXACIN KRKA IS AND WHAT IT IS USED FOR
Ciprofloxacin Krka is an antibiotic belonging to the fluoroquinolone
family. Ciprofloxacin Krka
contains the active substance ciprofloxacin hydrochloride.
Ciprofloxacin works by killing bacteria that
cause infections. It only works with specific strains of bacteria.
_Adults _
Ciprofloxacin Krka 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

Карактеристике производа

Health Products Regulatory Authority
24 January 2024
CRN00F2MZ
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Krka 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ciprofloxacin hydrochloride
equivalent to 250mg ciprofloxacin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Round, white, film-coated tablets with a scoreline on one side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin Krka 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- uncomplicated acute cystitisIn uncomplicated
acute cystitis ciprofloxacin 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 uretritis and cervicitis due to susceptible _Neisseria
gonorrhoeae_

Epididymo-orchitis including cases due to susceptible _Neisseria
gonorrhoeae_

Pelvic inflammatory disease including cases due to susceptible
_Neisseria gonorrhoeae_

Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea)

Intra-abdominal infections

Infections of the skin and soft tissue caused by