Ciproxin 750 mg Film-coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
31-03-2023
Summary of Product characteristics
(SPC)
31-03-2023
Active ingredient:
Ciprofloxacin hydrochloride
Available from:
Bayer Limited
ATC code:
J01MA; J01MA02
INN (International Name):
Ciprofloxacin hydrochloride
Dosage:
750 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Fluoroquinolones; ciprofloxacin
Authorization status:
Not marketed
Authorization date:
1988-12-20
Patient Information leaflet
BP22059_REC30945
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROXIN 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 Ciproxin is and what it is used for
2.
What you need to know before you take Ciproxin
3.
How to take Ciproxin
4.
Possible side effects
5.
How to store Ciproxin
6.
Contents of the pack and other information
1.
WHAT CIPROXIN IS AND WHAT IT IS USED FOR
Ciproxin 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
Ciproxin 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 Ciproxin.
BP22059_REC30945
Children and adolescents
Cipr
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Summary of Product characteristics
Health Products Regulatory Authority
30 March 2023
CRN00D80Z
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciproxin 750 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 750 mg ciprofloxacin (as
hydrochloride)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oblong, nearly white to slightly yellowish tablets marked with “CIP
750” on one side and “BAYER” on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciproxin 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
- exacerbation of chronic obstructive pulmonary disease. In
exacerbation of chronic obstructive pulmonary disease
Ciproxin 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 infection
- Uncomplicated acute cystitis. In uncomplicated acute cystitis
Ciproxin 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 includi
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