Profloxin 500 mg Film-coated Tablets

País: Malta

Língua: inglês

Origem: Malta Medicines Authority

Ingredientes ativos:

CIPROFLOXACIN

Disponível em:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

Código ATC:

J01MA02

DCI (Denominação Comum Internacional):

CIPROFLOXACIN 500 mg

Forma farmacêutica:

FILM-COATED TABLET

Composição:

CIPROFLOXACIN 500 mg

Tipo de prescrição:

POM

Área terapêutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Resumo do produto:

Licence number in the source country: NOT APPLICAPABLE

Status de autorização:

Authorised

Data de autorização:

2021-12-27

Folheto informativo - Bula

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROFLOXIN 250MG FILM-COATED TABLETS
PROFLOXIN 500MG FILM-COATED TABLETS
ciprofloxacin (as 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Profloxin is and what it is used for
2.
What you need to know before you take Profloxin
3.
How to take Profloxin
4.
Possible side effects
5.
How to store Profloxin
6.
Contents of the pack and other information
1.
WHAT PROFLOXIN IS AND WHAT IT IS USED FOR
Profloxin is an antibiotic belonging to the fluoroquinolone family.
The active substance is ciprofloxacin.
Ciprofloxacin works by killing bacteria that cause infections. It only
works on specific strains of bacteria.
_Adults _
Profloxin 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 treatmen

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Profloxin 500 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains ciprofloxacin hydrochloride equivalent
to 500 mg ciprofloxacin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White or yellowish 8.2 x 17 mm oval, biconvex, film-coated tablets.
Scored on one side and side wall
scored, marked C500 on one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Profloxin 500 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 chronic
obstructive pulmonary
disease, Profloxin 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.
•
Uncomplicated acute cystitis
In Uncomplicated acute cystitis, Profloxin 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
•
Gonoccocal 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 gen