Ciprinol 250 mg film-coated tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

CIPROFLOXACIN

Saadav alates:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC kood:

J01MA02

INN (Rahvusvaheline Nimetus):

CIPROFLOXACIN 250 mg

Ravimvorm:

FILM-COATED TABLET

Koostis:

CIPROFLOXACIN 250 mg

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIBACTERIALS FOR SYSTEMIC USE

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Authorised

Loa andmise kuupäev:

2021-12-02

Infovoldik

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPRINOL 250 MG FILM-COATED TABLETS
CIPRINOL 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.
-
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 Ciprinol is and what it is used for
2.
What you need to know before you take Ciprinol
3.
How to take Ciprinol
4.
Possible side effects
5.
How to store Ciprinol
6.
Contents of the pack and other information
1.
WHAT CIPRINOL IS AND WHAT IT IS USED FOR
Ciprinol 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 _
Ciprinol 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 Ciprinol.
_ _
_Children and adolescents _
Ciprinol is used in children and adolescents, under speciali

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ciprinol 250 mg film-coated tablets
Ciprinol 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciprinol film-coated tablets 250 mg
Each film-coated tablet contains 291.0 mg ciprofloxacin hydrochloride
monohydrate equivalent to
250 mg ciprofloxacin.
Ciprinol film-coated tablets 500 mg
Each film-coated tablet contains 582.0 mg ciprofloxacin hydrochloride
monohydrate equivalent to
500 mg ciprofloxacin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Ciprinol 250 mg film-coated tablets
The tablets are white, round, film-coated, plain on one side, with a
score line on the reverse.
The tablet can be divided into equal doses.
Ciprinol 500 mg film-coated tablets
The tablets are white, oval, film-coated, plain on one side, with a
score line on the reverse.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Ciprinol 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 exacerbation of chronic obstructive pulmonary disease,
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.
-
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 cystitis
In uncomplicated acute cystitis ciprofloxacin should be used only when
it is cons