Ciprofloxacine Sandoz 100 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

CIPROFLOXACINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; ; CIPROFLOXACINE 0-WATER 100 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J01MA02

INN (Algemene Internationale Benaming):

CIPROFLOXACINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; ; CIPROFLOXACINE 0-WATER 100 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ciprofloxacin

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); POVIDON (E 1201); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2002-08-06

Bijsluiter

Sandoz BV
Page 1/9
Ciprofloxacine 100 mg, filmomhulde tabletten
RVG 26342
1313-V19
1.3.1.3 Bijsluiter
Januari 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROFLOXACINE SANDOZ 100 MG, FILMOMHULDE TABLETTEN
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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] 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 _
[nationally completed name] 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

Productkenmerken

Sandoz BV
Page 1/21
Ciprofloxacine 100 mg, filmomhulde tabletten
RVG 26342
1311-V18
1.3.1.1 Summary of Product Characteristics
Januari 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ciprofloxacine Sandoz 100 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
[Nationally completed name] 100 mg:
Each film-coated tablet contains 100 mg ciprofloxacin (as
hydrochloride monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_[Nationally completed name] _
100 mg:
White, round, film-coated tablets with embossment “cip 100“ on one
side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[nationally completed name] 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.
_Adults _
•
Lower respiratory tract infections due to Gram-negative bacteria
−
exacerbations of chronic obstructive pulmonary disease
o
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
•
Uncomplicated acute cystitis
o
In 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 g