Ciprofloxacine 500 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 500 mg/stuk

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

J01MA02

INN (Algemene Internationale Benaming):

CIPROFLOXACINEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; ; CIPROFLOXACINE 0-WATER 500 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) ; SILICA, HYDRATE FORM UNKNOWN (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) ; SILICA, HYDRATE FORM UNKNOWN (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); SILICA, HYDRATE FORM UNKNOWN (E 551); STEARINEZUUR (E 570); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2001-09-17

Bijsluiter

Hexal AG
Ciprofloxacine 250 mg 500 mg 750 mg, filmomhulde
tabletten
RVG 27068-70
v16
1.3.1.3 Package leaflet
November 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROFLOXACINE 250 MG, FILMOMHULDE TABLETTEN
CIPROFLOXACINE 500 MG, FILMOMHULDE TABLETTEN
CIPROFLOXACINE 750 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 mana

Productkenmerken

Hexal AG
Page 1/23
Ciprofloxacine 250 mg 500 mg 750 mg, filmomhulde tabletten
RVG 27068-70
V17
1.3.1.1 Samenvatting van de Productkenmerken
November 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ciprofloxacine 250 mg, filmomhulde tabletten
Ciprofloxacine 500 mg, filmomhulde tabletten
Ciprofloxacine 750 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
[Nationally completed name] 100 mg:
Each film-coated tablet contains 100 mg ciprofloxacin (as
hydrochloride monohydrate).
[Nationally completed name] 250 mg:
Each film-coated tablet contains 250 mg ciprofloxacin (as
hydrochloride monohydrate).
[Nationally completed name] 500 mg:
Each film-coated tablet contains 500 mg ciprofloxacin (as
hydrochloride monohydrate).
[Nationally completed name] 750 mg:
Each film-coated tablet contains 750 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
_[Nationally completed name] _
250 mg:
White, round, film-coated tablets, scored on one side with embossment
“cip 250“ on one side
The tablet can be divided into equal doses.
_ _
_[Nationally completed name] _
500 mg:
White, oblong, film-coated tablets, scored on both sides with
embossment “cip 500“ on one side
The tablet can be divided into equal doses.
_[Nationally completed name] _
750 mgs:
White, oblong, film-coated tablets, scored on both sides, with
embossment “cip 750“ on one side
The tablet can be divided into equal doses.
Hexal AG
Page 2/23
Ciprofloxacine 250 mg 500 mg 750 mg, filmomhulde tabletten
RVG 27068-70
V17
1.3.1.1 Samenvatting van de Productkenmerken
November 2020
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