Cipro-Denk 500 tablets film-coated

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

ciprofloxacin (ciprofloxacin hydrochloride)

Tersedia dari:

Allphamed PHARBIL Arzneimittel GmbH

Kode ATC:

J01MA02

INN (Nama Internasional):

ciprofloxacin (ciprofloxacin hydrochloride)

Dosis:

500mg

Bentuk farmasi:

tablets film-coated

Unit dalam paket:

(10/1x10/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2016-11-10

Selebaran informasi

_Cipro-Denk 500_
Film-coated tablet – oral use
Antibiotic – fluoroquinolone
Active substance: ciprofloxacin
Package leaflet:
Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CON-
TAINS 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 CIPRO-DENK 500 IS AND
WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CIPRO-DENK 500
3.
HOW TO TAKE CIPRO-DENK 500
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CIPRO-DENK 500
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Cipro-Denk 500 is and what
it is used for
Cipro-Denk 500 contains the active substance
ciprofloxacin. Ciprofloxacin is an antibiotic
belonging
to
the
fluoroquinolone
group.
Ciprofloxacin works by killing bacteria that
cause infections. It only works in certain strains
of bacteria.
Adults
Cipro-Denk 500 is used in adults to treat the
following bacterial infections:
•
certain respiratory tract infections
•
certain forms of ear or sinus inflammations
•
urinary tract infections
•
infections of the male and female genitalia
•
infections of the gastrointestinal tract and
infections of the abdominal cavity
•
certain skin and soft-tissue infections
•
infections of the bones and joints
•
to prevent infections caused by the bacteri-
um _Neisseria meningitidis_
•
treatment after inhalation of anthrax path-
ogens.
Ciprofloxacin may be used in the management
of patients with a low number of certain white
blood cells (neutropenia) and fever and that is
suspected to be due to a bacterial infection.
If you have a severe infection or an infection
caused

Karakteristik produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cipro-Denk 500
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: ciprofloxacin
Each film-coated tablet contains 500 mg ciprofloxacin (as
ciprofloxacin hydrochloride).
Excipient with known effect: Each film-coated tablet contains less
than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, oblong film-coated tablets with a score on both sides and
imprint “Cipro 500” on one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cipro-Denk 500 is indicated for the treatment of the following
infections (see sections 4.4 and 5.1).
Before the start of treatment, particular consideration should be
given to the available information on
resistance.
Adults

Lower respiratory tract infections caused by Gram-negative bacteria:
-
bronchopulmonary infections in cystic fibrosis or in bronchiectasis
-
pneumonia

Genital tract infections
-
gonococcal urethritis and cervicitis caused by suspectible _Neisseria
gonorrhoeae_
-
epididymo-orchitis, including cases caused by suspectible _Neisseria
gonorrhoeae _
-
pelvic inflammatory disease, including infections caused by
suspectible _Neisseria _
_gonorrhoeae_

Chronic suppurative otitis media

Malignant external otitis

Acute exacerbation of chronic sinusitis especially when caused by
Gram-negative bacteria

Acute pyelonephritis

Complicated urinary tract infections

Bacterial prostatitis

Infections of the gastrointestinal tract

Intra-abdominal infections
2

Infections of the skin and soft tissues, caused by Gram-negative
bacteria

Infections of the bones and joints

Prophylaxis of invasive infections caused by _Neisseria meningitides_

Inhalation of anthrax pathogens (post-exposure prophylaxis and
curative treatment)

Ciprofloxacin may be used in the management of neutropenic patients
with fever that is
suspected to be due to a bacterial