CIPRODEX 500

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CIPROFLOXACIN AS HYDROCHLORIDE

متاح من:

DEXCEL LTD, ISRAEL

ATC رمز:

J01MA02

الشكل الصيدلاني:

CAPLETS

تركيب:

CIPROFLOXACIN AS HYDROCHLORIDE 500 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DEXCEL LTD, ISRAEL

المجموعة العلاجية:

CIPROFLOXACIN

المجال العلاجي:

CIPROFLOXACIN

الخصائص العلاجية:

* Adults :Broad spectrum antibiotic for infections caused by ciprofloxacin sensitive pathogens. * Children and adolescents:• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa• Complicated urinary tract infections and pyelonephritis• Inhalation anthrax (post-exposure prophylaxis and curative treatment)Ciprofloxacin may also be used to treat severe infections in children and adolescents when there is no other alternative .Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents

تاريخ الترخيص:

2021-10-31

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS)
– 1986
This medicine can be sold with a physician’s prescription
only
CIPRODEX
®
500, CAPLETS
EACH CAPLET CONTAINS ciprofloxacin as hydrochloride at a dose of 500
mg.
Inactive ingredients and allergens in the medicine
–
see section 6 "Additional information"
and in section 2 "Important information about some of the ingredients
of the medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about the medicine. If you have any
further questions, ask your
physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if you think that their illness is similar.
1. WHAT IS THE MEDICINE USED FOR?
CIPRODEX 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
Treatment for children and adolescents, under specialist medical
supervision, to treat the
following bacterial infections:

lung and bronchial infections in children and adolescents suffering
from cystic fibrosis

complicated urinary tract infections, including infections that have
reached the kidneys
(pyelonephritis).

anthrax inhalation exposure.

CIPRODEX may also be used to treat other specific severe infections in
children and
adolescents when your doctor considered this necessary.
THERAPEUTIC GROUP: antibiotic of the fluoroquinolone group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are hypersensitive (allergic) to the active ingredient
(ciprofloxacin), to other
medicines of the quinolone group or to one of the additional
ingre

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CIPRODEX 500 caplets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each caplet contains 500mg ciprofloxacin (as hydrochloride).
Excipient with known effect:
Each caplet of Ciprodex 500 contains approximately 46 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Caplet
White to Off-white, biconvex, caplet, scored on both sides.
The caplets can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprodex 500 caplets 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
Broad spectrum antibiotic for infections caused by ciprofloxacin
sensitive pathogens.

Lower respiratory tract infections due to Gram-negative bacteria
-
Exacerbations of chronic obstructive pulmonary disease
-
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

Genital tract infections
-
Gonococcal urethritis and cervicitis due to susceptible _Neisseria
gonorrhoeae_
-
epididymo-orchitis including cases due to susceptible _Neisseria
gonorrhoeae_
-
pelvic inflammatory disease including cases due to susceptible
_Neisseria gonorrhoeae_

Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea)

Intra-abdominal infections

Infections of the skin and soft tissue caused by Gram-negative
bacteria

Malignant external otitis

Infections of the bones and joints

Prophylaxis of invasive infections due to _Neisseria meningitidis_

Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may be used in the management of neutro