Ciprofloxacin-Asteria Tab. 500mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ciprofloxacin (ciprofloxacin hydrochloride)

Available from:

Hankook Korus Pharm Co.

ATC code:

J01MA02

INN (International Name):

ciprofloxacin (ciprofloxacin hydrochloride)

Dosage:

500mg

Pharmaceutical form:

tablets film-coated

Units in package:

(20/2x10/) in blister, (100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-07-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROFLOXACIN-ASTERIA TAB. 500MG
(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 Ciprofloxacin-Asteria Tab. is and what it is used for
2.
What you need to know before you take Ciprofloxacin-Asteria Tab.
3.
How to take Ciprofloxacin-Asteria Tab.
4.
Possible side effects
5.
How to store Ciprofloxacin-Asteria Tab.
6.
Contents of the pack and other information
1.
WHAT CIPROFLOXACIN-ASTERIA TAB. IS AND WHAT IT IS USED FOR
Ciprofloxacin-Asteria Tab. 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
Ciprofloxacin-Asteria Tab. is used in adults to treat the following
bacterial infections:
-
respiratory tract infections
-
long lasting or recurring ear or sinus infections
-
urinary tract infections. Ciprofloxacin should be used only when it is
considered
inappropriate to use other antibacterial agents that are commonly
recommended for the
tratement of these 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 s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTIC (SPC) OF
CIPROFLOXACIN-ASTERIA TAB. 500MG
1.
NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin-Asteria Tab. 500mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/ Tab.
1
Ciprofloxacin
Hydrochloride
582mg (500mg as
ciprofloxacin)
Excipients
No.
Chemical Name
Quantity/ Tab.
1
Lactose
56 mg
2
Corn starch
50 mg
3
Hydroxypropyl cellulose
14 mg
4
Sodium starch glycolate
8 mg
5
Magnesium stearate
10 mg
6
Hydroxypropyl-
methylcellulose 2910
8 mg
7
Polyethylene Glycol 6000
4 mg
8
Titanium oxide
3 mg
9
Methylene chloride
q.s
10
Ethanol
q.s
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL CHARACTERISTICS
4.1
THERAPEUTIC INDICATIONS
Ciprofloxacin-Asteria 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
-
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. Ciprofloxacin should be used only when it is
considered inappropriate to
use other antibacterial agents that are commonly recommended for the
tratement of these infections.
•
Genital tract infections
-
gonococcal uretritis 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-negat