Ciprofloxacin Demipharm tablets film-coated

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

ciprofloxacin

Предлага се от:

Farmalabor - Produtos Farmaceuticos

АТС код:

J01MA02

INN (Международно Name):

ciprofloxacin

дозиране:

500mg

Лекарствена форма:

tablets film-coated

Броя в опаковка:

(1), (8/1x8/) and (16/2x8/) in blister

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2021-06-29

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN DEMIPHARM
500 mg film-coated tablets
Ciprofloxacin
Read all of this leaflet carefully before you start taking this
medicine.
- 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. Do not pass it on to
others; it may harm them even if
their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please inform your doctor or pharmacist.
IN THIS LEAFLET:
1. What Ciprofloxacin Demipharm
is and what it is used for
2. Before you use Ciprofloxacin Demipharm
3. How to use Ciprofloxacin Demipharm
4. Possible side effects
5. How to store Ciprofloxacin Demipharm
6. Further information
1. WHAT CIPROFLOXACIN DEMIPHARM
IS AND WHAT IT IS USED FOR
Ciprofloxacin Demipharm is an antibiotic belonging to the
fluoroquinolone family. The active
substance is ciprofloxacin. Ciprofloxacin works by killing bacteria
that cause infections. It only
works with specific strains of bacteria.
ADULTS
Ciprofloxacin Demipharm is used in adults for the treatment of the
following bacterial infections:
- respiratory tract infections
- long-lasting or recurring ear or sinus infections
- urinary tract infections
- infections of the testicles
- genital tract infections in women
- gastro-intestinal tract infections and intra-abdominal infections
- skin and soft tissue infections
- bone and joint infections
- to treat infections in patients with a very low white blood cell
count (neutropenia)
- to prevent infections in patients with a very low white blood cell
count (neutropenia)
- to prevent infections due to the bacterium _Neisseria meningitidis_
- anthrax inhalation exposure
If you have a severe infection or an infection caused by more than one
type of bacterium, you may
be given additional antibiotic treatment in addition to Ciprofloxacin
Demipharm.
CHILDREN AND ADOLESCENTS
Ciprofloxacin
Demipharm
is
used
in
c

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Demipharm, 500 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION PER TABLET:
CIPROFLOXACIN DEMIPHARM
Active substance:
Ciprofloxacin (as hydrochloride)
500.0 mg
Excipients:
Lactose
48 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Ciprofloxacin Demipharm, 500 mg, film-coated tablets:
White, oblong, biconvex coated tablets, scored on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin Demipharm 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 the available information
on resistance to ciprofloxacin before initiating treatment.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
ADULTS
- Lower respiratory tract infections caused by Gram-negative bacteria:
. exacerbation of chronic obstructive pulmonary disease;
. broncho-pulmonary infections in cystic fibrosis or bronchiectasis;
. pneumonia.
- Chronic suppurative otitis media.
- Acute exacerbation of chronic sinusitis especially if caused by
Gram-negative bacteria.
- Urinary tract infections.
- Gonococcal urethritis and cervicitis.
- Epididymo-orchitis including cases due to _Neisseria gonorrhoeae_.
- Pelvic inflammatory disease including cases due to _Neisseria
gonorrhoeae_.
When it is suspected or known that the aforementioned genital tract
infections are due to _Neisseria _
_gonorrhoeae_, it is particularly important to obtain local
information on the prevalence of resistance
to ciprofloxacin and to confirm susceptibility, based on laboratory
tests.
- Gastrointestinal tract infections (e.g. traveller's 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.
- Treatment of infections in neutropenic patients.
- Prophy