Cefazim-200 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefixime (cefixime trihydrate)

Available from:

Zim Laboratories Ltd.

ATC code:

J01DD08

INN (International Name):

cefixime (cefixime trihydrate)

Dosage:

200mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFAZIM – 200
cefixime 200mg film-coated tablets
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 CEFAZIM – 200 is and what it is used for
2.
What you need to know before you take CEFAZIM – 200
3.
How to take
CEFAZIM – 200
4.
Possible side effects
5.
How to store
CEFAZIM – 200
6.
Contents of the pack and other information
1.
WHAT CEFAZIM – 200 IS AND WHAT IT IS USED FOR
CEFAZIM – 200 contains a medicine called cefixime. This belongs to a
group of antibiotics
called “cephalosporins”.
CEFAZIM – 200 is used to treat infections caused by bacteria.
These include infections of the:

Ear

Nose, sinuses (such as sinusitis)

Throat (such as tonsillitis, pharyngitis)

Chest and lungs (such as bronchitis, pneumonia)

Urinary system (such as cystitis and kidney
infections)
2.
WHAT YOU NEED TO KNOW BEFOR YOU TAKE CEFAZIM – 200
DO NOT TAKE
CEFAZIM – 200
:

if you are allergic to cefixime, any other cephalosporin antibiotics
including
penicillin or to any of the other ingredients of this medicine (listed
in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of
the lips, face, throat and tongue.
Do not take this medicine if the above applies to you. If you are not
sure, talk to your doctor or
pharmacist before taking CEFAZIM – 200.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking CEFAZIM – 200
:

if you have ever had colitis

if you have

Summary of Product characteristics

CEFAZIM – 200
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg cefixime (cefixime trihydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, circular, slightly biconvex, film-coated tablets plain on both
sides.
For oral administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CEFAZIM – 200 is an orally active cephalosporin antibiotic which has
marked _in vitro _bactericidal activity against a wide
variety of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of the following acute infections
when caused by susceptible micro-organisms:
UPPER RESPIRATORY TRACT INFECTIONS (URTI): e.g. otitis media; and
other URTI where the causative organism is known
or suspected to be resistant to other commonly used antibiotics, or
where treatment failure may carry significant risk.
LOWER RESPIRATORY TRACT INFECTION: e.g. bronchitis.
URINARY TRACT INFECTIONS: e.g. cystitis, cystourethritis,
uncomplicated pyelonephritis.
Clinical efficacy has been demonstrated in infections caused by
commonly occuring pathogens including _Streptococcus _
_pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus
mirabilis, Kliebsiella _species, _Haemophilus _
_influenzae _(beta-lactamase positive and negative), _Branhamella
catarrhalis _(beta- lactamase positive and negative)
and _Enterobacter _species. CEFAZIM – 200 is highly stable in the
presence of beta-lactamase enzymes.
Most strains of enterococci (_Streptococcus faecalis_, group D
Streptococci) and Staphylococci (including coagulase
positive and negative strains and meticillin- resistant strains) are
resistant to CEFAZIM – 200. In addition, most strains
of _Pseudomonas, Bacteriodes fragalis, Listeria monocytogenes _and
_Clostridia _are resistant to CEFAZIM – 200.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual course of treatment is 7 days. This may be continued for up
to 14 days if required.
Posology
_ADULTS AND CHILDREN OVER 10 YEARS OR WEIGHING MORE THAN 50 KG_:
The recommended a