LINEZOLID SANDOZ FILM-COATED TABLETS 600MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LINEZOLID

Available from:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (International Name):

LINEZOLID

Units in package:

100 Tablets; 30 Tablets

Manufactured by:

S.C. Sandoz S.R.L.

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
LINEZOLID SANDOZ
® FILM-COATED
TABLETS 600MG
Linezolid(600mg)
WHAT IS IN THIS LEAFLET:
1.
What Linezolid Sandoz is
used for
2.
How Linezolid Sandoz
works
3.
Before you use Linezolid
Sandoz
4.
How to use Linezolid
Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Linezolid Sandoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LINEZOLID SANDOZ IS USED
FOR
Linezolid Sandoz is used to treat
pneumonia and some infections
in the skin or under the skin.
Your doctor will decide if
Linezolid Sandoz is suitable to
treat your infection.
HOW LINEZOLID SANDOZ WORKS
Linezolid Sandoz is an antibiotic
of the oxazolidinones group that
works by stopping the growth of
certain bacteria (germs) that
cause infections.
BEFORE YOU USE LINEZOLID
SANDOZ
-
_When you must not use it _
Do not take Linezolid Sandoz
if you are
•
allergic to linezolid or any
of the other ingredients of
this medicine.
•
taking or have taken within
the last 2 weeks any
medicines known as
monoamine oxidase
inhibitors (MAOIs for
example phenelzine,
isocarboxazid, selegiline,
moclobemide). These may
be used to treat depression
or Parkinson’s disease.
•
breast-feeding. This is
because it passes into breast
milk and could affect the
baby.
-
_Before you start to use it _
Consult your doctor or
pharmacist before taking
Linezolid Sandoz if you are
having or have had the following
conditions:
•
high blood pressure
•
diagnosed with an
overactive thyroid
•
diagnosed with tumour of
the adrenal glands
(phaeochromocytoma) or
carcinoid syndrome (caused
by tumours of the hormone
system with symptoms of
diarrhoea, flushing of the
skin, wheezing)
•
suffer from manic
depression, schizoaffective
disorder, mental confusion
or other mental problems
•
history of seizures
•
kidney or liver problems
-
_Taking other medicines _
There is a risk that Linezolid
Sandoz may sometimes interact
with certain other medicines to
cause side effects such

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Sandoz
®
Film-Coated Tablets 600mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of linezolid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white colored biconvex oval shaped film-coated tablet
with “LZ600” debossed on one side and
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Linezolid formulations are indicated in the treatment of the following
infections caused by susceptible strains
of the designated microorganisms. Linezolid is active against
Gram-positive bacteria only. Linezolid has no
clinical
activity
against
Gram-negative
pathogens.
Specific
Gram-negative
therapy
is
required
if
a
concomitant Gram-negative pathogen is documented or suspected (See
sections 4.4 and 5.1).
Vancomycin-Resistant _Enterococcus faecium_ infections, including
cases with concurrent bacteremia.
Nosocomial pneumonia caused by _Staphylococcus aureus_
(methicillin-susceptible and -resistant strains), or
_Streptococcus pneumoniae_ (penicillin-susceptible strains).
Combination therapy may be clinically indicated
if the documented or presumptive pathogens include Gram-negative
organisms.
Complicated skin and skin structure infections including diabetic foot
infections, without concomitant
osteomyelitis
caused
by
_Staphylococcus _
_aureus_
(methicillin-susceptible
and
-resistant
strains),
_Streptococcus pyogenes_, or _Streptococcus agalactiae_. Linezolid has
not been studied in the treatment of
decubitus ulcers. Combination therapy may be clinically indicated if
the documented or presumptive
pathogens include Gram-negative organisms.
Uncomplicated skin and skin structure infections caused by
_Staphylococcus aureus_ (methicillin-susceptible
only) or _Streptococcus pyogenes_.
Community-acquired pneumonia caused by _Streptococcus pneumoniae_
(penicillin-susceptible strains only),
including cases with concurrent bacterem