LINEZOLID

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LINEZOLID (FORM III)

Available from:

Accord Healthcare Limited

ATC code:

J01XX08

INN (International Name):

LINEZOLID (FORM III)

Dosage:

600 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

oral use

Units in package:

1, 10, 20, 30, 50, 60 or 100 tablets

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

Accord Healthcare Limited

Therapeutic group:

Antibacterials for systemic use; Other antibacterials

Therapeutic area:

linezolid

Therapeutic indications:

Linezolid is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria. In determining whether linezolid is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Gram positive bacteria should be taken into consideration. (See section 5.1 for the appropriate organisms).

Authorization status:

Marketed

Authorization date:

2015-10-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 600 MG FILM-COATED
TABLETS
Linezolid
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,
pharmacist or nurse.
-
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, pharmacist
or nurse
. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS
LEAFLET
:
1.
What Linezolid tablet is and what it is used
for
2.
What you need to know before you take
Linezolid tablets
3.
How to take
Linezolid tablets
4.
Possible side
effects
5.
How to store
Linezolid tablets
6.
Contents of the pack and other information
1.
WHAT LINEZOLID
TABLET IS AND WHAT IT IS USED
FOR
Linezolid is an antibiotic of the oxazolidinones group that works by
stopping the growth of certain
bacteria
(germs) that cause infections. It is used to treat pneumonia and some
infections in the skin or
under the
skin.
Your doctor will have decided if Linezolid is suitable to treat your
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LINEZOLID TABLETS
DO NOT TAKE LINEZOLID TABLETS
:

if you are allergic (hypersensitive) to linezolid or any of the other
ingredients of this
medicine
(listed in section 6).

if you are taking or have taken within the last 2 weeks any medicines
known as monoamine
oxidase
inhibitors
(MAOIs, for example phenelzine, isocarboxazid, selegiline,
moclobemide).
These medications may be used to
treat
depression or Parkinson’s
disease.

if you are breast-feeding. This is because it passes into breast milk
and could affect the
baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Linezolid
tablets.
Linezolid
tablets
may not be suitable for you if you answer YES to any of the following
questi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 600 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg linezolid.
Excipient(s) with known effect:
Each tablet contains 0.82 mg soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval shaped, approximately 18.5 mm in length and
9.5 mm in width, biconvex, film coated tablets,
debossed with “EQ1” on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid is indicated in adults for the treatment of community
acquired pneumonia and nosocomial pneumonia when
known or suspected to be caused by susceptible Gram positive bacteria.
In determining whether linezolid is an
appropriate treatment, the results of microbiological tests or
information on the prevalence of resistance to antibacterial
agents among Gram positive bacteria should be taken into
consideration. (See section 5.1 for the appropriate
organisms).
Linezolid is not active against infections caused by Gram negative
pathogens. Specific therapy against Gram negative
organisms must be initiated concomitantly if a Gram negative pathogen
is documented or suspected.
Complicated skin and soft tissue infections (see section 4.4)
Linezolid is indicated in adults for the treatment of complicated skin
and soft tissue infections ONLY when
microbiological testing has established that the infection is known to
be caused by susceptible Gram positive bacteria.
Linezolid is not active against infections caused by Gram negative
pathogens. Linezolid should only be used in patients
with complicated skin and soft tissue infections with known or
possible co-infection with Gram negative organisms if
there are no alternative treatment options available (see section
4.4). In these circumstances treatment against Gram
negative organisms must be initiated concomitantly.
Linezolid should only be initiated