Linezolid 600 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

J01XX; J01XX08

INN (International Name):

Linezolid

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Other antibacterials; linezolid

Authorization status:

Marketed

Authorization date:

2015-03-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 600MG 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.
-
The full name of this medicine is Linezolid 600mg Film-coated Tablets
but within the leaflet it
will be referred to as Linezolid Tablets.
WHAT IS IN THIS LEAFLET
1.
What Linezolid Tablets are and what they are 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 TABLETS ARE AND WHAT THEY ARE USED FOR
Linezolid Tablets are an antibiotic of the oxazolidinones group that
work 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
Tablets are 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 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 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
Linezolid Tablets may not be suitab

Summary of Product characteristics

Health Products Regulatory Authority
05 October 2018
CRN008HK8
Page 1 of 22
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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, biconvex oval tablet, 9.3 mm x 19 mm. The tablet has “L” on
one side and
“600” on the opposite 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.
Health Products Regulatory Authority
05 October 2018
CRN008HK8
Page 2 of 22
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