Linezolid 600mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Fresenius Kabi Deutschland GmbH

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:

Not marketed

Authorization date:

2017-06-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USE
LINEZOLID 600 MG FILM-COATED TABLETS
For adults
Linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 is and what it is used for
2. What you need to know before you take Linezolid
3. How to take Linezolid
4. Possible side effects
5. How to store Linezolid
6. Contents of the pack and other information
1. WHAT LINEZOLID 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 in adults
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
DO NOT TAKE LINEZOLID
:

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 medications may be used to treat depression or Parkinson’s
disease;

if you are breastfeeding. This is because Linezolid passes into breast
milk and could affect
the baby.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE TAKING LINEZOLID
Linezolid may not be suitable for you if you answer
YES
to any of the following questions. In this
case tell your doctor as he/she will need to check you

Summary of Product characteristics

Health Products Regulatory Authority
13 October 2021
CRN009ZPT
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 600mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg of linezolid.
Excipient(s) with known effect:
Each Linezolid film-coated tablet contains 133 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
White to off white, oval shaped, approx. 18.4 mm in length and 9.6 mm
in width film-coated tablet with 'H' on one side and 'L8'
on the 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 mixed infection with 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 Gr