Linezolid 600 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Rowex 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:

2014-08-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 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 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)

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.
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 your general health and
your blood pressure before and
during your treatment, or may decide that another treatment is better
for you.
Ask your doctor if you are

Summary of Product characteristics

Health Products Regulatory Authority
22 April 2020
CRN009MR9
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 600 mg Film-Coated Tablets
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,
18.8 mm long, 9.9 mm wide and 6.4 mm thick with "LZ600"
debossed on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Nosocomial pneumonia
- Community acquired pneumonia
Linezolid is indicated 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 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 in a ho