LINEZOLID 600 Milligram Film Coated Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LINEZOLID (FORM II)

Commercializzato da:

Cipla (EU) Limited

Codice ATC:

J01XX08

INN (Nome Internazionale):

LINEZOLID (FORM II)

Dosaggio:

600 Milligram

Forma farmaceutica:

Film Coated Tablet

Tipo di ricetta:

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

Area terapeutica:

Other antibacterials

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-12-16

Foglio illustrativo

DATE : 17-10-2016
21059070
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 TABLET contains active substance linezolid. It 
belongs to group of medicines named other antibacterials.
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 in adults over 18 
years of age. 

  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 breast-feeding. This is because linezolid passes 
into breast milk and could affect the baby. 
WARNINGS AND PRECAUTIONS 
LINEZOLID  

Scheda tecnica

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 tablets
White to off white oval shaped biconvex film coated tablet debossed with CL on one side and plain on other side.
Length – 18.60 ± 0.20 mm
Breadth – 9.70 ± 0.20 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia and 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 treatme