Linezolid 600mg Film-coated Tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

linezolid

Available from:

Actavis Group PTC ehf

ATC code:

J01XX08

INN (International Name):

linezolid

Dosage:

600mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Packs of 1, 10, 20, 30, 50 or 60 tablets.

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Actavis ehf

Therapeutic group:

Other antibacterials

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.

Authorization status:

Authorised

Authorization date:

2015-03-03

Patient Information leaflet

_Continued top of next column _
AAAH6505
Linezolid 600mg film-coated tablets PIL - UK/Eire
item no: 
print proof no: 
origination date: 
originated by:
revision date:  
revised by: 
dimensions:  
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1.
2.
3.
4.
5.
6.
1.
2.
3.
date sent:  
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
Black
AAAH6505
3
11.02.15
DR
23.02.15
DR
Actavis Iceland
190x380
7pt (Body text 9pt min)
11.02.15
12.02.15
LINEZOLID 600MG FILM-COATED TABLETS
Linezolid
_Continued over page_
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.
•  
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 NEE

Summary of Product characteristics

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 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 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 negati