Linezolid 600mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Linezolid

Available from:

Genus Pharmaceuticals Ltd

ATC code:

J01XX08

INN (International Name):

Linezolid

Dosage:

600mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 0511309004717

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor 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 (hypersensitive) to linezolid or any of the other
ingredients of this
medicine
•
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
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
t

Summary of Product characteristics

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.
Excipient with known effect: Also contains 139.6 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets (tablet)
White to off white, oval shaped, bevel edged, biconvex film coated
tablets
debossed with ‘H’ on one side and ‘L8’ on the other side. The
tablet
dimensions are 18.4 ± 0.2 mm x 9.6 ± 0.2 mm.
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.
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.
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