LINEZOLID 600 Milligram Film Coated Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LINEZOLID

Commercializzato da:

Fresenius Kabi Limited

Codice ATC:

J01XX08

INN (Nome Internazionale):

LINEZOLID

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:

2017-06-16

Foglio illustrativo

_Linezolid tablets– Package leaflet – May.2017 _
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 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 an

Scheda tecnica

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 Gram negative organisms must be
initiated concomitantly.
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