Linezolid Teva 600 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Teva Pharma B.V.

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:

2014-11-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Linezolid Teva
3.
How to take Linezolid Teva
4.
Possible side effects
5.
How to store Linezolid Teva
6.
Contents of the pack and other information
1.
WHAT LINEZOLID TEVA 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 Teva is suitable to treat
your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID TEVA
DO NOT TAKE LINEZOLID TEVA
•
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
Talk to your doctor, pharmacist or nurse before taking Linezolid Teva.
Linezolid Teva 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

Summary of Product characteristics

Health Products Regulatory Authority
31 March 2023
CRN00CYY6
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid Teva 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑ coated tablet contains 600 mg linezolid.
Excipient with known effect:
Each film‑coated tablet contains 195.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet
White, film-coated modified capsule shaped tablet, debossed with 600
on one side. The other side is scored. Dimensions:
approx. 20 x 9 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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 adultsfor 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