Zyvox 600 mg Film-Coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
01-12-2022
Summary of Product characteristics
(SPC)
01-12-2022
Active ingredient:
Linezolid
Available from:
Pfizer Healthcare Ireland
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:
2001-07-27
Patient Information leaflet
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYVOX 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zyvox is
and what it is used for
2.
What you need to know before you take Zyvox
3.
How to take Zyvox
4.
Possible side effects
5.
How to store Zyvox
6.
Contents of the pack and other information
1.
WHAT ZYVOX IS AND WHAT IT IS USED FOR
Zyvox 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 Zyvox is suitable to
treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYVOX
DO NOT TAKE ZYVOX
:
•
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 Zyvox passes into breast
milk and could affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Zyvox.
Zyvox
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
duri
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
01 December 2022
CRN00CS50
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zyvox 600 mg 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, ovaloid tablet debossed with “ZYV” on one side and 600 on
the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Zyvox 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 Zyvox 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)
Zyvox 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.
Linezolid should only be initiated in a hospital environment and after
consultation with a relevant specialist such as a
microbiologist or infectiou
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