Linezolid 600 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Wockhardt UK Limited

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:

Not marketed

Authorization date:

2016-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 600MG 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 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, or pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet.
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 (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.
WARNING 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 treat

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 tablet contains 600 mg linezolid.
Excipient(s) with known effect:
Each Linezolid film-coated tablet contains 139.6 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped 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 adults
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 env