Grampolid 600 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LINEZOLID 600 mg/stuk

Beschikbaar vanaf:

Synthon B.V. Microweg 22 6545 CM NIJMEGEN

ATC-code:

J01XX08

INN (Algemene Internationale Benaming):

LINEZOLID 600 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Linezolid

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

M1.3.1_03.LII.tab.001.04.NL.3013.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
GRAMPOLID 600 MG, FILMOMHULDE TABLETTEN
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 Grampolid is and what it is used for
2.
What you need to know before you take Grampolid
3.
How to take Grampolid
4.
Possible side effects
5.
How to store Grampolid
6.
Contents of the pack and other information
1.
WHAT GRAMPOLID IS AND WHAT IT IS USED FOR
Grampolid is a medicine containing an active substance called
linezolid. Grampolid
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
Grampolid
is suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRAMPOLID
DO NOT TAKE GRAMPOLID
•
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 may be used to treat depression or Parkinson’s disease.
•
If you are breastfeeding. This is because it 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 wi

Productkenmerken

M1.3.1_01.LII.tab.002.01.NL.3013.02
1
NAME OF THE MEDICINAL PRODUCT
Grampolid 600 mg, filmomhulde tabletten
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 to off-white, oblong (approximately 18 mm x 6 mm), biconvex film
coated tablets
debossed with “L9II 600” on one 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 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.
Linezolid should only be initiated in a hospital environment and after
consultation with a
relevant specialist such as a microbiologist or infectious diseas