Levofloxacine Torrent 500 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVOFLOXACINE 0,5-WATER SAMENSTELLING overeenkomend met ; LEVOFLOXACINE

Beschikbaar vanaf:

Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)

ATC-code:

J01MA12

INN (Algemene Internationale Benaming):

LEVOFLOXACIN 0,5-WATER COMPOSITION corresponding to ; LEVOFLOXACIN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Levofloxacin

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Autorisatie datum:

2010-11-17

Bijsluiter

Levofloxacin Torrent 500 mg film-coated tablets– NL/H/1734/002/DC
NL (English) PL
NL/P/007/12/17
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN TORRENT 500 MG, FILMOMHULDE TABLETTEN
Levofloxacin
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 [Product name]
_ _
is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
The name of your medicine is [Product name].
[Product name] contain a medicine called levofloxacin. This belongs to
a group of medicines
called antibiotics. Levofloxacin is a ‘quinolone’ antibiotic. It
works by killing the bacteria
that cause infections in your body.
[PRODUCT NAME] CAN BE USED TO TREAT INFECTIONS OF THE:
▪
Sinuses
▪
Lungs, in people with long-term breathing problems or pneumonia
▪
Urinary tract, including your kidneys or bladder
▪
Prostate gland, where you have a long lasting infection
▪
Skin and underneath the skin, including muscles. This is sometimes
called ‘soft
tissue’
In some special situations, [Product name] may be used to lessen the
chances of getting a
pulmonary disease named anthrax or worsening of the disease after you
are exposed to the
bacteria causing anthrax.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME] AND TELL YOUR DOCTOR IF:
▪
You are allergic to levofloxacin, any ot

Productkenmerken

Levofloxacin Torrent 250/500 mg film-coated tablets–
NL/H/1734/001-002/DC
NL (English) SPC
NL/S/005/12/11
1
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Levofloxacin Torrent 250 mg, filmomhulde tabletten
Levofloxacin Torrent 500 mg, filmomhulde tabletten
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet of Levofloxacin Torrent 250 mg contains 250 mg
of levofloxacin as
levofloxacin hemihydrate.
Each film-coated tablet of Levofloxacin Torrent 500 mg contains 500 mg
of levofloxacin as
levofloxacin hemihydrate.
For the full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Film-coated tablet
Levofloxacin Torrent 250 mg film-coated tablet
Light pink coloured capsule shaped film-coated tablets debossed with
break line on both
sides, separating “2” & “50” on one side and “10” &
“82” on other side.
The tablet can be divided into equal doses.
Levofloxacin Torrent 500 mg film-coated tablet
Brick red coloured capsule shaped film-coated tablets debossed with
break line on both sides,
separating “8” & “3” on one side and plain on other side.
The tablet can be divided into equal doses.
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacin Torrent is indicated in adults for the treatment of the
following infections (see
sections 4.4 and 5.1):
▪
Acute Pyelonephritis and complicated urinary tract infections
(see section 4.4)
▪
Chronic bacterial prostatitis.
▪
Inhalation
Anthrax:
postexposure
prophylaxis
and
curative
treatment
(see
section 4.4)
In the following indications, Levofloxacin Torrent should be used only
when it is considered
inappropriate to use other antibacterial agents that are commonly
recommended for the
treatment of these infections.
▪
Acute exacerbations of chronic obstructive pulmonary disease including
bronchitis
▪
Acute bacterial sinusitis
▪
Community-acquired pneumonia
Levofloxacin Torrent 250/500 mg film-coated tablets–
NL/H/1734/001-002/DC
NL (English) SPC
NL/S/005/12/11
2
▪
Complicated skin