Levoxa 250mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

LEVOFLOXACIN

Tilgængelig fra:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-kode:

J01MA12

INN (International Name):

LEVOFLOXACIN 250 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

LEVOFLOXACIN 250 mg

Recept type:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisation status:

Withdrawn

Autorisation dato:

2008-02-26

Indlægsseddel

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVOXA 250 MG FILM-COATED TABLETS
LEVOXA 500 MG FILM-COATED TABLETS
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 Levoxa tablets are and what they are used for
2.
What you need to know before you take Levoxa tablets
3.
How to take Levoxa tablets
4.
Possible side effects
5.
How to store Levoxa tablets
6.
Contents of the pack and other information
1.
WHAT LEVOXA TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Levoxa tablets. Levoxa tablets 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.
LEVOXA TABLETS 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, Levoxa tablets 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 LEVOXA TABLETS
DO NOT TAKE LEVOXA
•
if you are allergic to levofloxacin, any other quinolone antibiotic
such as moxifloxacin,
ciprofloxacin or ofloxacin or any of the other

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levoxa 250 mg film-coated tablets
Levoxa 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Levoxa contains 250 mg of levofloxacin as
levofloxacin hemihydrate
Each film-coated tablet of Levoxa contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
Excipient(s) with known effect
Each 250 mg film-coated tablet of Levoxa contains 3.84 mg of lactose
monohydrate.
Each 500 mg film-coated tablet of Levoxa contains 7.68 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Levoxa 250 mg film coated tablets
Pink, oval, biconvex tablets, scored on one side and marked with
“L” on the other side. Approximately
13 mm long and 6 mm wide.
The tablet can be divided into equal halves.
Levoxa 500 mg film coated tablets
Pink, oval, biconvex tablets, scored on one side and marked with
“L” on the other side. Approximately
16 mm long and 8 mm wide.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacin 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 below mentioned infections levofloxacin 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 bacterial sinusitis
•
Acute exacerbation of chronic obstructive pulmonary disease including
bronchitis
•
Community-acquired pneumonia
•
Complicated skin and soft tissue infections
•
Uncomplicated cystitis (see section 4.4)
2
Levoxa tablets may also be used to complete a course of therapy in
patients who have shown
improvement during initial treatment with intravenous levo