Tavanic 500mg film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOFLOXACIN

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

J01MA12

INN (International Name):

LEVOFLOXACIN 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LEVOFLOXACIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2008-01-04

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
TAVANIC 250 MG FILM
COATED TABLETS
TAVANIC 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 Tavanic tablets are and what they are used for
2.
What you need to know before you take Tavanic tablets
3.
How to take Tavanic tablets
4.
Possible side effects
5.
How to store Tavanic tablets
6.
Contents of the pack and other information
1.
WHAT TAVANIC TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Tavanic tablets. Tavanic 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.
TAVANIC 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, Tavanic 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 TAVANIC TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic to levofloxacin, any other quinolone antibiotic s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERIST
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NAME OF THE MEDICINAL PRODUCT
Tavanic 500 mg film-coated tablets
1
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Tavanic 500 mg contains 500 mg of
levofloxacin as levofloxacin hemihydrate.
For the full list of excipients, see section 6.1.
2
PHARMACEUTICAL FORM
Film-coated tablet.
Score line pale yellowish-white to reddish-white film-coated tablets.
The tablet can be divided into equal
halves.
3
CLINICAL PARTICULARS
3.1
THERAPEUTIC INDICATIONS
Tavanic 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 Tavanic 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 exacerbations of chronic obstructive pulmonary disease including
bronchitis
•
Community-acquired pneumonia
•
Complicated skin and soft tissue infections
•
Uncomplicated cystitis (see section 4.4)
Tavanic may also be used to complete a course of therapy in patients
who have shown improvement during
initial treatment with intravenous levofloxacin.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
3.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tavanic tablets are administered once or twice daily. The dosage
depends on the type and severity of the
infection and the susceptibility of the presumed causative pathogen.
Tavanic tablets may also be used to complete a course of therapy in
patients who have shown improvement
during initial treatment with intravenous levofloxacin; given the
bioequivalence of the parenteral and oral
forms, the same dosage can be used.
Posology
The following dose recommendations can be given for Ta