Tavanic 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levofloxacin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

J01MA; J01MA12

INN (International Name):

Levofloxacin

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Fluoroquinolones; levofloxacin

Authorization status:

Marketed

Authorization date:

1998-01-09

Patient Information leaflet

TAVANIC 250MG FILM COATED TABLETS
TAVANIC 500MG FILM COATED TABLETS
_Levofloxacin _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP.
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

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2023
CRN00CTPM
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tavanic 500 mg film-coated tablets
2 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
3 PHARMACEUTICAL FORM
Film-coated tablet.
Score line pale yellowish-white to reddish-white film-coated tablets
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 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.
4.2 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