Tavanic 250 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:

250 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

16/08/2021 11:39 - VISTAlink folder 4142241 - Page 1/7
_créé le_
_par_
_modifié le_
_par_
09/12/2020
DERIGNY C
14/06/2021
DERIGNY C
SANOFI
IRLANDE
_Laboratoires_
_Pays_
_Couleur_
_Nbre/Réf._
_Version N°_
_Type Article_
_Nom du produit_
_Référence article_
_Dosage_
_Quantité_
_N° version Logo/Name_
_N° version Country Ex._
_N° plan Dimensionnel_
_N° plan positionnement_
_Dimensions_
_Taille mini caractères_
_Code sécurité_
R790360
N.A.
CRIE-V1-10/09/2012
1-606251
606251-1A
150 X 210 MM
9 PTS
2
NOTICE TRIPLE
TAVANIC
R790360
250 MG & 500 MG
CPRS
1
PANTONE REFLEX BLUE U
_Numéro de pages_
1/6
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

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2021
CRN00C2N2
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tavanic 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Tavanic 250 mg contains 250 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