TAVANIC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOFLOXACIN

Available from:

LTT Pharma Limited

ATC code:

J01MA12

INN (International Name):

LEVOFLOXACIN

Dosage:

500 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

levofloxacin

Authorization status:

Authorised

Authorization date:

2017-01-20

Patient Information leaflet

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:
What Tavanic tablets are and what they are used for
What you need to know before you take Tavanic tablets
How to take Tavanic tablets
Possible side effects
How to store Tavanic tablets
Contents of the pack and further information
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.
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 such
as
moxifloxacin, ciprofloxacin or ofloxacin or any of the other
ingredients of
this medicine (listed in section 6)
*
Signs of an allergic reaction include

Summary of Product characteristics

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.
_Product imported from Hungary_
Score line pale yellowish-white to reddish-white film-coated tablets
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA0540/077/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/077/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_TABLET CORE:_
Crospovidone
Hypromellose
Microcrystalline cellulose
Sodium stearyl fumarate.
_TABLET COATING:_
Hypromellose
Titanium dioxide E 171
Talc
Macrogol
Yellow ferric oxide E 172
Red ferric oxide E 172
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
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market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/Aluminium blisters containing film-coated tablets.
Pack sizes for 500 mg tablets: 5 or 10.
Not all pack sizes may be