Tavanic 500 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Levofloxacin

제공처:

PCO Manufacturing Ltd.

ATC 코드:

J01MA; J01MA12

INN (International Name):

Levofloxacin

복용량:

500 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

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

치료 영역:

Fluoroquinolones; levofloxacin

승인 상태:

Authorised

승인 날짜:

2013-01-25

환자 정보 전단

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 such
as moxifloxacin,
ciprofloxacin or ofloxacin or any of the oth

제품 특성 요약

Health Products Regulatory Authority
12 April 2023
CRN00DHP5
Page 1 of 2
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 500mg of
levofloxacin as levofloxacin hemihydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy and Greece_
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 E171
Talc
Macrogol
Yellow ferric oxide E172
Red ferric oxide E172
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
Health Products Regulatory Authority
12 April 2023
CRN00DHP5
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/Aluminium blisters containing film-coated tablets.
Pack sizes for 500 mg tablets: 10
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
A score line allows adaptation of the dose in patients with impaired
renal function.
As for all medicines, any unused medicinal product should be disposed
of accordingly and in compliance with local
environmental regulations.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/302/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
January 2013
10 DATE OF REVISION OF THE TEXT
April 2023