Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Levofloxacin
PCO Manufacturing Ltd.
J01MA; J01MA12
Levofloxacin
500 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; levofloxacin
Authorised
2013-01-25
_ _ _ _ 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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ