Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Levofloxacin
Sanofi-Aventis Ireland Limited T/A SANOFI
J01MA; J01MA12
Levofloxacin
500 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; levofloxacin
Marketed
1998-01-09
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 01 403 5600 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 Read the complete document
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 Read the complete document