Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Levofloxacin
McDermott Laboratories Ltd., T/A Gerard Laboratories
J01MA; J01MA12
Levofloxacin
500 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; levofloxacin
Marketed
2009-03-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAVAGER 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 effect, 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 Tavager is and what it is used for 2. What you need to know before you take Tavager 3. How to take Tavager 4. Possible side effects 5. How to store Tavager 6. Contents of the pack and other information. 1. WHAT TAVAGER IS AND WHAT IT IS USED FOR Tavager belongs to a group of medicines called antibiotics. Tavager is a ‘quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body. Tavager 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 ▪ Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’ In some special situations, Tavager 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 TAVAGER DO NOT TAKE TAVAGER 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: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue ▪ You have ever had epilepsy ▪ You have ever had a problem with your Perskaitykite visą dokumentą
Health Products Regulatory Authority 05 September 2022 CRN00CM20 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tavager 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg of levofloxacin as levofloxacin hemihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, capsule shaped, biconvex, film-coated tablet, debossed with “LVO” scoreline “500” on one side and “G” scoreline “G” on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tavager tablets are indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): • Community-acquired pneumonia • Acute pyelonephritis and complicated urinary tract infections (see section 4.4) • Bacterial prostatitis • Inhalation Anthrax (post-exposure prophylaxis and curative treatment) (see section 4.4). For the below-mentioned infections Tavager tablets 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 exacerbation of chronic obstructive pulmonary disease including bronchitis • Complicated skin and soft tissue infections • Uncomplicated cystitis (see section 4.4) Tavager tablets 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 Tavager 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. Tavager tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intra Perskaitykite visą dokumentą