Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Levofloxacin
Chanelle Medical
J01MA; J01MA12
Levofloxacin
500 milligram(s)
Film-coated tablet
Fluoroquinolones; levofloxacin
Not marketed
2020-07-03
ID: PL201M (IE) Version: 03 Revision Date: 16/03/2022 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFLOXACIN 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 Levofloxacin Tablets are and what they are used for 2. What you need to know before you take Levofloxacin Tablets 3. How to take Levofloxacin Tablets 4. Possible side effects 5. How to store Levofloxacin Tablets 6. Contents of the pack and other information 1. WHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Levofloxacin Tablets. Levofloxacin 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. LEVOFLOXACIN 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’. For the treatment of sinusitis, exacerbation of chronic obstructive pulmonary disease, bronchitis and uncomplicated cystitis, levofloxacin should only be used when it is not possible to use the antibiotics normally used for the initial treatment of these infections. In some special situations, Levofloxacin Tablets may be used to lessen the chances of getting a read_full_document
Health Products Regulatory Authority 26 April 2022 CRN00CV8L Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofloxacin 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 Light orange coloured, oval shaped, film-coated tablets with ‘500’ debossed on one side and ‘n’ debossed on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin 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) For the below-mentioned infections Levofloxacin Tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial 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) Levofloxacin 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 Levofloxacin 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. Levofloxacin 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 read_full_document