Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
LEVOFLOXACIN
Rowex Ltd
LEVOFLOXACIN
500 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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. WHAT IS IN THIS LEAFLET 1. What Levofloxacin is and what it is used for 2. What you need to know before you take Levofloxacin 3. How to take Levofloxacin 4. Possible side effects 5. How to store Levofloxacin 6. Contents of the pack and other information 1. WHAT LEVOFLOXACIN IS AND WHAT IT IS USED FOR The name of your medicine is Levofloxacin 500 mg Film-Coated Tablets. Levofloxacin 500 mg Film- Coated 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’ In some special situations, Levofloxacin 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 LEVOFLOXACI Izlasiet visu dokumentu
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 levofloxacin hemihydrate equivalent to 500 mg levofloxacin. Excipient(s): Contains 26.54 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light orange-pink, octagonal, biconvex film-coated tablet, with a score line on one side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin 500 mg Film-Coated Tablets are indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): • Acute bacterial sinusitis • Acute exacerbations of chronic bronchitis • Community-acquired pneumonia • Complicated skin and soft tissue infections For the above-mentioned infections Levofloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections. • Pyelonephritis and complicated urinary tract infections (see section 4.4) • Chronic bacterial prostatitis • Uncomplicated cystitis (see section 4.4) • Inhalation Anthrax: post exposure prophylaxis and curative treatment (see section 4.4) Levofloxacin film-coated 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 film-coated 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. L Izlasiet visu dokumentu