Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Levofloxacin
Bluefish Pharmaceuticals AB
J01MA; J01MA12
Levofloxacin
500 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; levofloxacin
Marketed
2011-02-11
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFLOXACIN BLUEFISH 250 MG FILM-COATED TABLETS LEVOFLOXACIN BLUEFISH 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 Bluefish is and what it is used for 2. What you need to know before you take Levofloxacin Bluefish 3. How to take Levofloxacin Bluefish 4. Possible side effects 5. How to store Levofloxacin Bluefish 6. Contents of the pack and other information 1. WHAT LEVOFLOXACIN BLUEFISH IS AND WHAT IT IS USED FOR The name of your medicine is Levofloxacin Bluefish tablets. Levofloxacin Bluefish 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 BLUEFISH 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 Bluefish 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 LEVOFLOXACIN BLUEFISH DO NOT TAKE LEVOFLOXACIN BLUEFISH 2 - if you are allergic to Izlasiet visu dokumentu
Health Products Regulatory Authority 26 August 2022 CRN00D0Q6 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofloxacin Bluefish 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains levofloxacin hemihydrate equivalent to levofloxacin 500 mg. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Pink coloured, capsule shaped, biconvex, film coated tablet with dimensions of 16 x 8 mm and break line on both sides. Debossed ‘L’ and ‘V’ on either side of the break line on one face. The tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin Bluefish is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1). - Acute bacterial sinusitis - Acute exacerbations of chronic obstructive pulmonary disease including bronchitis - Uncomplicated cystitis (see section 4.4) - Community-acquired pneumonia - Complicated skin and soft tissue infections For the above-mentioned infections Levofloxacin Bluefish 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 pyelonephritis and complicated urinary tract infections (see section 4.4) - Chronic bacterial prostatitis - Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4) Levofloxacin Bluefish 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 Bluefish 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 Bluefish tablets may also be used to complete a course of therap Izlasiet visu dokumentu