Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Levofloxacin hemihydrate
KRKA, d.d., Novo mesto
J01MA; J01MA12
Levofloxacin hemihydrate
500 milligram(s)
Film-coated tablet
oral use
1, 5, 7, 10 or 14 film-coated tablets in a box
Product subject to prescription which may not be renewed (A)
PHARMATHEN S.A.
quinolone antibacterials, fluoroquinolones
Fluoroquinolones; levofloxacin
It 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 bronchitis. - Community-acquired pneumonia. - Complicated skin and soft tissue infections
Marketed
2015-03-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Levofloxacin Krka 250 mg film-coated tablets Levofloxacin Krka 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 Krka is and what it is used for 2. What you need to know before you take Levofloxacin Krka 3. How to take Levofloxacin Krka 4. Possible side effects 5. How to store Levofloxacin Krka 6. Contents of the pack and other information 1. WHAT LEVOFLOXACIN KRKA IS AND WHAT IT IS USED FOR The name of your medicine is Levofloxacin Krka tablets. Levofloxacin Krka 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 KRKA 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 Krka 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 KRKA DO NOT TAKE LEVOFLOXACIN KRKA AND TELL YOUR DOCTOR: - if you are allergic to levofloxacin, any other quinolone anti Läs hela dokumentet
Health Products Regulatory Authority 07 February 2024 CRN00F09T Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofloxacin Krka 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg levofloxacin as levofloxacin hemihydrate. Excipient with known effect: Sunset yellow FCF (E110) 0.038 mg (mg/tablet) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 500 mg film-coated tablets are orange, oblong, biconvex, tablets with a scoreline and dimensions 19.3 mm x 7.8 mm and thickness 5.0 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin Krka 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: post exposure prophylaxis and curative treatment (see section 4.4) In the below-mentioned infections Levofloxacin Krka 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) Levofloxacin Krka 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 Krka 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. Health Products Regulatory Authority 07 February 2024 CRN00F09T Page 2 o Läs hela dokumentet