Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levofloxacin hemihydrate
Viatris UK Healthcare Ltd
J01MA12
Levofloxacin hemihydrate
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011200; GTIN: 5016695003689 5016695003696
_LEVOFLOXACIN _ _TABLETS _ _CAN _ _BE _ _USED _ _TO _ _TREAT _ _INFECTIONS OF THE:_ 6. Contents of the pack and other information You should not take fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible. - Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue - If you have any further questions, ask your doctor or pharmacist. 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. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking levofloxacin tablets. - You are 60 years of age or older Before taking this medicine 4. Possible side effects WARNINGS AND PRECAUTIONS - You are breast-feeding - You are pregnant, might become pregnant or think you may be pregnant - You are a child or a growing teenager READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign 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. LEVOFLOXACIN 500 MG FILM-COATED TABLETS - Keep this leaflet. You may need to read it again. PACKAGE LEAFLET: INFORMATION FOR THE USER 5. How to store levofloxacin tablets levofloxacin WHAT IS IN THIS LEAFLET: 1. What levofloxacin tablets are and what they are used for 3. How to take Læs hele dokumentet
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 corresponding to 512.46 mg of levofloxacin hemihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Peach, film-coated capsule shaped tablet, debossed with "LX" on the left side and "500" on the right side of the score on one side, scored and smooth on the opposite side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LEVOFLOXACIN IS INDICATED IN ADULTS FOR THE TREATMENT OF THE FOLLOWING INFECTIONS (SEE SECTIONS _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) In the below-mentioned infections Levofloxacin 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 • Community-acquired pneumonia • Complicated skin and soft tissue infections • Uncomplicated cystitis (see section 4.4) Levofloxacin 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 sensitivity of the presumed causative pathogen. Levofloxacin tablets may also be used to complete a course of Læs hele dokumentet