Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LEVOFLOXACINE 0,5-WATER SAMENSTELLING overeenkomend met ; LEVOFLOXACINE
Torrent Pharma GmbH Sudwestpark 50 90449 NURNBERG (DUITSLAND)
J01MA12
LEVOFLOXACIN 0,5-WATER COMPOSITION corresponding to ; LEVOFLOXACIN
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Levofloxacin
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);
2010-11-17
Levofloxacin Torrent 250 mg film-coated tablets– NL/H/1734/001/DC NL (English)PL NL/p/006/12/14 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFLOXACIN TORRENT250 MG FILMOMHULDE TABLETTEN 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR The name of your medicine is [Product name]. [Product name] 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. [PRODUCT NAME] 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, [Product name] 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 [PRODUCT NAME] DO NOT TAKE [PRODUCT NAME] AND TELL YOUR DOCTOR IF: ▪ You are allergic to levofloxacin, any other qui Lesen Sie das vollständige Dokument
Levofloxacin Torrent 250/500 mg film-coated tablets– NL/H/1734/001-002/DC NL (English) SPC NL/S/005/12/11 1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT Levofloxacin Torrent 250 mg, filmomhulde tabletten Levofloxacin Torrent 500 mg, filmomhulde tabletten 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each film-coated tablet of Levofloxacin Torrent 250 mg contains 250 mg of levofloxacin as levofloxacin hemihydrate. Each film-coated tablet of Levofloxacin Torrent 500 mg contains 500 mg of levofloxacin as levofloxacin hemihydrate. For the full list of excipients, see section 6.1. 3. P HARMACEUTICAL F ORM Film-coated tablet Levofloxacin Torrent 250 mg film-coated tablet Light pink coloured capsule shaped film-coated tablets debossed with break line on both sides, separating “2” & “50” on one side and “10” & “82” on other side. The tablet can be divided into equal doses. Levofloxacin Torrent 500 mg film-coated tablet Brick red coloured capsule shaped film-coated tablets debossed with break line on both sides, separating “8” & “3” on one side and plain on other side. The tablet can be divided into equal doses. 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin Torrent 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 following indications, Levofloxacin Torrent 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 exacerbations of chronic obstructive pulmonary disease including bronchitis ▪ Acute bacterial sinusitis ▪ Community-acquired pneumonia Levofloxacin Torrent 250/500 mg film-coated tablets– NL/H/1734/001-002/DC NL (English) SPC NL/S/005/12/11 2 ▪ Complicated skin Lesen Sie das vollständige Dokument