Package leaflet: Information for the user. Levofloxacin Ranbaxy 250 mg tablets Levofloxacin Ranbaxy 500 mg tablets. levofloxacin

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1 PACKAGE LEAFLET Package leaflet: Information for the user Levofloxacin Ranbaxy 250 mg tablets Levofloxacin Ranbaxy 500 mg 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 Ranbaxy tablets are and what they are used for 2. What you need to know before you take Levofloxacin Ranbaxy tablets 3. How to take Levofloxacin Ranbaxy tablets 4. Possible side effects 5. How to store Levofloxacin Ranbaxy tablets 6. Contents of the pack and other information 1. What Levofloxacin Ranbaxy tablets are and what they are used for The name of your medicine is Levofloxacin Ranbaxy tablets. Levofloxacin Ranbaxy 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 Ranbaxy 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 Ranbaxy 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 Ranbaxy tablets... [1]... [2]... [3] Eliminato: :... [4]... [5] Eliminato:... [6]... [7]... [8] Eliminato: film coated... [9] Eliminato:... [10]... [11] Eliminato: film coated... [12] Eliminato:... [13]... [14]... [15] Eliminato:.... [16]... [17]... [18]... [19] Eliminato: symptoms... [20]... [21] Eliminato: of the... [22] Eliminato: gets serious,... [23] or... [24] Eliminato:, please tell... your [25]... [26] Eliminato:... [27]... [28]... [29] Eliminato: :... [30]... [31] Eliminato: [Levofloxacin] is... [32] Eliminato: it is... [33] Eliminato: Before... [34] Eliminato: [Levofloxacin]... [35]... [36] Eliminato:... [37] Eliminato: [Levofloxacin]... [38]... [39]... [40] Eliminato: [Levofloxacin]... [41] Eliminato: Further... [42]... [43]... [44]... [45]... [46]... [47]... [48]... [49]

2 Do not take this medicine and tell your doctor if: You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have ever had epilepsy You have ever had a problem with your tendons such as tendonitis that was related to treatment with a quinolone antibiotic'. A tendon is the cord that joins your muscle to your skeleton You are a child or a growing teenager You are pregnant, might become pregnant or think you may be pregnant You are breast-feeding. 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 Ranbaxy. Warnings and precautions Talk to your doctor or pharmacist before taking your medicine if: You are 60 years of age or older You are using corticosteroids, sometimes called steroids (see section Other medicines and Levofloxacin Ranbaxy ) You have ever had a fit (seizure) You have had damage to your brain due to a stroke or other brain injury You have kidney problems You have something known as glucose 6 phosphate dehydrogenase deficiency. You are more likely to have serious problems with your blood when taking this medicine You have ever had mental health problems You have ever had heart problems: caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called bradycardia ), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Taking other medicines ). You are diabetic You have ever had liver problems You have myasthenia gravis. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Levofloxacin Ranbaxy. Other medicines and Levofloxacin Ranbaxy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levofloxacin Ranbaxy can affect the way some other medicines work. Also some medicines can affect the way Levofloxacin Ranbaxy work. In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chance of you getting side effects, when taken with Levofloxacin Ranbaxy: Corticosteroids, sometimes called steroids used for inflammation. You may be more 2... [55] Eliminato: (hypersensitive)... [56]... [57] Eliminato: to other active... [58]... [59] Eliminato: to Eliminato:.... [60]... [61] Eliminato: the... [62]... [63] Eliminato: if you suffer... from [64]... [65] Eliminato: tendon problems... [66]... [67]... [68] Eliminato: ) relating... [69] Eliminato: an active... [70]... [71] Eliminato: belongs... [72] Eliminato: the same class... [73] of... [74] Eliminato: if you... [75] Eliminato: planning to Eliminato: if... [76]... [77]... [78]... [79] Eliminato: -... [80]... [81] Eliminato: tablets have... [82]... [83] Eliminato: children or... [84]... [85] Eliminato: only intended... [86]... [87]... [88] Eliminato: you... [89] Eliminato: any... [90]... [91] Eliminato: taking medicines... [92]... [93] Eliminato: you are exposed... [94]... [95] Eliminato: the tablets... you [96]... [97] Eliminato: <#>if you have... [98]... [99]... [100]... [101]... [102]... [103]... [104]

3 likely to have inflammation and/or rupture of your tendons. Warfarin - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot. Theophylline - used for breathing problems. You are more likely to have a fit (seizure) if taken with Levofloxacin Ranbaxy Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with Levofloxacin Ranbaxy Ciclosporin - used after organ transplants. You may be more likely to get the side effects of ciclosporin Medicines known to affect the way your heart beats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine,), for psychiatric disorders (antipsychotics), and for bacterial infections ( macrolide antibiotics such as erythromycin, azithromycin and clarithromycin) Probenecid used for gout and cimetidine used for ulcers and heartburn. Special care should be taken when taking either of these medicines with Levofloxacin Ranbaxy. If you have kidney problems, your doctor may want to give you a lower dose. Do not take Levofloxacin Ranbaxy tablets at the same time as the following medicines. This is because it can affect the way Levofloxacin Ranbaxy tablets work: Iron tablets (for anemia), zinc supplements, magnesium or aluminum-containing antacids (for acid or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate below. Urine tests for opiates Urine tests may show false-positive results for strong painkillers called opiates in people taking Levofloxacin Ranbaxy. If your doctor has prescribed a urine test, tell your doctor you are taking Levofloxacin Ranbaxy. Tuberculosis tests This medicine may cause false negative results for some tests used in laboratory to search for the bacteria causing tuberculosis. Pregnancy and breast-feeding Do not take this medicine if: You are pregnant, might become pregnant or think you may be pregnant You are breast-feeding or planning to breast-feed DRIVING AND USING MACHINES You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention. 3. How to take Levofloxacin Ranbaxy tablets 3 Eliminato: breakage... [110] Eliminato: non... [111]... [112] Eliminato:... [113] Eliminato: [Levofloxacin]... [114]... [115]... [116] Eliminato: must tell your... [117]... [118] Eliminato: rhythm:... [119]... [120] Eliminato: amiodarone,... [121] Eliminato: ),... [122] Eliminato:,... [123]... [124] Eliminato: antimicrobials... [125]... [126] Eliminato:... [127]... [128]... [129] Eliminato: Breast... [130] Eliminato: [Levofloxacin]... [131]... [132] Eliminato: you... [133]... [134]... [135] Eliminato:... [136] Eliminato: a baby. It... could [137]... [138] Eliminato: Driving and... [139]... [140]... [141] Eliminato:... [142] Eliminato: like dizziness,... [143]... [144] Eliminato: ability... [145] Eliminato: react. Do... [146] Eliminato:, operate... [147]... [148] Eliminato: your ability... to [149]... [150] Eliminato:... [151] Eliminato: 9... [152]

4 Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth Swallow the tablets whole with a drink of water The tablets may be taken during meals or at any time between meals Protect your skin from sunlight Keep out of direct sunlight while taking this medicine and for 2 days after you stop taking it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions: Make sure you use high factor sun cream Always wear a hat and clothes which cover your arms and legs Avoid sun beds. If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate Do not take these medicines at the same time as Levofloxacin Ranbaxy. Take your dose of these medicines at least 2 hours before or after Levofloxacin Ranbaxy tablets. How much to take Your doctor will decide on how many Levofloxacin Ranbaxy tablets you should take The dose will depend on the type of infection you have and where the infection is in your body. The length of your treatment will depend on how serious your infection is. If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor. Adults and the elderly Sinuses infection Two tablets of Levofloxacin Ranbaxy 250 mg, once each day Or, one tablet of Levofloxacin Ranbaxy 500 mg, once each day Lungs infection, in people with long-term breathing problems Two tablets of Levofloxacin Ranbaxy 250 mg, once each day Or, one tablet of Levofloxacin Ranbaxy 500 mg, once each day Pneumonia Two tablets of Levofloxacin Ranbaxy 250 mg, once or twice each day Or, one tablet of Levofloxacin Ranbaxy 500 mg, once or twice each day Infection of urinary tract, including your kidneys or bladder One or two tablets of Levofloxacin Ranbaxy 250 mg, each day Or, 1/2 or one tablet of Levofloxacin Ranbaxy 500 mg, each day Prostate gland infection Two tablets of Levofloxacin Ranbaxy 250 mg, once each day Or, one tablet of Levofloxacin Ranbaxy 500 mg, once each day Infection of skin and underneath the skin, including muscles Two tablets of Levofloxacin Ranbaxy 250 mg, once or twice each day 4... [153]... [154] Eliminato: [Levofloxacin] Eliminato:... [155] Eliminato: your doctor or... [156]... [157]... [158] Eliminato: The duration... [159] of... [160]... [161] Eliminato:... [162] Eliminato:... [163] Eliminato: glass... [164] Eliminato:... [165]... [166] Eliminato: form... [167]... [168] Eliminato:... [169] Eliminato:.... [170] Eliminato: sverely... [171] Eliminato: precausions:... [172] Eliminato:... [173] Eliminato: creams... [174] Eliminato:... [175] Eliminato: arm... [176] Eliminato:.... [177] Eliminato:... [178]... [179]... [180] Eliminato: antacoids... [181] Eliminato: sulcralfate... [182] Eliminato:... [183] Eliminato: this... [184] Eliminato: Levofloxacin... [185]... [186]... [187]... [188]... [189]... [190]... [191]... [192]... [193]... [194]

5 Or, one tablet of Levofloxacin Ranbaxy 500 mg, once or twice each day Adults and the elderly with kidney problems Your doctor may need to give you a lower dose. Children and adolescents This medicine must not be given to children or teenagers. If you take more Levofloxacin Ranbaxy tablets than you should If you accidentally take more tablets than you should, tell a doctor or get other medical advice straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems - leading to uneven heart beats as well as feeling sick (nausea) or having stomach burning. If you forget to take Levofloxacin Ranbaxy tablets If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not double-up the next dose to make up for the missed dose. If you stop taking Levofloxacin Ranbaxy tablets Do not stop taking Levofloxacin Ranbaxy just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you. If you stop taking the tablets too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild or moderate and often disappear after a short time. Stop taking Levofloxacin Ranbaxy and see a doctor or go to a hospital straight away if you notice the following side effect: Very rare (may affect up to 1 in 10,000 people) You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue. Stop taking Levofloxacin Ranbaxy and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: Rare (may affect up to 1 in 1,000 people) Watery diarrhoea which may have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a severe bowel problem. Pain and inflammation in your tendons or ligaments, which could lead to rupture. The Achilles tendon is affected most often. 5 Eliminato: <#>... [200] Eliminato: ½ Eliminato:,each day... [201]... [202] Eliminato: Levofloxacin... [203]... [204]... [205] Eliminato: Or, ½ tablet... [206] or... [207]... [208]... [209] Eliminato: doctro... [210]... [211]... [212] Eliminato: teenagers... [213] Eliminato: The... [214] Eliminato: and... [215]... [216]... [217] Eliminato: [Levofloxacin]... [218]... [219] Eliminato: one tablet... too [220] Eliminato: too many,... [221]... [222] Eliminato:. If possible,... [223] take... [224]... [225] Eliminato: box... [226] Eliminato: to show... [227] Eliminato: consequences... [228] of... [229] Eliminato: )... [230] Eliminato: disorder,... [231]... [232] Eliminato: abnormal... [233] Eliminato: rhythm. In... the [234]... [235]... [236]... [237] Eliminato: [Levofloxacin]... [238]... [239] Eliminato: forget... [240] Eliminato:,... [241]... [242]... [243]... [244]... [245]... [246]

6 Fits (convulsions). Very rare (may affect up to 1 in 10,000 people) Burning, tingling, pain or numbness. These may be signs of something called neuropathy Other: Severe skin rashes which may include blistering or peeling of the skin around your lips, eyes, mouth, nose and genitals. Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver. If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Levofloxacin Ranbaxy, consult an eye specialist immediately. Tell your doctor if any of the following side effects gets serious or lasts longer than a few days: Common (may affect up to 1 in 10 people) Sleeping problems. Headache, feeling dizzy. Feeling sick (nausea, vomiting) and diarrhea. Increase in the level of some liver enzymes in your blood. Uncommon (may affect up to 1 in 100 people) Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated. Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia, eosinophilia). Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning feeling (vertigo). Shortness of breath (dyspnoea). Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in your stomach area, feeling bloated (flatulence) or constipation. Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis). Joint pain or muscle pain. Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems. General weakness. : Tipo di carattere: Times New Roman, Grassetto, Colore carattere: Automatico, Inglese Eliminato:, : Tipo di carattere: Times New Roman, Grassetto, Colore carattere: Automatico, Inglese Eliminato: if you notice any side effects Rare (may affect up to 1 in 1,000 people) Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia). Low number of white blood cells (neutropenia). Exaggerated immune response (hypersensitivity). 6 Eliminato: 9 : Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici

7 Lowering of your blood sugar levels (hypoglycaemia). This is important for people that have diabetes. Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions. Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares. Tingly feeling in your hands and feet (paraesthesia). Problems with your hearing (tinnitus) or eyesight (blurred vision). Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension). Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system). Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis. Fever. Other side effects include: Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia). Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a lowering in the number of white blood cells (agranulocytosis). Loss of circulation (anaphylactic like shock). Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels leading to coma (hypoglycaemic coma). This is important for people that have diabetes. Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia). Problems moving and walking (dyskinesia, extrapyramidal disorders). Temporary loss of consciousness or posture (syncope). Temporary loss of vision. Impairment or loss of hearing. Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration of the heart rhythm (called prolongation of QT interval, seen on ECG, electrical activity of the heart). Difficulty breathing or wheezing (bronchospasm). Allergic lung reactions. Pancreatitis. Inflammation of the liver (hepatitis). Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity). Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis). Inflammation of the tissue inside the mouth (stomatitis). Muscle rupture and muscle destruction (rhabdomyolysis). Joint redness and swelling (arthritis). Pain, including pain in the back, chest and extremities. Attacks of porphyria in people who already have porphyria (a very rare metabolic disease). Persistent headache with or without blurred vision (benign intracranial hypertension). 7 : Tipo di carattere: 12 pt, Inglese : Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Eliminato: listed in this leaflet, please tell your doctor. Eliminato: <#> Eliminato: rate, Eliminato:, fever, Eliminato: <#>swelling... [260] of Eliminato: ) Eliminato: Severe decrease Eliminato: ) leading to... [266] Eliminato: <#>Inflammatio... [268] Eliminato: Muscle Eliminato: with Eliminato: cell damage Eliminato: <#>Decrease... [280] in Eliminato: 9... [251]... [252]... [253]... [254]... [255]... [256]... [257]... [258]... [259]... [261]... [262]... [263]... [264]... [265]... [267]... [269]... [270]... [271]... [272]... [273]... [274]... [275]... [276]... [277]... [278]... [279]... [281]

8 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 5. How to store Levofloxacin Ranbaxy tablets Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions but it is best to keep Levofloxacin Ranbaxy tablets in the original strips and box in a dry place. Do not use this medicine after the expiry date which is stated on the carton and foil after EXP. The expiry date refers to the last day of the month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Levofloxacin Ranbaxy tablets contain The active ingredient is levofloxacin. Each tablet of Levofloxacin Ranbaxy 250 mg tablets contains 250 mg of levofloxacin and each tablet of Levofloxacin Ranbaxy 500 mg tablets contains 500 mg of levofloxacin. The other ingredients are: For the tablet core: crospovidone, hypromellose, microcrystalline cellulose and magnesium stearate. For the tablet coating: Hypromellose, FD&C blue #2/Indigo carmine aluminum lake (E132), FD&C yellow #6/Sunset Yellow aluminum lake (E110), iron oxide red (E172), macrogol 4000, titanium dioxide (E171). Additionally the 500 mg tablets contain iron oxide yellow. What Levofloxacin Ranbaxy tablets look like and contents of the pack Levofloxacin Ranbaxy 250 mg film-coated tablets are pink, oblong, biconvex tablets with a scoreline. The tablet can be divided into equal halves. Levofloxacin Ranbaxy 500 mg film-coated tablets are orange, oblong, biconvex, tablets with a scoreline. The tablet can be divided into equal halves. Levofloxacin Ranbaxy 250 mg film-coated tablets are packed in blister strips, and are available in pack sizes of 1, 5, 7 and 10 tablets. Levofloxacin Ranbaxy 500 mg film-coated tablets are packed in blister strips, and are available in pack sizes of 1, 5, 7 and 10 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder [To be completed nationally] Manufacturer 8... [282]... [283] Eliminato: reach and... [284]... [285]... [286]... [287] Eliminato: shown... [288] Eliminato: packaging.... [289] Eliminato: Keep the blister... [290]... [291] Eliminato: be disposed of... [292] Eliminato: of Eliminato:... [293]... [294]... [295] Eliminato: dispose of... [296] Eliminato: required.... [297] Eliminato: to... [298] Eliminato:... [299] Eliminato: [Levofloxacin]... [300]... [301]... [302]... [303] Eliminato: [Levofloxacin]... [304]... [305] Eliminato: substance... [306] Eliminato:... [307]... [308] Eliminato: levofloxacin... [309]... [310]... [311]... [312] Eliminato: Tablet... [313] Eliminato: Microcrystalline... [314]... [315] Eliminato: magnesium... [316]... [317]... [318] Eliminato: Film... [319] Eliminato: Hypromellose,... [320]... [321] Eliminato: hypromellose,... [322] E171).... [323]... [324]... [325]... [326]... [327]... [328]... [329]... [330]... [331]... [332]... [333]

9 [To be completed nationally] This medicine is authorised in the Member States of the EEA under the following names: Levofloxacin Ranbaxy This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in MM/YYYY [To be completed nationally] 9 : Tipo di carattere: 12 pt, Non Grassetto, Sottolineato, Inglese Eliminato: medicinal product : Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici : Tipo di carattere: 12 pt, Non Grassetto, Sottolineato, Inglese : Tipo di carattere: 12 pt, Non Grassetto, Colore carattere: Nero, Inglese Eliminato: UK/H/1477/01-02/DC United Kingdom Evoxil mg film-coated tablets Cyprus LEVOXACIN Greece Evoxil Germany Levofloxacin Q- GENERICS mg Italy Levofloxacina Chiesi UK/H/1479/01-02/DC United Kingdom Prixoter mg film-coated tablets Czech Republic Xaflon Hungary Prixoter... [339] Eliminato: Marketing Authorisation Holder, details provided above.... [340] : Tipo di carattere: 12 pt, Grassetto, Inglese : Tipo di carattere: 12 pt, Non Grassetto, Sottolineato, Inglese : Tipo di carattere: 12 pt, Non Grassetto, Sottolineato, Inglese Eliminato: approved : Tipo di carattere: 12 pt, Non Grassetto, Sottolineato, Inglese Eliminato: : Tipo di carattere: Verdana, 9 pt, Colore carattere: Nero, Italiano (Italia) Eliminato: 9... [341]... [342]... [343]... [344]

10 Pagina 1: [1] 01/10/ Sinistro: 2,15 cm, Destro 2,25 cm, Superiore: 2,43 cm, In basso: 1,13 cm, Inizio sezione: continua, Ometti note di chiusura, Larghezza 21 cm, Altezza: 29,7 cm, Distanza intestazione dal bordo: 1,27 cm, Distanza piè di pagina dal bordo: 1,27 cm Pagina 1: [2] 01/10/ Tipo di carattere: 12 pt, Italiano (Italia) Pagina 1: [3] 01/10/ Nessuna, Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 1: [4] Eliminato 01/10/ : INFORMATION FOR THE USER Pagina 1: [5] 01/10/ Tipo di carattere: 12 pt, Non Grassetto, Colore carattere: Nero, Italiano (Italia) Pagina 1: [6] Eliminato 01/10/ [Levofloxacin] Pagina 1: [7] 01/10/ Default, Centrato, Destro 0 cm Pagina 1: [8] 01/10/ Tipo di carattere: Times New Roman, 12 pt, Grassetto, Colore carattere: Automatico, Inglese Pagina 1: [9] 01/10/ Tipo di carattere: Times New Roman, 12 pt, Grassetto, Colore carattere: Automatico, Inglese Pagina 1: [9] 01/10/ Tipo di carattere: 12 pt Pagina 1: [10] Eliminato 01/10/ [Levofloxacin] Pagina 1: [11] 01/10/ Tipo di carattere: Times New Roman, 12 pt, Grassetto, Colore carattere: Automatico, Inglese Pagina 1: [12] 01/10/ Tipo di carattere: Times New Roman, 12 pt, Grassetto, Colore carattere: Automatico, Inglese Pagina 1: [12] 01/10/ Tipo di carattere: 12 pt, Inglese (Regno Unito) Pagina 1: [13] Eliminato 01/10/ Levofloxacin

11 Pagina 1: [14] 01/10/ Pagina 1: [15] 01/10/ Allineato a sinistra, Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 1: [16] 01/10/ Pagina 1: [17] 01/10/ Pagina 1: [17] 01/10/ Tipo di carattere: 12 pt, Colore carattere: Nero Pagina 1: [18] 01/10/ Pagina 1: [18] 01/10/ Pagina 1: [19] 01/10/ Pagina 1: [19] 01/10/ Pagina 1: [20] 01/10/ Pagina 1: [20] 01/10/ Pagina 1: [21] 01/10/ Pagina 1: [21] 01/10/ Pagina 1: [22] 01/10/ Pagina 1: [23] Eliminato 01/10/ gets serious, or if you notice Pagina 1: [24] 01/10/ Pagina 1: [24] 01/10/ Pagina 1: [25] Eliminato 01/10/ , please tell your doctor or pharmacist.

12 Pagina 1: [26] 01/10/ Pagina 1: [27] Eliminato 01/10/ In Pagina 1: [28] 01/10/ Allineato a sinistra, Nessuna, Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 1: [29] 01/10/ Pagina 1: [30] 01/10/ Pagina 1: [30] 01/10/ Pagina 1: [31] 01/10/ Pagina 1: [32] 01/10/ Pagina 1: [33] 01/10/ Pagina 1: [33] 01/10/ Pagina 1: [34] 01/10/ Pagina 1: [35] 01/10/ Pagina 1: [36] 01/10/ Pagina 1: [37] 01/10/ Pagina 1: [38] 01/10/ Pagina 1: [39] 01/10/ Pagina 1: [39] 01/10/ Pagina 1: [40] 01/10/ Pagina 1: [41] 01/10/

13 Pagina 1: [42] 01/10/ Pagina 1: [42] 01/10/ Pagina 1: [43] Eliminato 01/10/ WHAT [LEVOFLOXACIN] TABLETS IS AND WHAT IT IS USED FOR What this medicine is Pagina 1: [44] 01/10/ Tipo di carattere: Times New Roman, Inglese Pagina 1: [45] Eliminato 01/10/ active substance in Pagina 1: [46] 01/10/ Tipo di carattere: Times New Roman, Inglese Pagina 1: [47] 01/10/ Tipo di carattere: Times New Roman, Inglese Pagina 1: [48] Eliminato 01/10/ known as fluoroquinolone Pagina 1: [49] 01/10/ Tipo di carattere: Times New Roman, Inglese Pagina 1: [50] Eliminato 01/10/ , which kill bacteria. What this medicine does [ Pagina 1: [51] 01/10/ Pagina 1: [52] Eliminato 01/10/ ] tablets are used to treat infections caused Pagina 1: [53] 01/10/ Pagina 1: [53] 01/10/

14 Pagina 1: [54] 01/10/ Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 2: [55] 01/10/ Rientro: Sinistro: 0,25 cm, Sporgente 0,5 cm, Destro 0 cm, Interlinea singola, Puntato + Livello:1 + Allinea a: 0,63 cm + Tabulazione dopo: 0 cm + Rientra di: 1,27 cm, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfab Pagina 2: [56] Eliminato 01/10/ (hypersensitive) to Levofloxacin Pagina 2: [57] 01/10/ Pagina 2: [58] Eliminato 01/10/ to other active substances that belong to the same group of antibiotics (i.e. quinolones) Pagina 2: [59] 01/10/ Pagina 2: [60] 01/10/ Pagina 2: [61] 01/10/ Pagina 2: [62] 01/10/ Pagina 2: [63] 01/10/ Pagina 2: [64] Eliminato 01/10/ if you suffer from epilepsy. Otherwise, your risk of getting fits (convulsions) is increased. if you had Pagina 2: [65] 01/10/ Pagina 2: [66] Eliminato 01/10/ tendon problems (e.g. Pagina 2: [67] 01/10/ Rientro: Sinistro: 0,25 cm, Sporgente 0,5 cm, Destro 0 cm, Interlinea singola, Puntato + Livello:1 + Allinea a: 0,63 cm + Tabulazione dopo: 0 cm + Rientra di: 1,27 cm, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfab Pagina 2: [68] 01/10/

15 Pagina 2: [69] 01/10/ Pagina 2: [70] Eliminato 01/10/ an active substance Pagina 2: [71] 01/10/ Pagina 2: [72] 01/10/ Pagina 2: [73] Eliminato 01/10/ the same class of antibiotics (i.e. fluoroquinolones). Pagina 2: [74] 01/10/ Pagina 2: [75] 01/10/ Pagina 2: [75] 01/10/ Pagina 2: [76] 01/10/ Pagina 2: [77] 01/10/ Pagina 2: [78] 01/10/ Rientro: Sinistro: 0,25 cm, Sporgente 0,5 cm, Destro 0 cm, Interlinea singola, Puntato + Livello:1 + Allinea a: 0,63 cm + Tabulazione dopo: 0 cm + Rientra di: 1,27 cm, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfab Pagina 2: [79] 01/10/ Pagina 2: [80] 01/10/ Pagina 2: [80] 01/10/ Pagina 2: [81] 01/10/ Tipo di carattere: Times New Roman, Inglese Pagina 2: [81] 01/10/ Tipo di carattere: Times New Roman, Inglese Pagina 2: [82] Eliminato 01/10/ tablets have been prescribed

16 Pagina 2: [83] 01/10/ Tipo di carattere: Times New Roman, Inglese Pagina 2: [84] Eliminato 01/10/ children or growing teenagers. They could harm the cartilage of their growing bones. The tablets Pagina 2: [85] 01/10/ Tipo di carattere: Times New Roman, Non Grassetto, Inglese Pagina 2: [86] Eliminato 01/10/ only intended for adults. Tell Pagina 2: [87] 01/10/ Pagina 2: [88] 01/10/ Tipo di carattere: Times New Roman, Grassetto, Colore carattere: Automatico, Inglese Pagina 2: [89] 01/10/ Pagina 2: [90] 01/10/ Nessuna, Rientro: Sinistro: 0,25 cm, Sporgente 0,5 cm, Destro 0 cm, Interlinea singola, Puntato + Livello:1 + Allinea a: 0,63 cm + Tabulazione dopo: 0 cm + Rientra di: 1,27 cm, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e Pagina 2: [91] 01/10/ Pagina 2: [92] Eliminato 01/10/ taking medicines in the past. Take special care with [Levofloxacin] tablets if you have experienced fits or brain damage in the past (such as stroke or severe brain injury). Make sure your doctor knows about your medical history, so he can give you appropriate advice. Pagina 2: [93] 01/10/ Pagina 2: [94] Eliminato 01/10/ you are exposed to sunlight or UV light. Do not stay out in strong sunlight for unnecessarily long periods and do not use a sun-lamp or solarium. Your skin may become more sensitive to light whilst using this medicine (may cause sunburn like reactions). if you get pain or inflammation in your tendons, particularly if you are elderly or taking any medicines known as the corticosteroids (cortisone or similar medicines used as anti inflammatories in many disorders such as asthma,

17 allergic conditions/reactions and arthritis). If you experience any tendon complaints whilst or shortly after Pagina 2: [95] 01/10/ Pagina 2: [96] Eliminato 01/10/ the tablets you should seek medical advice immediately and rest the affected limb to avoid tendon damage. Do not take the next dose of [Levofloxacin] unless your doctor tells you to. Pagina 2: [97] 01/10/ Pagina 2: [98] Eliminato 01/10/ if you have severe, persistent and/or bloody diarrhoea during or after treatment with the tablets. This may be a sign of serious bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics. Tell your doctor immediately. It may be necessary to stop treatment and start specific therapy. if you have a family history of or have an actual defect in the liver enzyme called glucose-6-phosphate dehydrogenase (G6PD) (a rare hereditary disease). Patients with G6PD deficiency may be prone to destruction of red blood cells (haemolysis) when treated with quinolone antibacterial agents. if you suffer from kidney problems. Patients with reduced kidney activity (renal insufficiency) may need lower doses than patients with normal kidney activity. if you are taking any medicines which thin the blood (known as anti coagulants e.g. warfarin). if you have a history of psychiatric disease. Tell your doctor immediately if you experience a psychotic reaction. if you have ever had symptoms due to nerve damage such as kinetic or sensory problems in hand and feet, that are more severe at night.. if you Pagina 2: [99] 01/10/ Nessuna, Rientro: Sinistro: 0,25 cm, Sporgente 0,5 cm, Destro 0 cm, Interlinea singola, Puntato + Livello:1 + Allinea a: 0,63 cm + Tabulazione dopo: 0 cm + Rientra di: 1,27 cm, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e Pagina 2: [100] 01/10/ Pagina 2: [101] Eliminato 01/10/ if you are diabetic and you receive concomitant treatment with an oral medicine that lowers blood levels of glucose. if you have ever had liver problems. You should stop treatment and contact your doctor immediately if symptoms of liver disease develop such as reduced appetite, jaundice, dark urine, itching or gastrointestinal disturbances. Heart problems. Caution

18 Pagina 2: [102] 01/10/ Pagina 2: [102] 01/10/ Pagina 2: [102] 01/10/ Pagina 2: [102] 01/10/ Tipo di carattere: 12 pt, Non Corsivo, Inglese Pagina 2: [103] 01/10/ Pagina 2: [104] 01/10/ Pagina 2: [105] 01/10/ Nessuna, Destro 0 cm, Interlinea singola, Nessun elenco puntato o numerato, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 2: [106] 01/10/ Pagina 2: [107] Eliminato 01/10/ the medicine. In that case, Pagina 2: [108] 01/10/ Pagina 1: [109] 01/10/ Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 3: [110] 01/10/ Pagina 3: [110] 01/10/ Tipo di carattere: 12 pt, Colore carattere: Nero Pagina 3: [111] 01/10/ Pagina 3: [112] 01/10/ Destro 0 cm, Interlinea singola, Puntato + Livello:1 + Allinea a: 0,71 cm + Tabulazione dopo: 0 cm + Rientra di: 1,35 cm, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asi Pagina 3: [113] 01/10/ Pagina 3: [114] Eliminato 01/10/ [Levofloxacin] tablets.

19 Pagina 3: [115] 01/10/ Pagina 3: [116] 01/10/ Pagina 3: [117] Eliminato 01/10/ must tell your doctor if you are taking other medicines that can alter Pagina 3: [118] 01/10/ Pagina 3: [119] Eliminato 01/10/ rhythm: medicines that belong to the group of anti-arrhythmics (e.g. Pagina 3: [120] 01/10/ Pagina 3: [121] 01/10/ Pagina 3: [122] 01/10/ Pagina 3: [123] 01/10/ Allineato a sinistra, Destro 0 cm, Interlinea singola, Nessun elenco puntato o numerato, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 3: [124] 01/10/ Pagina 3: [125] Eliminato 01/10/ antimicrobials (that belong to the group of macrolides) and some antipsychotics. Pagina 3: [126] 01/10/ Pagina 3: [127] Eliminato 01/10/ Taking [Levofloxacin] tablets with food and drink [Levofloxacin] tablets may be taken during meals or at any time between meals. Swallow the tablets with a glass of water. Pagina 3: [128] 01/10/ Pagina 3: [129] 01/10/

20 Allineato a sinistra, Nessuna, Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 3: [130] 01/10/ Pagina 3: [130] 01/10/ Tipo di carattere: 12 pt, Non Grassetto, Colore carattere: Nero, Inglese Pagina 3: [131] Eliminato 01/10/ [Levofloxacin] tablets Pagina 3: [132] 01/10/ Pagina 3: [133] 01/10/ Pagina 3: [133] 01/10/ Pagina 3: [134] 01/10/ Allineato a sinistra, Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 3: [135] 01/10/ Pagina 3: [136] 01/10/ Pagina 3: [137] Eliminato 01/10/ a baby. It could harm your baby. Pagina 3: [138] 01/10/ Tipo di carattere: 12 pt, Non Grassetto, Colore carattere: Nero, Inglese Pagina 3: [139] Eliminato 01/10/ Driving and using machines Some Pagina 3: [140] 01/10/ Allineato a sinistra, Destro 0 cm, Interlinea singola, Nessun controllo righe isolate, Non regolare lo spazio tra testo asiatico e in alfabeto latino, Non regolare lo spazio tra testo asiatico e caratteri numerici Pagina 3: [141] 01/10/ Pagina 3: [142] 01/10/