Levofloxacin 500mg Film-Coated Tablets
I teva UK Ref: 231-30-87000-Z LEA LEVOFLOXACIN FC A/S TAB TUK
Version: 2 17 February 2015
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• Tingly feeling in your hands and feet (paraesthesia)
• Problems with your hearing (tinnitus) or eyesight (blurred vision)
• Unusual fast beating ofyour heart (tachycardia) or low blood pressure (hypotension)
• Muscle weakness.This is important in peoplewith myasthenia gravis (a rare disease ofthe 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.
Not known (frequency cannot be estimated from the available data)
• Lowering in red blood cells (anaemia): this can make the skin pale or yellow dueto damage ofthe 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 ofwhite blood cells (agranulocytosis).
• Loss of circulation (anaphylactic like shock)
• Increase ofyour blood sugar levels (hyperglycaemia) or lowering ofyour 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 andwalking (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss ofvision
• Impairmentor lossofhearing
• Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration ofthe heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity ofthe heart)
• Difficulty breathingorwheezing (bronchospasm)
• Allergic lung reactions
• Pancreatitis
• Inflammation ofthe liver (hepatitis)
• Increased sensitivity ofyour skin to sun and ultraviolet light (photosensitivity)
• Inflammation ofthe vessels that carry blood around your body due to an allergic reaction (vasculitis)
• Inflammation ofthetissue insidethe 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).
Reporting of side effects
Ifyou get any side effects, talkto your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
HOW TO STORE LEVOFLOXACIN TABLETS
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date, which is stated on the carton and blister.The expiry date refers to the last day ofthat month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.
©CONTENTS OF THE PACK AND OTHER INFORMATION
What Levofloxacin tablets contain
• The active substance is levofloxacin hemihydrate corresponding to 250 mg or 500 mg of levofloxacin
• The other ingredients are:
Core: silica (colloidal, anhydrous), hydroxypropylcellulose, sodium starch glycolate, talc, croscarmellose sodium, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate, red iron oxide (E172).
Additionally the 500 mg tablets contain black and yellow iron oxide (E172).
What Levofloxacin tablets look like and contents of the pack
• 250 mg: terracotta- or pink-coloured, film-coated, capsule-shaped tablet with a scoreline, debossed "LX" on the left side and "250" on the right side of the line.The other side of the tablet is scored and smooth.The tablets can be divided into equal halves.
• 500 mg: peach-coloured, film-coated, capsule-shaped tablet with a scoreline, debossed "LX" on the left side and "500" on the right side.The other side ofthe tablet is scored and smooth.The tablets can be divided into equal halves.
• Pack sizes (250 mg tablets): 1,2,3, 5, 7, 10, 30, 50 (5x10) and 200 (20x10) tablets. (500 mg tablets): 1, 2, 5, 7,10,14, 30, 50 (5x10) and 200 (20x10), 500 (50 x 10) tablets.
Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised in February 2015
PL 00289/1046-1047
ttwti
87000-Z
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LEVOFLOXACIN 250 mg AND 500 mg FILM-COATED TABLETS Levofloxacin
PACKAGE LEAFLET: INFORMATION FORTHE USER
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, pharmacist or nurse.
• 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, talkto your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Levofloxacin tablets are and what they are used for
2. What you need to know before you take Levofloxacin tablets
3. How to take Levofloxacin tablets
4. Possible side effects
5. How to store Levofloxacin tablets
6. Contents of the pack and other information
The name ofyour medicine is Levofloxacin 250 mg or 500 mg Film-coated Tablets but will be referred to in the rest ofthe text ofthe leaflet as Levofloxacin tablets.
OWHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR
The name ofyour medicine is Levofloxacin 250 mg or 500 mg Film-coatedTablets. Levofloxacin 250 mg or 500 mg Film-coatedTablets contain a medicinecalled 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 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 tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening ofthe disease after you are exposed to the bacteria causing anthrax.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOFLOXACIN TABLETS
Do not take Levofloxacin tablets:
• if you are allergic to levofloxacin, any other quinolone antibiotics such as moxifloxacin, ciprofloxacin or ofloxacin or any ofthe 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
• ifyou have ever had epilepsy
• ifyou 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.
• ifyou are a child or a growing teenager
• ifyou are pregnant, might become pregnant or think you may be pregnant
• ifyouarebreast-feeding.
Do not take this medicine if any of the above applies to you. Ifyou are not sure, talkto your doctor or pharmacist before taking Levofloxacin tablets.
Warnings and precautions Before using Levofloxacin tablets Talkto your doctor or pharmacist before taking Levofloxacin tablets:
• ifyouare60yearsofageorolder
• ifyouareusingcorticosteroids, sometimes called steroids (see section 2: Other medicines and Levofloxacin tablets)
• ifyou have ever had a fit (seizure)
• ifyouhavehaddamagetoyourbrain due to a stroke or other brain injury
• ifyou have kidney problems
• ifyou have something known as "glucose-6-phosphate dehydrogenase deficiency'.'You are more likely to have serious problems with your blood when taking this medicine.
• ifyou have ever had mental health problems
• ifyou have ever had heart problems. Caution should be taken when using this kind of medicine, ifyou 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 2: Other medicines and Levofloxacin tablets).
• ifyou are diabetic
• ifyou have ever had liver problems
• ifyouhavemyastheniagravis.
Ifyou are not sure if any ofthe above applies to you, talk to your doctor or pharmacist before taking Levofloxacin tablets.
While using Levofloxacin tablets
Ifyour eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately (see sections 2: Driving and using machines and 4: Possible side effects).
Other medicines and Levofloxacin tablets Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines.This is because Levofloxacin tablets can affect the way some other medicines work. Also some medicines can affecttheway Levofloxacin tablets 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 tablets:
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• Corticosteroids, sometimes called steroids - used for inflammation.You may be more 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) iftaken with Levofloxacin tablets.
• Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. You are more likely to have a fit (seizure) iftakenwith Levofloxacin tablets.
• Ciclosporin-usedafterorgan 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-usedforgoutand cimetidine - used for ulcers and heartburn. Special care should be taken when taking either ofthese medicines with Levofloxacin tablets Ifyou have kidney problems, your doctor may want to give you a lower dose.
Do not take Levofloxacin tablets at the same time as the following medicines. This is because it can affect the way Levofloxacin tablets work:
• lrontablets(foranaemia),zinc supplements, magnesium or aluminium-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 tablets. Ifyour doctor has prescribed a urine test, tell your doctor you are taking Levofloxacin tablets.
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 ofthese side effects can affect you being able to concentrate and your reaction speed. Ifthis happens, do not drive or carry out any work that requires a high level ofattention.
HOW TO TAKE LEVOFLOXACIN TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou 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 ofdirect 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 ifyou do nottakethe following precautions:
• Makesureyou usehighfactorsun 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 timeas Levofloxacintablets. Takeyour dose ofthese medicines at least 2 hours before or after Levofloxacin tablets.
How much to take
• Your doctor will decide on how many Levofloxacin 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 ofyourtreatmentwill depend on how serious your infection is
• Ifyou feel the effect ofyour medicine is too weak or strong, do not change the dose yourself, but ask your doctor.
Adults and older people Sinuses infection
• Twotablets ofLevofloxacin 250 mg Film-coatedTablets, once each day
• Or, one tablet of Levofloxacin 500 mg Film-coatedTablets, once each day.
Lungs infection, in people with long-term breathing problems
• Twotablets ofLevofloxacin 250 mg Film-coatedTablets, once each day
• Or, one tablet of Levofloxacin 500 mg Film-coatedTablets, once each day.
Pneumonia
• Twotablets ofLevofloxacin 250 mg Film-coatedTablets, once or twice each day
• Or, one tablet of Levofloxacin 500 mg film-coated tablets, once or twice each day.
Infection of urinary tract, including your kidneys or bladder
• OneortwotabletsofLevofloxacin 250 mg Film-coatedTablets, each day
• Or, 1/2 or one tablet of Levofloxacin 500 mg Film-coatedTablets, each day.
Prostate gland infection
• Twotablets ofLevofloxacin 250 mg Film-coatedTablets, once each day
• Or, one tablet of Levofloxacin 500 mg Film-coatedTablets, once each day.
Infection of skin and underneath the skin, including muscles
• Two tablets of Levofloxacin 250 mg Film-coatedTablets, once or twice each day
• Or, one tablet of Levofloxacin 500 mg Film-coatedTablets, once or twice each day.
Adults and older people with kidney problems
Your doctor may need to give you a lower dose.
Children and adolescents
This medicine must not be given to children orteenagers.
If you take more Levofloxacin 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 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 take a double dose to make upfora forgotten dose.
If you stop taking Levofloxacin tablets
Do not stop taking Levofloxacin tablets just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you. Ifyou 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 ofthis medicine, ask your doctor, pharmacist or nurse.
^ 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 tablets and see a doctor or go to a hospital straight away if you notice the following side effect: Very rare (may affectuptol in10,000 people)
• You have an allergic reaction.The signs may include: a rash, swallowing or breathing problems, swelling ofyour lips, face, throat, or tongue.
Stop taking Levofloxacin tablets 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, possiblywith stomach cramps and 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.
• 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'.
Not Known (frequency cannot be estimated from the available data)
• Severe skin rashes which may include blistering or peeling ofthe skin around your lips, eyes, mouth, nose and genitals
• Lossofappetite,skinandeyes 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 ofthe liver.
• Ifyour eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately (see section 2: While using Levofloxacin tablets and Driving and using machines).
Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:
Common (may affect uptol in10 people)
• Sleeping problems
• Headache,feelingdizzy
• Feeling sick (nausea, vomiting) and diarrhoea
• Increase in the level of some liver enzymes in your blood.
Uncommon (may affect up to 1 in 100 people)
• Changesinthenumberofother bacteria or fungi, infection by fungi named Candida, which may need to be treated
• Changes in the number ofwhite 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)
• Shortnessofbreath (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.
Rare (may affect up to 1 in 1,000 people)
• Bruising and bleeding easily duetoa lowering in the number of blood platelets (thrombocytopenia)
• Lownumberofwhitebloodcells (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Lowering ofyour 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