Document: leaflet MAH GENERIC_PL 00289-1046 change

• leaflet MAH GENERIC_PL 00289-1046
• leaflet MAH GENERIC_PL 20775-0005
• leaflet MAH GENERIC_PL 29392-0001
• leaflet MAH GENERIC_PL 30306-0238
• leaflet MAH GENERIC_PL 34771-0014
• leaflet MAH GENERIC_PL 40378-0019

---

PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

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:

Peel Here To Open

•    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.