Compatibilities

Mixture with other solutions for infusion:

Levofloxacin is compatible with the following solutions for infusion:

-    Glucose 50mg/ml (5%).

-    Glucose-Ringer25mg/ml(2.5%).

-    Sodium chloride 9mg/ml (0.9%).

-    Combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Incompatibilities

- Levofloxacin should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate).

Conservation

Keep the medicine in the outer carton in order to protect from light.

Do not refrigerate orfreeze.

Levofloxacin should be used immediately (within 3 hours) after opening in order to prevent any bacterial contamination.

FRESENIUS

KABI

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacin 5 mg/ml solution for infusion

Levofloxacin

Read all of this leaflet carefully before you are given this medicine because it contains important information foryou.

•    Keep this leaflet. You may need to read it again

•    If you have any further questions, ask your doctor, nurse or pharmacist

•    If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

1.    What Levofloxacin is and what it is used for

2.    What you need to know before you are given Levofloxacin

3.    Howto use Levofloxacin

4.    Possible side effects

5.    How to store Levofloxacin

6.    Contents of the pack and other information

1.    What Levofloxacin is and what it is used for

The name of your medicine is Levofloxacin. Levofloxacin contains 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 can be used to treat infections of the:

•    Lungs, in people with 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 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 are given Levofloxacin

Do not have 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 reactivon 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 tendinitis 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 ora growing teenager

•    You are pregnant, might become pregnant, or think you may be pregnant

•    You are breast-feeding

Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you are given Levofloxacin.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you have your medicine if:

•    You are 60 years of age or older

•    You are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin ”)

•    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 bom 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 “Other medicines and Levofloxacin”).

•    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, nurse or pharmacist before being given Levofloxacin.

Other medicines and Levofloxacin

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines. This is because Levofloxacin can affect the way some other medicines work. Also some medicines can affect the way Levofloxacin works.

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:

•    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) if taken with Levofloxacin.

•    Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation, such as aspinn, ibuprofen, fenbufen, ketoprofen, indomethacin. You are more likely to nave a fit (seizure) if taken with Levofloxacin.

■ 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 rnythm (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 fmacrolide' 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 . If you have kidney problems, your doctor may want to give a lower dose.

Urine tests for opiates

Urine tests may show 'false-positive' results for strong painkillers called 'opiates' in people having Levofloxacin. If your doctor has prescribed a urine test, tell yourdoctoryou are having Levofloxacin.

Tuberculosis tests

This medicine may cause “false negative" results for some tests used in laboratory to search for the bactena causing tuberculosis.

Pregnancy and breast-feeding

Do not have 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 being given 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.

Levofloxacin contains sodium

This medicine contains 15.4 mmol (354.2 mg) of sodium per 100 ml ml and 7.7 mmol (177.1 mg) of sodium per 50 ml. This should be taken into consideration by patients on a controlled sodium diet.

3. Howto use Levofloxacin

Howto use Levofloxacin

•    Levofloxacin is a medicine for use in hospitals

•    It will be given to you by a doctor or nurse as an injection. The injection will be into one or your veins and be given over a period of time (this is called an intravenous infusion)

•    For250 mg Levofloxacin, the infusion time should be 30 minutes or more

•    For 500 mg Levofloxacin, the infusion time should be 60 minutes or more

•    Your heart rate and blood pressure should be closely monitored. This is because an unusual fast beating of the heart and a temporary lowering of blood pressure are possible side effects that have been seen during the infusion of a similar antibiotic. If your blood pressure drops noticeably while you are being given the infusion, it will be stopped straight away.

How much Levofloxacin is given

If you are not sure why you are being given Levofloxacin or have any questions about how much Levofloxacin is being given to you, speak to your doctor, nurse or pharmacist.

•    Yourdoctorwill decide on how much Levofloxacin you should have

•    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

Adults and older people

•    Pneumonia: 500 mg once or twice daily

•    Infection of urinary tract, including your kidneys or bladder: 500 mg once daily

•    Prostate gland infection: 500 mg once daily

Adults and older people with kidney problems

Your doctor may need to give you a lower dose.

Children and Teenagers

This medicine must not be given to children orteenagers.

Protect yourskin from sunlight

Keep out of direct sunlight while having this medicine and for 2 days after you stop having 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 coveryour arms and legs

•    Avoid sun beds

If you have more Levofloxacin than you should

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine.

Having too much Levofloxacin may cause the following effects to 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).

If you miss a dose of Levofloxacin

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed.However if you do think you have missed a dose, tell your doctor ornurse.

If you stop having Levofloxacin solution for infusion

Your doctor or nurse will continue giving you Levofloxacin , even if you feel better. Ifit is stopped too soon, yourcondition may get worse or the bacteria may become resistant to the medicine. Alter a few days treatment with the solution for infusion, your doctor may decide to switch you to the tablet form of this medicine to complete your course of treatment.

If you have any further questions on the use of this medicine, ask your doctor, nurse, 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 having Levofloxacin and tell a doctor or nurse 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 having Levofloxacin and tell a doctor or nurse 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 affectedmost 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'

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 unne, 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, consult an eye specialist immediately.

Tell your doctor if any of the following side effects gets serious or lasts longerthan afewdays:

Common (may affect up to 1 in 10 people)

•    Sleeping problems

•    Headache, feeling dizzy

•    Feeling sick (nausea, vomiting) and diarrhoea

•    Increase in the level of some liver enzymes in your blood

•    Reactions at the site of infusion

•    Inflammation of a vein

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 (leukopaenia, 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

Rare (may affect up to 1 in 1,000 people)

•    Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopaema)

•    Low number of white blood cells (neutropaenia)

•    Exaggerated immune response (hypersensitivity)

•    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: 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 (pancytopaenia)

•    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 reading to coma (hypoglycaemic coma). This is important for people that nave 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)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes

any side effects not listed in this leaflet. By reporting side effects you can

help provide more information on the safety of this medicine.

For UK - You can also report side effects directly via the Yellow Card

Scheme at: www.mhra.aov.uk/vellowcard

For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:

FREEPOST

Pharmacovlgllance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2

Tel: +3531 6764971 Fax: +35316762517

Website: www.imb.ie e-mail: imbDharmacoviailance@imb.ie

5.    How to store Levofloxacin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the bottle/bag after EXP. The expiry date refers to the last day of the month.

Bottlepack:

Keep the medicine in the outer carton in orderto protect from light.

Do not refrigerate or freeze.

freeflex® bags:

Do not store above 25°C.

Keep container in the outer carton in orderto protect from light.

Do not refrigerate or freeze.

No protection from light is required during the infusion.

Levofloxacin should only be used if clear, greenish-yellow solution, and free from particles. Discard any unused solution.

Do not throw away any medicines via wastewater or household waste. Ask your nurse or pharmacist how 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 contains

• The active substance is levofloxacin

•    Each ml of solution contains 5mg of Levofloxacin

•    50ml of solution for infusion contains 250mg of Levofloxacin

•    100ml of solution for infusion contains 500mg of Levofloxacin

■ The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid and water for injection

What Levofloxacin looks like and contents of the pack Levofloxacin is supplied as a solution for infusion (to be given via a drip). The solution is clear and greenish-yellow.

It is provided in:

-    100 ml polyethylene KabiPac bottles filled with 50 ml or 100 ml (1,10 and 25 bottles per pack).

-    100 ml polyolefine Freeflex bag system filled with 50 ml or 100 ml (10 and 20 bags perpack)

Not all pack sizes may be marketed.

Marketing Authorisation Holder

FreseniusKabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn, Cheshire WA71NT

Manufacturers)

Bottles

Fresenius Kabi Polska Sp. z o.o.

Wytwdrnia Ptynbw Infuzyjnych ul.Sienkiewicza25 99-300 Kutno Poland

and

freeflex® bags:

Fresenius Kabi NorgeAS Svinesundsveien 80 1789 Berg 10stfold Norway

This medicinal product is authorised in the Member States of the EEAunderthe following names:

Austria    Levofloxacin Kabi 5 mg/ml Infusionslosung

Belgium    Levofloxacine Fresenius Kabi 5 mg/ml oplossing

voor infusie

Bulgaria    Levofloxacin Kabi 5 mg/ml MH(py3MOHeH pa3TBop

Cyprus    Levofloxacin Kabi 5 mg/ml SiaAupa yia EYXuaq

Czech Republic Levofloxacin Kabi 5 mg/ml infuzni roztok

Levofloxacin Kabi 5 mg/ml Infusionslosung Levofloxacin Kabi 5 mg/ml SiaAupa yia Eyxuari Levofloxacin Fresenius Kabi 5 mg/ml infuusioneste, liuos

Levofloxacin Kabi 5 mg/ml oldatos infuzio Levofloxacin 5 mg/ml solution for infusion Levofloxacina Kabi 5 mg/ml soluzione per infusione Levofloxacin Kabi 5 mg/ml Infusionslosung Levofloxacin 5 mg/ml solution for infusion Levofloxacine Fresenius Kabi 5 mg/ml oplossing voorinfusie Levofloxacin Kabi Levofloxacina Kabi

Levofloxacin Kabi 5 mg/ml solutie perfuzabila Levofloxacin Kabi 5 mg/ml infuzny roztok Levofloksacin Kabi 5 mg/ml raztopina za infundiranje

Levofloxacino Kabi 5 mg/ml solution para perfusion.

Levofloxacin 5 mg/ml solution for infusion

This leaflet was last revised in Nov 2013.

The following information is intended for medical or healthcare

professionals only:

Administration

-    Levofloxacin is administered by slow intravenous infusion.

-    Inspect the bottle/bag before use. It must only be used if the solution is clear, greenish-yellow, practically free from particles.

Infusion time

-    The recommended infusion time is at least 30 minutes for 250 mg or 60 minutes for500 mg Levofloxacin

-    No protection from light is necessary during infusion.

-    It is known that infusions with ofloxacin (a related compound to levofloxacin) may cause tachycardia (abnormally rapid beating of the heart) and decrease in blood pressure, and in rare cases collapse may occur.

-    If a clear drop in blood pressure is observed during infusion with levofloxacin, the infusion will be stopped immediately.

Dosage in patients with normal kidney function (creatinine clearance

above 50 ml/min)

-    The dosage in patients with normal kidney function depending on the indication is described under section 3 “How Levofloxacin is given”.

9    10 11