Dimension: 200 x 325 mm

Material : HVS 60 gsm

325 mm

Package leaflet: Information for the patient

Levofloxacin 5 mg/ml solution for infusion Levofloxacin hemihydrate

Read all of this leaflet carefully before you start using 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, 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.    How Levofloxacin is given

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 active substance in the solution is levofloxacin hemihydrate. It belongs to a group of medicines called braoad-spectrum 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 reaction include: rash, swallowing or breathing problems, swelling in the area of the lips, face, throat or tongue

•    if you have ever had epilepsy

•    if 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

•    if you are a child or a growing teenager

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

•    if 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 are given Levofloxacin:

• if you are 60 years of age or older

•    if you are using corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacin")

• if you have ever had a fit (seizure)

• if you have damage to your brain due to a stroke or other brain injury;

• if you have kidney problems

•    if 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

• if you have ever had mental health problems

•    if 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 or are taking vitamin K antagonists which can possible increase coagulation tests and/or bleading (see section "Other medicines and Levofloxacin)

• if you are diabetic

• if you have ever had liver problems

• if you have myasthenia gravis (a rare disease of the nervous system)

•    if your eyesight becomes impaired of if your eyes seem to be otherwise affected, consult an eye specialist immediately.

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 work.

In particular, tell your doctor if you are taking any of the following medicines. This is because taking these medicines togethter with Levofloxacin can in crease the chance of getting side effects:

•    Corticosteroids, sometines called steroids- used for inflammations. 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.

Use in adults and the elderly with kidney problems

Your doctor may need to give you a lower dose.

200 mm

325 mm

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 forget to take 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 think you have missed a dose, tell your doctor or nurse.

If you stop taking Levofloxacin

Your doctor or nurse will continue giving you Levofloxacin, even if you feel better. If it is stopped too soon, your condition may get worse or the bacteria may become resistant to the medicine. After 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 using Levofloxacin and tell a doctor or nurse straight away if you notice the following side effects:

Very rare (may affect up to 1 in 10,000 patients)

Allergic reactions. The signs include: a rash, swallowing and/or breathing problems, swelling in the area oft he lips, face, throat, or tongue.

Stop using Levofloxacin if you notice any of the following serious side effects you may need an emergency medical treatment:

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

•    Pain and inflammation in your tendons or ligaments which could lead to rupture. The achilles tendon is most commonly affected.

•    Seizures (convulsions).

Not known (frequency cannot be estimated from the available data)

•    Bloody diarrhea, that can be attended by stomach cramps and fever. These could be signs of serious bowel problems and infection of the large intestine (pseudomembranous colitis).

•    Burning, tingling, pain, or numbness. These may be signs of something called 'neuropathy'.

•    Severe rashes including blistering or peeling of the skin around your lips, eyes, mouth, nose and genitals (toxic epidermal necrolysis, Stevens-Johnson-Syndrom, erythema multiforme) .

•    Yellowing of the skin and eyes, dark urine, itching or a sensitive stomach (abdomen). These may be signs of liver problems, which also can contain a fatal liver failure.

If you notice any vision changes or other eye problems among levofloxacin, contact a medical specialist for advice.

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 patients)

•    Problems sleeping (insomnia).

•    Headache, dizziness.

•    Indisposition (nausea, vomiting) and diarrhoea.

•    Increased levels of certain liver enzymes in your blood.

•    Reactions at the injection site.

•    Inflammation of a blood vessel (phlebitis).

Uncommon (may affect up to 1 in 100 patients)

•    Increase in the number of other bacteria or fungi, which may need to be treated.

•    Decrease in white blood cells (leukopenia), increase of other blood cells (eosinophilia), as seen in the results of some tests.

•    Loss of appetite

•    Anxiety, confusion, nervousness.

•    Sleepiness (somnolence), tremor, taste disorders.

•    Spinning feeling (vertigo).

•    Breathlessness (dyspnoea).

•    Stomach upset or indigestion (dyspepsia), nausea (vomiting) or pain in your stomach, bloating (flatulence) or constipation.

•    Itching and rash, severe itching (pruritus) and hives (urticaria).

•    Excessive sweating (hyperhidrosis).

•    Pain in joints or muscles.

•    Blood tests may show unusual results because of problems with the liver (increased bilirubin) or kidneys (increased creatinine).

•    General feeling of weakness.

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

•    Easy bruising or bleeding due to a decrease in blood platelets (thrombocytopenia).

•    Low white blood cell count (neutropenia).

•    Exaggerated immune response (hypersensitivity).

•    Low blood sugar (hypoglycemia). This is especially important for people who have diabetes.

•    Seeing or hearing things that are not there (hallucinations), change in your mind and thoughts (psychotic reactions).

•    Dreams, nightmares.

•    Convulsion, tremor, tingling in hands or feet (paresthesia).

•    Hearing disorders (tinnitus) and visual disturbances (blurred vision).

•    Unusually rapid heartbeat (tachycardia), or drop in blood pressure (hypotension).

•    Muscle weakness. This is important for people with myasthenia gravis (a rare disease the nervous system).

•    Kidney failure, called interstitial nephritis, which may be caused by an allergic reaction of the kidneys.

•    Fever.

Not known (frequency cannot be estimated from the available data)

•    Decrease in red blood cells (hemolytic anemia). This can make the skin pale or yellow due to damage to red blood cells. Decrease in the number of all types of blood cells (pancytopenia).

•    Pain, including pain in the back, chest and extremities and general feeling of illness that does not go away. This may be due to a decrease in white blood cells (agranulocytosis).

•    Circulatory collapse (anaphylaxis like shock).

•    Raised blood sugar (hyperglycemia) or low blood sugar (hypoglycaemia), which may lead to hypoglycemic coma. This is especially important for people who have diabetes.

•    Change in your mind and thoughts (psychotic reactions) with the risk of having suicidal thoughts or suicidal tendencies.

•    Changes in perception of odour, loss of smell or taste (parosmia, anosmia, ageusia).

•    Disorders of movement and muscle coordination (dyscenisia, extrapyramidal disorder).

•    Temporary loss of consciousness, or posture (syncope).

•    Temporary loss of vision.

•    Decrease or loss of hearing.

•    Abnormally rapid heartbeat, life-threatening irregular heartbeat, including cardiac arrest, changes in heart rhythm (prolongation of the QT interval, visible in the ECG, an electrical recording of the heart).

•    Difficulty breathing or whistling breathing (bronchospasm).

•    Lung reactions caused by an allergic reaction.

•    Inflammation of the pancreas (pancreatitis).

•    Inflammation of the liver (hepatitis).

•    Increased sensitivity of the skin to sun or ultraviolet (UV) light (photosensitivity).

•    Inflammation of the blood vessels due to an allergic reaction (hypersensitive vasculitis).

•    Inflammation of the mouth (stomatitis).

•    Torn muscle and muscle breakdown (rhabdomyolysis).

•    Redness and swelling of the joints (arthritis).

•    Pain, including back, chest and limbs.

•    Persistent headache with or without blurred vision (benign intracranial hypertension)

•    Attacks of porphyria in people who already have porphyria (a rare metabolic disorder).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.u^yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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 vial. The expiry date refers to the last day of that month.

Keep this medicine in the outer carton in order to protect from light. Protection from light is not necessary during the infusion, and during the first three days after removal of the outer packaging (if kept under indoor light conditions).

This medicine does not require any special temperature storage conditions.

Do not use this medicine if you notice the solution is not clear light yellow and free of particles.

For single use only.

Unused substance should be disposed.

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 hemihydrat. 1 ml of solution contains 5.12 mg levofloxacin hemihydrate corresponding to 5 mg levofloxacin.

-    The excipients are sodium chloride, sodium hydroxid (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injection

What Levofloxacin looks like and contents of the pack

Levofloxacin is a light yellow clear solution in 100 ml glass vials.

Packs of 1, 5 and 10 vials are available.

Marketing Authorisation Holder and Manufacturer

Pharma Resources GmbH DomeierstraGe 29/31 31785 Hameln - Germany

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

The Netherlands Levofloxacine Pharma Resources 5 mg/ml, oplossing voor infusie

Germany    Levofloxacin PhaRes 5 mg/ml Infusionslosung

United Kingdom Levofloxacin 5 mg/ml solution for infusion

This leaflet was last revised in May 2015.