Levofloxacin 5 Mg/Ml Solution For Infusion

Document: leaflet MAH GENERIC_PL 36780-0003 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Levofloxacin 5 mg/ml Solution for Infusion

(Levofloxacin 250 mg/50 ml and 500 mg/100 ml)

Read all of this leaflet carefully before you are given 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.

What is in this leaflet:

1. What Levofloxacin solution for infusion is and what it is used for

2. What you need to know before you are given Levofloxacin solution for infusion

3. How Levofloxacin solution for infusion is given

4. Possible side effects

5. How to store Levofloxacin solution for infusion

6. Contents of the pack and other information

1. What Levofloxacin solution for infusion is and what it is used for

The name of your medicine is Levofloxacin solution for infusion.

Levofloxacin solution for infusion 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 solution for infusion may 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 solution for infusion 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 solution for infusion

E Do not have this medicine and tell your doctor if:

X 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

X You have ever had epilepsy

X You have ever had a problem with your tendons such as tendonitis that was related to treatment with a drug that belongs to the same class of antibiotics (quinolone antibiotic). A tendon is the cord that joins your muscle to your skeleton

X You are a child or a growing teenager

X You are pregnant, might become pregnant, or think you might be pregnant X 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 solution for infusion.

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 solution for infusion”)

^ 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’

(G6PD). 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 a salt imbalance in the blood (especially a 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 bleeding (see section ‘Other medicines and Levofloxacin solution for infusion’)

^ You are diabetic

^ You have ever had liver problems

^ You have myasthenia gravis (a chronic disease that weakens the muscles)

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before being given Levofloxacin solution for infusion.

Tuberculosis tests

This medicine may cause ‘false negative’ results for some laboratory tests that search for the bacteria causing tuberculosis.

Pregnancy and breast-feeding

Do not have this medicine if you are pregnant or breast-feeding, you think you might be pregnant or are planning to have a baby.

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 solution for infusion contains sodium

This medicine contains approximately 7 mmol (177 mg) of sodium per 50 ml and 15.4 mmol (354 mg) of sodium per 100 ml. This should be taken into consideration by patients on a controlled sodium diet and in cases where fluid restriction is required.

3. How Levofloxacin solution for infusion is given

How Levofloxacin solution for infusion is given

• Levofloxacin solution for infusion 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 of your veins and be given over a period of time (this is called an intravenous infusion)

• For 250 mg Levofloxacin solution for infusion, the infusion time should be 30 minutes or more

• For 500 mg Levofloxacin solution for infusion, 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 solution for infusion is given

If you are not sure why you are being given Levofloxacin solution for infusion or have any

questions about how much Levofloxacin solution for infusion is being given to you, speak to

your doctor, nurse or pharmacist.

• Your doctor will decide on how much Levofloxacin solution for infusion 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 the elderly

• Pneumonia: 500 mg once or twice daily

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

• Prostate gland infection: 500 mg once daily

• Infection of the skin and underneath the skin, including muscles: 500 mg once or twice daily

• Inhalation anthrax exposure: 500 mg once daily Adults and the elderly with kidney problems Your doctor may need to give you a lower dose.

Use in children and adolescents

This medicine must not be given to children or teenagers.

Protect your skin 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 cover your arms and legs

• Avoid using sun beds

If you have more Levofloxacin solution for infusion than you should

Your doctor will ensure that you will receive the correct dose into the vein.

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 solution for infusion

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 or nurse.

If you stop using Levofloxacin solution for infusion

Your doctor or nurse will continue giving you Levofloxacin, even if you feel better. If it is stopped too soon, the infection may return, 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 having Levofloxacin solution for infusion and tell your doctor or nurse straight away if you notice the following side effect:

Not known (cannot be estimated from the available data)

• 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 your 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)

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

• Fits (convulsions)

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

• 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

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

• 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

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 longer than a few

days:

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 (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

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 (leukopenia)

• 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)

• Feeling depressed, 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), awareness of your heart beat (palpitation), 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

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

• Lowering in red blood cells (anaemia): 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)

• Risk of having suicidal thoughts or actions

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. 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.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levofloxacin solution for infusion

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 bag label after “EXP". The expiry date refers to the last day of that month.

Do not freeze

Store in the original package in order to protect from light.

Use only if the solution is clear, yellow to greenish-yellow and does not contain particles.

Do not throw away medicines via wastewater or household waste. Your pharmacist or nurse should throw away any medicines that are no longer required. These measures will help protect the environment.

The product should be used immediately after opening.

What Levofloxacin solution for infusion contains

The active substance is levofloxacin (as levofloxacin hemihydrate).

Each ml contains 5 milligrams levofloxacin (as levofloxacin hemihydrate).

The 50 ml bag contains 250 milligrams levofloxacin.

The 100 ml bag contains 500 milligrams levofloxacin.

The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

What Levofloxacin solution for infusion looks like and contents of the pack

Levofloxacin solution for infusion is a clear yellow to a greenish-yellow solution for infusion.

Levofloxacin solution for infusion is supplied in infusion bags wrapped in a laminated foil overpouch.

Pack sizes:

10 x 50 ml bags 50 x 50 ml bags 10 x 100 ml bags 30 x 100 ml bags

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Infomed Fluids SRL

50 Theodor Pallady blvd., District 3,

032266 Bucharest, Romania Tel: +40 21 345 02 22 Fax: +40 21 345 3185 E-mail: office@infomedfluids.ro

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

Austria

France

Germany

Italy

Romania United Kingdom

6. Contents of the pack and other information

Levofloxacin Infomed 5 mg/ml Infusionslosung Levofloxacine Infomed 5 mg/ml solution pour perfusion Levofloxacin Infomed Fluids 5 mg/ml Infusionslosung Levofloxacina Infomed

Levofloxacina Infomed 5 mg/ml Solufie perfuzabila Levofloxacin 5 mg/ml Solution for Infusion

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 05/2016

The following information is intended for healthcare professionals only:

For single use only. Discard any remaining solution after use. Keep the infusion bag within the overwrap before use, in order to protect from light. No protection from light is necessary during infusion under indoor light conditions.

Instruction for use

• Inspect the solution prior to administration. It must only be used if the solution is a clear, yellow to greenish-yellow solution, practically free from particles.

• Hold the plastic bag with the connection ports uppermost.

• Twist off the protection cap from the connection port.

• Insert the piercing pin of the intravenous set into the connection port with a twisting motion.

• Suspend the bag from the hanger.

Method of administration

Levofloxacin solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin solution for infusion. During the infusion time, the patient should be examined for tachycardia (rapid heart beat) and a temporary decrease in blood pressure. In rare cases, as a consequence of a profound drop in blood pressure, circulatory problems may occur.

Mixture with other solutions for infusion

This medicinal product is compatible with the following solutions for infusion:

• Sodium chloride 9 mg/ml (0.9 %);

• Glucose 50 mg/ml (5 %);

• Glucose 25 mg/ml (2.5 %) in Ringer’s solution.

Incompatibilities

This medicinal product should not be mixed with

• Heparins or

• Alkaline solutions (e.g. sodium hydrogen carbonate).