Skip to Content

LEVOFLOXACIN IBIGEN 5 MG/ML SOLUTION FOR INFUSION

Active substance(s): LEVOFLOXACIN

View full screen / Print PDF » Download PDF ⇩
Transcript
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 for you
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• 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, 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 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 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 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
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 a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
• you have ever had epilepsy
• you have ever had problems 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
• you are a child or a 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 are given Levofloxacin 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- 6phosphate 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 born with or have a
family history of prolonged QT interval (seen
on ECG, electrical recording of the heart), salt
imbalance in the blood (especially low level of
potassium or magnesium in the blood), a very
slow heart rhythm (called ‘bradycardia’), a
weak heart (heart failure), 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.
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 sun beds
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 aspirin, ibuprofen, fenbufen,
ketoprofen and indomethacin. You are more
likely to have a fit (seizure) if taken with
Levofloxacin
• Cyclosporine - used after organ transplants. You
may be more likely to get the side effects of
cyclosporine.
• 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 - 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 you 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 your doctor you are having Levofloxacin.
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 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 solution for infusion contains sodium
This medicine contains 177 mg of sodium per 250 mg
dose. This should be taken into consideration by
patients on a controlled sodium diet.

3. How Levofloxacin solution for
infusion is given
Your doctor will explain to you exactly how much
Levofloxacin you will be given as well as how often
and for how long.
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
• Your doctor will decide on how much
Levofloxacin 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.
Use in adults and elderly
The recommended dose is:
• 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
• Infection of skin and underneath the skin
including muscles: 500 mg once or twice daily.
Use in adults and elderly with kidney problems
Your doctor may need to give you a lower dose.

The following information is intended for medical
or healthcare professionals only.

No protection from light is necessary during
infusion.

Levofloxacin solution for infusion should be used
immediately (within 3 hours) after perforation of the
rubber stopper in order to prevent any bacterial
contamination.

This medicinal product is for single use only.

Use in children and adolescents
This medicine must not be given to children or
adolescents.
If you have more Levofloxacin solution for infusion
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 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 having Levofloxacin solution for
infusion
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 having Levofloxacin and tell a doctor or
nurse straight away if you notice any of the
following serious side effects:
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 affected most often
• Muscle weakness. This is important in people
with myasthenia gravis (a rare disease of the
nervous system)
• Fits (convulsions)
• Reduction in blood platelets, which increases risk
of bleeding or bruising (thrombocytopenia).
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
• Burning, tingling, pain, or numbness. These
may be signs of something called ‘neuropathy’.
Frequency unknown (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
• Abnormal muscle breakdown which can lead to
kidney problems (rhabdomyolysis).
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)
• Low number of white blood cells (neutropenia)
• Exaggerated immune response
(hypersensitivity)
• Lowering of your blood sugar levels
(hypoglycaemia). This is important for people
who 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

The solution should be visually inspected prior to
use. It must only be used if the solution is clear,
greenish-yellow and practically free from particles.
As for all medicines, any unused medicinal product
should be disposed of accordingly and in compliance
with local environmental regulations.

• 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)
• 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 (anemia): 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 who 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)
• 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,
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.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.
Keep the vial in the outer carton in order to protect
from light.
No protection from light is required during the
infusion.
Once the infusion vial has been opened (rubber
stopper perforated), the solution should be used
immediately (within 3 hours) in order to prevent any
bacterial contamination.
Do not use this medicine after the expiry date which
is stated on the carton and the vial after EXP.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the
solution is not clear, greenish-yellow solution
and/or has particles in it.
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 solution for infusion contains
The active substance is levofloxacin as levofloxacin
hemihydrate.
One ml of solution for infusion contains 5 mg of
levofloxacin.
Each 50 ml glass vial contains levofloxacin 250 mg.
Each 100 ml glass vial contains levofloxacin 500 mg
The other ingredients are sodium chloride,
hydrochloric acid and water for injection.
What Levofloxacin solution for infusion looks like
and contents of the pack
Levofloxacin solution for infusion is a clear solution,
greenish-yellow, without particles. It is presented in
a glass vial.
The 50 ml vial is available in packs of 1 and 10
The 100 ml vial is available in packs of 1 and 10.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Ibigen S.r.l.
Via Fossignano, 2
04011 Aprilia (LT) - Italy
Manufacturer
Istituto Biochimico Italiano “G. Lorenzini” S.p.A.
Via Fossignano, 2
04011 Aprilia (LT) – Italy
This leaflet was last revised in 08/2015

Levofloxacin solution for infusion is compatible with
the following solutions for infusion:
• 0.9% sodium chloride solution
• 5% glucose
• 2.5% glucose in Ringer’s solution
• Combination solutions for parenteral nutrition
(amino acids, carbohydrates, electrolytes).

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide