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AVELOX 400MG/250ML SOLUTION FOR INFUSION

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE

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Package leaflet: Information for the user

Avelox 400 mg/250 ml solution for infusion
®

Moxifloxacin

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, pharmacist or nurse.
- If you get any side effects, talk to 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 Avelox is and what it is used for
2. What you need to know before you are administered Avelox
3. How to use Avelox
4. Possible side effects
5. How to store Avelox
6. Contents of the pack and other information

1. What A
Avelox is and what it is used for
Avelox contains the active substance moxifloxacin, which belongs to a group of
antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause
infections if they are caused by bacteria that are susceptible to moxifloxacin.
Avelox is used in adults for treating the following bacterial infections:
- Infection of the lungs (pneumonia) acquired outside the hospital
- Infections of the skin and soft tissue

2. What you need to know before you are administered Avelox
Contact your doctor if you are not sure if you belong to a patient group described
below.
Do not use Avelox
- If you are allergic to the active substance moxifloxacin, any other quinolone
antibiotics or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or breast-feeding.
- If you are under 18 years of age.
- If you have a history of tendon disease or disorder which was related to treatment
with quinolone antibiotics (see sections Warnings and precautions ... and 4. Possible
side effects
effects).
- If you were born with or have had any condition with abnormal heart rhythm (seen
on ECG, electrical recording of the heart).
- If you have salt imbalance in the blood (especially low levels of potassium or
magnesium in the blood).
- If you have a very slow heart rhythm (called ‘bradycardia’).
- If you have a weak heart (heart failure).
- If you have a history of abnormal heart rhythms.
- If you are taking other medicines that result in abnormal ECG changes (see section
Other
Ot
her medicines and Avelox
Avelox).). This is because Avelox can cause changes on the ECG,
that is a prolongation of the QT-interval i.e. delayed conduction of electrical signals.
- If you have a severe liver disease or liver enzymes (transaminases) that are higher
than 5 times the upper normal limit.
Warnings and precautions
Talk to your doctor before Avelox is administered for the first time
- Avelox can change your heart’s ECG, especially if you are female, or if you are
elderly. If you are currently taking any medicine that decreases your blood
potassium levels, consult your doctor before Avelox is administered (see also
section Do not use Avelox and Other medicines and Avelox
Avelox).
- If you suffer from epilepsy or a condition which makes you likely to have
convulsions, tell your doctor before Avelox is administered.
- If you have or have ever had any mental health problems, consult your doctor
before Avelox is administered.
- If you suffer from myasthenia gravis using Avelox may worsen the symptoms of
your disease. If you think you are affected consult your doctor immediately.
- If you or any member of your family have glucose-6-phosphate dehydrogenase
deficiency (a rare hereditary disease), inform your doctor, who will advise whether
A
Avelox
is suitable for you.
- Avelox should be given intravenously (in the vein) only, and should not be
administered into an artery.
When using Avelox
- If you experience palpitations or irregular heart beat during the period of
treatment, you should inform your doctor immediately. He/she may wish to perform
an ECG to measure your heart rhythm.
- The risk of heart problems may increase with increase of the dose and the
speed of the perfusion into your vein.
- There is a rare chance that you may experience a severe, sudden allergic
reaction (an anaphylactic reaction/shock) even with the first dose, with symptoms
that may include tightness in the chest, feeling dizzy, feeling sick or faint, or
experience dizziness on standing. If this happens, treatment with Avelox
solution for infusion has to be discontinued immediately.
- Avelox may cause a rapid and severe inflammation of the liver which could
lead to life-threatening liver failure (including fatal cases, see section 4. Possible
side effects
effects). Please contact your doctor before you continue the treatment if you
suddenly start to feel unwell or notice yellowing of the whites of the eyes, dark urine,
itching of the skin, a tendency to bleed or disturbances of thought or wakefulness.
- If you develop a skin reaction or blistering and/or peeling of the skin and/
or mucosal reactions (see section 4. Possible side effects
effects) contact your doctor
immediately before you continue the treatment.
- Quinolone antibiotics, including Avelox, may cause convulsions. If this happens,
treatment with Avelox has to be discontinued.
- You may experience symptoms of neuropathy such as pain, burning, tingling,
numbness and/or weakness. If this happens, inform your doctor immediately prior to
continuing treatment with Avelox.
- You may experience mental health problems even when taking quinolone
antibiotics, including Avelox, for the first time. In very rare cases depression or
mental health problems have led to suicidal thoughts and self-injurious behaviour
such as suicide attempts (see section 4. Possible side effects
effects). If you develop such
reactions, treatment with Avelox has to be discontinued.
- You may develop diarrhoea whilst taking, or after taking, antibiotics including Avelox.
If this becomes severe or persistent or you notice that your stool contains blood or
mucus you should stop using Avelox immediately and consult your doctor. In this
situation, you should not take medicines that stop or slow down bowel movement.
- Avelox may cause pain and inflammation of your tendons, even within 48 hours
of starting treatment and up to several months after discontinuing Avelox therapy.
The risk of inflammation and rupture of tendons is increased if you are elderly or if
you are currently being treated with corticosteroids. At the first sign of any pain or
inflammation you should stop using Avelox, rest the affected limb(s) and consult your
doctor immediately. Avoid any unnecessary exercise, as this might increase the risk of
a tendon rupture (see sections 2. Do not use Avelox
Avelox… and 4. Possible side effects
effects).

For use in adults
- If you are elderly with existing kidney problems take care that your fluid intake is
sufficient because dehydration may increase the risk of kidney failure.
- If your 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).
- Fluoroquinolone antibiotics may cause disturbances in blood sugar, including both
a decrease in blood sugar below normal levels (hypoglycemia) and an increase in
blood sugar above normal levels (hyperglycemia). In patients treated with Avelox,
disturbances in blood sugar occurred predominantly in elderly patients receiving
concomitant treatment with oral antidiabetic medicines that lower blood sugar (e.g.
sulfonylurea) or with insulin. If you suffer from diabetes, your blood sugar should be
carefully monitored (see section 4. Possible side effects
effects).
- Quinolone antibiotics may make your skin become more sensitive to sunlight or
UV light. You should avoid prolonged exposure to sunlight or strong sunlight and
should not use a sunbed or any other UV lamp while using Avelox.
- There is limited experience on use of sequential intravenous/oral Avelox for the
treatment of infection of the lungs (pneumonia)
acquired outside the hospital.
- The efficacy of Avelox in the treatment of severe burns, infections of deep tissue
and diabetic foot infections with osteomyelitis (infections of the bone marrow) has
not been established.
Children and adolescents
This medicine must not be administered to children and adolescents under the age
of 18 because efficacy and safety have not been established for this age group (see
section Do not use Avelox
Avelox).
Other medicines and Avelox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines besides Avelox.
For Avelox, be aware of the following:
- If you are using Avelox and other medicines that affect your heart there is an
increased risk for altering your heart rhythm. Therefore, do not use Avelox together
with the following medicines: Medicines that belong to the group of anti-arrhythmics
(e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide,
ibutilide), antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol,
sultopride), tricyclic antidepressants, some antimicrobials (e.g. saquinavir,
sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly
halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine),
and other medicines (e.g. cisapride, intravenous vincamine, bepridil and
diphemanil).
- You must tell your doctor if you are taking other medicines that can lower your blood
potassium levels (e.g. some diuretics, some laxatives and enemas [large doses] or
corticosteroids [anti-inflammatory drugs], amphotericin B) or cause a slow heart rate
because these can also increase the risk of serious heart rhythm disturbances while
using Avelox.
- If you are currently taking oral anti-coagulants (e.g. warfarin), it may be necessary for
your doctor to monitor your blood clotting times.
Avelox with food and drink
The effect of Avelox is not influenced by food including dairy products.
Pregnancy, breast-feeding and fertility
Do not use Avelox if you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before using this medicine.
Animal studies do not indicate that your fertility will be impaired by using this
medicine.
Driving and using machines
Avelox may make you feel dizzy or light-headed, you may experience a sudden,
transient loss of vision, or you might faint for a short period. If you are affected in this
way do not drive or operate machinery.
Avelox contains sodium
This medicinal product contains 787 milligram (approximately 34 millimol) sodium per
dose. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Avelox
Avelox will always be given to you by a doctor or healthcare professional.
The recommended dose for adults is one bottle once daily.
A
Avelox
is for intravenous use. Your doctor should ensure that the infusion is given at
a constant flow over 60 minutes.
No adjustment of the dose is required in elderly patients, patients with a low
bodyweight or in patients with kidney problems.
Your doctor will decide on the duration of your treatment with Avelox. In some cases
your doctor may start your treatment with Avelox solution for infusion and then continue
your treatment with Avelox tablets.
The duration of treatment depends upon the type of infection, and how well you respond to
treatment but the recommended durations of use are:
- Infection of the lungs (pneumonia) acquired outside the hospital
7 - 14 days
Most patients with pneumonia were switched to oral treatment with Avelox tablets
within 4 days.
- Infections of the skin and soft tissue
7 - 21 days
For patients with complicated skin and skin structure infections the mean duration of
intravenous treatment was approximately 6 days and the average overall duration of
treatment (infusion followed by tablets) was 13 days.
It is important that you complete the course of treatment, even if you begin to feel
better after a few days. If you stop using this medicine too soon your infection may not
be completely cured, the infection may return or your condition may get worse, and
you may also create a bacterial resistance to the antibiotic.
The recommended dose and duration of treatment should not be exceeded (see
section 2. What you need to know before you are administered Avelox, Warnings and
precautions).
If you receive more Avelox than you should
If you are concerned that you may have received too much Avelox, contact your
doctor immediately.
If you miss a dose of Avelox
If you are concerned that you may have missed a dose of Avelox, contact your doctor
immediately.
If you stop using Avelox
If the treatment with this medicine is stopped too soon your infection may not be
completely cured. Consult your doctor if you wish to stop the treatment with Avelox
solution for infusion or Avelox tablets before the end of the course of treatment.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
The most serious side effects observed during the treatment with Avelox are listed
below:
If you notice
• an abnormal fast heart rhythm (rare side effect)
• that you suddenly start feeling unwell or notice yellowing of the whites of the eyes,
dark urine, itching of the skin, a tendency to bleed or disturbances of thought or
wakefulness (these can be signs and symptoms of fulminant inflammation of the
liver potentially leading to life-threating liver failure (very rare side effect, fatal cases
have been observed))
• alterations of the skin and mucous membranes like painful blisters in the mouth/
nose or at the penis/vagina (Stevens-Johnson syndrome or toxic epidermal
necrolysis) (very rare side effects, potentially life threatening)
• a severe, sudden generalised allergic reaction incl. very rarely a life-threatening
shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) (rare side effect)
• swelling incl. swelling of the airway (rare side effect, potentially life-threatening)
• convulsions (rare side effect)
• troubles associated with the nervous system such as pain, burning, tingling,
numbness and/or weakness in extremities (rare side effect)
• depression (in very rare cases leading to self-harm, such as suicidal ideations/
thoughts, or suicide attempts) (rare side effect)
• insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or
suicide attempts) (very rare side effect)
• severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl.
pseudomembranous colitis), which in very rare circumstances, may develop into
complications that are life-threatening (rare side effects)
• pain and swelling of the tendons (tendonitis) (rare side effect) or a tendon rupture
(very rare side effect)
stop taking Avelox and tell your doctor immediately as you may need urgent
medical advice.
In addition, if you notice
• transient loss of vision (very rare side effect),
contact an eye specialist immediately.
If you have experienced life-threatening irregular heart beat (Torsade de Pointes) or
stopping of heart beat while taking Avelox (very rare side effects), tell your treating
doctor immediately that you have taken Avelox and do not restart the treatment.
A worsening of the symptoms of myasthenia gravis has been observed in very rare
cases. If this happens, consult your doctor immediately.
If you suffer from diabetes and you notice that your blood sugar is increased or
decreased (rare or very rare side effect), inform your doctor immediately.
If you are elderly with existing kidney problems and you notice decrease in urine
output, swelling in your legs, ankles or feet, fatigue, nausea, drowsiness, shortness of
breath or confusion (these can be signs and symptoms of kidney failure, a rare side
effect), consult your doctor immediately.
Other side effects which have been observed during treatment with Avelox are listed
below by how likely they are:
Common (may affect up to 1 in 10 people)
• nausea
• diarrhoea
• dizziness
• stomach and abdominal ache
• vomiting
• headache
• increase of a special liver enzyme in the blood (transaminases)
• infections caused by resistant bacteria or fungi e.g. oral and vaginal infections
caused by Candida
• pain or inflammation at injection site
• change of the heart rhythm (ECG) in patients with low blood potassium level
Uncommon (may affect up to 1 in 100 people)
• rash
• stomach upset (indigestion/heartburn)
• changes in taste (in very rare cases loss of taste)
• sleep problems (predominantly sleeplessness)
• increase of a special liver enzyme in the blood (gamma-glutamyl-transferase and/
or alkaline phosphatase)
• low number of special white blood cells (leukocytes, neutrophils)
• constipation
• itching
• sensation of dizziness (spinning or falling over)
• sleepiness
• wind
• change of the heart rhythm (ECG)
• impaired liver function (incl. increase of a special liver enzyme in the blood (LDH))
• decreased appetite and food intake
• low white blood cells count
• aches and pains such as back, chest, pelvic and extremities pains
• increase of special blood cells necessary for blood clotting
• sweating
• increased specialised white blood cells (eosinophils)
• anxiety
• feeling unwell (predominantly weakness or tiredness)
• shaking
• joint pain
• palpitations
• irregular and fast heart beat
• difficulty in breathing incl. asthmatic conditions
• increase of a special digestive enzyme in the blood (amylase)
• restlessness / agitation
• tingling sensation (pins and needles) and/or numbness
• skin hives
• widening of blood vessels
• confusion and disorientation
• decrease of special blood cells necessary for blood clotting
• visual disturbances incl. double and blurred vision
• decreased blood clotting
• increased blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reaction
• increase of bilirubin in the blood
• inflammation of a vein
• inflammation of the stomach
• dehydration
• severe heart rhythm abnormalities
• dry skin
• angina pectoris
Rare (may affect up to 1 in 1,000 people)
• muscle twitching
• muscle cramp
• hallucination
• high blood pressure
• swelling (of the hands, feet, ankles, lips, mouth, throat)
• low blood pressure

• kidney impairment (incl. increase in special kidney laboratory test results like urea
and creatinine)
• inflammation of the liver
• inflammation of the mouth
• ringing/noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• impairment of skin sensation
• abnormal dreams
• disturbed concentration
• difficulty in swallowing
• changes in smell (incl. loss of smell)
• balance disorder and poor co-ordination (due to dizziness)
• partial or total loss of memory
• hearing impairment including deafness (usually reversible)
• increased blood uric acid
• emotional instability
• impaired speech
• fainting
• muscle weakness
Very rare (may affect up to 1 in 10,000 people)
• inflammation of joints
• abnormal heart rhythms
• increase of skin sensitivity
• a feeling of self-detachment (not being yourself)
• increased blood clotting
• muscle rigidity
• significant decrease of special white blood cells (agranulocytosis)
The following symptoms have been observed more frequently in patients treated
intravenously:
Common (may affect up to 1 in 10 people)
• Increase of a special liver enzyme in the blood (gamma-glutamyl-transferase)
Uncommon (may affect up to 1 in 100 people)
• severe diarrhoea containing blood and/or mucus (antibiotic associated colitis)
which in very rare circumstances, may develop into complications that are lifethreatening
• abnormal fast heart rhythm
• hallucination
• low blood pressure
• kidney impairment (incl. increase in special kidney laboratory test results like urea
and creatinine)
• kidney failure
• swelling (of the hands, feet, ankles, lips, mouth, throat)
• convulsions
Furthermore, there have been very rare cases of the following side effects reported
following treatment with other quinolone antibiotics, which might possibly also occur during
treatment with Avelox: increased blood sodium levels, increased blood calcium levels, a
special type of reduced red blood cell count (haemolytic anaemia), muscle reactions with
muscle cell damage, increased sensitivity of the skin to sunlight or UV light.
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
(see details below). By reporting side effects, you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Avelox
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 label of the bottle
and on the carton. The expiry date refers to the last day of that month.
Do not store below 15°C.
Use immediately after first opening and/or dilution.
This product is for single use only. Any unused solution should be discarded.
At cool storage temperatures precipitation may occur, which will re-dissolve at room
temperature.
Do not use this medicine if you notice any visible particulate matter or if the solution
is cloudy.
Do not throw away any medicines via wastewater or household waste. Ask your
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 Avelox contains
- The active substance is moxifloxacin. Each bottle contains 400 milligram
moxifloxacin (as hydrochloride). 1 milliliter contains 1.6 milligram moxifloxacin (as
hydrochloride).
- The other ingredients are sodium chloride, hydrochloric acid 1N (for pHadjustment), sodium hydroxide solution 2N (for pH-adjustment) and water for
injections (see section Avelox contains sodium)
What Avelox looks like and contents of the pack
Avelox is a clear, yellow solution for infusion.
Avelox is packaged in cartons containing a 250 milliliter glass bottle with a chlorobutyl
or bromobutyl rubber stopper. Avelox is available in packs containing 1 bottle and in
multipacks comprising 5 packs, each containing 1 bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom
Manufacturer:
Bayer Pharma AG
51368 Leverkusen
Germany
This medicinal product is authorised in the Member States of the EEA under
the following names:
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece,
Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland,
Portugal, Slovak Republic, Slovenia, Sweden, United Kingdom: Avelox
France: Izilox
Germany, Italy: Avalox
This leaflet was last revised in June 2015
U

The following information is intended for healthcare professionals only:
A
Avelox
can be administered via a T-tube together with the following solutions:
Water for injections, sodium chloride 0.9%, sodium chloride 1 molar, glucose 5%/10%/40%, Xylitol 20%, Ringer’s solution, compound sodium lactate solution (Hartmann’s
solution, Ringer-lactate solution).
Avelox should not be co-infused with other drugs.
The following solutions were incompatible with Avelox:
Sodium chloride 10% and 20% solutions,
Sodium bicarbonate 4.2% and 8.4% solutions
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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.

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