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MOXIFLOXACIN 400 MG/250 ML SOLUTION FOR INFUSION

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE

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PACKAGE LEAFLET
Package leaflet: Information for the user


Moxifloxacin 400 mg/250 ml
solution for infusion
Moxifloxacin


U15XXX/X XX V001

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 or pharmacist.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Moxifloxacin is and what it is used for
2. What you need to know before you use
Moxifloxacin
3. How to use Moxifloxacin
4. Possible side effects
5. How to store Moxifloxacin
6. Contents of the pack and other information

1. What Moxifloxacin is and what it is used
for
Moxifloxacin contains the active substance
moxifloxacin which belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin
works by killing bacteria that cause infections if
they are caused by bacteria that are susceptible
(sensitive) to moxifloxacin.
Moxifloxacin 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
Moxifloxacin is only used to treat these
infections when usual antibiotics cannot be used
or have not worked.
2. What you need to know before you use
Moxifloxacin
Contact your doctor if you are not sure if you
belong to a patient group described below.
Do not use Moxifloxacin











If you are allergic to 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).
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 level of potassium or
magnesium in the blood);
If you have a very slow heart rhythm (called
'bradycardia'), have a weak heart (heart
failure), have a history of abnormal heart
rhythms, or you are taking other medicines
that result in abnormal ECG changes (see
section Other medicines and Moxifloxacin).
This is because Moxifloxacin can cause
changes on the ECG, that is a prolongation
of the QT-interval, that is a 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 Moxifloxacin is
administered to you for the first time. It is
important you know that:
• Moxifloxacin 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 Moxifloxacin is
administered to you (also see sections Do not
use Moxifloxacin and Other medicines and
Moxifloxacin).
• If you suffer from epilepsy or a condition
which makes you likely to have convulsions,
tell your doctor before Moxifloxacin is
administered to you.
• If you have or have ever had any mental
health problems, consult your doctor before
Moxifloxacin is administered to you.
• If you suffer from myasthenia gravis (rare
disease leading to muscle weakness)
because using Moxifloxacin 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
Moxifloxacin is suitable for you.
• Moxifloxacin should be given intravenously
(in the vein) only, and should not be
administered into an artery.
Treatment with Moxifloxacin should be
stopped immediately in the following cases:
• There is a rare chance that you may experience
a severe, sudden allergic reaction (an
anaphylactic reaction/shock) even with the first
dose. Tell your doctor if you experience
symptoms that may include tightness in the
chest, feeling dizzy, feeling sick or faint, or
experience dizziness on standing.
• Moxifloxacin 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).
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.
• Quinolone antibiotics, including Moxifloxacin,
may cause convulsions. If this happens,
treatment with Moxifloxacin has to be
discontinued.
• You may experience mental health problems
even when taking quinolone antibiotics,
including Moxifloxacin, 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).
If you develop such reactions, treatment with
Moxifloxacin has to be discontinued.
• Moxifloxacin may cause pain and
inflammation of your tendons, even within
48 hours of starting treatment and up to
several months after discontinuing
M o x i f l o x a c i n t h e r a p y. T h e r i s k o f
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 Moxifloxacin, 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 Do not use
Moxifloxacin and 4. Possible side effects).
During treatment with Moxifloxacin you
should inform your doctor immediately:
• If you experience palpitations or irregular
heart beat during the period of treatment.
He/she may wish to perform an ECG to
measure your heart rhythm.
• If you develop a skin reaction or blistering
and/or peeling of the skin and/or mucosal
reactions (see section 4. Possible side effects)
contact your doctor immediately before you
continue the treatment.
• Yo u 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 Moxifloxacin.
You may develop diarrhoea whilst taking, or
after taking, antibiotics including Moxifloxacin.
If this becomes severe or persistent or you
notice that your stool contains blood or mucus
you should stop using Moxifloxacin
immediately and consult your doctor. In this
situation, you should not take medicines that
stop or slow down bowel movement.
If your eyesight becomes impaired or if you
have any other eye disturbances whilst
using Moxifloxacin, consult an eye specialist
immediately (see sections Driving and using
machines and 4. Possible side effects).

When using Moxifloxacin you should be
aware that:
• The risk of heart problems may increase
with increase of the dose and the speed of the
perfusion into your vein.
• 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.
• 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 Moxifloxacin.
• There is limited experience on use of
sequential intravenous/oral Moxifloxacin for
the treatment of infection of the lungs
(pneumonia) acquired outside the hospital.
• The efficacy of Moxifloxacin 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 Moxifloxacin).
Other medicines and Moxifloxacin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
When receiving treatment with Moxifloxacin
be aware of the following
If you are using Moxifloxacin together with other
medicines that affect your heart there is an
increased risk for altering your heart rhythm.
Therefore, do not use Moxifloxacin together with
the following medicines:
• Medicines that belong to the group of antiarrhythmics (such as quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide,
ibutilide);
• Antipsychotics (such as phenothiazines,
pimozide, sertindole, haloperidol, sultopride);
• Tricyclic antidepressants, some antimicrobials
(such as saquinavir, sparfloxacin, intravenous
erythromycin, pentamidine, antimalarials
particularly halofantrine);
• Some antihistamines (such as terfenadine,
astemizole, mizolastine);
• Other medicines such as cisapride, intravenous
vincamine, bepridil and diphemanil.
You must tell your doctor:
• if you are taking other medicines that can
lower your blood potassium levels (for
instance some diuretics, some laxatives and
enemas [large doses] or corticosteroids [antiinflammatory medicines], amphotericin B);
• if you are taking other medicines that can
cause a slow heart rate because these can
also increase the risk of serious heart rhythm
disturbances while using Moxifloxacin;
• if you are currently taking oral anticoagulants (for instance warfarin); it may be
necessary for your doctor to monitor your
blood clotting times.
Moxifloxacin with food, drink and alcohol
The effect of Moxifloxacin is not influenced by
food, including dairy products.
You should not drink alcohol while using
Moxifloxacin.
Pregnancy, breast-feeding and fertility
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.
Do not use Moxifloxacin if you are pregnant or
breast-feeding.
Animal studies do not indicate that your fertility
will be impaired by using this medicine.
Driving and using machines
Moxifloxacin may make you feel dizzy or lightheaded, you may experience a sudden, brief
(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.
Moxifloxacin contains sodium
This medicinal product contains 1206 mg
(approximately 54 mmol) sodium per dose. If
you are on a controlled-salt diet, please inform
your doctor immediately.
3. How to use Moxifloxacin
Moxifloxacin will always be given to you by a
doctor or healthcare professional.
The recommended dose for adults is 1 bottle
once daily.
Moxifloxacin is for intravenous (into a vein) 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.
Duration of treatment
Your doctor will decide on the duration of your
treatment with Moxifloxacin. In some cases your
doctor may start your treatment with
Moxifloxacin solution for infusion and then
continue your treatment with respective 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:
Indication
Duration of
treatment
Infection of the lungs (pneumonia) 7 - 14 days
acquired outside the hospital
Most patients with pneumonia were
switched to oral treatment with
respective tablets within 4 days.
Infections of the skin and soft
7 - 21 days
tissue
For patients with complicated skin
and skin structure infections the
average duration of intravenous
treatment was approximately 6
days and the average overall
duration of treatment (infusion
followed by respective 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.
If you receive more Moxifloxacin than you
should
If you are concerned that you may have received
more Moxifloxacin than prescribed, contact your
doctor immediately.

If you miss a dose of Moxifloxacin
If you are concerned that you may have missed
a dose of Moxifloxacin, contact your doctor
immediately.
If you stop using Moxifloxacin
If your treatment with this medicine is stopped
too soon your infection may not be completely
cured. Consult your doctor if you wish to stop
your treatment with Moxifloxacin before the end
of your course of treatment.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately and treat ment
should be stopped if you experience the side
effects listed below, because they may be lifethreatening:
Rare side effects (may affect up to 1 in 1,000
people)
• Severe, sudden generalised allergic reaction
including very rarely life-threatening shock (for
instance difficulty in breathing, drop of blood
pressure, fast pulse), swelling (including
potentially life-threatening swelling of the
airway).
• Depression (in very rare cases leading to selfharm, such as suicidal thoughts or suicide
attempts);
• Severe diarrhoea containing blood and/or
mucus (antibiotic associated colitis including
pseudomembranous colitis), which in very rare
circumstances, may develop into
complications that are life-threatening.
Very rare side effects (may affect up to 1 in
10,000 people)
• A feeling of self-detachment (not being
yourself), insanity (potentially leading to selfharm, such as suicidal thoughts or suicide
attempts).
• Life-threatening irregular heartbeat, stopping
of heartbeat.
• Fulminant (dangerous) inflammation of the
liver potentially leading to life-threatening liver
failure (including fatal cases);
• Alterations of the skin and mucous
membranes (painful blisters in the mouth or
nose or at the penis or vagina), potentially lifethreatening (Stevens-Johnson-Syndrome,
toxic epidermal necrolysis).
The following side effects have been observed
during treatment with Moxifloxacin.
Common side effects (may affect up to 1 in 10
people)
• Infections caused by resistant bacteria or
fungi, for instance, oral and vaginal
infections caused by Candida;
• Headache, dizziness;
• Change of the heart rhythm (as seen on the
ECG) in patients with low blood potassium
level (see section 2. What you need to know
before you are using Moxifloxacin);
• Nausea, vomiting, stomach and abdominal
ache, diarrhoea;
• Increase of a special liver enzyme in the
blood (transaminases);
• Pain or inflammation at injection site.
Uncommon side effects (may affect up to 1 in
100 people)
• Low red blood cell count, low white blood
cells count, low numbers of special white
blood cells (neutrophils), decrease or
increase of special blood cells necessary for
blood clotting (thrombocytes), increased
specialised white blood cells (eosinophils),
decreased blood clotting;
• Allergic reaction;
• Increased blood lipids (fats);
• Anxiety, restlessness/agitation;
• Tingling sensation (pins and needles) and/or
numbness, changes in taste (in very rare cases
loss of taste), confusion and disorientation,
sleep problems (mainly sleeplessness),
shaking, sensation of dizziness (spinning or
falling over), sleepiness;
• Visual disturbances including double and
blurred vision;
• Change of the heart rhythm (as seen on the
ECG), palpitations, irregular and fast heartbeat,
severe heart rhythm abnormalities, angina
pectoris (chest pain);
• Widening of blood vessels;
• Difficulty in breathing including asthmatic
conditions;
• Decreased appetite and food intake, wind and
constipation, stomach upset (indigestion or
heartburn), inflammation of the stomach,
increase of a special digestive enzyme in the
blood (amylase);
• Impaired liver function (including increase of
a special liver enzyme in the blood (LDH),
increase of bilirubin in the blood, increase of
a special liver enzyme in the blood
(gammaglutamyl-transferase and/or alkaline
phosphatase);
• Itching, rash, skin hives, dry skin;
• Joint pain, muscle pain;
• Dehydration;
• Feeling unwell (predominantly weakness or
tiredness), aches and pains such as back,
chest, pelvic and extremities pains, sweating;
• Inflammation of a vein.
Rare side effects (may affect up to 1 in 1,000
people)
• Increased blood sugar, increased blood uric
acid;
• E m o t i o n a l i n s t a b i l i t y, h a l l u c i n a t i o n
impairment of skin sensation, changes in
smell (including loss of smell), abnormal
dreams, balance disorder and poor
coordination (due to dizziness), convulsions,
disturbed concentration, impaired speech,
partial or total loss of memory, troubles
associated with the nervous system such as
pain, burning, tingling, numbness and/or
weakness in extremities;
• Ringing or noise in the ears, hearing
impairment including deafness (usually
reversible);
• Fainting;
• High blood pressure, low blood pressure;
• Difficulty in swallowing, inflammation of the
mouth, jaundice (yellowing of the whites of
the eyes or skin), inflammation of the liver;
• Pain and swelling of the tendons (tendonitis),
muscle cramp, muscle twitching, muscle
weakness;
• Kidney impairment (including increase in
special kidney laboratory test results like
urea and creatinine), kidney failure;
• Swelling (of the hands, feet, ankles, lips,
mouth, throat).
Very rare side effects (may affect up to 1 in
10,000 people)
• Increased blood clotting, significant decrease
of special white blood cells (agranulocytosis);
• Increase of skin sensitivity;
• Transient loss of vision;
• Abnormal heart rhythms;
• Rupture of tendon, inflammation of joints,
muscle rigidity, worsening of the symptoms
of myasthenia gravis.
The following symptoms have been
observed more frequently in patients treated
intravenously:
Common (may affect up to 1 in 10 users)
• Increase of a special liver enzyme in the
blood (gamma-glutamyl-transferase).
Uncommon (may affect up to 1 in 100 users)
• Abnormally fast heart rhythm;
• Low blood pressure;
• Swelling (of the hands, feet, ankles, lips,
mouth, throat);
• Severe diarrhoea containing blood and/or
mucus (antibiotic associated colitis) which in
very rare circumstances, may develop into
complications that are life-threatening;
• Convulsions;
• Hallucination;
• Kidney impairment (including increase in
special kidney laboratory test results like urea
and creatinine), kidney failure.

antibiotics, which might possibly also occur
during treatment with Moxifloxacin:
Very rare (may affect up to 1 in 10,000 people)
• 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 or
pharmacist immediately to get advice before
receiving the next dose. 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 report side effects directly via
t h e Ye l l o w C a r d S c h e m e a t :
www.mhra.gov.uk/yellowcard
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
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie (http://www.imb.ie)
e-mail: imbpharmacovigilance@imb.ie
5. How to store Moxifloxacin
Since this product will be administered by
medical proffesionals they will be responsible for
the correct storage of the product both before and
during its use, as well as for the correct disposal.
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 on the bottle and
carton after EXP. The expiry date refers to the
last day of the month.
Do not refrigerate or freeze. Keep the bottle in
the outer carton in order to protect from light.
This product is for single use only. Any unused
solution should be discarded.
At cool storage temperatures precipitation may
o c c u r, w h i c h w i l l r e - d i s s o l v e a t r o o m
temperature.
Do not use this medicine if you notice any visible
particulate matter or if the solution is cloudy.
Your doctor or the hospital staff will normally
store Moxifloxacin and they are responsible for
the quality of the product when it has been
opened and if it is not used immediately. They
are also responsible for disposing of any unused
Moxifloxacin correctly.
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 Moxifloxacin contains




The active substance is moxifloxacin. Each
250 ml bottle contains 400 mg moxifloxacin
(as hydrochloride). Each ml contains 1.6 mg
moxifloxacin (as hydrochloride).
The other ingredients are sodium acetatetrihydrate, sulphuric acid (for pHadjustment), sodium sulfate, anhydrous and
water for injections (see section Moxifloxacin
contains sodium).

What Moxifloxacin looks like and contents of
the pack
Moxifloxacin is a clear, yellow solution for
infusion.
Moxifloxacin is packaged in cartons containing
250 ml low-density polyethylene bottles
(KabiPac) with a chlorobutyl or bromobutyl
rubber stopper. Packs contain 1, 10, 20, 25 or 40
bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, UK
WA7 1NT
Manufacturer
Fresenius Kabi Polska Sp. z.o.o
Sienkiewica 25,
99-300 Kutno
Poland
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Country
Austria

Trade Name
Moxifloxacin Kabi 400 mg/250 ml
Infusionslösung
Belgium
Moxifloxacine Fresenius Kabi
400 mg/250 ml oplossing voor
infusie
Bulgaria
Моксифлоксацин Каби
400 mg/250 ml инфузионен
разтвор
Czech
Moxifloxacin Kabi 400 mg/250 ml
Republic
infuzní roztok
Denmark
Moxifloxacin Fresenius Kabi
Germany
Moxifloxacin Kabi 400 mg/250 ml
Infusionslösung
Finland
Moxifloxacin Fresenius Kabi
400 mg/250 ml infuusioneste,
liuos
Hungary
Moxifloxacin Kabi 400 mg/250 ml
oldatos infúzió
Ireland
Moxifloxacin 400 mg/250 ml
solution for infusion
Italy
Moxifloxacina Kabi
Luxembourg Moxifloxacin Kabi 400 mg/250 ml
Infusionslösung
Netherlands Moxifloxacine Fresenius Kabi
400 mg/250ml oplossing voor
infusie
Poland
Moxifloxacin Kabi
Romania
Moxifloxacină Kabi
400 mg/250 ml soluţie
perfuzabilă
Slovakia
Moxifloxacin Kabi 400 mg/250 ml
infúzny roztok
Slovenia
Moksifloksacin Kabi
400 mg/250 ml raztopina za
infundiranje
Spain
Moxifloxacin Fresenius Kabi
400 mg/250 ml, solución para
perfusión
Sweden
Moxifloxacin Fresenius Kabi
400 mg/250 ml, infusionsvätska,
lösning
United
Moxifloxacin 400 mg/250 ml
Kingdom
solution for infusion

This leaflet was last revised Nov 2013
The following side effects have been reported
following treatment with other quinolone
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _
The following information is intended for
medical or healthcare professionals only:

Moxifloxacin should not be co-infused with other
drugs.

Moxifloxacin can be administered via a T-tube
together with the following solutions:
Water for injections, sodium chloride 0.9%,
glucose 5% / 10%, Ringer's solution, compound
sodium lactate solution (Hartmann's solution,
Ringer-lactate solution).

The following solutions are incompatible with
Moxifloxacin:
Sodium chloride 10% and 20% solutions,
Sodium bicarbonate 4.2% and 8.4% solutions.

Label specification number:

01-59-13-xxx

Package leaflet: Information for the user

Moxifloxacin 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 or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Moxifloxacin is and what it is used for
2. What you need to know before you use Moxifloxacin
3. How to use Moxifloxacin
4. Possible side effects
5. How to store Moxifloxacin
6. Contents of the pack and other information
1. What Moxifloxacin is and what it is used for
Moxifloxacin contains the active substance moxifloxacin which belongs to a group of antibiotics
called fluoroquinolones. Moxifloxacin works by killing bacteria that cause infections if they are
caused by bacteria that are susceptible (sensitive) to moxifloxacin.
Moxifloxacin 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
Moxifloxacin is only used to treat these infections when usual antibiotics cannot be used or have
not worked.
2. What you need to know before you are administered Moxifloxacin
Contact your doctor if you are not sure if you belong to a patient group described below.
Do not use Moxifloxacin
• If you are allergic to 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).
• 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 level of potassium or magnesium in the
blood);
• If you have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure),
have a history of abnormal heart rhythms, or you are taking other medicines that result in
abnormal ECG changes (see section Other medicines and Moxifloxacin). This is because
Moxifloxacin can cause changes on the ECG, that is a prolongation of the QT‑interval, that
is a 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.

977

Warnings and precautions
Talk to your doctor before Moxifloxacin is administered to you for the first time. It is important you
know that:
• Moxifloxacin 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 Moxifloxacin is administered to you (also see sections Do not use
Moxifloxacin and Other medicines and Moxifloxacin).
• If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your
doctor before Moxifloxacin is administered to you.
• If you have or have ever had any mental health problems, consult your doctor before
Moxifloxacin is administered to you.
• If you suffer from myasthenia gravis (rare disease leading to muscle weakness) because using
Moxifloxacin 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 Moxifloxacin is suitable
for you.
• Moxifloxacin should be given intravenously (in the vein) only, and should not be administered
into an artery.

• 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.
• 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 Moxifloxacin.
• There is limited experience on use of sequential intravenous/oral Moxifloxacin for the treatment
of infection of the lungs (pneumonia) acquired outside the hospital.
• The efficacy of Moxifloxacin 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.

Moxifloxacin is for intravenous (into a vein) use. Your doctor should ensure that the infusion is
given at a constant flow over 60 minutes.

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
Moxifloxacin).

The duration of treatment depends upon the type of infection, and how well you respond to
treatment but the recommended durations of use are:


Treatment with Moxifloxacin should be stopped immediately in the following cases:
• There is a rare chance that you may experience a severe, sudden allergic reaction (an
anaphylactic reaction/shock) even with the first dose. Tell your doctor if you experience
symptoms that may include tightness in the chest, feeling dizzy, feeling sick or faint, or
experience dizziness on standing.
• Moxifloxacin 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). 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.
• Quinolone antibiotics, including Moxifloxacin, may cause convulsions. If this happens, treatment
with Moxifloxacin has to be discontinued.
• You may experience mental health problems even when taking quinolone antibiotics, including
Moxifloxacin, 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). If you develop such reactions, treatment with Moxifloxacin has to be
discontinued.
• Moxifloxacin may cause pain and inflammation of your tendons, even within 48 hours of
starting treatment and up to several months after discontinuing Moxifloxacin 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 Moxifloxacin, 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 Do not
use Moxifloxacin and 4. Possible side effects).

When receiving treatment with Moxifloxacin be aware of the following
If you are using Moxifloxacin together with other medicines that affect your heart there is an
increased risk for altering your heart rhythm. Therefore, do not use Moxifloxacin together with the
following medicines:
• Medicines that belong to the group of anti-arrhythmics (such as quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• Antipsychotics (such as phenothiazines, pimozide, sertindole, haloperidol, sultopride);
• Tricyclic antidepressants, some antimicrobials (such as saquinavir, sparfloxacin, intravenous
erythromycin, pentamidine, antimalarials particularly halofantrine);
• Some antihistamines (such as terfenadine, astemizole, mizolastine);
• Other medicines such as cisapride, intravenous vincamine, bepridil and diphemanil.

During treatment with Moxifloxacin you should inform your doctor immediately:
• If you experience palpitations or irregular heart beat during the period of treatment. He/she
may wish to perform an ECG to measure your heart rhythm.
• If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal
reactions (see section 4. Possible side effects) contact your doctor immediately before you
continue the treatment.
• 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
Moxifloxacin.
• You may develop diarrhoea whilst taking, or after taking, antibiotics including Moxifloxacin. If
this becomes severe or persistent or you notice that your stool contains blood or mucus you
should stop using Moxifloxacin immediately and consult your doctor. In this situation, you should
not take medicines that stop or slow down bowel movement.
• If your eyesight becomes impaired or if you have any other eye disturbances whilst using
Moxifloxacin, consult an eye specialist immediately (see sections Driving and using machines
and 4. Possible side effects).

When using Moxifloxacin you should be aware that:
• The risk of heart problems may increase with increase of the dose and the speed of the
perfusion into your vein.

Pregnancy, breast-feeding and fertility
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.

Other medicines and Moxifloxacin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

You must tell your doctor:
• if you are taking other medicines that can lower your blood potassium levels (for instance
some diuretics, some laxatives and enemas [large doses] or corticosteroids [anti-inflammatory
medicines], amphotericin B);
• if you are taking other medicines that can cause a slow heart rate because these can also
increase the risk of serious heart rhythm disturbances while using Moxifloxacin;
• if you are currently taking oral anti-coagulants (for instance warfarin); it may be necessary for
your doctor to monitor your blood clotting times.
Moxifloxacin with food, drink and alcohol
The effect of Moxifloxacin is not influenced by food, including dietary products.
You should not drink alcohol while using Moxifloxacin.

Do not use Moxifloxacin if you are pregnant or breast-feeding.
Animal studies do not indicate that your fertility will be impaired by using this medicine.
Driving and using machines
Moxifloxacin may make you feel dizzy or light-headed, you may experience a sudden, brief
(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.
Moxifloxacin contains sodium
This medicinal product contains 1206 mg (approximately 54 mmol) sodium per dose. If you are on
a controlled-salt diet, please inform your doctor immediately.
3. How to use Moxifloxacin
Moxifloxacin will always be given to you by a doctor or healthcare professional.

No adjustment of the dose is required in elderly patients, patients with a low bodyweight or in
patients with kidney problems.
Duration of treatment
Your doctor will decide on the duration of your treatment with Moxifloxacin. In some cases your
doctor may start your treatment with Moxifloxacin solution for infusion and then continue your
treatment with respective tablets.

Indication
Infection of the lungs (pneumonia) acquired outside the hospital

Duration of treatment
7 - 14 days

Most patients with pneumonia were switched to oral treatment with
respective tablets within 4 days.
Infections of the skin and soft tissue
7 - 21 days
For patients with complicated skin and skin structure infections
the average duration of intravenous treatment was approximately
6 days and the average overall duration of treatment (infusion
followed by respective 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.
If you receive more Moxifloxacin than you should
If you are concerned that you may have received more Moxifloxacin than prescribed, contact your
doctor immediately.
If you miss a dose of Moxifloxacin
If you are concerned that you may have missed a dose of Moxifloxacin, contact your doctor
immediately.
If you stop using Moxifloxacin
If your treatment with this medicine is stopped too soon your infection may not be completely
cured. Consult your doctor if you wish to stop your treatment with Moxifloxacin before the end of
your course of treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and treatment should be stopped if you experience the side
effects listed below, because they may be life-threatening:
Rare side effects (may affect up to 1 in 1,000 people)
• Severe, sudden generalised allergic reaction including very rarely life-threatening shock (for
instance difficulty in breathing, drop of blood pressure, fast pulse), swelling (including potentially
life-threatening swelling of the airway).
• Depression (in very rare cases leading to self-harm, such as suicidal thoughts or suicide
attempts).
• Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis
including pseudomembranous colitis), which in very rare circumstances, may develop into
complications that are life-threatening.

The recommended dose for adults is 1 bag once daily.

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Very rare side effects (may affect up to 1 in 10,000 people)
• A feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm, such
as suicidal thoughts or suicide attempts).
• Life-threatening irregular heartbeat, stopping of heartbeat.
• Fulminant (dangerous) inflammation of the liver potentially leading to life-threatening liver failure
(including fatal cases);
• Alterations of the skin and mucous membranes (painful blisters in the mouth or nose or at
the penis or vagina), potentially life-threatening (Stevens-Johnson-Syndrome, toxic epidermal
necrolysis).
The following side effects have been observed during treatment with Moxifloxacin.
Common side effects (may affect up to 1 in 10 people)
• Infections caused by resistant bacteria or fungi, for instance, oral and vaginal infections caused
by Candida;
• Headache, dizziness;
• Change of the heart rhythm (as seen on the ECG) in patients with low blood potassium level (see
section 2. What you need to know before you are using Moxifloxacin);
• Nausea, vomiting, stomach and abdominal ache, diarrhoea;
• Increase of a special liver enzyme in the blood (transaminases);
• Pain or inflammation at injection site.
Uncommon side effects (may affect up to 1 in 100 people)
• Low red blood cell count, low white blood cells count, low numbers of special white blood
cells (neutrophils), decrease or increase of special blood cells necessary for blood clotting
(thrombocytes), increased specialised white blood cells (eosinophils), decreased blood clotting;
• Allergic reaction;
• Increased blood lipids (fats);
• Anxiety, restlessness/agitation;
• Tingling sensation (pins and needles) and/or numbness, changes in taste (in very rare cases loss
of taste), confusion and disorientation, sleep problems (mainly sleeplessness), shaking,
sensation of dizziness (spinning or falling over), sleepiness;
• Visual disturbances including double and blurred vision;
• Change of the heart rhythm (as seen on the ECG), palpitations, irregular and fast heartbeat,
severe heart rhythm abnormalities, angina pectoris (chest pain);
• Widening of blood vessels;
• Difficulty in breathing including asthmatic conditions;
• Decreased appetite and food intake, wind and constipation, stomach upset (indigestion or
heartburn), inflammation of the stomach, increase of a special digestive enzyme in the blood
(amylase);
• Impaired liver function (including increase of a special liver enzyme in the blood (LDH),
increase of bilirubin in the blood, increase of a special liver enzyme in the blood
(gammaglutamyl-transferase and/or alkaline phosphatase);
• Itching, rash, skin hives, dry skin;
• Joint pain, muscle pain;
• Dehydration;
• Feeling unwell (predominantly weakness or tiredness), aches and pains such as back, chest,
pelvic and extremities pains, sweating;
• Inflammation of a vein.
Rare side effects (may affect up to 1 in 1,000 people)
• Increased blood sugar, increased blood uric acid;
• Emotional instability, hallucination;
• Impairment of skin sensation, changes in smell (including loss of smell), abnormal dreams,
balance disorder and poor coordination (due to dizziness), convulsions, disturbed concentration,
impaired speech, partial or total loss of memory, troubles associated with the nervous system
such as pain, burning, tingling, numbness and/or weakness in extremities;
• Ringing or noise in the ears, hearing impairment including deafness (usually reversible);
• Fainting;
• High blood pressure, low blood pressure;
• Difficulty in swallowing, inflammation of the mouth;
• Jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver;
• Pain and swelling of the tendons (tendonitis), muscle cramp, muscle twitching, muscle weakness;
• Kidney impairment (including increase in special kidney laboratory test results like urea and
creatinine), kidney failure;
• Swelling (of the hands, feet, ankles, lips, mouth, throat).

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Very rare side effects (may affect up to 1 in 10,000 people)
• Increased blood clotting, significant decrease of special white blood cells (agranulocytosis);
• Increase of skin sensitivity;
• Transient loss of vision;
• Abnormal heart rhythms;
• Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of
myasthenia gravis.

Do not refrigerate or freeze.
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.

The following symptoms have been observed more frequently in patients treated
intravenously:

Your doctor or the hospital staff will normally store Moxifloxacin and they are responsible for the
quality of the product when it has been opened and if it is not used immediately. They are also
responsible for disposing of any unused Moxifloxacin correctly.

Common (may affect up to 1 in 10 users)
• Increase of a special liver enzyme in the blood (gamma-glutamyl-transferase).

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.

Uncommon (may affect up to 1 in 100 users)
• Abnormally fast heart rhythm;
• Low blood pressure;
• Swelling (of the hands, feet, ankles, lips, mouth, throat);
• Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis) which in
very rare circumstances, may develop into complications that are life-threatening;
• Convulsions;
• Hallucination;
• Kidney impairment (including increase in special kidney laboratory test results like urea and
creatinine), kidney failure.
The following side effects have been reported following treatment with other quinolone
antibiotics, which might possibly also occur during treatment with Moxifloxacin:
Very rare (may affect up to 1 in 10,000 people)
• 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.

6. Contents of the pack and other information
What Moxifloxacin contains





The active substance is moxifloxacin. Each 250 ml bag contains 400 mg moxifloxacin (as
hydrochloride). Each ml contains 1.6 mg moxifloxacin (as hydrochloride).
The other ingredients are sodium acetate-trihydrate, sulfuric acid (for pH‑adjustment), sodium
sulfate, anhydrous and water for injections (see section Moxifloxacin contains sodium).

What Moxifloxacin looks like and contents of the pack

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
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie (http://www.imb.ie) e-mail: imbpharmacovigilance@imb.ie

Country
Austria
Belgium
Bulgaria
Croatia
Czech Republic
Denmark
Germany
Finland
Hungary
Ireland
Italy
Luxembourg
Netherlands

Moxifloxacin is a clear, yellow solution for infusion.
Moxifloxacin is packaged in cartons containing 250 ml Polyolefine bags (freeflex) with an
administration port (infusion port) and addition port (injection port) consisting of a polypropylene
housing and an aluminium over pouch. Packs contain 1, 10, 20, 25 or 40 bags.
Not all pack sizes may be marketed.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist immediately to get advice before
receiving the next dose. 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 report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, UK
WA7 1NT
Manufacturer
Fresenius Kabi Norge AS
Svinesundsveien 80,
1789 Berg Østfold
Norway

Poland
Romania
Slovakia
Slovenia
Spain
Sweden
United
Kingdom

Trade Name
Moxifloxacin Kabi 400 mg Infusionslösung
Moxifloxacine Fresenius Kabi 400mg/250ml oplossing voor
infusie
Моксифлоксацин Каби 400 mg/250 ml инфузионен разтвор
Moxifloxacin Kabi 400 mg/250 ml otopina za infuziju
Moxifloxacin Kabi 400 mg/250 ml infuzní roztok
Moxifloxacin Fresenius Kabi
Moxifloxacin Kabi 400 mg Infusionslösung
Moxifloxacin Fresenius Kabi 400 mg/250 ml infuusioneste,
liuos
Moxifloxacin Kabi 400 mg/250 ml oldatos infúzió
Moxifloxacin 400 mg/250 ml solution for infusion
Moxifloxacina Kabi
Moxifloxacin Kabi 400 mg/250 ml solution pour perfusion
Moxifloxacine Fresenius Kabi 400mg/250ml oplossing voor
infusie
Moxifloxacin Kabi
Moxifloxacina Kabi 400 mg/250 ml soluţie perfuzabilă
Moxifloxacin Kabi 400 mg/250 ml infúzny roztok
Moksifloksacin Kabi 400 mg/250 ml raztopina za
infundiranje
Moxifloxacino Kabi 400 mg/250 ml solución para perfusión
Moxifloxacin Fresenius Kabi 400 mg/250 ml,
infusionsvätska, lösning
Moxifloxacin 400 mg/250 ml solution for infusion

This leaflet was last revised Nov 2013.
-----------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Moxifloxacin can be administered via a T-tube together with the following solutions:
Water for injections, sodium chloride 0.9%, glucose 5% / 10%, Ringer’s solution, compound
sodium lactate solution (Hartmann’s solution, Ringer-lactate solution).
Moxifloxacin should not be co‑infused with other drugs.
The following solutions are incompatible with Moxifloxacin:
Sodium chloride 10% and 20% solutions,
Sodium bicarbonate 4.2% and 8.4% solutions.

5. How to store Moxifloxacin
Since this product will be administered by medical professionals they will be responsible for the
correct storage of the product both before and during its use, as well as for the correct disposal.
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 on the bag and carton
after EXP. The expiry date refers to the last day of the month.

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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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