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MOXIFLOXACIN 400MG/250ML SOLUTION FOR INFUSION

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE

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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, 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
The name of your medicine is Moxifloxacin 400 mg / 250 ml
solution for infusion.
In the rest of this leaflet this medicine will be called Moxifloxacin.
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
The active substance is moxifloxacin which belongs to a group of
antibiotics called fluoroquinolones. This medicine works by killing
bacteria that cause infections, provided that these bacteria are
sensitive to the active substance.
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 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 2.
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 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 medicines and Moxifloxacin). This
is because Moxifloxacin 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.
If you are not sure if any of the above applies to you, talk to your
doctor, nurse or pharmacist before using Moxifloxacin.
Warnings and precautions
Before using Moxifloxacin for the first time
Talk to your doctor, pharmacist or nurse before using Moxifloxacin.
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 using Moxifloxacin.
If you suffer from epilepsy or you are prone to seizures, tell
your doctor before using Moxifloxacin.
If you have or have ever had any mental health problems,
consult your doctor before using Moxifloxacin.
If you suffer from myasthenia gravis 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-6phosphate dehydrogenase deficiency (a rare hereditary
disease), inform your doctor, who will decide 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 not sure if any of the above applies to you, talk to your
doctor or nurse, before having Moxifloxacin.
When using Moxifloxacin
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. Therefore
the recommended dose must not be exceeded.
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 Moxifloxacin solution for infusion has to be
discontinued immediately.
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 (symptoms of
a reduced liver function or a rapidly progressive and severe
liver inflammation).
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 before you continue the
treatment.
Quinolone antibiotics, including Moxifloxacin, may cause
convulsions. If this happens, treatment with Moxifloxacin 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 Moxifloxacin.
You may experience mental health problems 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-endangering behaviour such
as suicide attempts (see section 4. Possible side effects). If
you develop such reactions discontinue treatment with
Moxifloxacin and please inform your doctor.
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.
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 must 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 2. Do not use Moxifloxacin and 4.
Possible side effects).
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 you have any other eye
disturbances whilst using Moxifloxacin, consult an eye
specialist immediately (see sections 2. Driving and using
machines and 4. Possible side 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 Moxifloxacin.
There is limited experience on use of sequential intravenous
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 or have recently
taken any other medicines besides Moxifloxacin, including
medicines obtained without a prescription.
For Moxifloxacin, be aware of the following:
If you are using Moxifloxacin and other medicines that affect
your heart there is an increased risk for altering your heart
rhythm. Therefore, do not take Moxifloxacin together with the
following medicines: medicines that belong to the group of antiarrhythmics (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. diuretics, laxatives
or enemas [large doses] or corticosteroids [anti-inlammatory
drugs], amphotericin B), or 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 (e.g. warfarin), it
may be necessary for your doctor to monitor your blood
clotting times.
Moxifloxacin with food and drink
The effect of Moxifloxacin is not influenced by food including dairy
products.
Pregnancy, breast-feeding and fertility
Do not use Moxifloxacin if you are pregnant or breast-feeding.
If you 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
Moxifloxacin may make you feel dizzy or light-headed, you may
experience a sudden, temporary 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
Moxifloxacin contains 356mg (approximately 16mmol) sodium per
vial. 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 usual dose for adults is 1 bottle, once daily. Moxifloxacin 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.
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 Moxifloxacin 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 Moxifloxacin 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.
The recommended dose and duration of treatment should not be
exceeded.
If you use more Moxifloxacin than you should
If you are concerned that you may have received too much
Moxifloxacin, contact your doctor immediately.
If you forget to use Moxifloxacin
If you are concerned that you may have missed a dose of
Moxifloxacin, contact your doctor immediately.
If you stop using Moxifloxacin
It is important that you complete the course of treatment, even if
you begin to feel better after a few days. If you stop taking / 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.
Consult your doctor if you wish to stop the treatment with
Moxifloxacin solution for infusion or Moxifloxacin 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The following side effects have been observed during treatment
with Moxifloxacin.
Serious side effects
If you experience the following side effects you may need urgent
medical treatment. You must tell your doctor or go to the nearest
hospital immediately if you notice:
Severe, sudden generalised allergic reaction including very
rarely life-threatening shock (such as difficulty in breathing,
drop of blood pressure, fast pulse), swelling (including
potentially life-threatening swelling of the airway). Rare side
effect: affects 1 to 10 users in 10,000.
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. Rare side effect: affects
1 to 10 users in 10,000.
A feeling of self-detachment (not being yourself), insanity
(potentially leading to self-harm, such as suicidal thoughts, or
suicide attempts).
Jaundice, and feeling unwell, which may be a sign of a
fulminant inflammation of the liver potentially leading to lifethreatening liver failure (including fatal cases). Very rare side
effect: affects 1 user in 10,000.
Alterations of the skin and mucous membranes (painful blisters
in the mouth / nose or at the level of penis / vagina), potentially
life-threatening
(Stevens-Johnson
Syndrome,
toxic
epidermal necrolysis). Very rare side effect: affects 1 user in
10,000.

Common (affects 1 to 10 users in 100)
Infections caused by resistant bacteria or fungi; for instance,
oral and vaginal infections caused by Candida.
Headache, dizziness.
Change of the heart rhythm (ECG) in patients with low blood
potassium level.
Nausea, vomiting, stomach and abdominal ache, diarrhoea.
Increase of a special liver enzyme in the blood
(transaminases).
Pain or inflammation at injection site.
Uncommon (affects 1 to 10 users in 1,000)
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,
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
(predominantly
sleeplessness), shaking, sensation of dizziness (spinning or
falling over), sleepiness.
Visual disturbances including double and blurred vision.
Change of the heart rhythm (ECG), palpitations, irregular and
fast heart beat, severe heart rhythm abnormalities, angina
pectoris (chest pain caused by lack of blood to the heart
muscle).
Widening of blood vessels.
Difficulty in breathing including asthmatic conditions.
Loss of appetite, wind and constipation, stomach upset
(indigestion / 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 at the injection site.
Rare (affects 1 to 10 users in 10,000)
Increased blood sugar, increased blood uric acid.
Emotional instability, depression (in very rare cases leading to
self-harm, such as suicidal ideations / thoughts, or suicide
attempts), 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.
Ringing / noise in the ears, hearing impairment, including
deafness (usually reversible)
fainting.
High blood pressure, low blood pressure.
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).
Difficulty in swallowing, inflammation of the mouth,

Very rare (affects less than 1 user in 10,000)
Increased blood clotting, significant decrease of special white
blood cells (agranulocytosis).
Increase in skin sensitivity.
Temporary loss of vision.
Abnormal heart rhythms, life-threatening irregular heart beat,
stopping of heart beat.
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 (affects 1 to 10 users in 100)
Increase of a special liver enzyme in the blood (gammaglutamyl-transferase).
Uncommon (affects 1 to 10 users in 1,000)
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.
Furthermore, there have been very rare cases of the following
side effects reported after treatment with other quinolone
antibiotics, which might possibly also occur during treatment with
Moxifloxacin: 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, troubles
associated with the nervous system such as pain, burning,
tingling, numbness and/or weakness in extremities.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
Please tell your doctor or pharmacist immediately to get advice
before receiving / taking the next dose.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via via Yellow Card Scheme,
Website: 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 Moxifloxacin
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 that month.
Do not store below 15oC.
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 Moxifloxacin contains
The active substance is moxifloxacin. Each bottle contains
400 mg moxifloxacin (as hydrochloride). 1 ml contains 1.6 mg
moxifloxacin (as hydrochloride).
The other ingredients are sodium chloride, glycine, disodium
edetate, hydrochloric acid (for pH-adjustment) and water for
injections.
What Moxifloxacin looks like and contents of the pack
Moxifloxacin is a clear, yellow solution for infusion.
Moxifloxacin is packaged in carton boxes containing 250 ml
polypropylene bottles. Packs of 1, 5, 10 and 12 bottles.
Not all pack sizes may be marketed.
Medicinal product subject to medical prescription.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd.,
Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia,
Cyprus.
Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia,
14568 Krioneri, Athens, Greece.
This medicinal product is authorised in the Member States of
the EEA under the following names:
United Kingdom: Moxifloxacin 400mg/250ml Solution for Infusion
Germany: Moxifloxacin Noridem 400mg/250ml Infusionslösung
Austria: Moxifloxacin Noridem 400mg Infusionslösung
Spain: Moxifloxacino KERN PHARMA 400mg/250ml solución para
perfusion
Cyprus: Moxifloxacin 400mg/250ml Διάλυμα για έγχυση
Poland: Moxifloxacin Noridem
Greece: MOXIFALON 400mg/250ml διάλυμα για έγχυση
This leaflet was last revised in 03/2014
---------------------------------------------------------------------------------------The following information is intended for healthcare professionals
only:
Moxifloxacin 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).
Moxifloxacin should not be co-infused with other drugs.
The following solutions were incompatible with Moxifloxacin:
Sodium chloride 10% and 20% solutions,
Sodium bicarbonate 4.2% and 8.4% solutions

If this leaflet is difficult to see or read, please
contact the following
address for help:
Fannin Limited, Fannin House, South County
Business Park,
Leopardstown, Dublin 18, Ireland Tel +353-12907000.

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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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